{"id":40124,"date":"2021-10-08T12:08:32","date_gmt":"2021-10-08T19:08:32","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=40124"},"modified":"2026-04-02T14:27:35","modified_gmt":"2026-04-02T21:27:35","slug":"consent","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/","title":{"rendered":"Consent"},"content":{"rendered":"<div class=\"box-outer\">\n<div class=\"box\">\n<div style=\"padding: none; border-style: none solid solid solid; border-color: #bdc3c7; border-width: 1px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<p><a name=\"quick\"><\/a><\/p>\n<h2 style=\"left: 50%; top: 0; padding: 10px 50px; background-color: #4b2e83; color: #fff; font-size: 14px; text-align: center;\">QUICK GUIDE<\/h2>\n<div style=\"padding: 5px; font-size: 13px;\">\n<p>While all stakeholders are encouraged to read and become familiar with this entire guidance, the following resources provide a summary of the most vital aspects of consent:<\/p>\n<ul>\n<li><a href=\"#4\"><strong>Consent Overview<\/strong><\/a> [Five high-level consent considerations which must be a part of a meaningful informed consent process and form]<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/consent-tip-sheets\/\"><strong>TIPSHEET Consent<\/strong><\/a> [Researcher summary of the main points in this guidance]<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-consent-elements-externally-reviewed-studies\/\"><strong>GUIDANCE Consent Elements for Externally Reviewed Studies<\/strong><\/a> [Consent requirements for studies reviewed by a non- 91探花IRB.]<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/templates\/\"><strong>Consent Templates<\/strong><\/a> [Webpage with links to all current HSD consent templates.]<\/li>\n<li>Guidance on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\"><strong>Designing the Consent Process<\/strong><\/a> [Use with or without a  91探花template to build the consent process and form.]<\/li>\n<\/ul>\n<\/div>\n<div style=\"padding: 5px; font-size: 13px;\">Specific information about consent for studies being reviewed by a non- 91探花IRB can be found in the webpages and documents related to <a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/general-information\/\"><strong>External IRB<\/strong><\/a>.<\/div>\n<div style=\"padding: 5px; font-size: 13px;\">Many other topics that intersect with consent are referenced within this guidance and linked in <strong><a href=\"#12\">RELATED MATERIALS<\/a><\/strong>.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"table-of-contents\">\n<h3 id=\"toc\">GUIDANCE Contents<\/h3>\n<ul class=\"list-unstyled\">\n<li style=\"list-style-type: none;\">\n<ul class=\"list-unstyled\">\n<li><a href=\"#1\">Purpose and Applicability<\/a><\/li>\n<li><a href=\"#2\">Definitions<\/a><\/li>\n<li><a href=\"#3\">Regulatory Oversight<\/a><\/li>\n<li><a href=\"#e\">Exempt Research<\/a><\/li>\n<li><a href=\"#4\">Consent Overview<\/a><\/li>\n<li><a href=\"#5\">The Key Information Requirement<\/a><\/li>\n<li><a href=\"#r\">Identifying and Describing Reasonably Foreseeable Risks in Research<\/a><\/li>\n<li><a href=\"#6\">Protected and Vulnerable Populations<\/a>\n<ul>\n<li><a href=\"#6a\">Undue influence and coercion<\/a><\/li>\n<li><a href=\"#6e\">Assent<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#7\">Diminished or Fluctuating Consent Capacity and Use of a Legally Authorized Representative (LAR)<\/a><\/li>\n<li><a href=\"#8\">Participants with Comprehension Barriers (e.g., language, literacy, visual impairment) or Who Cannot Write or Speak<\/a>\n<ul>\n<li><a href=\"#8a\">Anticipated involvement of participants with non-English language preference<\/a>\n<ul>\n<li><a href=\"#8a1\">Interpretation<\/a><\/li>\n<li><a href=\"#8a2\">Translation<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#8b\">Unanticipated involvement of participants with non-English language preference<\/a>\n<ul>\n<li><a href=\"#8b1\">Short form consent process<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#8c\">Participants with low literacy<\/a><\/li>\n<li><a href=\"#8d\">Participants with visual impairments<\/a><\/li>\n<li><a href=\"#8e\">Participants who cannot write a signature on a consent form<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#9\">Electronic Consent<\/a><\/li>\n<li><a href=\"#10\">Documentation of Consent<\/a>\n<ul>\n<li><a href=\"#10a\">Required signatories<\/a><\/li>\n<li><a href=\"#10b\">Verification of identity<\/a><\/li>\n<li><a href=\"#10c\">Signature format<\/a><\/li>\n<li><a href=\"#10d\">Approvable methods for obtaining handwritten signatures<\/a><\/li>\n<li><a href=\"#10e\">Approvable methods for obtaining electronic signatures<\/a><\/li>\n<li><a href=\"#10f\">Approval watermark<\/a><\/li>\n<li><a href=\"#10g\">Records retention and access<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#11\">Reconsent and Ongoing Participant Communication<\/a><\/li>\n<li><a href=\"#rcw\">Washington State Law and Consent<\/a>\n<ul>\n<li><a href=\"#audio\">Recording Private Communication<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#12\">Related Materials<\/a><\/li>\n<li><a href=\"#13\">References<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul class=\"list-unstyled\">\n<li><a href=\"#14\">Version Table<\/a><\/li>\n<\/ul>\n<\/div>\n<h2 id=\"1\">Purpose and Applicability<\/h2>\n<p>This guidance provides researchers, the Human Subjects Division (HSD), and the  91探花Institutional Review Boards (IRBs) with an overview of the requirements and best practices for obtaining regulatorily compliant and meaningful consent, parental permission, and assent for participation in research. This information applies to:<\/p>\n<ul>\n<li>All research reviewed by the  91探花IRB, including non- 91探花institutions and sites for which the  91探花IRB is providing review, unless otherwise indicated.<\/li>\n<li> 91探花research reviewed by an external (non-UW) IRB.<\/li>\n<\/ul>\n<p>The following specialized consent-related topics are covered elsewhere:<\/p>\n<ul>\n<li> 91探花research determined to be exempt or reviewed by the Limited IRB process. Details can be found in the guidance on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/exempt\/#lirb\">Exempt Research<\/a>.<\/li>\n<li>Exception from Informed Consent (<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/supplement-exception-from-informed-consent-for-emergency-research-efic\/\">EFIC supplement<\/a>), which may be appropriate when the time frame between recruiting and study procedures is too short for obtaining consent (e.g., emergency medicine studies).<\/li>\n<li>Emergency or Compassionate Use of investigational drugs or devices for clinical care (not research) (<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/specu\/\">Single Patient Emergency or Compassionate Use<\/a>).<\/li>\n<li>Clinical use of <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/\">Humanitarian Use Devices<\/a>.<\/li>\n<\/ul>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"2\">Definitions<\/h2>\n<p><strong>Informed consent for research<\/strong> must be <a href=\"https:\/\/www.washington.edu\/research\/glossary\/legally-effective-research-consent\/\">legally effective<\/a> and obtained before the participant can participate in any study-related activities. It should include an <em>active<\/em> process of sharing information between the researcher and potential participant and an <em>affirmative agreement<\/em> by the participant that they want to participate. The concept of &#8220;implied&#8221; or &#8220;passive&#8221; consent (e.g., parental permission is assumed unless the parent &#8220;opts out&#8221; of their child&#8217;s participation in the research) does not meet the requirements for informed consent for research. Informed consent serves to:<\/p>\n<ol>\n<li>provide sufficient details about the study so prospective participants can make an informed decision about whether to participate;<\/li>\n<li>facilitate understanding of what has been disclosed; and<\/li>\n<li>promote voluntariness about whether to participate.<\/li>\n<\/ol>\n<p><strong>Consent method<\/strong>. The method by which consent is obtained depends on the specifics of the study and the regulations that govern the research. When <a href=\"#10\">documentation of consent<\/a> can be waived, researchers have greater flexibility in the ways in which they can design the consent process. For example, it may be appropriate to conduct an oral consent process without providing the participants with printed consent materials if the study is a low risk, one-time interview with adults. If participants will participate in the study remotely (e.g., low risk computer surveys) then providing the participants with an electronic <a href=\"https:\/\/www.washington.edu\/research\/glossary\/information-statement\/\">information statement<\/a> would be appropriate. Regardless of the method used (e.g., oral, electronic, in-person), consent processes must include all the applicable regulatory requirements (<a href=\"#3\">Regulatory Oversight<\/a>) unless the IRB determines any requirements can be waived.<\/p>\n<p><strong>Assent<\/strong> is obtained from participants who are unable to provide legally-effective informed consent on their own behalf because they are minors or have diminished decision-making capacity. Participants who have the cognitive capability may provide their assent to participate and a parent\/guardian or legally-authorized representative (LAR) may provide consent on behalf of the participant. Alternatively, assent, LAR consent, and\/or parental permission may be waived by the IRB. Failure to object should not be equated with an active willingness to participate. Review the section on <a href=\"#6e\">Assent<\/a> for more information.<\/p>\n<p><strong>Participant<\/strong>. Unless otherwise indicated, in this guidance the term &#8220;participant&#8221; refers to: the participant, the parent(s) or guardian of a minor participant, and the LAR for a decisionally-impaired adult participant.<\/p>\n<p><strong>Recruitment<\/strong>. Advertisements, announcements, social media (e.g., Facebook, Twitter) postings, and other recruitment processes and materials are generally considered to be part of the consent process.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"3\">Regulatory Oversight<\/h2>\n<h3 id=\"3a\">Which regulations apply?<\/h3>\n<p>Consent requirements may vary depending on the participant population, federal regulations, state laws, international laws, and institutional polices that apply to the research.<\/p>\n<h3 id=\"3b\">Federal agency consent requirements<\/h3>\n<p>It is <strong>HSD policy<\/strong> to voluntarily apply the <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/index.html\">Common Rule<\/a> (45 CFR 46) consent regulations to all research reviewed by the  91探花IRB except as described in the <strong>HSD Flexibility Policy<\/strong> (<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-authority-and-responsibilities-of-hsd-and-uw-irb\/\">GUIDANCE Authority and Responsibilities of HSD and  91探花IRB<\/a>), in addition to other applicable requirements. The guidance, <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/\">Designing the Consent Process<\/a> provides information about the general requirements and elements of consent as well as the criteria for waiving elements and documentation of consent for the Common Rule, FDA, and other federal regulatory agencies. That guidance also lists the consent requirements for federally-designated protected populations (i.e., pregnant women and neonates, <a href=\"https:\/\/www.washington.edu\/research\/glossary\/prisoner\/\">prisoners<\/a>, children).<\/p>\n<h3 id=\"3c\">State or other local law<\/h3>\n<p>State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). Refer to the guidance on <a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-human-subjects-regulations-2\/\">Human Subjects Regulations<\/a>, <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/mandatory-reporting\/\">Mandatory State Reporting<\/a>, and the sections in this guidance on consent using a <a href=\"#7\">legally authorized representative<\/a> and the <a href=\"#audio\">Washington State law on audio recording<\/a> for details. Researchers are responsible for identifying applicable state or other local laws when the research is conducted outside of Washington State, including internationally (<a href=\"https:\/\/www.hhs.gov\/ohrp\/international\/index.html\" target=\"_blank\" rel=\"noopener\">OHRP webpage for international research<\/a>).<\/p>\n<h3 id=\"3d\">HSD\/ 91探花IRB policy<\/h3>\n<p>HSD\/ 91探花IRB policies related to consent can be found in this guidance, the guidance on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/\">Designing the Consent Process<\/a>, and the worksheet <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-consent\/\">Consent Requirements and Waivers<\/a>.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"e\">Exempt Research<\/h2>\n<p>HSD does not apply consent regulations to research that is determined to be exempt from IRB review. Nor does HSD review and approve consent plans and consent materials for exempt research. Researchers are still responsible for protecting the rights and the welfare of participants in their research and for providing participants with information about the research prior to their agreement to participate. Review the section on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/exempt\/#5\">Information for participants<\/a> in the guidance on Exempt Research for full details.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"4\">Consent Overview<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> HSD has identified five high-level consent considerations which must be a part of creating a meaningful informed consent process and form. These considerations were developed using the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/ethical-principles\/belmont\">Belmont Ethical Principles<\/a>, the Common Rule general requirements for consent, guidance from federal agencies, and <a href=\"#13\">current academic literature<\/a>.<\/div>\n<\/div>\n<\/div>\n<div style=\"background-color: #4b2e83; color: white; padding: 20px; border-bottom: 5px solid #d1d1d1;\"><strong>CONSIDERATION 1: The Purpose of Consent<\/strong><br \/>\nThe primary purpose of the consent process is to help prospective participants make voluntary informed decisions about whether to participate in research. Consent processes also promote public trust in, and the professional integrity of, the research enterprise and researchers.<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">More on The Purpose of Consent<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>An effective consent process provides the information that a <em>reasonable person<\/em> would want to have, in a <em>transparent way<\/em>, so that the prospective participants are in <em>control<\/em> of their decision to provide authorization (or not) to participate, based on whether their own <em>values and opinions<\/em> align with those of the research, and considering the <em>risks and benefits<\/em> from their individual perspectives.<\/p>\n<p>Most research generates knowledge to promote a common good. It is often funded by public sources and is increasingly integrated into health care delivery systems. In addition to the value of consent to the individual, there is a social value to establishing effective and ethical consent processes and norms to ensure accountability of the research enterprise.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<div id=\"c2\" style=\"background-color: #4b2e83; color: white; padding: 20px; border-bottom: 5px solid #d1d1d1;\"><strong>CONSIDERATION 2: Facilitating Informed Decision-Making<\/strong><br \/>\nResearch consent must be designed from the perspective of the participant population to ensure informed decision-making.<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">More on Facilitating Informed Decision-Making<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Information provided during consent should emphasize the <a href=\"#5\">Key Information<\/a> that is most likely to assist the particular participant population with making a decision about whether to participate in research. This means that the consent process and\/or form does not necessarily need to include a detailed description of every procedure the enrolled participant would undergo. Rather, it should emphasize the information that will be most influential for enrollment decisions. Participants can be provided with tables or supplemental information sheets with additional study details after the enrollment decision has been made.<\/p>\n<p>Consent information must be presented in a way that facilitates comprehension. This means providing consent information in a logical sequence and in a way that allows for real-time review during discussion between study staff and the prospective participant. Providing context that is meaningful and language that is familiar and at an appropriate reading level for the particular participant population will make the content easier for participants to understand.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<div style=\"background-color: #4b2e83; color: white; padding: 20px; border-bottom: 5px solid #d1d1d1;\"><strong>CONSIDERATION 3: Written Consent Materials<\/strong><br \/>\nConsent forms should be designed as teaching tools that provide information in a thoughtful, meaningful way rather than serving as a checklist of regulatory requirements.<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">More on Written Consent Materials<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Written consent materials should be presented from the perspective of the participant and what it would mean to them to participate (e.g., the pros and cons, and whys and why nots of the many aspects of the study). When consent information is provided in writing, understanding may be facilitated by breaking up dense text with sectioning, pictures, icons, schematic diagrams of study design, or putting information in side-by-side comparison tables. Headings should be participant-focused rather than regulations-focused. For example, depending on the study and population-specifics, information about risks and benefits, time commitments, and certain procedures may be appropriate under the headings, &#8220;Why I may want to participate&#8221; and, &#8220;Why I may not want to participate&#8221;. As described in Consideration 2, the consent form does not need to include every procedure the participant would undergo and should instead <em>focus on the procedures and other information that would be most likely to influence the participant&#8217;s decision about whether to enroll in the study<\/em>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div style=\"background-color: #4b2e83; color: white; padding: 20px; border-bottom: 5px solid #d1d1d1;\"><strong>CONSIDERATION 4: The Consent Process<\/strong><br \/>\nConsent is a continuous, dynamic, and interactive process.<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">More on The Consent Process<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>The presentation and discussion of consent information, as well as the consent form itself, are single elements of the overall consent process. Decision-making by prospective participants typically begins with the information presented in recruitment materials and in initial discussions with study staff, well before the consent form is presented. This information may be equally or more influential in final decision-making as the consent form. Post-enrollment communication, such as answering participant questions and providing them with relevant new information, is also part of the consent process, because participants consider throughout a study whether they wish to continue their participation. The continued education and engagement of participants throughout the research process is vital. In addition, it is a way to demonstrate respect and gratitude for their contribution and to maintain trust. Finally, the initial consent procedure may need to be repeated or supplemented if relevant new information becomes available or if the study involves a lengthy commitment from participants.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div style=\"background-color: #4b2e83; color: white; padding: 20px; border-bottom: 5px solid #d1d1d1;\"><strong id=\"c5\">CONSIDERATION 5: Coercion, Undue Influence, Diminished Consent Capacity, and Vulnerable Populations<\/strong><br \/>\nWhen prospective participants are at risk of being unduly influenced or coerced to participate in research, or have diminished capacity to consent, additional safeguards must be considered to ensure consent comprehension and protect participant autonomy and voluntary participation.<\/div>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">More on Coercion, Undue Influence, Diminished Consent Capacity, and Vulnerable Populations<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Federal regulations identify pregnant women*, prisoners, and children as Protected Populations and specify additional protections and consent requirements for them. However, these additional required protections may not be enough to ensure consent comprehension and voluntary participation for these groups. Other populations are also vulnerable to undue influence or coercion. Similar protections may be appropriate for them. These additional safeguards must be considered throughout the vulnerable participant&#8217;s time in the study (i.e., recruitment, obtaining consent, and after enrollment).<br \/>\n<span style=\"font-size: 12px;\">*Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. However, there are additional regulatory requirements for enrolling this population for research funded or supported by the agencies that signed Subpart B. Review <em><a href=\"#6\">Protected and Vulnerable Populations<\/a><\/em> for additional discussion.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"5\">The Key Information Requirement<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> All consent processes must begin with a concise and focused presentation of &#8220;Key Information&#8221; about the study that a reasonable person would need when deciding to enroll in research. What constitutes Key Information will be specific to the participant population (<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/example-key-info\/\">Key Information examples<\/a>). It is the researcher&#8217;s responsibility to identify Key Information.<\/div>\n<\/div>\n<\/div>\n<h3 id=\"5a\">The Key Information requirement and its purpose<\/h3>\n<p>The Common Rule requires that informed consent must <strong>begin with a concise and focused presentation of Key Information<\/strong> that is most likely to assist prospective participants or their representatives in <strong>understanding the reasons why they might or might not want to participate in the research<\/strong>. The Key Information must be organized and presented in a way that facilitates comprehension. Although a Key Information section may serve as an abstract or executive summary for a longer consent form, that is not its primary function.<\/p>\n<h3 id=\"5b\">When is Key Information required?<\/h3>\n<p>All consent-related materials must include Key Information if the study meets these criteria:<\/p>\n<ul>\n<li>The study is non-exempt human subjects research reviewed by the  91探花IRB (per <strong>HSD policy<\/strong>, it does not matter whether the Common Rule governs the study); and<\/li>\n<li>The IRB has not fully waived the requirement to obtain consent; and<\/li>\n<li>This includes consent forms, online or paper information statements, e-consent information, the short form consent process, oral consent with no written component, parental permission, and LAR consent.<\/li>\n<\/ul>\n<p>The Common Rule does not require Key Information in assent forms for children and decisionally-impaired adults, however, it is <strong>HSD policy<\/strong> to require Key Information when assent forms have more than 2000 words.<br \/>\n<strong>Consent materials must have a distinct Key Information section when they are more than 2,000 words<\/strong> (not counting any signatures sections; approximately 5 pages; single-spaced; 1-inch margins). It is <strong>HSD policy<\/strong> to consider shorter documents (less than 2000 words) to have met the requirement to present Key Information in a concise and focused manner because of their short length. However, the IRB has the authority to require a separate Key Information section if appropriate.<\/p>\n<h3 id=\"5c\">Content<\/h3>\n<p>There is no specific information that must be included in the Key Information. The appropriate information depends on the nature of the study, nature of the participant population, and on the other information presented as part of the consent process and\/or form. <a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/attachment-c-november-13-2018\/index.html\" target=\"_blank\" rel=\"noopener\">Federal guidance<\/a> stresses that the Key Information should be meaningful within the context of the study and in a <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/key-information-and-facilitating-understanding-informed-consent-guidance-sponsors-investigators-and\">draft guidance document<\/a> has provided non-binding recommendations about what information should be included. However, the guidance does generally expect that Key Information include a concise explanation of the following elements:<\/p>\n<h4>Key Information Elements<\/h4>\n<ol>\n<li>voluntary consent is being sought for research;<\/li>\n<li>research purpose, expected duration of participation, procedures &#8211; including experimental procedures, and whether the study design includes a placebo;<\/li>\n<li>the most important, reasonably foreseeable risks or discomforts; <a href=\"#rad\">*<\/a>;<\/li>\n<li>reasonably expected benefits to the participants or others;<\/li>\n<li>appropriate alternative procedures or courses of treatment, if any;<\/li>\n<li>for studies in which a treatment is administered as part of the research, a notice that refusal to participate or the decision to withdraw from the study will result in no penalty or loss of benefits to which the participant is otherwise entitled.<\/li>\n<\/ol>\n<p id=\"rad\" style=\"margin-left: 80px; font-size: 12px;\">*Risks and discomforts in Key Information should be described with the study context and participant perspective in mind. For example, if the most important risks associated with the study are from a blood draw, these risks should be described in Key Information. However, if a blood draw is only one of many procedures and the other study procedures are associated with more significant risks to participants, then information about the blood draw may be left out of Key Information and instead described in a more detailed Risks section later in the consent process or form.<\/p>\n<p><strong>HSD tip<\/strong>. For most biomedical studies, detailed information about compensation for injury, specific protections for privacy and confidentiality, and how data and specimens will be shared and stored does not need to be in the Key Information. Such information can be briefly mentioned in Key Information with a page number reference or hyperlink to a later section of the consent form where it is described in detail.<\/p>\n<h4>Primary factor: the participant population<\/h4>\n<p>Key information is intended to be the information that is most likely to assist the specific participant population (e.g., end-stage cancer patients; first-year college students; parents of toddlers with autism; prisoners). <em>Identifying this information is the responsibility of the researcher<\/em>. This may mean that the researcher needs to consult with publications about research participant preferences, disease-focused nonprofit groups, patient interest groups, or other researchers\/study staff with experience with the specific population. It may also involve directly consulting selected members of the study population.<\/p>\n<h4><strong>When writing Key Information, consider the following questions<\/strong>:<\/h4>\n<ul style=\"margin-left: 40px;\">\n<li>What are the main reasons a participant will want to join, or not join, this study?<\/li>\n<li>What is the research question the study is trying to answer and why is it relevant to the prospective participant?<\/li>\n<li>What aspects of research participation in this study are likely to be unfamiliar to a prospective participant, diverge from a participant&#8217;s expectations, or require special attention?<\/li>\n<li>What information about the participant is being collected as part of this research?<\/li>\n<li>What are the types of activities (procedures) that participants will do in the research?<\/li>\n<li>What impact will participating in this research have on the participant outside of the research? For example, will it reduce options for standard treatments?<\/li>\n<li>How will their experience as a research participant in this study differ from treatment they might receive as a patient outside of the study?<\/li>\n<li>In what ways is this research novel?<\/li>\n<li>What is the anticipated time commitment for the participant?<\/li>\n<\/ul>\n<h4>Relationship to the rest of the consent form\/materials<\/h4>\n<p>A Key Information section may appropriately include a summary of relevant pieces of information that are then explained in greater detail later in the consent form or process. Generally, information that is fully described in the Key Information section does not need to be repeated later in the form or process. Similarly, if the Key Information section includes any of the elements of consent described in the worksheet <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-consent\/\">Consent Requirements and Waivers<\/a>, those elements do not need to be repeated later in the form or consent process. There may be some limited situations when intentional repetition of information could improve comprehension or clarify complex concepts (e.g., certain risks, alternatives, uncertainty about direct benefits). For example, it may improve comprehension to briefly describe the most serious or common reasonably foreseeable risks in the Key Information section and to repeat that information again, perhaps in greater detail, in the section of the consent form that includes a comprehensive description of reasonably foreseeable risks.<\/p>\n<p>Review our <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/example-key-info\/\">Key Information examples<\/a>.<\/p>\n<h3 id=\"5d\">Structure and presentation<\/h3>\n<p>The Key Information may be in a separate document or in the beginning of the consent form, but it must be presented to participants at the beginning of the consent process. The Key Information requirement applies to the consent <em>process<\/em> as a whole \u2013 not simply to consent documents. In other words, there is flexibility in how the presentation of Key Information is structured if it is organized and presented in a way that facilitates comprehension for prospective participants.<\/p>\n<p>In most cases, when there is a separate Key Information section, it will be relatively short compared to the rest of the consent document or process. For example, complicated clinical trials involving high risk procedures typically involve consent forms of more than 20 pages. In these cases, the federal agencies expect that the Key Information section would be no more than a few pages. However, those agencies have also stressed that the section should be meaningful within the context of the study and have therefore purposely avoided specifying length requirements. Review our <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/example-key-info\/\">Key Information examples<\/a>.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"r\">Identifying and Describing Reasonably Foreseeable Risks in Research<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> Reasonably foreseeable research risks must be described to participants as part of informed consent. Reasonably foreseeable risks are those that participants in the target population would find meaningful to their decision about whether to participate in the research. These generally include risks that: are more likely to occur, are serious, or are being evaluated as part of the research.<\/div>\n<\/div>\n<\/div>\n<p>The  91探花IRB is defining the regulatory term <em>reasonably foreseeable<\/em> as those risks or discomforts that must be included in the informed consent process because they are both reasonably foreseeable and meet any of several additional criteria. A workable definition of <em>reasonably foreseeable<\/em> is required to ensure that <strong>a description of any reasonably foreseeable risks or discomforts to the participant<\/strong> are presented to a potential research participant as part of the informed consent process (<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/revised-common-rule-regulatory-text\/index.html#46.116\">45 CFR 46. 116 (b) (2)<\/a>; <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr=50.25\">21 CFR 50.25(a)(2)<\/a>). This is particularly relevant for risks associated with drugs, devices, or complex procedures where the number of risks may be large, and inclusion of all possible risks may detract from an individual\u2019s ability to consider those risks that are relevant to their decision to participate in the research.<\/p>\n<p>The following definition, built upon <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/informed-consent#risks\">FDA guidance<\/a> and <a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2015-february-11-attachment-a\/index.html\">SACHRP guidance<\/a>, should be used to help evaluate which risks the  91探花IRB considers <em>reasonably foreseeable<\/em> and, therefore, should be included in the consent form or included as part of the informed consent process.<\/p>\n<p><strong>Reasonably Foreseeable Risks<\/strong><br \/>\nReasonably foreseeable risks are those risks that a reasonable person in the target population would find meaningful to their decision to participate in the research. This should include (but not be limited to) any of the following: <strong>(a)<\/strong> risks that are <em>more likely to occur<\/em>; <strong>(b)<\/strong> risks that are <em>serious<\/em>; <strong>OR (c)<\/strong> risks that the research is <em>evaluating<\/em> and that an individual would not otherwise be exposed to if they were to decide not to participate in the research.<\/p>\n<p style=\"margin-left: 30px;\"><strong>(a) &#8220;More likely to occur&#8221;<\/strong> are risks that <em>are frequent\/common or very frequent\/very common<\/em> as described in the table below. <strong>Risks expected or known to be very frequent\/very common or frequent\/common should generally be included in the consent form and\/or consent process.<\/strong> The IRB can always exclude frequent\/very frequent risks that don\u2019t apply to the target population (for example the study includes an adverse drug reaction with acetaminophen but participants taking acetaminophen are excluded from participating). Conversely, the IRB can require the inclusion of infrequent, rare, or very rare risks that don\u2019t otherwise meet the overall definition above if they determine the target population would find them meaningful to their decision to participate in the research (e.g., rare permanent teeth discoloration).<\/p>\n<p style=\"margin-left: 30px;\">We recognize that in some cases, there is no written source or data (e.g., drug Investigator Brochure or package insert) to rely on when determining frequency of risks. In those instances, the expert judgement of the researcher, or relevant published literature, would need to be applied when determining frequency. The IRB, in their review, would have the opportunity to check these assumptions.<\/p>\n<table style=\"margin-left: 40px;\">\n<tbody>\n<tr>\n<td style=\"background-color: #000000; color: #fff;\" width=\"33%\"><strong>Group Descriptor<\/strong><\/td>\n<td style=\"background-color: #000000; color: #fff;\" width=\"33%\"><strong>Frequency Rate<\/strong><\/td>\n<td style=\"background-color: #000000; color: #fff;\" width=\"33%\"><strong>Percentage<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"background-color: #880808; color: #fff;\" width=\"33%\">very frequent\/very common<\/td>\n<td style=\"background-color: #880808; color: #fff;\" width=\"33%\">&gt;1 in 10<\/td>\n<td style=\"background-color: #880808; color: #fff;\" width=\"33%\">10% or higher<\/td>\n<\/tr>\n<tr>\n<td style=\"background-color: #880808; color: #fff;\" width=\"33%\">frequent\/common<\/td>\n<td style=\"background-color: #880808; color: #fff;\" width=\"33%\">1 in 100 to 1 in 10<\/td>\n<td style=\"background-color: #880808; color: #fff;\" width=\"33%\">1-10%<\/td>\n<\/tr>\n<tr>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">infrequent\/uncommon<\/td>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">1 in 1,000 to 1 in 100<\/td>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">0.1-1%<\/td>\n<\/tr>\n<tr>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">rare<\/td>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">1 in 10,000 to 1 in 1,000<\/td>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">0.01-0.1%<\/td>\n<\/tr>\n<tr>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">very rare<\/td>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">&lt;1 in 10,000<\/td>\n<td style=\"background-color: #808080; color: #fff;\" width=\"33%\">&lt;0.01%<\/td>\n<\/tr>\n<tr>\n<td style=\"background-color: #ececec;\" colspan=\"3\">\n<p style=\"font-size: 15px;\">Table adapted from the <a href=\"https:\/\/www.pharmacy180.com\/article\/cioms-iii---core-clinical-safety-information-3194\/\">Council for International Organizations of Medical Sciences<\/a> and <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/adverse-reactions-section-labeling-human-prescription-drug-and-biological-products-content-and\">FDA prescription drug labeling guidance<\/a>.<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p style=\"margin-left: 30px;\"><strong>(b) &#8220;Serious&#8221;<\/strong> are risks that fall under the FDA\u2019s definition of a Serious Adverse Event (i.e., anything that would result in death, be life-threatening, would require hospitalization to treat, could cause disability\/permanent damage, cause birth defects, require an intervention to prevent permanent impairment or damage or other important medical events). For a full description of the definition, visit <a href=\"https:\/\/www.fda.gov\/safety\/reporting-serious-problems-fda\/what-serious-adverse-event\">this FDA webpage<\/a>. These risks should generally be included regardless of the potential frequency of occurrence. As with \u2018more likely to occur\u2019 the IRB has discretion to leave out serious risks that are not relevant to a particular population, may be theoretical or unsupported by the data, or would detract from a participant&#8217;s understanding of the more significant risks associated with the primary aim(s) of the research.<br \/>\nFor example:<\/p>\n<ul style=\"margin-left: 40px;\">\n<li>A drug can be life threatening to children under 5 years of age, but all children are excluded from participating in the study<\/li>\n<li>A researcher proposes including Stevens-Johnson syndrome (SJS) as a possible risk of the study but there has been no incident of SJS to date<\/li>\n<li>A study of a novel diabetes drug involves routine blood draws with use of topical lidocaine to numb the area of the needlestick but the very rare risk of anaphylaxis from the lidocaine is excluded (i.e., inclusion is not relevant to a reasonable person&#8217;s meaningful decision to participate in the research).<\/li>\n<\/ul>\n<p style=\"margin-left: 30px;\"><strong>(c) &#8220;Risks that the research is evaluating.&#8221;<\/strong> If researchers design and conduct a study for the purpose of <em>evaluating<\/em> a particular risk then the research risk being evaluated has been recognized as a sufficiently possible outcome to be considered \u201creasonably foreseeable\u201d and should be disclosed to prospective participants (adapted from <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/requests-for-comments\/draft-guidance-disclosing-risk-in-standards-of-care\/index.html\">OHRP Comparative Effectiveness Guidance<\/a>).<\/p>\n<div style=\"margin-left: 80px; background-color: #ffffff;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>A researcher may suspect a new study drug might cause slightly increased blood sugar levels. There is no prior evidence of this, and they think it\u2019s very unlikely (so it doesn\u2019t trigger inclusion based on frequency), and it doesn&#8217;t meet the &#8216;serious&#8217; criteria for inclusion in the consent. However, they are planning to actively monitor participant blood glucose levels throughout the study and intervene when appropriate. This would be an example where we would expect the researcher to include risks of increased blood sugar levels in the consent form.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><strong>Additional Considerations<\/strong><br \/>\nRisk statements in consent forms should be simplified such that the information included is understandable and relevant to the participant population. Detailed descriptions of all potential risks are counterproductive if they do not provide potential participants with useful information and may inadvertently distract participants from relevant data. (<a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2011-october-13-letter-attachment-a\/index.html\">SACHRP recommendations<\/a>)<\/p>\n<p>For <em>minimal risk procedures<\/em>, risks or burdens that are immaterial or obvious to potential participants need not be explicitly addressed in the consent form or dialogue. For example, participants need not be told that needle sticks can cause minor pain or that surveys can be boring. There is also no need to specifically state the absence of risk where none exists. (<a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2015-september-28-attachment-a\/index.html\">SACHRP recommendations<\/a>)<\/p>\n<p><strong>Applying the Guidance &#8211; Examples<\/strong><\/p>\n<div style=\"margin-left: 40px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example 1<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Study Summary<\/strong><br \/>\nA particular condition has several treatment options, but an individual\u2019s response to the treatment can be highly variable and unpredictable. Many patients undergo a trial-and-error period until they find a treatment plan that is effective for them. The purpose of this study is to identify biomarkers that may help predict a response to a specific drug in individuals diagnosed with the condition. The drug is an FDA-approved drug for the treatment of this condition and is frequently used in clinical care. A revised package insert includes three new post-market risks.<\/p>\n<ul>\n<li>risk of serious infection (12%)<\/li>\n<li>diarrhea (5.3%)<\/li>\n<li>mild back pain (0.5%)<\/li>\n<\/ul>\n<p style=\"color: #d2042d;\"><strong>Should these risks be added to the consent form\/process as reasonably foreseeable risks?<\/strong><\/p>\n<p><strong>Analysis<\/strong><br \/>\nSerious infections are very frequent according to the investigator\u2019s brochure. Diarrhea is a frequent risk according to the investigator\u2019s brochure. Therefore, both serious infections and diarrhea meet the definition of a reasonably foreseeable risk as they are risks that are <em>more likely to occur<\/em>.<\/p>\n<p>Risk of mild back pain does not meet the definition of a reasonably foreseeable risk because it is not <em>more likely to occur<\/em>, nor is it <em>serious<\/em> or being <em>evaluated by the study<\/em>.<\/p>\n<p><strong>Answer<\/strong><br \/>\nThe risks of serious infection and diarrhea need to be added to the consent form\/process.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example 2<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Study Summary<\/strong><br \/>\nThe study aims to optimize the imaging of abdominal organs with a contrast enhanced ultrasound comparing clinical ultrasounds with research ultrasounds. Study procedures include a contrast-enhanced ultrasound using a contrast agent (FDA approved). This procedure adds approximately 15 additional minutes to the patient\u2019s standard of care ultrasound. Although rare, the contrast agent does have a risk of severe allergic reaction.<\/p>\n<p style=\"color: #d2042d;\"><strong>Should this risk be added to the consent form\/process as a reasonably foreseeable risk?<\/strong><\/p>\n<p><strong>Analysis<\/strong><br \/>\nSevere allergic reaction is a rare risk and is therefore not <em>more likely to occur<\/em>. However, severe allergic reaction meets the definition of a <em>serious<\/em> risk as it could be life threatening.<\/p>\n<p><strong>Answer<\/strong><br \/>\nYes, the risk of severe (life-threatening) allergic reaction should be added to the consent form.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example 3<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Study Summary<\/strong><br \/>\nThe purpose of this study is to investigate the safety and effectiveness of long-term treatment using either a combination of drugs or a single drug to prevent acquiring HIV in participants who are HIV negative. The investigator brochure lists three rare but serious risks for the drug combination that are not currently in the consent form (viral resistant mutations, interstitial nephritis, and immune reconstitution syndrome) that exclusively affect HIV positive individuals.<\/p>\n<p style=\"color: #d2042d;\"><strong>Should these risks be added to the consent form\/process as reasonably foreseeable risks?<\/strong><\/p>\n<p><strong>Analysis<\/strong><br \/>\nThese are risks associated with taking the drug if HIV positive, however, the study is excluding HIV positive participants and regularly testing participants for HIV transmission.<\/p>\n<p><strong>Answer<\/strong><br \/>\nNo, these risks do not need to be added to the consent form.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><a style=\"text-decoration: none; color: #000000;\" name=\"stdofcare\"><\/a><strong>When to Describe Risks for Studies Evaluating Medically Recognized Standards of Care<\/strong><br \/>\nIt can be difficult to determine which risks to include in the consent form when the research involves medically recognized standards of care procedures or treatments in addition to, or instead of, any investigational procedures or treatments.<\/p>\n<p>In general, the reasonably foreseeable risks associated with a standard of care procedure or treatment should be described in the consent form when:<\/p>\n<ul style=\"margin-left: 20px;\">\n<li>the standard care procedure or treatment is required <em>solely for research purposes<\/em>;<\/li>\n<li>the research design <em>dictates<\/em> the procedure or treatment that will be provided to the subject;<\/li>\n<li>the research design <em>restricts<\/em> the ability of the participant or the participant&#8217;s care provider to choose the procedure or treatment that will be provided to the participant.<\/li>\n<\/ul>\n<p>The examples below illustrate how to identify: <strong>(1)<\/strong> which risks are research risks and should be described in the consent process\/form; <strong>and (2)<\/strong> which risks are not research risks and should not be described in the consent process\/form. Additional information can be found in the OHRP draft Guidance, <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/requests-for-comments\/draft-guidance-disclosing-risk-in-standards-of-care\/index.html\">&#8220;Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care&#8221;<\/a>.<\/p>\n<div style=\"margin-left: 40px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example 1 - biomedical<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Study Summary<\/strong><br \/>\nA physician researcher plans to compare the effects of two different FDA-approved vascular stents on oxygen flow in patients with significantly blocked arteries that are life-threatening and for whom the only appropriate clinical treatment is implantation of a vascular stent.<br \/>\n<strong>Research Risks<\/strong><br \/>\nThe risks associated with each of the two stents are research risks and must be included in the consent process\/form. There are many stents that a physician could use, but the research protocol is restricting the physician&#8217;s (and participant&#8217;s) choice to the two that are the focus of the study.<br \/>\n<strong>Not research risks<\/strong><br \/>\nThe risks associated with the surgery, including the surgical procedures, general anesthesia, and any angiography with radio-opaque dyes performed during the surgery to verify the placement and efficacy of the stent are not different than they would be if the patient were not enrolled in the research and should not be included in the consent process\/form.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example 2 - biomedical<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Study Summary<\/strong><br \/>\nA physician researcher at a local clinic plans to do a research study with patients who have been recently diagnosed with osteoporosis and who require treatment. The physician wants to compare the effects of two different FDA-approved estrogens on the osteoporosis. As part of clinical care, the physician normally does a DEXA scan to measure bone density before beginning any osteoporosis treatment, and then repeats the DEXA scan after one year to see whether the treatment is having any beneficial effects.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Design A<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The physician will randomly assign each participant to one of two FDA-approved estrogen treatments for osteoporosis.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The risks associated with the two estrogen treatments are research risks and must be included in the consent process\/form. The choice of how the osteoporosis will be treated has been restricted by the research design (to the two estrogens).<\/p>\n<p style=\"margin-left: 20px;\"><strong>Not Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The risks associated with the two DEXA scans are not research risks because the physician obtains DEXA scans for all of their patients being treated for osteoporosis, not just those who are in the research study.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Design B<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The physician is interested in the effects of the two FDA-approved estrogens. However, they will prescribe osteoporosis treatment to all of their patients based solely on clinical factors. The treatment could be one of many estrogens (including the two they are interested in), or one of many bisphosphonate drugs. For example, patients who are breast cancer survivors would receive a bisphosphonate drug instead of estrogen because of the effects of estrogens on the growth of some types of cancer cells. Per the physician&#8217;s normal clinical procedures, they will do DEXA scans on all their patients before they begin any treatment and after one year on the treatment.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Not Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">None of the risks associated with the two estrogen treatments and none of the risks associated with the DEXA scans are research risks because they are not dictated by the research protocol.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Example 3 - behavioral<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Study Summary<\/strong><br \/>\nA university has counseling services available for students who engage in binge alcohol drinking. The counseling always includes two educational sessions, followed by sessions based on one of several widely accepted approaches to reducing binge drinking. All students fill out a series of standard validated questionnaires about drinking behavior and attitudes before and after they receive counseling.<br \/>\nA psychologist at the counseling center is interested in comparing the effectiveness of two of these approaches: a short series of motivational interviews versus participation in a weekly cognitive-behavioral group session.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Design A<\/strong><\/p>\n<p style=\"margin-left: 20px;\">Each student who agrees to participate in the research will have the two educational sessions and will then be randomly assigned to either the motivational interviews or the cognitive-behavioral group. The psychologist will use the results of the clinic&#8217;s pre\/post questionnaires to assess the two approaches.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The risks associated with motivational interview and the cognitive-behavioral group are research risks and must be described in the consent process\/form. the choice of counseling techniques is being dictated by the research design. The confidentiality risks associated with the questionnaire for research purposes are research risks and must be described in the consent form.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Not Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The risks associated with the educational session are not research risks because all students who come into the counseling center participate in those sessions whether or not they are in the research study.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Design B<\/strong><\/p>\n<p style=\"margin-left: 20px;\">Each psychologist at the counseling center works with their student clients to decide which approach is best suited to the student&#8217;s circumstances. Students who join the cognitive-behavioral group or who undergo the motivational interview approach are referred to the psychologist researcher before they begin counseling. The psychologist researcher gives those students a series of questionnaires about depression, social anxiety, and stress coping strategies before and after they receive the counseling. The psychologist researcher also obtains the results of their standard clinic questionnaires.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">The risks associated with the research questionnaires (depression, social anxiety, stress coping strategies) and with research use of the standard clinic questionnaires are research risks and must be described in the consent process\/form.<\/p>\n<p style=\"margin-left: 20px;\"><strong>Not Research Risks<\/strong><\/p>\n<p style=\"margin-left: 20px;\">None of the risks associated with the two counseling approaches or with <em>administration<\/em> of the standard clinic questionnaires are research risks.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"6\">Protected and Vulnerable Populations<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> The consent process must minimize the potential for undue influence or coercion, and additional protections must be put in place for populations that are at particular risk. Some of the best tools for minimizing the potential for undue influence or coercion are ensuring that <strong>1)<\/strong> participants have adequate time to consider and discuss participation before giving consent and <strong>2)<\/strong> consent processes and materials are understandable and include Key Information in sufficient detail for the specific participant population to be able to make an informed decision about participation. When participants are unable to provide consent on their own behalf because they are children or have diminished consent capacity, the consent of a parent\/guardian or legally-authorized representative may be provided instead and assent should be provided by the participants if they are capable of providing it and\/or it is appropriate.<\/div>\n<\/div>\n<\/div>\n<h3 id=\"6a\">Undue influence and coercion<\/h3>\n<p>Human subjects regulations require that the consent process minimizes the possibility of undue influence or coercion and notes that some populations of participants are considered especially vulnerable. The regulations designate three &#8220;protected populations&#8221; (pregnant women, prisoners, children) that each have additional required protections. Other vulnerable groups may also require additional protections against the potential for coercion or undue influence.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Undue influence<\/strong> may occur through an excessive offer of something valuable or desirable that influences decision-making in inappropriate ways. Undue influence is often scrutinized by the IRB when participants will receive significant payment for participation (<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/subject-payment\/\">Payment guidance<\/a>). There are other situations when concerns about undue influence may arise. Federal regulatory guidance concedes that there is no bright line between mere influence and undue influence and so it is up to the IRB to make that distinction.<\/p>\n<p style=\"margin-left: 40px;\">A study benefit might raise concerns about undue influence when it is likely to: <strong>1)<\/strong> inhibit a potential subject&#8217;s adequate consideration of, and reflection about, important study features such as risks, burdens, and discomforts; or <strong>2)<\/strong> impair a potential participant&#8217;s understanding of the research and their participation in it.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Coercion<\/strong> occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. Prior to implementation of human subjects research regulations, there were many instances of participants being coerced into research. Regulatory protections and IRB oversight have reduced the likelihood of coercion in research, but it is still something researchers and the IRB should be cautious about, particularly when researchers are in a position of power over participants (e.g., physician and patient or professor and student).<\/p>\n<p style=\"margin-left: 40px;\"><strong>Minimizing the potential for undue influence or coercion<\/strong>. It is important to remember that the IRB is tasked with <em>minimizing<\/em>, not eliminating the possibility of undue influence or coercion. Whether a participant may be vulnerable to being unduly influenced or coerced to participate in research is contextual and dependent upon the individual participant&#8217;s situation, yet the IRB approves research on a population-level.<\/p>\n<p style=\"margin-left: 40px;\">There will be some situations where identification of the potential for unduly influencing a participant group or groups will be clear, as will the steps for minimizing that potential. For example, when there are power dynamics involved (e.g., professor\/student; supervisor\/employee), it may be appropriate to ensure the consent process is conducted by someone outside the power dynamic. It may also be important to ensure that the person in power is not aware of which of their students, supervisees, etc. participated and which did not. For many other situations, rather than trying to anticipate what might be unduly influential for every individual participant, the IRB should make use of existing minimization tools including some of the other regulatory consent requirements and protections that have been described in this guidance. These include ensuring that:<\/p>\n<ol style=\"margin-left: 60px;\">\n<li>participants have adequate time to consider and discuss participation prior to giving consent; and<\/li>\n<li>consent processes and materials are understandable and include Key Information in sufficient detail for the specific participant population to be able to make an informed decision about participation.<\/li>\n<\/ol>\n<p style=\"margin-left: 40px;\">The IRB should pay particular attention to the way a study&#8217;s benefits are described. Known benefits should be accurately described and not exaggerated. Potential or uncertain benefits should be described clearly as to what is known about the uncertainty or likelihood of the potential benefits. A meaningful consent process enables prospective participants to decline participation in research that they judge to be harmful or inappropriate according to their own interests, values, and obligations.<\/p>\n<p id=\"ce\" style=\"margin-left: 40px;\">Examples of undue influence and coercion adapted from an <a href=\"https:\/\/www.advarra.com\/blog\/the-many-faces-of-coercion-and-undue-influence\/\" target=\"_blank\" rel=\"noopener\">Advarra IRB blog post<\/a>:<\/p>\n<div style=\"margin-left: 40px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Examples of Undue Influence and Coercion<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<div style=\"padding-left: 40px;\">\n<div class=\"box-outer\">\n<div class=\"box one box-tan\">\n<div class=\"tile\"><strong>Examples<\/strong>: A physician offers special services (e.g., private hospital room for all visits) for patients who enroll in their study. A professor offers to write positive letters of recommendation for students who enroll in their research study. These are examples of potential <strong>undue influence<\/strong> because the researcher is offering the prospective participant an enticing benefit that could inhibit the participant&#8217;s ability to adequately consider the potential risks of the study.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div style=\"padding-left: 40px;\">\n<div class=\"box-outer\">\n<div class=\"box one box-tan\">\n<div class=\"tile\"><strong>Examples<\/strong>: A professor asks their students to enroll in a research study for which they will earn course credit, but does not provide them with an alternative, non-research method by which to earn those same course credits. An investigator threatens to withhold payment for the first phase of a study, in which the participant has completed participation, unless the participant agrees to participate in the second phase of the research. These are examples of <strong>coercion<\/strong> where the researcher threatens the prospective participant with a penalty unless they participate in the research.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<h3 id=\"6b\">Children<\/h3>\n<p>Children are a federally designated &#8220;protected population&#8221; with additional regulatory protections and requirements described in Subpart D of the Common Rule. When children participate in research, parent\/guardian permission and child assent are sought rather than consent.<\/p>\n<p style=\"margin-left: 40px;\">Review our guidance on <a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-involvement-of-children-in-research-2\/\">Involvement of Children in Research<\/a> for a discussion of who qualifies as a child. Review the <a href=\"#6e\">assent section of this guidance<\/a> for details about when assent must be obtained and for guidance about designing the assent process and form.<\/p>\n<p id=\"pgp\" style=\"margin-left: 60px;\"><strong>Parent\/guardian permission<\/strong><\/p>\n<p style=\"margin-left: 80px;\"><strong>Definitions<\/strong>. <strong>Permission<\/strong> is the agreement of parent(s) or guardian(s) to a child&#8217;s participation in research. A <strong>parent<\/strong> is defined as the child&#8217;s biological or adoptive parent and a <strong>guardian<\/strong> is an individual who is authorized under applicable State or local law to consent on behalf of the child to general medical care. In general, one or both parents or guardians must be provided with the same information that is provided during an adult consent process, unless the regulatory criteria are met for waiving permission or waiving or altering elements of permission (<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-children\/\">Children worksheet<\/a>).<\/p>\n<p style=\"margin-left: 80px;\"><strong>One or two parent permission<\/strong>. The permission of one or both parents may be required depending on the children&#8217;s risk level category as determined by the IRB (<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-involvement-of-children-in-research-2\/\">Involvement of Children in Research guidance<\/a>; <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-children\/\">Children worksheet<\/a>).<\/p>\n<p style=\"margin-left: 80px;\"><strong>Waivers and alterations<\/strong>. Parental permission can be waived or altered, and documentation of permission can be waived, under the same criteria for waiving or altering consent and consent documentation. [<em>For FDA-regulated research, parental permission can only be waived under the minimal risk criteria<\/em>.] Review the <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-children\/\">Children worksheet<\/a> for a full description of waiver criteria.<\/p>\n<h3 id=\"6c\">Pregnant women and neonates<\/h3>\n<p>Pregnant women and neonates are a federally designated &#8220;protected population&#8221; with additional regulatory requirements and protections described in Subpart B of the Common Rule. However, bioethicists now tend to view pregnant participants as a <em>complex<\/em> or <em>special<\/em> rather than <em>vulnerable<\/em> population, because pregnancy itself does not impair a participant&#8217;s ability to comprehend an informed consent process. Some research with pregnant women may have additional complexities such as weighing the risks and benefits of both the pregnant woman and the fetus or mitigating risk of exploitation in some specific contexts. However, these potential complexities are dependent upon the specific research design and are not necessarily applicable to all studies enrolling pregnant women. It is noteworthy that, in the 2018 revision to the Common Rule, pregnant women were removed as an example of a population that is potentially vulnerable to coercion or undue influence. Subpart B consent requirements for pregnant women and neonates are listed in the worksheets on <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-pregnant-women\/\">Pregnant Women<\/a> and <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-neonates\/\">Neonates<\/a>.<\/p>\n<h3 id=\"6d\">Prisoners<\/h3>\n<p>Prisoners are a federally designated &#8220;protected population&#8221; with additional regulatory requirements and protections described in Subpart C of the Common Rule (<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/prisoners\/\">Prisoners guidance<\/a>). These protections, and restrictions about the types of research in which prisoners may participate, were put into place to prevent a return to past research practices that exploited prisoners by exposing them to an unfair burden of risks, coercive and unduly influential enrollment practices, and an absence of informed consent procedures. However, these same protections can unfortunately restrict prisoners&#8217; autonomy to independently weigh what risks they are willing to assume and possibly limit their access to potentially beneficial research.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Designing consent with prisoners<\/strong>. Poor reading and communication skills tend to be more common in prison populations (<a href=\"#13\">Committee on Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, 2006<\/a>). This creates challenges for obtaining informed consent because the process typically relies heavily on written materials. For example, it has been shown that undue influence was significantly higher among prisoners with lower educational attainment and those who had spent a longer time in prison (<a href=\"#13\">Ravi et al., 2018<\/a>). This makes it particularly important that the Key Information about a study be tailored to the prisoner population and communicated in language that is understandable to them. Allowing adequate time during the consent process for discussion and opportunities for the participant to ask questions becomes extremely important when enrolling prisoners. Providing a clear and accurate description of confidentiality measures should also be discussed in detail, given the confidentiality limits that may exist in prisons because of institutional policies. As is noted in <a href=\"#c5\">Consent Consideration # 5<\/a>, with the appropriate protections in place, prisoners may still be able to take advantage of opportunities to share in the risks and benefits of research.<\/p>\n<h3 id=\"6e\">Assent<\/h3>\n<p>Assent is a participant&#8217;s affirmative agreement to participate in research. It must be accompanied by <a href=\"#pgp\">parent\/guardian permission<\/a> or the consent of a legally authorized representative (<a href=\"#7\">Use of a LAR<\/a>). Alternatively, assent, LAR consent, and\/or parental permission may be waived by the IRB. It is <strong>HSD policy<\/strong> that researchers must obtain assent from participants who are minors or decisionally-impaired adults, when the individuals are capable of providing assent and when it is appropriate to do so. Researchers who do not plan to obtain assent from these participants must provide the IRB with justification about why obtaining assent is not appropriate.<\/p>\n<div style=\"padding-left: 40px;\">\n<div class=\"box-outer\">\n<div class=\"box one box-tan\">\n<div class=\"tile\"><strong>Example<\/strong>: The research has the potential of directly benefiting the child and the IRB has approved the researcher&#8217;s plan to allow the parent(s)\/guardian(s) decision about the child&#8217;s participation to override the child&#8217;s wishes. In this case, it may be inappropriate to seek assent because the child&#8217;s wishes will not inform the decision.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p style=\"margin-left: 40px;\"><strong>Assent determinations<\/strong>. The IRB must determine whether the prospective participants are capable of providing assent and, if they are, whether the proposed assent process is adequate for helping participants decide whether they want to participate in the research (<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-consent\/\">Consent Requirements and Waivers worksheet<\/a>). If the IRB determines that assent is possible, the IRB may nonetheless waive the assent requirement under the same criteria for waiving consent (<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-consent\/\">Consent Requirements and Waivers worksheet<\/a>). These determinations will depend on several factors including the age, maturity of a minor, psychological state, and\/or cognitive capabilities of the prospective participants. The decision may apply to all participants in the study or may differ by individual participant or group of participants.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Assent requirements<\/strong>. Researchers are asked to describe their plans (if any) for obtaining and documenting assent in the IRB application. The assent process and any materials should <strong>provide information that is relevant for the participant population considering their capacity for comprehension and the research procedures<\/strong>. There is no regulatory requirement to provide all the standard elements of consent during the assent process. There is also no requirement to document assent with an assent form, although researchers should have some way of recording that they obtained assent.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Assent outcomes<\/strong>. Potential participants may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). Failure to object should not be equated with an active willingness to participate. In general, dissent should be respected. A disagreement between a parent(s)\/LAR and the potential participant may arise for many reasons and every effort should be made to reach consensus between the parent(s)\/LAR and potential participant. However, the IRB may allow the parent(s)\/LAR wishes to prevail over the potential participant&#8217;s dissent when the potential participant may directly benefit from the research. In these cases, it may be more appropriate to waive assent, rather than ask the participant and then not take their wishes into account. A potential participant&#8217;s assent cannot override a &#8220;no&#8221; from a parent or LAR unless the IRB has waived the requirement for parental permission or completely waived consent.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Child assent<\/strong><\/p>\n<p style=\"margin-left: 80px;\"><strong>Design<\/strong>. When designing the assent process and, if applicable, assent form, researchers should consider the nature of the research as well as the age, maturity, and psychological state of the children. When the research involves adolescents whose capacity to understand resembles that of adults, the assent procedure and form would be similar to one designed for adults. In some cases it may be appropriate to use a single form to obtain both parental permission and child assent. For younger children, researchers should focus the assent process and information on the aspects of the research that the children would be mostly likely to understand and be interested in. This would likely be a short description of what the experience would be like, how long it would take, and whether there would be any pain or discomfort as a result of participating. For studies that span several age groups, it may be necessary to design multiple assent procedures and\/or forms based on the comprehension capability of the different groups.<\/p>\n<p style=\"margin-left: 80px;\"><strong>Longitudinal research and children who reach the age of majority<\/strong>. The assent process should be viewed as ongoing throughout the duration of the research. If a participant enrolls in research at a young age and remains enrolled for many years, it may be necessary to re-assent as the child&#8217;s capacity to understand increases. If the child reaches the legal age of consent while enrolled, the regulations about child participants no longer apply. In these cases, unless the IRB has waived the requirement, the researcher must obtain <a href=\"https:\/\/www.washington.edu\/research\/glossary\/legally-effective-research-consent\/\">legally effective research consent<\/a> from the now-adult participant for any ongoing interactions or interventions or continued analysis of identifiable specimens or data.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"7\">Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR)<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> When participants with decision-making impairments will be enrolled, researchers should be prepared to assess consent capacity at the outset of the study and, if the study is longitudinal, to re-assess consent capacity if it is likely to change over time. Participants who were consented using a legally authorized representative (LAR) may need to provide consent on their own behalf if they experience a sufficient increase in cognitive capability. Participant who consented on their own behalf may need to be reconsented using a LAR if there is a significant decrease in cognitive capability. Review the section of this guidance on <a href=\"#11\">Reconsent and Ongoing Participant Communication<\/a> for more information.<\/div>\n<\/div>\n<\/div>\n<h3 id=\"7a\">Presumption of capacity to consent<\/h3>\n<p>Individuals who have reached the age of legal consent in the jurisdiction in which the research is being conducted are presumed to have <a href=\"https:\/\/www.washington.edu\/research\/glossary\/capacity-to-consent\/\">capacity to give informed consent<\/a> for research. In the absence of indications to the contrary (e.g., a diagnosis of advanced dementia; impaired decision-making ability due to a stroke in specific brain areas), such capacity can be assumed without further evaluation of documentation unless required by the IRB.<\/p>\n<h3 id=\"7b\">Nature of decision-making impairments<\/h3>\n<p>Decision-making impairments may be permanent, temporary, progressive, or fluctuating. Also, the capacity to consent is protocol-specific and situation-specific. For example, an individual may have the capacity to make the research participation decision for a low-risk study in usual circumstances but not have the capacity in a stressful situation to understand and evaluate a high-risk study. In other words, the presence of a cognitive impairment or cognitive-state-altering circumstances does not necessarily mean that the person is incapable of an informed consent decision. However, the IRB will expect the researcher to assess the impact of the circumstances on the person&#8217;s decision-making ability about the specific participation decision.<\/p>\n<h3 id=\"7c\">Legally-authorized representative<\/h3>\n<p>If an adult&#8217;s capacity to consent is reduced, then they can participate in the research only if a <a href=\"https:\/\/www.washington.edu\/research\/glossary\/legally-authorized-representative-lar\/\">legally-authorized representative (LAR)<\/a> provides consent on their behalf. In addition, researchers must obtain some type of assent from the participant, when the individuals are capable of providing assent (<a href=\"#6e\">assent<\/a>). A careful balance of the Belmont Ethical Principles is vital to enrolling participants with diminished consent capacity. So long as the additional protections afforded by LAR consent are in place to offset the participant&#8217;s diminished autonomy, it is possible that individuals with reduced consent capacity can still participate in research.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Who can be a LAR<\/strong> is determined by the laws of the jurisdiction in which the research is conducted. There are no Washington State laws that directly address the use of LARs in research. However, <a href=\"https:\/\/app.leg.wa.gov\/rcw\/default.aspx?cite=7.70.065\" target=\"_blank\" rel=\"noopener\">Washington State law RCW 7.70.65<\/a> defines who may serve as a LAR for providing informed consent for health care. Established legal opinion has determined that it is appropriate to apply this definition of LAR for research consent as well.<\/p>\n<p style=\"margin-left: 80px;\"><strong>For information about who can be LAR for a minor<\/strong>, review the section on Parent\/Guardian Permission in <a href=\"#pgp\">Protected and Vulnerable Populations<\/a> and RCW 7.70.65(2) which describes the somewhat different requirements for an LAR for minors in Washington State, when the parents are not available.<\/p>\n<div style=\"margin-left: 80px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Washington State Law about who can be a LAR for an adult<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>A LAR for an adult<\/strong> must be a member of one of the following classes of persons in the following order or priority:<\/p>\n<ul>\n<li>The appointed guardian<\/li>\n<li>An individual, if any, to whom the person has given a durable power of attorney that encompasses the authority to make health care decisions<\/li>\n<li>Spouse or state-registered domestic partner<\/li>\n<li>Children, if they are at least 18 years old<\/li>\n<li>Parents<\/li>\n<li>Adult siblings<\/li>\n<li>Adult grandchildren, who are familiar with the person<\/li>\n<li>Adult nieces and nephews, who are familiar with the person<\/li>\n<li>An adult who meets all of the following criteria:\n<ul>\n<li>Has exhibited special care and concern for the person<\/li>\n<li>Is familiar with the person&#8217;s personal values<\/li>\n<li>Is reasonably available to make health care (and research) decisions<\/li>\n<li>Is not any of the following: a physician for the person; an employee of the person; the owner, administrator, or employee of a health care facility, nursing home, or long-term care facility where the person resides or receives care; or a person who receives compensation to provide care to the person<\/li>\n<li>Provides the following declaration, which is effective for up to 6 months, signed and dated under penalty of perjury, that recites facts and circumstances demonstrating that they are familiar with the person and that they:\n<ul>\n<li>Meet the requirements described above<\/li>\n<li>Are a close friend of the person<\/li>\n<li>Are willing and able to become involved in the person&#8217;s healthcare (or research participation)<\/li>\n<li>Have maintained such regular contact with the person as to be familiar with the person&#8217;s activities, health, personal values and morals, and<\/li>\n<li>Are not aware of a person in a higher priority class willing and able to provide informed consent on behalf of the person.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Availability<\/strong>. If reasonable efforts to locate and secure consent from a competent person in the first of succeeding class are unsuccessful, then consent may be given by any person in the next class in order of descending priority.<\/p>\n<p><strong>Disagreement among possible LARs<\/strong>. No LAR may provide consent on behalf of the person if:<\/p>\n<ul>\n<li>A person of higher priority has refused to give consent, or<\/li>\n<li>There are two or more individuals in the same class and the decision is not unanimous among all available members of that class.<\/li>\n<\/ul>\n<p><strong>Decision-making standard<\/strong>. The LAR must decide in good faith whether the person would consent to the research. If this is not possible, the LAR should consider the person&#8217;s best interests.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<h3 id=\"7d\">IRB approval and authority<\/h3>\n<p>Prior IRB approval of using LARs to obtain consent is not required by federal regulations. However, the IRB has the authority to limit, or explicitly not allow the use of LARs to obtain consent when such limits or prohibition is appropriate for a specific study.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"8\">Participants with Comprehension Barriers (e.g., language, literacy, visual impairment) or Who Cannot Write or Speak<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> Consent information must be presented in a language that is understandable to participants. Accommodations for the consent process or form specific to a particular population may be needed to ensure this requirement. Researchers and the IRB should carefully consider the ethical and legal issues of enrolling participants when a consent comprehension barrier exists. Sufficient time for an extended consent process is vital to ensuring participant comprehension and an accurate assessment of the voluntariness of their participation. Researchers must have a plan for high-quality interpretation and translation if they intend to enroll participants with non-English language preference. The short form consent process may be used for the infrequent and incidental enrollment of participants with non-English language preference. Additional precautions may be required to ensure comprehension in populations who have low literacy, are visually impaired, or cannot write or speak.<\/div>\n<\/div>\n<\/div>\n<p><strong>Researchers may encounter individuals who are interested in participating in research and have the cognitive ability to consent on their own behalf, but who have limited ability to understand or read consent information presented in English, or to sign a consent form<\/strong>.<\/p>\n<p><em>The consent process for these individuals must meet the same regulatory requirements as for any other consent process<\/em>. This includes the requirement for consent information to be presented in a language that is understandable to the participant. The researcher may need to take additional steps to ensure the participant comprehends the consent process, has adequate opportunity to ask questions, and voluntarily agrees to participate. Accommodations for the consent form or process will be specific to the needs of the particular participant(s).<\/p>\n<p style=\"margin-left: 40px;\"><em>The IRB must approve the consent plan<\/em>, including the process that will be used to ensure that oral and written information will be in a language understandable to participants throughout the study and at an appropriate reading and comprehension level. The IRB has the authority to require revisions or additions to the consent process to ensure that all participants are adequately informed and are providing truly voluntary consent.<\/p>\n<p>In keeping with the Belmont Principle of <em>Justice<\/em> that selection of participants should be equitable in terms of fairly distributing the risks and benefits of research, researchers should carefully consider the purpose of the research and the scientific question when considering the inclusion and exclusion of these participant populations. This is particularly important when the study may offer significant benefit to the individual participants or participant population.<\/p>\n<h3 id=\"8a\">Anticipated involvement of participants with non-English language preference<\/h3>\n<p>For research intended, or likely, to involve participants who are not fluent in English, researchers are responsible for ensuring all consent information and materials are presented in a language understandable by the participants and in a way that accurately conveys the information. Remembering that consent is a process, researchers must have a plan for ongoing communication between the research team and the participants throughout their participation in the research.<\/p>\n<p id=\"8a1\" style=\"margin-left: 40px;\"><strong>Interpretation<\/strong>. Researchers must describe in their IRB application how and when interpretation will be provided and the qualifications of the interpreter(s) (e.g., certifications, experience, familiarity with research-related vocabulary in English and the target language). If no member of the research team is fluent in the participant&#8217;s preferred language, interpretation services should be made available throughout the course of the research.<\/p>\n<p style=\"margin-left: 50px;\"><strong>When working with interpreters, consider the following:<\/strong><\/p>\n<ul style=\"margin-left: 60px;\">\n<li>If the participant&#8217;s family members or friends will be asked to serve as interpreter, the researcher should think carefully about privacy and confidentiality issues, particularly for research that involves health or other sensitive topics. They should also ensure that the interpreter will accurately convey the information (e.g., Are they capable of interpreting complicated biomedical information?).<\/li>\n<li>It is almost never appropriate to use children as interpreters. Exceptions may rarely be allowed when the children are considered adults in the local setting, the risks are low, there are no alternatives, and there are no potential conflicts of interest.<\/li>\n<li>Researchers should discuss the consent process, including the <a href=\"#4\">HSD Consent Considerations<\/a>, with interpreters before conducting consent. For example, how will the researcher and interpreter determine whether the participant truly understands the consent information?<\/li>\n<\/ul>\n<p id=\"8a2\" style=\"margin-left: 40px;\"><strong>Translation<\/strong>. Researchers must describe in the IRB application how translations will be obtained for consent and all study materials that will be presented to participants (e.g., surveys). The qualifications of the translator must also be described. Translated documents must be: <strong>1)<\/strong> linguistically accurate; <strong>2)<\/strong> at an appropriate reading level for the participant population; and <strong>3)<\/strong> culturally sensitive for the locale in which they will be used. The IRB review focuses on whether the translation <em>method<\/em> is appropriate rather than approving the translated text.<\/p>\n<ul style=\"margin-left: 40px;\">\n<li><strong>Translated materials that must be provided to the IRB<\/strong>. It is <strong>HSD policy<\/strong> that researchers obtain and provide the IRB with translations for all consent materials that will be provided to the participant in written or electronic form. The IRB may request translated versions of any other materials.<\/li>\n<li>The IRB will request that researchers fill out the, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-translation-attestation\/\">Translation Attestation<\/a> for studies that are greater than minimal risk or if they otherwise deem it necessary. Researchers should only submit this form in response to a request from the IRB.<\/li>\n<li><strong>Who does the translation?<\/strong> HSD does not require researchers to use a specific translation service.<\/li>\n<\/ul>\n<p id=\"8a2\" style=\"margin-left: 40px;\"><strong>Translation and Interpretation Services<\/strong>.<br \/>\n<a href=\"https:\/\/uwnetid.sharepoint.com\/sites\/uwlaca\/SitePages\/LearningTeamHome.aspx\"> 91探花Medicine Language Access and Cultural Advocacy<\/a> has many resources that are available to all  91探花researchers, even when the study is not taking place at  91探花Medicine or Harborview. Interpretation services can be accessed anywhere telephone service or video conferencing are available. You can contact them directly at <a href=\"mailto:uwlaca@uw.edu\">uwlaca@uw.edu<\/a>.<\/p>\n<h3 id=\"8b\">Unanticipated involvement of participants with a non-English language preference<\/h3>\n<p>The regulations allow an alternative method of obtaining and documenting consent called <strong>short form consent<\/strong>. This method is intended to be used only for the infrequent and unanticipated enrollment of an individual with a non-English language preference in a study for which no consent form in the participant&#8217;s language has been prepared and there is insufficient time and opportunity to obtain an appropriate written translation of the IRB-approved English consent forms.<\/p>\n<p>It is <strong> 91探花policy<\/strong> that:<\/p>\n<ul>\n<li>The short form method may only be used when an appropriately qualified interpreter will be available to the participant throughout their participation in the research.<\/li>\n<li><strong>For minimal risk research that is not FDA regulated<\/strong>, the IRB does not need to approve the use of the short form method in advance, and no additional steps are required following use of the short form.<\/li>\n<li><strong>For research that is more than minimal risk or is FDA regulated, the short form method may only be used with advance approval from the IRB.<\/strong> The appropriateness of the short form method for the research and target study population is generally assessed by the IRB at the time of initial review. If not assessed at the time of initial review, a study modification must be submitted requesting use of the short form method. The IRB will determine if there is sufficient justification for obtaining participant consent without waiting for translation of the consent form and consider if use of the short form in this circumstance will provide the participant with sufficient opportunity to understand the information presented.<strong>In addition, the following steps must be taken after a participant is enrolled using the short form method:<\/strong>\n<ul>\n<li>The use must be reported to the IRB <strong>asap (no later than 30 days after use)<\/strong> as a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/modifications-to-uw-reviewed-studies\/\">Study Modification<\/a> with the study consent form translated into the participant\u2019s language.<\/li>\n<li>Once the translated consent form has been reviewed and approved by the IRB, it must be provided to the participant <strong>within 2 weeks<\/strong> of IRB approval. The consent form does not have to be provided to the participant in person. It could, for example, be sent by email. It does not require any signature. The translated consent form must thereafter be kept up to date.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><a name=\"8b1\"><\/a><\/p>\n<h4 id=\"8b1\">Short Form Consent Process<\/h4>\n<ul>\n<li><strong>Short form written consent form<\/strong>. This generic document states that the required elements of consent (unless waived by the IRB) have been presented to the participant in their language of preference, with Key Information being presented first. The short form written consent form must be translated into the participant&#8217;s language of preference so that literate participants have the opportunity to read it. A pre-approved English version of the short form and translations in common languages spoken in King County are posted on the HSD website [<strong><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/templates\/\"> 91探花Consent Templates<\/a><\/strong>]. The  91探花short form should be used by  91探花studies and for sites that are relying on the  91探花IRB for review <strong>unless this conflicts with the policy of the relying site institution<\/strong>. Contact <a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a> if the language you need is not posted. The short form written consent form is signed by the participant and a witness. A copy of the form is provided to the participant.<\/li>\n<li><strong>Summary document<\/strong>. The IRB must approve a written summary of the information that will be presented orally to the participant during the consent process. This summary is almost always the IRB-approved English version of the consent form that is presented by a member of the research team through use of a qualified interpreter. The summary document is signed by the witness and the person obtaining consent. A copy of the form is provided to the participant, but it is not signed by the participant.<\/li>\n<li><strong>Witness<\/strong>. The short form process requires an observer to the oral presentation of the consent information and the participant&#8217;s voluntary participation.\n<ul>\n<li><strong>They must be an impartial adult<\/strong> (i.e., not a member of the research team and not an advocate for either the researcher or the participant).<\/li>\n<li><strong>They should have sufficient proficiency in the language of the oral presentation<\/strong> to be able to attest to the information that was presented orally to the prospective participant. The interpreter may serve in this role provided that they are not a member of the research team. The interpreter should be asked about serving as an impartial observer <strong>before<\/strong> starting the consent process. If the interpreter is unable or unwilling to serve in this role and there is no other impartial adult with sufficient language proficiency available, the researcher may forego the language proficiency requirement provided that:\n<ul>\n<li>The study offers the prospect of direct benefit to the participant.<\/li>\n<li>The attempt to identify an impartial adult with language proficiency to serve as witness is documented.<\/li>\n<\/ul>\n<\/li>\n<li><strong>They must be present physically or by phone or video conference<\/strong> for the oral presentation and signing of the forms. The purpose of this role is generally to attest to: 1) the voluntariness of the participant\u2019s consent; 2) that the consent information was accurately communicated; and 3) that the participant\u2019s questions were answered.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4>Interpreter Services for Short Form Consent<\/h4>\n<p><a href=\"https:\/\/uwnetid.sharepoint.com\/sites\/uwlaca\/SitePages\/LearningTeamHome.aspx\"> 91探花Medicine Language Access and Cultural Advocacy<\/a> has on their website information about <a href=\"https:\/\/uwnetid.sharepoint.com\/sites\/uwlaca\/SitePages\/Contracted Vendors.aspx\">interpreter services<\/a> that are available to all  91探花researchers and additional information about <a href=\"https:\/\/uwnetid.sharepoint.com\/sites\/uwlaca\/SitePages\/Completing-Short-Form-Consents-via-interpreters.aspx\">use of interpreters for short form consent<\/a>. Researchers who wish to have the interpreter sign the short form document as a witness should be aware that:<\/p>\n<ul>\n<li>It is generally <strong>not<\/strong> the professional practice of certified medical interpreters to sign documents as witnesses.<\/li>\n<li>Telephonic and video interpretation vendors contracted with  91探花Medicine are <strong>not<\/strong> able to sign as witnesses.<\/li>\n<li>It is important to discuss the short form process with the in-person interpreter when scheduling their services to confirm that they agree to sign as a witness.<\/li>\n<\/ul>\n<h3 id=\"8c\">Participants with low literacy<\/h3>\n<p>It is <strong>HSD policy<\/strong> to generally apply the guidelines described in the FDA Guidance on Informed Consent when enrolling participants who are illiterate or who have low literacy.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">FDA guidelines<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Consent materials are read to the participant in the presence of an impartial witness who observes the entire consent process.<\/li>\n<li>Sufficient time is allowed for questions to ensure participant comprehension.<\/li>\n<li>Researchers may consider using a video or audio recording of the consent process as part of documenting consent. If the consent process is not captured by audio or video, the researcher should create a written description of how the consent information was communicated to the participant and how the researcher ensured the participant&#8217;s questions were answered.<\/li>\n<li>If the IRB did not waive documentation of consent, the participant documents their willingness to participate by signing, or marking an X, on the consent form. The witness and the researcher should also sign and date the form. On rare occasions, the IRB may approve a process that involves reading the consent form to the participant and noting the consent in some official record that is not part of the research records (e.g., the participant&#8217;s medical record).<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<h3 id=\"8d\">Participant with visual impairments<\/h3>\n<p>The consenting process described above for illiterate individuals may be used, but it is preferable to provide the participants with an electronic copy of the materials which can then be examined by using an electronic device (e.g., computer) with a screen reader. In general, the use of Braille-based materials is discouraged.<\/p>\n<h3 id=\"8e\">Participant who cannot write a signature on a consent form<\/h3>\n<p>A participant may be unable to physically sign a consent form due to some impairment (e.g., injury to hands). in these cases, the participant may &#8220;sign&#8221; the form by marking an X on the signature line. An impartial witness should witness the mark and sign the form. If the participant cannot use their hands at all, the IRB will consider alternative methods of documenting consent.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"9\">Electronic Consent<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> Electronic methods of consent may be useful for remote and in-person consent procedures. It is important to consider the participant populations&#8217; needs and capabilities related to technology when opting to use e-consent. When conducting consent remotely, researchers should carefully consider methods to ensure participant comprehension including making sure there is a way participants can have their questions answered by the research team. FDA-regulated studies using e-consent must comply with the <a href=\"https:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/ucm125125.pdf\" target=\"_blank\" rel=\"noopener\">FDA Part 11 requirements<\/a>. Watch HSD&#8217;s tutorial, <a href=\"https:\/\/www.washington.edu\/research\/learning\/online\/index.php\/lessons\/electronic-consent-what-you-need-to-know\/\">Electronic Consent: What You Need to Know<\/a> for an overview.<\/div>\n<\/div>\n<\/div>\n<p><strong>Electronic informed consent (&#8220;e-consent&#8221;)<\/strong> refers to the use of electronic systems and processes that employ some type of electronic media (including text, graphics, audio, video, podcasts, passive and interactive websites, biological recognition devices, card readers, etc.) to convey consent information and\/or to document informed consent. These may be used in place of, or in combination with, paper-based consent methods.<\/p>\n<h3 id=\"9a\">Paper vs. e-consent &#8211; choosing the appropriate method<\/h3>\n<p>E-consent processes are invaluable when it is not possible to have an in-person interaction with a participant. E-consent can take many different forms including, consent information or documents that are delivered electronically (e.g., email, text message); passive or interactive websites; social media platforms; audio; video; podcasts; or any combination of these. E-consent may also be useful and appropriate for in-person consent interactions. For example, a consent form may be emailed in advance to a potential participant, followed by an in-person meeting in which the study is discussed, after which an electronic signature is obtained.<\/p>\n<p>E-consent allows for using images, animations, embedded comprehension checks, and other technological tools that can improve consent comprehension. However, there are also potential limitations to using e-consent. The participant population will require infrastructure (e.g., reliable internet connection), hardware (e.g., smartphone, computer), and technological experience in order to benefit from the potential advantages of e-consent.<\/p>\n<p>When choosing whether to employ paper-based consent or e-consent, it is important to <em>understand the needs and capabilities of the participant population(s)<\/em>. To ensure participant comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods.<\/p>\n<h3 id=\"9c\">Facilitating comprehension and the opportunity to consider participation<\/h3>\n<p>When consent is not an &#8220;in-person&#8221; process, the researcher and the IRB must consider how participants will be provided with an opportunity to ask questions and have the research team answer them (if appropriate) and\/or whether alternative ways of facilitating comprehension may be appropriate. For example, this may be accomplished through telephone calls, electronic messaging (examples: email, text messages), video conferencing, live chat, or other methods. Regardless of the participant&#8217;s location, there may also be optional information (for example, hyperlinks or help text) embedded in the electronically delivered material to aid in comprehension of key study elements. Similarly, participants may be asked questions embedded during the electronic process to gauge their comprehension.<\/p>\n<h3 id=\"9b\">Regulatory requirements for e-consent<\/h3>\n<p>Electronic delivery of consent information must meet the same human participants regulatory requirements as paper-based delivery of the information. This includes ensuring the information is accessible by participants for the duration of the research and is easily retrievable for auditors and monitors.<br \/>\n<strong>FDA-regulated research<\/strong>. Use of electronic systems, archiving, and retention of consent materials must meet the <a href=\"https:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/ucm125125.pdf\" target=\"_blank\" rel=\"noopener\">FDA &#8220;Part 11&#8221; requirements<\/a>. The Part 11 regulations are separate from the FDA&#8217;s human subjects regulations and have nothing to do with IRB review and approval. Part 11 compliance is the responsibility of the researcher.<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>The Part 11 requirements are outlined in the <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application\" target=\"_blank\" rel=\"noopener\">FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures \u2013 Scope and Application (September 2003)<\/a>.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3 id=\"9d\">Electronic Documentation of Consent (e-signature)<\/h3>\n<p>Review <a href=\"#10\">Documentation of Consent<\/a>.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"10\">Documentation of Consent<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> Participants must document their agreement to participate in research by signing the consent form, unless the IRB has waived that requirement. Signatures may be handwritten or electronic. There are additional regulatory requirements specific to e-signatures. Four e-signature tools have been vetted by the UW:  91探花eSignatures (powered by Docusign),  91探花Florence eConsent,  91探花Medicine Research IT (RIT) REDCap Part 11, and  91探花ITHS REDCap. Only  91探花Florence eConsent and  91探花Medicine RIT REDCap Part 11 meet the requirements outlined in 21 CFR 11 that are necessary for FDA regulated research. Instructions for using those tools can be found at <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/econsent\/\"> 91探花E-Consent Tools<\/a>. Using other e-consent methods is considered on a case-by-case basis (<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#10e\">Approvable methods for obtaining electronic signatures<\/a>).<\/div>\n<\/div>\n<\/div>\n<p><strong>Documentation of Consent<\/strong>. Prior to initiating any research activities, including screening procedures or extracting information from records, federal regulations require that the participant sign the IRB-approved consent form and that a copy of the consent form be provided to the participant. HSD considers it best practice for the participant to receive a copy of the consent form that they have signed and dated, but it is not a regulatory requirement.<\/p>\n<p><strong>Waiver of documentation of consent<\/strong>. Alternatively, the IRB may grant a waiver of documentation of consent if the criteria are met (<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/#waivedoc\">Conditions for waiving documentation of consent<\/a>). Most minimal risk studies will qualify for a waiver of documentation of consent. If a waiver is granted, none of the requirements listed below in this section apply to the study.<\/p>\n<p><strong>Researchers must provide the IRB with a written description of what participants will be told during the consent process<\/strong>, even if consent will not be documented (i.e., no consent form). The process and information presented must include the general requirements and elements of consent as described in the guidance on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/\">Designing the Consent Process<\/a>. HSD recommends, and the IRB may require, that researchers provide participants with a written description of the consent information (e.g., information statement) even when a waiver of consent documentation has been granted (i.e., no consent form).<\/p>\n<h3 id=\"10a\">Required Signatories<\/h3>\n<h4>Standard Consent<\/h4>\n<p style=\"margin-left: 40px;\"><strong>Participant<\/strong>. The participant is required to sign and date the consent form to document that all their questions have been answered and they agree to participate in the research.<\/p>\n<p style=\"margin-left: 40px;\">When a legally authorized representative (LAR) or parent\/guardian provides consent, the participant&#8217;s name should be printed on the participant&#8217;s signature line. Ideally there should be a designated line for the LAR or parent\/guardian signature and date, but this information can be added anywhere in the signature area of the consent form. The LAR or parent\/guardian name and relationship to the participant should also be recorded in the signature area.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Researcher<\/strong>. It is <strong>HSD policy<\/strong> that for greater than minimal risk research, the consent form must contain the legible name of the person who obtained consent from the participant. The person&#8217;s signature is not required. The name may be placed on the consent form in advance of the consenting interaction. It is best practice to date the form at the time when consent is obtained. By placing their name on the consent form, the researcher is confirming that they provided the participant with information about the study, that the participant was given sufficient time to consider participation, that the researcher answered all the participant&#8217;s questions, and that the participant indicated they understood the nature of the study, including the risks and benefits of participating.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Witness<\/strong>. Witness signatures are required by federal regulations in limited circumstances (e.g., when using short form consent) or may be required by the IRB to ensure an adequate informed consent process. A witness signature documents that the requirements for consent have been satisfied and that consent was voluntarily given by the participant.<\/p>\n<h4>Short Form Consent<\/h4>\n<p>Review <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#8b\">HSD policy<\/a> before using the short form process. When it is allowed, the short form process includes the short form itself and a summary document and must involve an impartial (not a member of the research team) adult witness who is fluent in both English and the participant\u2019s primary language.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Short form written consent form.<\/strong> Use one of the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/templates\/\">HSD provided translations<\/a> or contact HSD if the language you need is not provided. The short form is signed by the participant and the witness. A copy is provided to the participant.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Summary document.<\/strong> This is a written summary of the information that will be presented orally to the participant during the consent process and is usually the English version of the full consent form. The summary document is signed by the person obtaining consent and the witness. A copy is provided to the participant, but the participant should not sign it.<\/p>\n<h3 id=\"10b\">Verification of identity<\/h3>\n<p>This refers to the process for confirming that the individual who provided the signature is the participant. This can be accomplished in a number of ways such as: the research team visually witnesses the signature; participants share some form of official identification with the research team (e.g., scanned copy or digital photo); the participant answers security questions (similar to questions sometimes used by banks).<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>General principle<\/strong>. A signature that is personally witnessed by a member of the study team, either in-person or visually using a video conferencing service (e.g., Zoom, Facetime, Skype) is generally considered sufficient verification and documentation of a participant&#8217;s identity. In all other circumstances, federal Common Rule guidance encourages researchers and the IRB to apply a risk-based approach to determine if more formal verification is required. For example, how likely is it that someone other than the participant would provide the consent and signature, and how risky would that be to the actual participant and to the integrity of the study?\n<ul>\n<li>Examples where more formal verification might be appropriate include: <strong>1)<\/strong> a study that involves giving alcohol to participants (verify age); <strong>2)<\/strong> a longitudinal study where it is necessary to ensure that the same person is providing information over time; and <strong>3)<\/strong> a study involving access to sensitive data such as a person&#8217;s mental health or sexually-transmitted infection (STI) records.<\/li>\n<\/ul>\n<\/li>\n<li><strong>FDA-regulated research<\/strong>. The <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/use-electronic-informed-consent-clinical-investigations-questions-and-answers\" target=\"_blank\" rel=\"noopener\">FDA requires verification of identity<\/a> when electronic signatures (per the <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-11\/subpart-C\" target=\"_blank\" rel=\"noopener\">FDA definition of e-signature<\/a>) are used to document consent. Review <a href=\"#10e\">Approvable Methods for Obtaining Electronic Signature<\/a> for details but briefly:\n<ol>\n<li> 91探花eSignatures (powered by Docusign) and  91探花ITHS REDCap are not valid for FDA-regulated research;<\/li>\n<li> 91探花Florence eConsent meets FDA 21 CFR Part 11 signature requirements; and<\/li>\n<li>FDA considered the  91探花Medicine RIT REDCap Part 11 signature tool a &#8220;hand-written&#8221; signature so the identity verification requirements under 21 CFR 11.100(b) do not apply.<\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3 id=\"10c\">Signature format<\/h3>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>Handwritten signature<\/strong> using a permanent method (e.g., ballpoint pen).<\/li>\n<li><strong>Electronic signature<\/strong> (e.g., REDCap,  91探花Florence eConsent, or  91探花eSignatures).<\/li>\n<li><strong>Other formats<\/strong>. Review <a href=\"#8\">Participant With Comprehension Barriers or Who Cannot Write or Speak<\/a> for alternative formats.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3 id=\"10d\">Approvable methods for obtaining handwritten signatures<\/h3>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>The participant signs the consent form in the presence of the researcher. The research may begin immediately.<\/li>\n<li>The participant receives the consent form by mail or email, the consent discussion occurs by phone or video, the participant signs the form and texts or emails a photo of the signature to the researcher, and the participant mails the signed consent form to the researcher. The research may begin as soon as the researcher receives the photo of the signature.<\/li>\n<li>The IRB may approve other methods so long as they meet regulatory requirements and are consistent with any applicable local law.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3 id=\"10e\">Approvable methods for obtaining electronic signatures<\/h3>\n<p>There are many electronic alternatives to a handwritten signature, including: electronic signatures using tools such as  91探花eSignatures (powered by Docusign),  91探花Florence eConsent, or REDCap; digital signatures; computer-readable ID cards; biometrics; or username and password combinations. Watch HSD&#8217;s tutorial, <a href=\"https:\/\/www.washington.edu\/research\/learning\/online\/index.php\/lessons\/electronic-consent-what-you-need-to-know\/\">Electronic Consent: What You Need to Know<\/a> for an overview.<\/p>\n<p style=\"margin-left: 40px;\"><strong>There are four electronic signature tools that have been vetted by the UW<\/strong> and its legal counsel as meeting the federal and Washington State definitions of a &#8220;legally valid&#8221; electronic signature. Review the instructions for using <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/econsent\/\"> 91探花E-Consent Tools<\/a> for more information.<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul style=\"margin-left: 40px;\">\n<li><strong> 91探花Medicine RIT REDCap Part 11<\/strong> is provided and supported by  91探花Medicine Research Information Technologies ( 91探花Medicine RIT).<\/li>\n<li><strong> 91探花ITHS REDCap<\/strong> is hosted and administered by  91探花Medicine Research Information Techologies ( 91探花Medicine RIT).\n<ul>\n<li>NOTE: The REDCap Mobile software application <strong>does not<\/strong> support a &#8220;legally valid&#8221; electronic signature under federal and Washington State law.<\/li>\n<\/ul>\n<\/li>\n<li><strong> 91探花Florence eConsent<\/strong> is managed by the  91探花Clinical Trial Office (CTO).<\/li>\n<li><strong> 91探花eSignatures (powered by Docusign)<\/strong> is an electronic signatures service provider, centrally managed and supported by UW-IT.\n<ul>\n<li>Not valid for FDA-regulated research (details in <a href=\"#fda\">Requirements specific to electronic consent documentation<\/a>).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"margin-left: 40px;\"><strong>Using a non- 91探花or other UW-managed REDCap installation (exluding  91探花ITHS REDCap and  91探花Medicine RIT REDCap Part 11)<\/strong>\u00a0may be permitted, so long as it meets all of the requirements outlined in the supplement, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/supplement-other-redcap-installation\/\">Other REDCap Installation<\/a> and a copy is provided with the IRB application.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Using an e-consent method not vetted by the UW<\/strong> is permitted on a case-by-case basis. The researcher must provide (as part of their Zipline application) a signed <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-other-esignature-attestation-letter\/\">Other E-Consent Tool Attestation Letter<\/a> confirming the signature system meets all the applicable e-signature laws in the jurisdiction where the signature will be obtained and follows best practices for technical security. This letter must be signed by the Chief Information Officer, Chief Information Security Officer, or other individual at the company\/institution with sufficient authority and subject matter expertise to make the above attestation. Due to limited resources, HSD and the  91探花cannot vet other non-enterprised supported e-consent methods.<\/p>\n<p style=\"margin-left: 40px;\"><strong>HSD and\/or IRB approval<\/strong>. It is <strong>HSD policy<\/strong> that that IRB approval must be obtained in advance for the use of any e-signature or electronic signature capture system (e.g.,  91探花eSignatures,  91探花Florence eConsent,  91探花Medicine RIT REDCap Part 11,  91探花ITHS REDCap).<\/p>\n<h4 id=\"econsentrequirements\"><strong>Regulatory requirements specific to electronic consent documentation<\/strong><\/h4>\n<p style=\"margin-left: 40px;\">Electronic documentation of consent must meet the same requirements as for handwritten signatures in addition to the following requirements that are specific to electronic consent documentation:<\/p>\n<div id=\"fda\" style=\"margin-left: 40px;\">\n<ul>\n<li><strong>Legally effective electronic signature<\/strong>. The signature method must be consistent with general laws about electronic signatures in the jurisdiction in which the research will be conducted. Only  91探花eSignatures (powered by Docusign),  91探花Florence eConsent,  91探花Medicine RIT REDCap Part 11, and  91探花ITHS REDCap have been vetted as meeting U.S. federal and Washington State requirements. HSD cannot advise researchers about the legality of other e-signature methods.<\/li>\n<li><strong>Additional required consent\/HIPAA authorization information<\/strong>. Washington State and federal e-signature laws require specific information to be provided to participants when signatures are obtained electronically or through capture of a handwritten signature as an electronic record. These requirements are listed in the worksheet, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-consent\/\">Consent Requirements and Waivers<\/a>. These requirements also apply to e-signature for HIPAA authorizations. Read our <a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-hipaa-2\/\">HIPAA guidance<\/a> for more information.\n<ul>\n<li>It is HSD&#8217;s general expectation that this additional required information is provided in the consent form(s). In rare instances, HSD may permit the required information to be communicated to study participants via an alternative method. For example, a  91探花researcher participates in a multicenter trial using an external IRB and there may be no UW-site-specific form that can include this information. Any alternative method of providing this additional required information must still provide the information: <strong>1)<\/strong> in writing; <strong>2)<\/strong> prior to obtaining documentation of informed consent or authorization (e-signature); <strong>3)<\/strong> in a manner that allows the participant to print, access it at a later date, or otherwise retain a copy in some fashion.<\/li>\n<\/ul>\n<\/li>\n<li><strong>FDA-regulated research<\/strong>. The <strong id=\"ki\">key issues<\/strong> to consider are <strong>(a)<\/strong> the FDA&#8217;s definition of &#8220;electronic signature&#8221;; <strong>(b)<\/strong> the general Part 11 regulations about electronic systems; and <strong>(c)<\/strong> whether verification of the participant&#8217;s identity is required.\n<ul>\n<li><strong> 91探花Medicine RIT REDCap Part 11<\/strong> and <strong> 91探花Florence eConsent<\/strong> meet these requirements.<\/li>\n<li><strong> 91探花ITHS REDCap<\/strong> and <strong> 91探花eSignatures (powered by Docusign)<\/strong>\u00a0<strong>do NOT meet these requirements<\/strong>.<\/li>\n<li><strong>Other e-consent tools<\/strong> must be considered against the three <strong>key issues<\/strong> named above.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n<h4>Special considerations<\/h4>\n<ul>\n<li><strong>HIPAA authorization<\/strong>. Users cannot edit the UW\/Fred Hutch Cancer Center HIPAA Authorization template to add any missing electronic consent elements. Instead, any missing consent elements should be added to the consent form. Example language is provided on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/#econsent\">Designing the Consent Process<\/a>. For authorization to obtain\/access PHI at any other HIPAA-covered institution, consult that institution&#8217;s privacy and\/or health records information office.<\/li>\n<li><strong>Review by an external IRB<\/strong>. It is <strong>HSD policy<\/strong> that  91探花research that is being reviewed by an external IRB instead of the  91探花IRB must obtain HSD concurrence before implementing the use of e-signatures for consent and\/or HIPAA authorization. This is accomplished by answering the e-signature questions in the <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/external-irb-review\/\">External IRB Review request form<\/a> and, if applicable, uploading the <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/supplement-other-redcap-installation\/\">Other REDCap Installation supplement<\/a> or <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-other-esignature-attestation-letter\/\">Other E-Consent Tool Attestation Letter<\/a> to the <em>Local Site Documents<\/em> SmartForm in Zipline.<\/li>\n<li><strong>International research<\/strong>. Other countries may have their own laws regarding the legal validity of an e-signature and what methods of capture are acceptable. It is the researcher&#8217;s responsibility to be aware of and comply with these laws. Review online resources such as <a href=\"https:\/\/www.docusign.com\/how-it-works\/legality\/global\" target=\"_blank\" rel=\"noopener\">Docusign eSignature Legality Guide<\/a>. This resource is published by Docusign and is informational only. HSD cannot guarantee that it remains current and accurate. Collaborating partners and experts in the target country(ies) may also be consulted.<\/li>\n<\/ul>\n<h3 id=\"10f\">Approval watermark<\/h3>\n<p>The  91探花IRB system (&#8220;Zipline&#8221;) automatically places a watermark on consent forms when IRB approval is granted. It is best practice (but not required) for researchers to use the Zipline watermarked version of the consent form. Any non-watermarked version used must match exactly the content and format of the IRB-approved watermarked version.<\/p>\n<h3 id=\"10g\">Records retention and access<\/h3>\n<p>The original signed consent form, regardless of format (e.g., paper, electronic) is considered a research record and federal regulations require researchers to retain consent forms for a minimum of three years after completion of the research. Washington State records retention periods are much longer (<a href=\"https:\/\/finance.uw.edu\/recmgt\/gs\" target=\"_blank\" rel=\"noopener\"> 91探花Records Management website<\/a>).<\/p>\n<p>Signed consent materials must be easily retrievable for auditors and monitors.<\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"11\">Reconsent and Ongoing Participant Communication<\/h2>\n<div class=\"box-outer\">\n<div class=\"box one\">\n<div style=\"box-shadow: 2px 3px 4px rgba(0, 0, 0, 0.5); border-left: 15px solid #4b2e83; padding: 20px;\"><strong style=\"color: #4b2e83;\">Key take-away.<\/strong> The IRB will determine the method by which new or revised information is communicated to participants and whether consent is required. Below is guidance and examples of situations when <em>verbal discussion<\/em>, <em>letter or email<\/em>, <em>consent addendum<\/em>, or <em>a full reconsent using a revised consent form<\/em> may be appropriate.<\/div>\n<\/div>\n<\/div>\n<p>Throughout the course of a study, participants may need to be informed about new information or consent may need to be revisited due to fluctuating decision-making capacity [<a href=\"#7\">Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR)<\/a>] or because a child participant has reached the age of majority (review the section on Children under <a href=\"#6\">Protected and Vulnerable Populations<\/a>). In these situations, it is important for participants to be able to reaffirm their willingness to participate in research.<\/p>\n<p><strong>The regulations<\/strong> do not provide details about how new information should be provided and do not specifically mention &#8220;reconsent&#8221;, although the Secretary&#8217;s Advisory Committee on Human Research Protections (SACHRP) provides <a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/april-7-2020-attachment-a2-reconsent-appendix-2\/index.html\">recommendations on reconsent<\/a>. Ultimately, it is up to the IRB to determine whether reconsent is required and to identify the most appropriate method for communicating new or revised information. In making this determination, the IRB should consider:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Study status (procedures: not yet begun; ongoing; limited to long-term follow-up; complete)<\/li>\n<li>Time sensitivity of the information<\/li>\n<li>Magnitude of the changes and their likelihood to influence a participant&#8217;s decision to continue participation<\/li>\n<li>Enrollment of any participants with non-English language preference<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Methods for providing new information to participants. <\/strong>These methods are based on the SACHRP recommendations and an article from WCG IRB. The  91探花IRB may consider alternative methods.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Verbal discussion.<\/strong> This method may be appropriate for communicating information that: <strong>(1)<\/strong> is simple;<strong> (2)<\/strong> does not change the individual participant&#8217;s anticipated risks or benefits; <strong>(3)<\/strong> is not likely to affect a participant&#8217;s willingness to continue participation; and<strong> (4)<\/strong> does not require documentation that participants are willing to remain in the study.<\/p>\n<div style=\"margin-left: 80px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Examples<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Eliminating certain procedures from a study visit<\/li>\n<li>Payment method being changed from cash to a gift card<\/li>\n<li>A verbal discussion may be the first step for time sensitive information that should be shared immediately with participants while a written notification (e.g., consent addendum; revised consent form) is being prepared<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p style=\"margin-left: 40px;\"><strong>Letter or email.<\/strong> Sending the new information in a letter or by email may be appropriate when:\u00a0<strong>(1)<\/strong> the information is\u00a0easy to understand; <strong>(2)<\/strong> the information is not likely to affect a participant&#8217;s willingness to participate; and <strong>(3)<\/strong> it is important for participants to have the information in writing for future reference.<\/p>\n<div style=\"margin-left: 80px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Examples<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>A new questionnaire is being added to the weekly battery of measures that participants complete that does not change the type of scope of questions that were already being asked and is estimated to increase participation time by about 5-7 minutes each week<\/li>\n<li>A confidentiality breach is described in a Report of New Information (RNI). This risk is already described in the consent form but as part of the corrective action plan, the IRB determines that participants should be informed of the breach.<\/li>\n<li>Informing participants that there is a new principal investigator<\/li>\n<li>Informing participants that they can use a commercial lab for blood draws<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p style=\"margin-left: 40px;\"><strong>Consent addendum.<\/strong> This method may be appropriate for complicated or important information that requires consent because it <strong>(1)<\/strong> may impact a participant&#8217;s willingness to continue participation; but <strong>(2)<\/strong> does not require a full reconsent and review of the entire study. An addendum tends to be the least burdensome for participants as it allows them to focus on the new information as they consider whether they want to continue participation. For this reason, HSD recommends the use of a consent addendum, rather than a re-review of the entire consent form, for most situations.<\/p>\n<div style=\"margin-left: 80px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Examples<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>A modification to add a new battery of measures is submitted; the new measures include sensitive mental health topics that participants did not previously consent to<\/li>\n<li>The researchers want to add a new genetic analysis to the samples already being collected for the study<\/li>\n<li>New research-related risks are identified or there is an increase in the frequency or magnitude of previously described risks<\/li>\n<li>A decrease in anticipated benefits to participants is identified<\/li>\n<li>New or alternative therapies are identified (e.g., FDA approval of a new drug or device for the condition under study) or there is a change on the impact of participation on alternative therapies [e.g., the investigational drug or device reduces the effectiveness of alternative treatment(s)]<\/li>\n<li>When a study includes online or in-app check-ins, a consent refresher or informing participants about changes to the research can occur electronically with a checkbox or other method for the participant to confirm they wish to continue participation<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p style=\"margin-left: 40px;\"><strong>Reconsent. <\/strong>This method requires the most time and effort and should be used when <strong>(1)<\/strong> there is no time sensitivity; and <strong>(2) <\/strong>the new information is complicated and\/or affects many aspects of the study. A full reconsent is required when a LAR consent or parental permission is being replaced by the participant consenting on their own behalf.<\/p>\n<div style=\"margin-left: 80px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Examples<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>Participants are moving into a new phase of the study with very different procedures<\/li>\n<li>Many changes are being made to the study<\/li>\n<li>A participant enrolled with parental permission as a minor reaches the age of majority and must provide adult consent<\/li>\n<li>Changes in the cognitive functioning, mental health, or physical health of the participant have occurred over the course of the research and the participant can replace LAR consent with consent on their own behalf<\/li>\n<li>There is a significant delay between providing consent and beginning the study<\/li>\n<li>Participants are enrolled in a longitudinal study and a consent refresher may be appropriate even if procedures have not changed<\/li>\n<li>There are concerns about the way in which consent has been obtained (e.g., the wrong version of the consent form was used; study staff have not been appropriately trained in obtaining consent)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><strong>Additional considerations.<\/strong><\/p>\n<p style=\"margin-left: 40px;\"><strong>Study status.\u00a0<\/strong>In many cases, multiple approaches will be required depending on where participants are in the course of the study. For example, if new risks are identified for a study in which enrollment is ongoing, it might be appropriate to provide participants who have already been enrolled with an addendum while also updating the consent form for participants who have not yet been enrolled.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Revised consent form.\u00a0<\/strong>Changes to the consent form do not necessarily require researchers to inform all enrolled participants. Researchers should use the information in this guidance to assess the new\/revised information and determine what, if any, method should be used to inform participants of new information and\/or obtain reconsent. Note that some sponsors or funders may require a full reconsent for any change to the consent form. In these cases, HSD defers to the sponsor\/funder.<\/p>\n<p style=\"margin-left: 40px;\"><strong>Waiver of documentation of consent.\u00a0<\/strong>The IRB should assess the criteria for waiving documentation of consent when reconsent is being obtained whether it is an addendum, or full consent, or some alternative method.<\/p>\n<div style=\"margin-left: 80px;\">\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Examples<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li>New risk information alters the IRB&#8217;s previous determination that the study is no greater than minimal risk and waiver of documented consent. The IRB requires a full reconsent for all enrolled participants including obtaining documentation.<\/li>\n<li>A new genetic analysis is presented to participants in the form of an addendum. Although the overall study is greater than minimal risk and requires documentation of consent, the new component is minimal risk, so the IRB waives documentation of consent for the addendum.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"rcw\">Washington State Law and Consent<\/h2>\n<h3 id=\"audio\">Washington State Law on Consent for Recording Private Communication (RCW 9.73.030)<\/h3>\n<p>When a <strong>private communication or conversation<\/strong> between two or more individuals will be captured, Washington State law requires that consent must be obtained from all individuals who will be recorded. The law applies if any participant in the conversation or communication is in Washington State at the time of recording.<\/p>\n<p><strong>Private<\/strong> refers to situations in which an individual can reasonably expect privacy, such as a confidential interview with a research participant or a conversation between doctor and patient. In some circumstances, it can be challenging to determine whether a communication or conversation is private. This will be assessed by HSD staff as part of the HSD\/IRB review process.<\/p>\n<p><strong>Communication or conversation<\/strong> includes any exchange captured through audio, video with audio, text, or digital transcription.<\/p>\n<p>Consent may be obtained from a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#7\">legally authorized representative<\/a> when appropriate. If a child will be recorded, permission should be obtained from a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/#6\">parent or guardian<\/a>.<\/p>\n<p><strong>Consent methods.<\/strong> The Washington State law consent requirement for audio recording may be satisfied using various methods:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ol>\n<li><strong>Written consent.<\/strong> This can be a short statement signed by participants (included with research consent or separately). This option is generally appropriate when the research plan is to obtain documented consent from research participants.<\/li>\n<li><strong>Recording verbal consent with the communication or recording an announcement that the conversation is being recorded.<\/strong> This option is generally appropriate when the research plan is to obtain verbal consent and the IRB approves a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/#4\">waiver of the requirement for documented consent<\/a> under human subjects regulations.<\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Consent should consider the individuals\u2019 preferred language(s), literacy, and whether individuals may be subject to coercion if they decline to be recorded (e.g., an employee unable to perform their job duties in an area being recorded).<\/p>\n<p><strong>Recording in a healthcare setting.<\/strong><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>HIPAA requirements:<\/strong> When in a healthcare setting, recordings are likely to capture Protected Health Information (PHI). If PHI will be captured on the recording, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-hipaa-authorization\/\">HIPAA Authorization<\/a> must be obtained from the participant <strong>unless<\/strong> the IRB approves a Waiver of HIPAA Authorization. Refer to HSD\u2019s <a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-hipaa-2\/\">HIPAA Guidance<\/a> for more information about HIPAA requirements.<\/li>\n<li><strong> 91探花Medicine approval:<\/strong>  91探花Medicine policy requires approval from the applicable  91探花Medicine entity\u2019s Chief Executive Officer or Executive Director when audio recordings will be made for research purposes in a  91探花Medicine clinical setting. Refer to the <a href=\"https:\/\/depts.washington.edu\/comply\/audio-recordings\/\">Audio Recordings in a Clinical Setting policy and FAQ<\/a> on the  91探花Medicine Compliance website for more information about this requirement. The IRB may request documentation of  91探花Medicine approval.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"12\">Related Materials<\/h2>\n<h3>Other Consent Materials<\/h3>\n<p><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/examples\/\">Consent Examples<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/templates\/\">Consent Templates<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/example-key-info\/\">EXAMPLE Key Information<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-consent-elements-externally-reviewed-studies\/\">GUIDANCE Consent Elements for Externally Reviewed Studies<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/\">GUIDANCE Designing the Consent Process<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/econsent\/\">INSTRUCTIONS  91探花E-Consent Tools<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-translation-attestation\/\">TEMPLATE Translation Attestation<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/policies\/tipsheet-consent\/\">TIPSHEET Consent<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/learning\/online\/index.php\/lessons\/electronic-consent-what-you-need-to-know\/\">TUTORIAL Electronic Consent: What You Need to Know<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-consent\/\">WORKSHEET Consent Requirements and Waivers<\/a><\/p>\n<h3>Help Materials for HSD Staff and IRB Members<\/h3>\n<p>SOP Consent <em>[HSD staff and IRB member access only]<\/em><br \/>\nWORKSHEET Consent Review for IRB Members <em>[HSD staff and IRB member access only]<\/em><\/p>\n<h3>Other Materials Referenced in this Guidance<\/h3>\n<p><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/checklist-exception-from-informed-consent\/\">CHECKLIST Exception from Informed Consent<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/glossary\/capacity-to-consent\/\">GLOSSARY Capacity to Consent<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/glossary\/exempt-research\/\">GLOSSARY Exempt Research<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/glossary\/legally-authorized-representative-lar\/\">GLOSSARY Legally Authorized Representative<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/glossary\/legally-effective-research-consent\/\">GLOSSARY Legally Effective Research Consent<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-authority-and-responsibilities-of-hsd-and-uw-irb\/\">GUIDANCE Authority and Responsibilities of HSD and  91探花IRB<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/ethical-principles\/belmont\">GUIDANCE The Belmont Report<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/exempt\/\">GUIDANCE Exempt Research<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-hipaa-2\/\">GUIDANCE HIPAA<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/\">GUIDANCE Humanitarian Use Devices (HUDs)<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-human-subjects-regulations-2\/\">GUIDANCE Human Subjects Regulations <\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-involvement-of-children-in-research-2\/\">GUIDANCE Involvement of Children in Research<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/mandatory-reporting\/\">GUIDANCE Mandatory State Reporting<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/prisoners\/\">GUIDANCE Prisoners<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/subject-payment\/\">GUIDANCE Subject Payment<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/external-irb-review\/\">REQUEST External IRB Review<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/supplement-other-redcap-installation\/\">SUPPLEMENT Other REDCap Installation<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/template-other-esignature-attestation-letter\/\">TEMPLATE Other E-Consent Tool Attestation Letter<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/\">WEBPAGE Reliance on a Non- 91探花IRB<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/specu\/\">WEBPAGE Single Patient Emergency or Compassionate Use<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-children\/\">WORKSHEET Children<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-neonates\/\">WORKSHEET Neonates<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-pregnant-women\/\">WORKSHEET Pregnant Women<\/a><br \/>\n<a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-prisoners\/\">WORKSHEET Prisoners<\/a><\/p>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"13\">References<\/h2>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul style=\"list-style-type: none; padding-left: 25px; text-indent: -25px;\">\n<li>45 CFR 46.116 [pre-2018 requirements and 2018 requirements]<\/li>\n<li>45 CFR 46.117 [pre-2018 requirements and 2018 requirements]<\/li>\n<li>45 CFR 46.204 &#8211; .205<\/li>\n<li>45 CFR 46.305<\/li>\n<li>45 CFR 46.408<\/li>\n<li>21 CFR 11<\/li>\n<li>21 CFR 50.20<\/li>\n<li>21 CFR 50.27<\/li>\n<li>21 CFR 56.109<\/li>\n<li>21 CFR 50, Part D<\/li>\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/requests-for-comments\/draft-guidance-disclosing-risk-in-standards-of-care\/index.html\">OHRP Draft Guidance on Disclosing Reasonably Foreseeble Risks in Research Evaluating Standards of Care, 2014<\/a><\/li>\n<li>OHRP, Guidance on Institutional Review Board Review of Clinical Trial Websites; September 20, 2005.<\/li>\n<li>OHRP Guidance Documents on Informed Consent, from the OHRP website <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/informed-consent\/index.html\">https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/informed-consent\/index.html<\/a><\/li>\n<li>OHRP, &#8220;Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English&#8221;, memorandum; November 9, 1995.<\/li>\n<li>OHRP, &#8220;Simplifying Informed Consent&#8221;, webinar <a href=\"https:\/\/www.hhs.gov\/ohrp\/education-and-outreach\/online-education\/videos\/simplifying-informed-consent-ohrp\">https:\/\/www.hhs.gov\/ohrp\/education-and-outreach\/online-education\/videos\/simplifying-informed-consent-ohrp<\/a><\/li>\n<li>FDA, Guide to Informed Consent Information Sheet, July, 2014<\/li>\n<li>FDA and OHRP Guidance, &#8220;Use of Electronic Informed Consent: Questions and Answers&#8221;, December, 2016<\/li>\n<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/adverse-reactions-section-labeling-human-prescription-drug-and-biological-products-content-and\">FDA Guidance, \u201cAdverse Reactions Section of Labeling for Human Prescription Drug and Biological Products \u2013 Content and Format\u201d January 2006<\/a><\/li>\n<li>FDA Guidance, &#8220;Part 11, Electronic Records: Electronic Signatures \u2013 Scope and Application&#8221;, August 2003<\/li>\n<li>FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (updated July 2, 2020)<\/li>\n<li>FDA. &#8220;Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance&#8221;, April 1996, section 4.8.9.<\/li>\n<li><a href=\"https:\/\/www.fda.gov\/safety\/reporting-serious-problems-fda\/what-serious-adverse-event\">FDA \u2013 Reporting Serious Problems to FDA, \u201cWhat is a Serious Adverse Event?\u201d, 2016<\/a><\/li>\n<li>Meeting of the Secretary&#8217;s Advisory Committee on Human Research Protections, Key Information videotape, July 10-11, 2018<\/li>\n<li>SACHRP Recommendations, &#8220;Attachment A \u2013 Addressing Ethical Concerns Regarding Offers of Payment to Research Participants&#8221;, October 18, 2019<\/li>\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2011-october-13-letter-attachment-a\/index.html\">SACHRP Recommendations, \u201cAttachment A \u2013 Guidance on Applying the Regulatory Requirements for Research Consent Forms: What Should and Should Not be Included?\u201d, July 2011<\/a><\/li>\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2015-september-28-attachment-a\/index.html\">SACHRP Recommendations, \u201cAttachment A \u2013 Recommended Guidance on Minimal Risk Research and Informed Consent\u201d, 2015<\/a><\/li>\n<li>SACHRP Recommendations, &#8220;Attachment A1 &#8211; Reconsent Appendix 1. New Information Provided to Previously Enrolled Subjects&#8221;, May 4, 2020<\/li>\n<li>SACHRP Recommendations, &#8220;Attachment A2 &#8211; Reconsent Appendix 2. Additional Information Scenarios and Suggested Options&#8221;, May 4, 2020<\/li>\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2015-february-11-attachment-a\/index.html\">SACHRP Recommendations, \u201cAttachment A \u2013 SACHRP Commentary on the FDA Draft Guidance Entitled, \u2018Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors\u2019\u201d, February 11, 2015<\/a><\/li>\n<li><a href=\"https:\/\/www.pharmacy180.com\/article\/cioms-iii---core-clinical-safety-information-3194\/\">CIOMS III \u2013 Core Clinical Safety Information, \u201cGuidelines for Preparing Core Clinical-Safety Information on Drugs\u201d, 1995<\/a><\/li>\n<li>15 U.W. Code Chapter 96 &#8211; The Electronic Signatures in Global and National Commerce Act (E-Sign Act)<\/li>\n<li>National Conference of Commissioners of Uniform State Laws, Uniform Electronic Transactions Act (UETA), (1999)<\/li>\n<li>Revised Code of Washington (RCW) Chapter 19.360, Electronic Signatures and Records<\/li>\n<li>Chapter 1.80 Revised Code of Washington (RCW) Uniform Electronic Transactions Act (Washington&#8217;s adoption of UETA)<\/li>\n<li>Committee On Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, &#8220;Ethical Considerations for Research Involving Prisoners&#8221; (2006)<\/li>\n<li>Dickert et al., &#8220;Reframing Consent for Clinical Research: A Function-Based Approach&#8221;. American Journal of Bioethics, 17:12, 3-11 (2017)<\/li>\n<li>Dickert et al., &#8220;Partnering with Patients to Bridge Gaps in Consent for Acute Care Research&#8221;. The American Journal of Bioethics, 20(5), 7-17 (2020)<\/li>\n<li>Gelinas, L. &#8220;The Many Faces of &#8216;Coercion&#8217; and &#8216;Undue Influence'&#8221;. Advarra Blog, Dec 2, 2020 <a href=\"https:\/\/www.advarra.com\/blog\/the-many-faces-of-coercion-and-undue-influence\/\">https:\/\/www.advarra.com\/blog\/the-many-faces-of-coercion-and-undue-influence\/<\/a><\/li>\n<li>Kraft et al., &#8220;Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not&#8221;. The American Journal of Bioethics, 17:7, 53-55 (2017)<\/li>\n<li>Ravi et al., &#8220;Financial Payments for Participating in Research while Incarcerated: Attitudes of Prisoners&#8221;. IRB Ethics &amp; Human Research, 40:6, 1-6 (2018)<\/li>\n<li>The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979<\/li>\n<li>The PHASES Working Group, Pregnancy and HIV\/AIDS: Seeking Equitable Study, &#8220;Ending the evidence gap for pregnant women around HIV and co-infections: A call to action&#8221; (2020)<\/li>\n<li>WCG IRB Insights, &#8220;Providing Research Participants with New Information: Is &#8216;Re-Consent&#8217; Always Necessary?&#8221; <a href=\"https:\/\/www.wcgirb.com\/insights\/providing-research-participants-with-new-information-is-re-consent-always-necessary\/\">https:\/\/www.wcgirb.com\/insights\/providing-research-participants-with-new-information-is-re-consent-always-necessary\/<\/a><\/li>\n<li>Wilfond and Kraft, &#8220;Attending to the Interrelatedness of the Functions of Consent&#8221;. The American Journal of Bioethics, 17:12, 12-13 (2017)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<div align=\"right\"><a href=\"#toc\">Back to Table of Contents<\/a><\/div>\n<h2 id=\"14\">Version Information<\/h2>\n<p>Open the accordion below for version changes to this guidance.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Version History<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<table>\n<tbody>\n<tr>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Version Number<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Posted Date<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Implementation Date<\/th>\n<th style=\"background-color: #4b2e83; color: #ffffff; text-align: center;\">Change Notes<\/th>\n<\/tr>\n<tr>\n<td>3.0<\/td>\n<td>04.02.2026<\/td>\n<td>04.02.2026<\/td>\n<td>Added information about  91探花Medicine REDCap Part 11 and  91探花Florence eConsent, clarified expectations around other UW-managed REDCap installations, updates to information on RCW 9.73.030<\/td>\n<\/tr>\n<tr>\n<td>2.9<\/td>\n<td>10.30.2025<\/td>\n<td>10.30.2025<\/td>\n<td>Updated DocuSign to Docusign; update to structure to add anchor links<\/td>\n<\/tr>\n<tr>\n<td>2.8<\/td>\n<td>06.26.2025<\/td>\n<td>06.26.2025<\/td>\n<td>Remove note that  91探花DocuSign and  91探花ITHS RedCap are the only acceptable methods of obtaining e-signatures for HIPAA authorization to access PHI held by  91探花Medicine and Seattle Children\u2019s<\/td>\n<\/tr>\n<tr>\n<td>2.7<\/td>\n<td>03.27.2025<\/td>\n<td>03.27.2025<\/td>\n<td>Revise FDA Part 11 compliance statement to note that  91探花ITHS REDCap is not compliant<\/td>\n<\/tr>\n<tr>\n<td>2.6<\/td>\n<td>01.30.2025<\/td>\n<td>01.30.2025<\/td>\n<td>Update information about translation and interpretation services<\/td>\n<\/tr>\n<tr>\n<td>2.5<\/td>\n<td>12.23.2024<\/td>\n<td>12.23.2024<\/td>\n<td>Update FDA Part 11 compliance statement for  91探花ITHS REDCap<\/td>\n<\/tr>\n<tr>\n<td>2.4<\/td>\n<td>10.31.2024<\/td>\n<td>01.01.2025<\/td>\n<td>Revise short form requirements<\/td>\n<\/tr>\n<tr>\n<td>Previous versions<\/td>\n<td><\/td>\n<td><\/td>\n<td>For older versions: HSD staff refer to the SharePoint Document Library; Others \u2013 contact hsdinfo@uw.edu.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<p><strong>Keywords<\/strong>: Consent<\/p>\n","protected":false},"excerpt":{"rendered":"<p>QUICK GUIDE While all stakeholders are encouraged to read and become familiar with this entire guidance, the following resources provide a summary of the most vital&#8230;<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":40122,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-40124","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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