May 6, 2025
For the Record- May 6, 2025: New HIPAA Templates, PAVE Report, Updated International Guidance
In this Issue:
New HIPAA Authorization Forms
Effective 5/6/2025
An updated HIPAA Authorization Form for research has been developed for use at both the Fred Hutchinson Cancer Center and the 91探花. 91探花also provides a HIPAA Authorization Form for Pregnant Participants or Pregnant Partners.
- These forms should be used for new studies going forward.
- They are intended to be used as stand-alone documents.
- There will no longer be a mechanism for exceptions to allow for HIPAA authorization language incorporated into the consent form to be used to obtain HIPAA authorization.
Studies that were issued an exception before the effective date of the new HIPAA Authorization forms may continue to use the approved consent form to obtain authorization. Similarly, the older versions of the HIPAA Authorization forms will continue to be accepted for studies approved before the effective date of the updated form.
If you have any questions about the new forms, please contact us at hsdinfo@uw.edu.
PAVE 2024 Annual Report
Findings and Recommendations
HSD鈥檚 Post Approval Verification and Education (PAVE) program’s聽annual report summarizes outcomes of PAVE evaluations conducted during the prior calendar year. It includes human subjects research studies under 91探花or External IRB review where a routine or IRB-directed evaluation was conducted. In 2024, the program reviewed 23 studies, which included 22 routine evaluations and 1 administratively directed evaluation. The good news is that the vast majority of findings were minor noncompliance. 91探花researchers are generally conducting their studies in a safe and compliant manner.
Some of the most common issues observed (and ways to avoid them) include:
- Failure to follow the IRB-approved data security requirements. For example, we found studies that had study participant identifiers maintained with study data. This is generally not allowed for any study with a Level 3-5 data security level because it may put participants at increased risk of harm if identifiable information is inadvertently disclosed.
- Suggestion: In some instances, it may be appropriate to request an IRB exception to this requirement. For example, it may be necessary to temporarily keep participant names with data collection forms to facilitate in-person study visits. HSD allows researchers to request exceptions to individual data security requirements if necessary for the study and if the exceptions do not significantly increase risk to study participants. Exceptions can be requested under Section 9.6.b of the APPLICATION IRB Protocol.
- Failure to use the current, IRB-approved consent form. Some researchers were not using the most current IRB-approved version of the consent form.
- Suggestion: Consider using only the IRB stamped approved consent form so it鈥檚 easy to see the approval watermark with the IRB approval date so you know you have the current form. Alternatively, use version control in the footer and update this with each consent revision. Also consider putting in place a process to inform all study staff of any consent form changes as well as where to find the most current IRB approved consent form. The current IRB approved version of your consent document can be downloaded directly from Zipline under the Documents tab in the 鈥淔inal鈥� column.
International Research Guidance
Update
HSD has recently revised our international research guidance. This guidance provides information to researchers conducting international research about additional review requirements and considerations. Updates include:
- Additional language clarifying that when the 91探花is the IRB of record, we review all activities for the proposed research project for which the 91探花is engaged, including those conducted at international sites. For the international portions of a project the 91探花IRB generally reviews the in-country protocol to ensure it complies with U.S. regulations. This is a courtesy we currently provide for 91探花investigators and is not a change in either policy or process. This review does not replace any locally required review for compliance with in-country regulations.
- Removing the option to certify Fogerty grants without 91探花study involvement. These projects now need to follow our usual review pathway.
- Offering a new service. If your study is being reviewed by a non- 91探花IRB you should follow that IRB鈥檚 policies and procedures about the IRB review of international research. However, if the non- 91探花IRB will not review the international aspects of the study in which the 91探花in engaged for compliance with U.S. regulations the 91探花IRB will conduct this review as a courtesy for 91探花investigators. This will only be done upon request.
Email hsdinfo@uw.edu with any questions.