91̽»¨

General Information

Rapidly Changing Requirements

The 91̽»¨IRB used to review almost all 91̽»¨research. The 91̽»¨IRB is usually the right IRB for most 91̽»¨research in which the 91̽»¨is conducting all or a majority of the research activities.

But rapidly changing requirements mean that there are many circumstances in which an external IRB must review 91̽»¨research instead of the 91̽»¨IRB. For example, many funders and research networks now expect a single specific IRB to do the review. The reasons for these rapid and still-evolving changes are:

• Federal regulations and policy. A recent federal regulation (Revised Common Rule) and NIH policy now require the use of a Single IRB for most federally-funded research that involves more than one institution. The single IRB will almost always be a non- 91̽»¨IRB (i.e., external IRB) when another institution is the lead institution for the study or is conducting most of the research.
• Reduce multiple IRB reviews. The use of a single IRB reduces the need for multiple IRB applications and reviews.
• IRB expertise. The expertise of an external IRB may be stronger or more appropriate than 91̽»¨IRB expertise for specific medical conditions, subject populations, or research methodology. Relying on an external IRB may result in a better review of the research risks and ethical issues.

External IRBs

The term external IRB refers to any non- 91̽»¨IRB that reviews 91̽»¨research. The 91̽»¨is willing to rely on an external IRB for many types of studies – but the review must be authorized by HSD in advance.

Sometimes the external IRB is serving as the Single IRB for all of the institutions that are participating in a specific collaborative study or multi-site study.

Which External IRBs are Required or Allowed for 91̽»¨Research

Consult Identify the Correct IRB for a list of types of research that must be reviewed by an external IRB instead of the 91̽»¨IRB. External IRBs not listed on that page may also be used, with the permission of HSD.

91̽»¨can rely on a large variety of different IRBs, however HSD must grant permission for the use of any external IRB for each study, even under pre-established cooperative agreements or other agreements. Whether or not the 91̽»¨can rely on a particular IRB depends on a number of factors such as accreditation status, what kind of institution it is operated by, and whether or not the IRB has the expertise to review the proposed research project.

Not allowed. The 91̽»¨does not rely on:

• International IRBs or Ethics Review Committees (ERCs).
• IRBs of the U.S. Veteran’s Health Administration – for example, the VA Puget Sound Health Care System. This is VA policy.

Each Use of an External IRB Must Be Authorized

Research that is at the funding application stage. Read Letters of Support for a Single IRB for instructions on how to obtain guidance, preliminary permission, and/or a Letter of Support for the use of an external IRB.

Research that is now funded or otherwise ready to begin. Read How to Ask for a Non- 91̽»¨IRB.

Resources

• • Identify the Correct IRB
  • How to Ask for a Non- 91̽»¨IRB
  • The 91̽»¨IRB as the Single IRB
  • External IRB Initial Review Process Diagram