Rapidly Changing Requirements
The UW IRB used to review almost all UW research. The UW IRB is usually the right IRB for most UW research in which the UW 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 UW research instead of the UW 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-UW 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 UW 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.
The term external IRB refers to any non-UW IRB that reviews UW research. The UW 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 UW Research
See Identify the Correct IRB for a list of types of research that must be reviewed by an external IRB instead of the UW IRB. External IRBs not listed on that page may also be used, if authorized by HSD.
HSD must authorize the use of any external IRB for each study, even under pre-established cooperative agreements or other agreements.
Not allowed. The UW 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 grant application stage. Contact HSD at email@example.com to obtain guidance, informal authorization, and/or a Letter of Support for the use of an external IRB. Include in your email:
- The name of the UW PI
- A brief description of the study, and a copy of the protocol or research plan if available
- The name of the funding agency, if there is one
- The names of the other organizations involved in the research
- For multi-site studies, whether UW is the lead site or a participating site
- The name of the external IRB you are considering
Research that is now funded or otherwise ready to begin. See How to Ask for a Non-UW IRB.