The Single IRB Mandate
The single IRB (sIRB) policy is a NIH policy that applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site non-exempt human subjects research. The policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites. The information on this webpage may also be useful for multi-site studies that are not federally-funded but that wish to use a single IRB.
Revised Common Rule. The 2019 revised federal “Common Rule” also contains a new requirement for single IRB review for studies that involve multiple institutions. This is separate from the NIH policy and will apply to all federally-funded research. It is not scheduled to go into effect until January 21, 2020. HSD is currently evaluating the impact of this requirement and developing guidance. The information on these pages is specific to the NIH policy.
Definition of “multi-site” research
“Multi-site” means that the same research procedures (i.e., protocol) are being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. This typically involves a lead site that receives the grant or contract directly from NIH and that then establishes a subaward or subcontract to each participating site. The research could be a clinical trial, an observational study, or a basic clinical research study.
“Same research protocol”. Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.” Additionally, sites that are accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the “same research protocol.” If a study involves a separate site for study coordination or coordination of data and statistical analyses and the site is conducting the same protocol as the other participating sites, then all sites would be expected to rely on the designated single IRB.
Illustrative examples. Suppose that you are interested assessing whether discharged surgery patients can effectively use their cell phones to communicate information (and photos) about surgical wound healing to their physicians. The study design determines whether the single IRB policy applies:
- Design 1: You (a UW faculty member) will work with a Harborview unit to train patients and to collect information about the impact of the cell phone procedure on post-surgical infection.
This is not a multi-site study.
- Design 2: Same as Design 1, but it also involves a unit at UWMC.
This is not a multi-site study, because its is occurring only at the UW and with a single principal investigator (you).
- Design 3: You know that the procedure is already being used at several hospitals in the Puget Sound region. You decide to collect and analyze medical record information about the outcomes associated with the procedure, compared to case control patients at the same hospitals. Your research coordinator contacts the medical records department of each hospital to obtain the information.
This is not a multi-site study because the non-UW hospitals are not conducting any parts of the protocol.
- Design 4: Same as Design 3, but you are also collecting the cell phone photos sent by the discharged patients. You will send the photos to a colleague at another U.S. university who has developed software that analyzes digital images and that can produce objective measurements of wound size, shape, and color (indicating the presence of infection). You will establish a subaward to him, so that he can be paid for the work.
Although this study involves two domestic sites, it is not consider a “multi-site study” because each site is conducting a different part of the study protocol.
- Design 5: You want to establish the effectiveness of the cell phone in a wide variety of settings. You decide to set up a national multi-site clinical trial, to take place at 50 different hospitals and clinics across the country. Each participating site will have a participating site investigator who will be in charge of recruiting and consent patients, training them on using the cell phones, and collecting the outcome data to send to you for analysis. You will establish a subaward to each site investigator, to pay for the study expenses.
This is a multi-site study, because it involves separate domestic sites, each under the control of an investigator and each conducting the same protocol.
- Design 6: The same as Design 5, but you have decided to include two hospitals in Canada as well as the domestic (U.S.) sites.
The Canadian sites are not required to be reviewed by the single IRB because the multi-site policy applies only to domestic sites. However, the Canadian hospitals may voluntarily choose to rely on the single IRB. See the section below for other exceptions to the policy.
Types of awards. The NIH sIRB policy does not apply to:
- Exempt human subjects research
- Career development, research training, or fellowship awards (“K”, “T”, and “F” grants)
Types of sites. The NIH sIRB policy does not apply to the following types of participating sites in multi-site research:
- VA sites
- Foreign sites (though domestic sites of the same study must be reviewed by a sIRB)
- Sites involving tribal nations
- Sites for which review by the proposed sIRB is prohibited by a federal, tribal, or state law, regulation, or policy
Note that a study may involve sites that must comply with the policy and other sites that are not required to comply.
NIH will consider requests for exceptions if there is a compelling justification, but it has stated that exceptions will be rarely granted.
There are two key roles in multi-site research. Each has specific requirements and responsibilities during grant preparation, study set up, and conduct of the study.
Who should I contact if I want more information?
General sIRB questions
Email your questions to singleIRBpolicy@mail.nih.gov
Budget, resources, personnel
The Scientific/Research Contact and/or the Financial/Grants Management Contact described in the FOA, RFA or PA to which your grant is directed
Choosing a single IRB
The Scientific/Research contact described in the FOA, RFA, or PA to which your grant is directed
For all questions about single IRB, including requesting letters of support, choosing a single IRB, and establishing reliance agreements, contact: the Reliance Team at email@example.com.
Complete List of Resources
National Institutes of Health (NIH)
- NIH Single IRB Policy Announcement
- NIH Revised Implementation Date Announcement
- NIH Single IRB Frequently Asked Questions
- NIH Guidance about Single IRB Costs
- NIH Guidance on Implementation of the Single IRB Policy
- NIH Guidance on Requesting an Exception to the Single IRB…
- PHS Human Subjects and Clinical Trials Information Form Application Guide
University of Washington (UW)
- Current List of Master Reliance Agreements Signed by UW
- Fees Charged by Single IRBs
- IRB Liaison: Key Personnel Description for NIH Grant and Draft…
- Letter of Support Template for Participating Sites
- Selecting the Single IRB
- Single IRB Plan Template for NIH Grant Applications
- ONLINE TUTORIAL: When the UW is Not the Right IRB:…