The Single IRB Mandates
The federal requirement for single IRB (sIRB) review comes from two separate mandates:
Revised Common Rule
The revised federal Common Rule contains a new requirement for single IRB review for collaborative, non-exempt human subjects research that involve multiple institutions. This applies to all federally-funded or supported research (with the exception of Department of Justice funded projects). It went into effect January 21, 2020.
This is distinct from the Common Rule requirement and 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 defines multi-site research as a subset of collaborative research that requires the use of a single IRB. It is important to identify when a project must comply with the NIH policy because there are specific, NIH requirements that must be present in the grant or contract applications for studies subject to this policy that do not apply to studies under the broader Common Rule requirement.
The information on these webpages is designed for studies that must comply with either of these mandates, however it may also be useful for researchers wishing to use a single IRB for multi-institutional (multi-site or collaborative) studies that are not federally-funded.
Definition of “multi-site” for NIH funded 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.
What to Do If You Are Unsure
If you are unsure whether a project you are proposing is subject to the NIH policy, work with the NIH program officer.
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 NIH-funded study design determines whether the single IRB policy applies:
- Design 1: You (a UW faculty member) will work with a Harborview unit and a UWMC 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, because it is occurring only within the UW and with a single principal investigator (you).
- Design 2: 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 3: Same as Design 2, 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 them, so that they 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 4: 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 consenting 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.
Types of Research
The mandates do not apply to exempt human subjects research.
Types of Sites
The mandates do not apply to the following types of participating sites in multi-site research:
- Many Veteran’s Affairs (VA) sites due to strict VA policy. For each study you must check with the VA site to understand whether or not they qualify for exception.
- 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.
In October 2020, OHRP issued an exception for research conducted during the Coronavirus Disease (COVID-19) Public Health Emergency declared by the Secretary of HHS. Funding agencies supporting the research must approve the use of this exception. NIH has confirmed that its use of this exception will be rare.
In November 2019, OHRP issued an exception for all HHS-funded research subject to the Common Rule Single IRB requirement and that was approved by an IRB prior to January 21, 2020. This means that at least one IRB has approved any part of the study. This exception does not apply if the study must comply with the NIH multi-site policy.
NIH has established a process by which it will consider other requests for exceptions from its multi-site policy if there is a compelling justification, but it has stated that exceptions will be rarely granted. If you believe that your study should be excepted, work with the NIH program officer to identify how to request an exception.
The Common Rule mandate allows funding agencies to make exceptions, however, at this time, there is no formal process established for requesting an exception from non-NIH funding agencies. If you believe that your study should be excepted from the Common Rule requirement, you may be able to work with the federal agency’s program officer to identify how to request an exception.
Most multi-institutional research has a lead site which directs and coordinates the activities of participating or collaborative sites. Although some research, such as Multiple-PI or Co-PI projects, may not have a clear lead site, the investigators must accomplish the tasks of the role. Thus, for the purposes of obtaining single IRB review, one site or PI will typically play the lead role and the others are considered to be participating sites. Each role 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 firstname.lastname@example.org.
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