A single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by federal agencies that are carried out at more than one site in the United States. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.
Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections.
The Single IRB requirement comes from two mandates, the revised Common Rule (45CFR46) and NIH.
The Common Rule requirement applies to all federally-funded or supported research (with the exception of Department of Justice funded projects). Grants and contracts submitted to NIH on or after January 25, 2018, that involve multi-site, non-exempt human subjects research are expected to receive single IRB review.
Definition of “multi-site”
“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.
The mandates do not apply to exempt human subjects research.
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
Most multi-institutional research has a lead site which directs and coordinates the activities of participating or collaborative sites. Although some research may not have a clear lead site, the investigators must still 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 (the reviewing site) and the others are considered to be participating sites (the relying sites). Each role has specific requirements and responsibilities during grant preparation, study set up, and conduct of the study.
Single IRB at RIT
If your funded, non-exempt research involves collaboration with any sites and/or personnel outside of RIT, then it is considered multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies involving sites/personnel external to RIT.
When an RIT PI is conducting research involving human subjects, the RIT IRB will review and oversee the conduct of the research, with some exceptions when data or subjects are predominantly coming from another institution. RIT protects the rights and welfare of participants when collaborating with other organizations for the oversight of research. The HSRO will take into consideration the source of funding for the research activity, federal regulations, specific sponsor regulations governing human research protections, and institutional policies to determine which IRB will perform the review. RIT will enter into formal agreements with other institutions to provide research review (act as the Reviewing IRB), or to rely on other institutions for research review (act as the Relying IRB), RIT enters into these types of arrangements through an IRB Authorization Agreement (IAA)/Reliance Agreement, and may rely on the SMARTIRB platform to coordinate this process.
When RIT is the Relying IRB the RIT investigator will be required to provide information to the HSRO as part of an administrative review.
Studies that are not federally funded are reviewed on a case-by-case basis. Please contact the HSRO if you want to use a single IRB for a non-funded study.
Other situations where Single IRB may be appropriate:
You are transferring your project to RIT or want to work with your previous institution on a project,
You or your colleagues are transferring to another institution and want to continue to work on the project
Exempt-category research is not eligible for Single IRB review. Some federal, tribal and state laws exclude Single IRB for some populations.
RIT uses Smart IRB to facilitate the communication for a single IRB review. Smart IRB is not a reviewing IRB; it is an electronic platform that supports the reliance process. The reviewing institution still conducts a review and the relying institutions may have requirements specific to their own institution.
Please contact the Director of the HSRO if you need to plan for a single IRB.