HRP recently had a very helpful email dialogue with OHRP regarding the cooperative review (single IRB) provisions in the revised Common Rule. OHRP has graciously provided permission for us to disseminate the information they provided and have asked that we remind everyone to please check in with the funding agency when uncertain whether the mandate applies because the funding agency may have a definition of support that is more strict or different than OHRP’s.
From: OS OPHS OHRP (HHS/OPHS) <OHRP@hhs.gov>
Sent: Tuesday, October 31, 2023 1:15 PM
To: OS OPHS OHRP (HHS/OPHS) <OHRP@hhs.gov>; Karen Christianson <ChristiansonK@thehrpconsultinggroup.com>
Subject: RE: Cooperative Research Question
Thank you so much for your patience. Please see your questions with my answers in purple below.
You asked: I’m writing with a few questions that come up from time to time related to the cooperative research provisions and single IRB.
Jaime Hernandez: A preliminary question that I’d like to answer first relates to when a study has to comply with the single IRB requirement. The single IRB requirement applies to institutions engaged in cooperative research (see 45 CFR 46.114(b)). Cooperative research is defined as non-exempt, human subjects research conducted or supported by HHS in which two or more institutions are involved or cooperating in (see 46.114(a)). If the research activities of only one researcher are non-exempt, human subjects research conducted or supported by HHS, then the study is not cooperative research, and it doesn’t have to comply with the single IRB requirement (but it can if the institutions want to do so). If the research activities of two or more of researchers are non-exempt, human subjects research conducted or supported by HHS, then only those researchers are involved in cooperative research and must comply with the single IRB requirement. The other researchers who are NOT engaged in non-exempt, human subjects research conducted or supported by HHS don’t have to rely on the single IRB together with the two or more researchers who are engaged (although they all can use the single IRB if they want to).
Therefore, to answer the scenarios below, the main issue is whether the different participants in a study are engaged in non-exempt, human subjects research conducted or supported by HHS. For all the scenarios, I assume the research studies are all non-exempt, human subjects research. So the remaining issue is whether they are supported by HHS under the different grant mechanisms you describe in each scenario.
- When a cooperative research project is not itself conducted or supported by HHS (or other Common Rule Department or Agency) funds, but one or more members of the research teams are supported, for example, by a career development, training, or fellowship award, would the cooperative research project be subject to the single IRB requirement?
Jaime Hernandez: We can’t speak for other Common Rule agencies since they may have a different approach to “support.” But, for HHS funded research, OHRP generally looks at the career development, training, or fellowship award to see if the specific human subjects study in question was described in the award. For example, if an award doesn’t describe any specific research study, and the awardee joins the research team of a senior PI, that PI’s research does not become supported by HHS even if the salary of the new team member is covered by a training or fellowship grant. On the other hand, if the study was initiated by the awardee and proposed to NIH (either in the original grant or subsequent submission), and NIH approves the conduct of the specific study under the award, then OHRP would consider it to be supported by HHS.
These are only two examples, of course, and often it is not so simple. I would suggest looking at the awards to see if it describes the specific research study. Also, I would look at the terms and condition of the award or reach out to the award administrator at the funding agency to see if the funding agency would consider the study supported by them.
- When a Center or Institute is supported by HHS (or other Common Rule Department or Agency) funds, and the Center/Institute in turn funds cooperative research projects, would those research projects be subject to the single IRB requirement?
Jaime Hernandez: In this scenario too, OHRP looks at whether a specific research project was identified in the grant that HHS supported. If so, then the center or institute would be considered engaged.
- When an organization is considered engaged in research by virtue of being the awardee institution but all activities involving human subjects are carried out by another organization, and the research is not exempt, would the cooperative research provisions apply and would IRB reliance need to be documented in accordance with .103(e)?
Jaime Hernandez: Consistently with 1 and 2, and as I said in my prior email, OHRP usually looks at whether the grant includes plans for specific human subjects research or just un-specified, future research. Note that for grants for the conduct of non-exempt human subjects research in which the primary awardee only “passes the money,” OHRP asks that institutions send the grant to us for a case-by-case determination (see, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/september-22-2011-non-engaged-scenarios/index.html). This is different than for a center or institute grant in scenario 2, for example. But in any of the 3 scenarios, feel free to send us the grant if you need a more specific answer. It may take us a while to review it, but we are here to help.
I hope this answers your question,
Jaime O. Hernandez, J.D., M.Be.
Office for Human Research Protection (OHRP)