Research Collaborations and IRB Reliance Agreements
If you are planning a research collaboration with researchers external to UMass Amherst, you should contact our office for advice and guidance. There are several factors that must be clarified to figure out the best path forward for collaborative research. Usually, the first aspect that must be clarified is whether all the research collaborators are “engaged in human subjects research.” Our IRB considers researchers “engaged in human subjects research” if any of the following apply:
- researcher will be involved in a direct intervention or interaction with human subjects of research,
- researcher will obtain identifiable private information for the research,
- researcher will be involved in the consent process, or
- researcher will be provided identifiable data.
It is important to note that “engagement” in human research has no bearing on whether a researcher can be a co-author or have another integral role in the study.
If our IRB determines that some or all study personnel are “engaged in human subjects research,” the next step would be to determine which institution’s IRB should review the study and what category of review will be assigned to the study. If the study is categorized as a non-exempt study, to avoid duplicative reviews and administrative burdens, one institution may act as the “IRB of Record.” Identifying the “IRB of Record” can sometimes be simple, for example, if the interventions are occurring at one university, or one university is the prime awardee on a grant. However, there are situations in which more than one IRB may feel they should be the “IRB of Record,” and in those cases, IRB representatives and researchers may have to engage in negotiations to get on the same page. Once the “IRB of Record” is identified, that IRB would be responsible for reviewing the study while other participating IRBs would rely on that IRB’s review. Participating IRBs would then enter into a formal agreement to outline responsibilities and document which institution will be the “IRB of Record.” The agreement should describe:
- the role and authority of the IRB(s) involved in the study,
- investigator responsibilities regarding human subjects protection education, training, policies, and reporting,
- the term/time period of the agreement and the number of protocols to be reviewed.
The agreement itself can vary in format depending on what the “IRB of Record” requests but these agreements are signed by legally authorized signatories who can bind the university, as such, the signing of these agreements may take some time. Many institutions, like UMass Amherst, use the SMART IRB system to streamline the reliance process, please click here for more information regarding SMART IRB.
Collaborating with Researchers Not Affiliated with Another IRB
If you are planning on including study personnel who are not part of our university and are not affiliated with a university with an IRB please contact our office. It may be possible to include unaffiliated researchers under the auspices of our IRB by using an “Individual Investigator Agreement” (IIA). The IIA is a commitment statement that an unaffiliated researcher will comply with the federal regulations on human subject protection, complete CITI training, UMass policies, and UMass IRB oversight. Once fully executed, the collaborating unaffiliated investigator is able to be listed in UMass IRB-reviewed protocols.
Instructions for Accessing CITI Training for Non-UMass Personnel
Non-UMass personnel can complete CITI training without having to pay out of pocket if they affiliate themselves with our university. Please follow the following instructions:
- Go to www.citiprogram.org.
- Click “Register” on the upper right-hand side of the screen.
- Type University of Massachusetts Amherst in the “Select Your Organization Affiliation’ box.
- Select “University of Massachusetts Amherst” NOT “University of Massachusetts Amherst (SSO)”.
- Click the checkboxes to agree to the Terms of Service and Affirm your affiliation with UMass Amherst
- Click “Continue to Create Your CITI Program Username/Password”
You will then be able to provide all of the information required for CITI registration.
Given the potential complexity and areas for discussion, we recommend reaching out to our office to set up a time to chat about your planned collaborative study and develop the most efficient path forward. Please contact email@example.com or call 413-545-3428 to set up a consultation.
 The federal regulations do not have formal agreement processes for studies categorized as Exempt. IRBs treat these collaborations in a variety of ways. The UMass IRB requests that researchers collaborating with another institution on an Exempt study submit a Kuali “protocol” attaching the other university’s protocol and approval letter. This Kuali “protocol” will act as a record of the collaboration.