Research collaborations are becoming more and more common. Many research sponsors, consortiums, and networks now strongly encourage use of a single IRB for research conducted at multiple sites. In addition, when investigators at different institutions collaborate on research projects, especially those which are minimal risk, requiring dual IRB review at both institutions often simply increases burden instead of providing additional protections to human subjects. The IU Human Research Protection Program (HRPP) is committed to enhancing research collaborations to maintain the highest protections for human subjects while minimizing burdens on researchers and obstacles to research. HRPP staff are pleased to announce a revised reliance policy, effective October 26, 2017, which provides increased flexibility for relying on external IRBs.
What is Reliance?
Reliance is the process of using a single IRB for review of multiple sites or investigators at multiple institutions. Reliance and single IRB review is now required by several federal initiatives including the National Institutes of Health Single IRB (sIRB) policy, Common Rule revisions, and the 21st Century Cures Act.
When Can Reliance on an External IRB Be Requested?
The new policy is extremely flexible and allows investigators to request reliance for any of several reasons, including:
- The sponsor or funding agency requests or requires single IRB review
- Study is part of an existing network, consortium, or agency which encourages or mandates single IRB review
- Proposed external IRB has already reviewed the study or a similar study
- IRB expertise concerns (e.g. special subject population, untypical research design, sensitive topics)
- Efficiency considerations, especially for collaborating research
- Feedback or request from Institutional Official, HRPP staff, IRB, etc.
- Conflict of interest concerns (e.g. institutional conflict of interest)
It is important to note that the previous eligibility criteria for use of independent IRBs are no longer in effect, so reliance on independent IRBs may be requested for any research; however, reliance is generally not considered appropriate for the following types of research, without a compelling reason:
- Research previously approved by the IU IRBs
- Research for which an IU investigator holds the IND or IDE
- Compassionate use when approval of each patient is required by the FDA, IRB, or sponsor in order to provide treatment at the participating institution
- Comparative effectiveness research, as identified by the IU Human Subjects Office (HSO)
- Planned emergency research
- VA research, unless the reviewing IRB is the VHA Central Office IRB, an IRB of another VA facility, or an IRB of another federal agency, pursuant to VHA Handbook 1200.05(5)(d)(1).
When a reliance request is submitted, Human Subjects Office (HSO) staff will evaluate the request, ensure all institutional responsibilities are met, and determine on a case-by-case basis whether reliance is acceptable.
What Do I Need to Know About Reliance?
Reliance may change the number of IRBs which are involved in the IRB review process for a single study, but it doesn't change the amount of work required to obtain IRB approval for a protocol or a specific site. Instead, that work is simply shifted from the participating sites to the site responsible for IRB review. Reliance often means additional work both for the HRPP and the study team. If you are interested in requesting reliance on an external IRB in the future, or requesting that the IU IRBs provide approval for non-affiliated investigators or external sites, please review the revised HRPP policy on reliance carefully, as it includes important information about when and how to request reliance, the institutional requirements associated with reliance, and your responsibilities in a reliance situation.
How Do I Submit a Reliance Request?
Reliance requests must be submitted via KC IRB. To request reliance on an external IRB, create a new protocol with Protocol Type “Reliance Request.” To request that the IU IRBs provide approval for non-affiliated investigators or external site, please obtain initial approval for the local site, then submit an amendment to add non-affiliated investigators and external sites. Please visit Reliance Requests to review the Quick Guides for specific information regarding the reliance process and how to request reliance.
What Changes are Being Made with the Revised Policy?
The new policy has been uploaded on the Human Subjects Policies & Guidance webpage. In order to facilitate the revised policy, the KC IRB Reliance Request questionnaire has been updated. Previously-approved deferral or reliance requests will not need to be updated. For investigators requesting IU IRBs provide approval for non-affiliated investigators or external sites, Questionnaire C has also been revised and should be updated if any additional non-affiliated investigators or sites are added to the protocol. Final versions of the questionnaires can be viewed in print format in the Completing an IRB Application - KC Crosswalk document also found on the Policies & Guidance page linked above.
The KC IRB Personnel Tab has also been updated with two new functionalities.
- Provide a mechanism for identifying a site-specific PI for research which is conducted at multiple sites. Study teams can now designate Site-Specific PIs for multi-site research. The site-specific PI is the responsible leader of a team of investigators at a specific research site under oversight of the IU IRBs, who has the ultimate responsibility for the conduct of the research only at that site. Please note that KC IRB will still require listing of a single Principal Investigator. KC IRB will still require that one individual be designated as the Principal Investigator. If a study is being conducted at multiple IU-affiliated sites, the PI should leader of the team responsible for IRB submissions and communication of IRB information for the study.
- Allow uploading of attachments which are associated with an individual investigator. You can now upload CVs or training documentation for research personnel, or Site Personnel Lists when requested by HRPP staff.
Changes to the KC IRB questionnaires may require you to update your previously-completed information in some cases. If an update is required, you will see a prompt in the KC IRB questionnaire which indicates “A newer version of the questionnaire has been published. An update is required.” Simply choose “Copy the answers from the old version of questionnaire to the new one. Only questions that have been changed in the new version will have to be answered,” then click Update. You may need to click Save at the bottom of the page to display all new questions.
Who Should I Contact About Reliance?
Please contact a member of the HSO reliance team for questions about IRB reliance, including:
- When reliance on external IRBs is allowable
- How to request reliance on external IRBs
- Relationships with external IRBs
- Requesting IU IRB approval for non-affiated investigators
- NIH single IRB policy
Amy Waltz, Associate Director – Regulatory Affairs, Reliance, Outreach
Avril Pitt, Research Compliance Consultant
Brian Stage, Research Compliance Consultant