Overview
The General Implementation date for the Revised Common Rule went into effect January 19, 2018. As part of the Revised Common Rule, the regulations require that Federally-funded or supported non-exempt cooperative research studies (that is, studies involving more than one institution) must rely on the use of a single reviewing IRB for the portion(s) of the research being conducted in the U.S.
Which IRB Serves as the Single IRB?
The regulations allow for some flexibility in the designation of the sIRB. In some situations, the sIRB may be designated by the Federal sponsor supporting this research; in the event that the Federal sponsoring agency does not designate a specific IRB to serve as the sIRB, the lead institution supporting the research will typically serve as the sIRB.
Process for Initiating Single IRB Review
As sIRB involves direct, ongoing communication and coordination among multiple IRBs, it is necessary to reach out to the Research Integrity office prior to the initiation of the sIRB process.
IRB review of eligible non-exempt multi-site cooperative research is handled through the IRB Authorization Agreement process. Researchers will need to determine which IRB will be serving as the sIRB of record. Once the sIRB has been designated, signed Authorization Agreement(s) will need to established prior to the initiation of the collaborative research.
How to request that Lehigh University’s IRB cede review to another IRB:
- Submit a Request for Lehigh to Rely on External IRB via IRBNet:
- Log in to irbnet.org. (If you have not used the system before, you'll first need to register for an account as a new user.)
- Click "Create New Project" and fill in the required information for your study.
- Click "Designer" to access the “Request for Lehigh to Rely on External IRB” form. Click "Download" to save the application to your local computer. (Note: this form can also be found under the "Forms and Templates" menu option.)
- Once you have completed the “Request for Lehigh to Rely on External IRB” form, click "Attach New Document" to upload the completed request form as part of your submission package.
- Also attach the following documents within your submission in IRBNet:
- Approved version of the consent form(s)
- Approval letter from the external IRB of Record indicating the period of approval
- Human Research Protection training certificates for all non-faculty personnel and for any faculty personnel who have not previously submitted training certificates to the IRB.
- Click "Sign this Package" to indicate that all necessary application materials have been uploaded to the IRBNet package.
- Click "Submit this Package". Be sure to select "Lehigh University IRB" as the reviewing board.
- If the request to cede authority to another IRB is approved, the Lehigh University IRB Signatory Official will reach out to the IRB of Record to complete the IRB Authorization Agreement (IAA). Note: if the Lehigh University IRB does not approve a request to cede authority to another IRB, the IRB staff will consult with the Lehigh University PI to determine how to proceed with approval of the project.
- When the IRBNet submission has been submitted and the IAA has been signed by the Signatory Official from the IRB of Record and from Lehigh, a copy of the completed IAA and an IAA Acknowledgement letter will be returned to you via IRBNet. The expiration date listed on the letter and entered into IRBNet will be the date that is listed on the approval letter from the IRB of Record.
- The study will continue following the original expiration date, the PI is required to submit the continuing review (CR) approval letter from the IRB of Record indicating the new approval period. This must be submitted in IRBNet as a Continuing Review submission. Lehigh University IRB staff will update IRBNet and a new IAA-Acknowledgement letter will be emailed to the PI.
How to request that Lehigh University act as the IRB of Record (i.e., Lehigh University IRB accepts responsibility for the review)
- Submit a complete IRB application through IRBNet.
- Attach copies of your study documents to your IRBNet submission as usual. Describe the specific procedures to be conducted at each research site and the research personnel at each institution responsible for conducting those procedures.
- If the request for the Lehigh University IRB to act as the IRB of Record is approved, the Lehigh University IRB Signatory Official will sign the IAA and will request the signature of the Signatory Official at the deferring institution. The IAA will be active once both signatory officials have signed the IAA and the research is approved by the Lehigh University IRB. A copy of the completed IAA will be returned to you via IRBNet. Upon approval, the Lehigh University PI should provide the collaborating institution(s) with the fully executed IAA, along with the Lehigh University IRB approval letter. Note: if the Lehigh University IRB does not approve a request to act as the IRB of Record, the IRB staff will consult with the Lehigh University PI to determine how to proceed with approval of the project.
Exceptions to the Single IRB Review Requirement
The Office for Human Research Protections (OHRP) outlines several specific exceptions to the sIRB requirement; sIRB compliance will not be required in the following situations involving research conducted or supported by the Dept. of Health and Human Services (HHS):
- Protocols initially approved by at least 1 IRB between January 21, 2019 and January 20, 2020
- Protocols initially approved by at least 1 IRB before January 21, 2019, and for which an institution has determined and an IRB or institution has documented that the research will comply with the 2018 Requirements
- Protocols for which an NIH exception determination was issued on or before January 20, 2020, regardless of when at least 1 IRB reviews and approves a specific cooperative research protocol
In certain situations, specific state / federal / tribal laws may require the use of more than one reviewing IRB; in these situations, the sIRB requirement may be suspended. Additionally, the Federal agency sponsoring the research may determine that the use of an sIRB may not be appropriate, given the specifics of the research project. In this case, the use of an sIRB may be suspended with PI providing documentation supporting the determination made by the Federal agency sponsor.
Research that has been given a determination of Exempt status is also not subject to the sIRB requirements; investigators at each institution are responsible for seeking their own independent Exempt determination(s) for research to be conducted at their site.
Resources
Revised Common Rule's Cooperative Research Provision (45 CFR 46.114)
Determination of Exception for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements
Guidance: IRB Authorization Agreements for Human Subjects Research