IRB Reliance

Single IRB and the Revised Common Rule (45CFR46.116)

NIH Single IRB Policy effective January 2018

Effective on January 25, 2018, the NIH Single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program with receipt dates on or after January 25, 2018. It does not apply to career development, research training, or fellowship awards. This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
 

New Common Rule Single IRB Policy effective January 2020

  1. Effective on January 20, 2020, the Common Rule Single IRB policy applies to:
    Federally-funded Cooperative research projects that involve more than one research institution in which each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
  2. (1). Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. As a result, this policy does not apply to international sites
     

(2). The policy does not apply to research that is subject to the following provision:

  1. The cooperative research project is required by law to be reviewed by more than a single IRB (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
  2. Any Federal department or agency supporting or conducting the cooperative research project determines and documents that the use of a single IRB is not appropriate for the particular project.
  1. Cooperative research projects not subject to paragraph (B), an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.
     

Exceptions to the Common Rule Single IRB policy:

  1. The cooperative research project conducted or supported by Health and Human Services agencies other than the National Institutes of Health (NIH), was initially approved by IRB before January 20, 2020.
  2. The cooperative research project conducted or supported by NIH if either:
    1. The NIH single IRB policy did not apply to the research when it was initially approved, and the research was initially approved by an IRB before January 20, 2020, or
    2. NIH found the research to be exempt from its single IRB policy before January 20, 2020.
  3. At the University of Chicago, if the cooperative research project is not federally funded.

 

If you are participating in a multi-center study that requires the use of a Single IRB or have questions about the reliance process, please email irbreliance@bsd.uchicago.edu

Please note that "single IRB" and "central IRB" are interchangeable terms used to refer to the process by which an IRB serves as the IRB of record for multiple sites. 

GUIDANCE:

Instructions: UChicago Relying Upon an External IRB

Instructions: UChicago Serving as the IRB of Record

IRB Reliance Frequently Asked Questions

Suggested Language for Inclusion in NIH Grant Applications if University of Chicago will serve as reviewing IRB

SMART IRB – Language to be utilized if the SMART IRB agreement will be used for relying upon another site to serve as the IRB of record.

AAMC FAQs regarding the NIH Policy

 

FORMS/AUTHORIZATION AGREEMENTS:

DRAFT Formal Request from Relying Site or Individual

Site Specific or Individual U of C CF Template

IRB Authorization Agreement

Individual Investigator Agreement

Local Site Context Form

Relying Site Continuing Review Form

 

IRB Reliance FAQs

The policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training, or fellowship awards.

This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.

The policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. For contracts, the policy applies to all solicitations issued on or after January 25, 2018. For the intramural program, the policy applies to intramural multi-site studies submitted for initial review on or after January 25, 2018. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

The earlier you contact the IRB office, the better we can assist you. Please contact irbreliance@bsd.uchicago.edu

Yes. We can assist in language describing the use of a Single IRB review process to be included in the grant submission. 

Contact the IRB office as soon as possible so that the reliance process can begin with the relying sites’ IRBs. Provide the IRB number of the currently funded study. 

Note, the NIH policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. 

It depends. If the study is a network or consortium funded study, the network will often name the IRB of Record. For NIH funded studies, the lead PI may request his/her institution to be the IRB of Record; however, the institutional official (IO) makes the determination of whether the institution will serve as IRB or Record or not. All requests should be submitted to IRB office for consideration using the proposed reliance form.

The NIH may grant exception if the use of a single IRB review is prohibited by federal, state, or tribal laws or regulations or where the use of a single IRB review is prohibited by established policy. 

At this time, the University of Chicago is not charging for single IRB review. The NIH policy states that costs associated with single IRB review may be charged as direct or indirect costs, provided they are well-justified and consistently treated according to applicable cost principles of the NIH. We will have more information forthcoming regarding costs for single IRB review.

NIH Guidance:https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html

Yes. The Medicare Coverage Analysis (MCA)/ completed schema review memo and signed schema are required to be submitted in ARTEMIS at the time of IRB submission. This applies both when the University of Chicago IRB will serve as IRB of record AND when a CIRB form is submitted with a request to rely on an external IRB. For more information, please contact our office. 

When serving as the lead PI and the University of Chicago is the IRB of Record, you are responsible for contacting the IRB office as soon as possible so that the reliance process can begin with the relying site IRBs. The IRB office will aid in gathering appropriate local context information and can provide assistance to you in submitting the appropriate information via AURA-IRB. You are responsible for submitting all study-related materials based upon University of Chicago policies and procedures, just as you would if you were conducting a single site research project at the University of Chicago. In addition, amendments adding relying sites will need to be submitted so that the relying sites receive the appropriate consent forms and documentation. The IRB office will aid in this process.

You are responsible for communicating approvals to the participating site PIs, as well as providing the approved study materials (application, protocol, site consent form, approval letter, measures, etc.). You are also responsible for submitting any study related reports from relying sites to the UChicago IRB for review and approval. Essentially, you are submitting all sites’ study reports, revisions for local context, amendments, continuing reviews, reports of non-compliance, and adverse events as you would if you were conducting the study only at the University of Chicago. The key difference is that you are now reporting for every site to the University of Chicago IRB.

At continuing review, you will submit a continuing review application, along with all continuing review documents for ALL SITES approved by the University of Chicago IRB.

Report the event to the University of Chicago IRB as soon as possible. The IRB office will facilitate review of this submission and communicate with the relying IRB. As Lead PI, you are agreeing to be responsible for reporting these events in accordance to University of Chicago IRB policies and procedures.

You will need to obtain the study documents from the local site and submit these materials as an amendment to the University of Chicago IRB via AURA-IRB. Please consider whether the participating site’s revisions may also affect the other sites and make revisions, as necessary.

Submit an amendment to the University of Chicago IRB via AURA-IRB with any revised documents.

Submit an amendment to add the site. 

YES! You are required to submit an abbreviated application via AURA-IRB (through the Central IRB pathway). Even though another IRB has taken responsibility for the review of your research under the criteria required by the applicable federal regulations, there are still pieces of review that must occur at the University of Chicago. The IRB also requests copies of the consent document, protocol, and IRB approval letter from the IRB of Record for documentation purposes. An acknowledgement letter will be provided via AURA-IRB once all documentation has been reviewed.

The University of Chicago requires that consent forms include U of C institutionally approved template language for subject injury and HIPAA authorizations. If you have any questions about language in the consent document, contact the IRB office.

Yes, after receiving the approved study documents from the Lead site, submit the approved consent document, approval letter from the IRB of Record, and any additional supporting materials related to enrollment at the University of Chicago. In AURA-IRB, please utilize the activity “edit study” to revise any documentation, including the protocol, consent form, or other documents consistent with the continuing review. The protocol should then return to the “acknowledged” state once all changes have been incorporated.

Any adverse event or non-compliance with the protocol that takes place at University of Chicago should be reported via AURA-IRB as well. This is to ensure that appropriate human subjects protections are in place, and to aid in compliance monitoring for the study and investigator.

In AURA-IRB, please utilize the activity “edit study” to revise any documentation, including the protocol, consent form, or other documents consistent with the changes approved in the amendment. The protocol should then return to the “acknowledged” state once all changes have been incorporated.

The University of Chicago remains responsible for ensuring all staff listed on a protocol, even one reviewed by another IRB, are appropriately trained in human subjects research protections. As such, a personnel change amendment should be submitted if new staff are to be added. As with other personnel changes, approval of the personnel changes for a study reviewed by a single IRB must be granted before the individuals may begin work on the study.