Frequently Asked Questions (FAQs) - IRB Reliance Agreements

 Frequently Asked Questions (FAQs): IRB Reliance Agreements at University of Pittsburgh

General Information

When Requesting UPitt IRB Cede Review to an External IRB

When Requesting UPitt IRB to Act as the IRB of Record

 

General Information

What is a Reliance Agreement?

A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site.

 

What is the purpose of a Reliance Agreement?

A reliance agreement avoids duplicate IRB initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site research protocol. Once the agreement is executed, it can lessen the administrative burden and regulatory oversight of multiple institutions’ IRBs.

 

Are reliance agreements accepted by all institutions?

Institutions vary as to whether they will utilize reliance agreements. Many institutions will decide if they will allow a reliance agreement based on the research protocol being reviewed. Some institutions have standing arrangements to utilize other IRBs for specific types of research. From a regulatory perspective, federal regulations allow for reliance agreements to be used for multi-site research.

However, as of March 2017, The National Institutes of Health (NIH) will require the use of a single Institutional Review Board (IRB) for non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. 

The policy is available for review at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

 

Does the University of Pittsburgh utilize reliance agreements?

Yes, the University of Pittsburgh has both agreed to act as the IRB of record, allowing other institutions to cede review to the UPitt IRB and it has also agreed to cede review to an external IRB. However, the UPitt IRB does not currently engage in reliance agreements with international IRBs.

 

When should I submit a request for use of a Single IRB?

A request can be submitted at any time.

If you are submitting an NIH grant that requires use of a Single Site IRB, a reliance request should be submitted to the UPitt IRB at the time you are drafting the grant. The UPitt IRB is capable of providing letters of support indicating we are willing to use a Single Site IRB mechanism. This letter of support can then be submitted with your grant application.

 

WHEN REQUESTING  UPitt IRB CEDE REVIEW TO AN EXTERNAL IRB  

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How is a decision made whether UPitt is willing to cede review to an external IRB?

The UPitt IRB first collects preliminary information from Pitt Investigators to determine our willingness to cede IRB review for a particular project.

The first step is to complete the form “Application for an External Institution to Serve as IRB of Record” and submit to askirb@pitt.edu.  This form will prompt you to provide information about the study, the funding source, and the IRB you are requesting to rely upon. 

Your information will be reviewed to determine if the UPitt IRB is willing to cede review based upon the details provided. If it is determined UPitt is willing to cede, you will be contacted about additional details and the type of agreement required.  Legal counsel and the Institutional Official will be involved in the decision making process and in drafting the reliance agreement.

 

If Pitt cedes review to an external IRB, what responsibilities does the UPitt Principal Investigator and research staff have?

Once a reliance agreement has been executed for Pitt to cede review to another IRB, the Pitt PI is responsible for obtaining all regulatory protocol information (approved protocol, approved consent documents, etc.) from the ‘overall PI’. Any questions or required reporting will need to go through the PI at the reviewing IRB site. You will no longer interact with the UPitt IRB for protocol issues related to that research. You will be responsible to providing information needed at the time of continuing review or if any unanticipated problems occur.

The final Agreement will dictate any additional responsibilities the Pitt PI will have.

 

If UPitt IRB cedes review to an external IRB, is an application still needed with the UPitt  IRB?

Yes, an ‘External IRB of Record” submission is needed to locally register the protocol via OSIRIS. This type of submission is generated by selecting “External IRB of Record” in item T1.0 of OSIRIS. This submission is not an IRB review process (since the IRB review will be ceded to another institution) but rather is a means to review/approve the cede request, trigger applicable ancillary reviews, and track research activities occurring at Pitt.

 

Continuing Reviews (Renewal): I am the PI for a protocol at Pitt but we have relied on another IRB review. Do I need to submit continuing reviews at Pitt?

The continuing review that occurs at the external IRB of record IRB will include Pitt’s involvement in the research. Therefore, you will need to provide all necessary information for the external IRB’s continuing review to the ‘overall PI’ at the site Pitt is relying on. A continuing review at UPitt will not occur.

 

Reportable Events: I am a PI for a protocol at Pitt but we have relied on another IRB review. If an unanticipated problem has occurred with one of my subjects, who do I report it to?

All unanticipated problems, deviations, suspensions and terminations, noncompliance, subject complaints, etc. should be reported to the ‘overall PI’ at the external institution that is acting as the IRB of Record. The overall PI will be responsible for reporting these to the external IRB. The external IRB of record IRB will notify UPitt IRB of any such issues.

 

Consent forms: I am the PI for a protocol at Pitt but we have relied on another IRB review. Do I still use a Pitt consent form?

The consent forms to be used at UPitt will be reviewed and approved by the external IRB of record. However, they should include Pitt-specific information (headers, HIPAA/privacy language, injury language, contact information, etc.).

Typically, what occurs is that the multi-centered protocol submitted to the external IRB of record includes template consent forms that get approved by the IRB of Record. Once approved, the templates are distributed to all relying sites for them to insert local information. The site-specific consent forms are then submitted as a Modification to the external IRB of record and approved for use.

Consent forms used at Pitt can be separate Pitt-only forms or ‘hybrid’ forms can be created to include all sites’ information in the same form.

 

WHEN REQUESTING UPitt IRB TO ACT AS THE IRB of RECORD:

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How is a decision made whether UPitt is willing to act as the IRB of Record?

The UPitt IRB first collects preliminary information from Pitt Investigators to determine our willingness to cede IRB review for a particular project.

The first step is to complete the form “Initial Application for Pitt to Serve as the IRB of Record” and submit it to askirb@pitt.edu.  You will be asked to provide information about the study, the funding source, risk level, use of drugs and devices, need for FDA exceptions from informed consent and how many sites you are requesting the UPitt IRB cover.  The UPitt IRB will use this information to determine if they are willing to act as the IRB of record.

If the UPitt IRB determines it is willing to act as IRB of Record, you will then need to complete an “Appendix A – Relying Site” for each site that will rely on UPitt IRB. The appendix will collect information about the relying institution and the local investigator’s responsibilities for oversight of the research activities being conducted at external sites. Completed Appendices should be submitted via askirb@pitt.edu.

 

If another institution relies upon UPitt IRB, what responsibilities does the Pitt Principal Investigator and research staff have?

If you agree to be a principal investigator for a protocol that assumes responsibility for IRB review of other sites, your responsibilities increase.

Not only are you responsible for the IRB review/oversight/reporting of research activities conducted at University of Pittsburgh you now become responsible for IRB review and reporting for the sites that are relying on the UPitt IRB as part of your protocol. It is important that before you consider assuming this responsibility, you have the resources and infrastructure to do so. This will likely depend on relationships with investigators at the other sites since you will need to depend on them to provide information about the research activities at their sites.

Once a reliance agreement has been executed for other sites to rely upon (cede review to) Pitt IRB, the Pitt PI is considered the ‘overall PI’ for the multi-site research protocol and obtains overall responsibility for the protection of human subjects for all sites. This includes the collection of all regulatory information needed by Pitt IRB and the external sites.

This includes ensuring external sites are complying with local state laws and regulations.

 

If an external site agrees to rely the UPitt IRB, is an application still needed at the Relying institutions IRB?

This will depend on the external institution’s policies. Researchers may need to submit through their IRB system even if that IRB will rely upon the UPitt IRB. Further information should be obtained from that institution’s IRB office.

 

Continuing Reviews (Renewal): I am the PI for a protocol and another institution is relying on UPitt IRB. What do I need to consider at the time of continuing review?

As the ‘overall PI’ with another institution relying on UPitt, you need to collect all required information needed to complete the continuing review submission form. The continuing review at the UPitt IRB will be conducted for all sites. Therefore, all information such as enrollment numbers, reportable events, etc. must be collected from all relying sites and included in Pitt’s continuing review.

 

Reportable Events: I am the PI for a protocol and another institution is relying on the UPitt IRB. If there is an unanticipated problem at another site, do I need to report it to the UPitt IRB?

Yes. All unanticipated problems, deviations, suspensions and terminations, noncompliance, subject complaints, etc. from any relying site should be reported to UPitt IRB. UPitt IRB review and notify the relying site’s IRB of any such issues.

 

Consent forms: I am the PI for a protocol and another institution is relying on the Pitt IRB. Do they use a Pitt consent?

The consent forms to be used at a relying site will be reviewed and approved by the UPitt IRB.

When initially submitting to the UPitt IRB, template consent forms should be included. Once these templates are approved by the UPitt IRB, the overall PI should distribute the approved template to all relying sites for them to add their site-specific information such as letterhead, local personnel and compensation for injury (if applicable). A Modification must then be submitted to the UPitt IRB to get the site-specific consent forms approved for use.

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