As one of the leading academic research centers in the nation, faculty researchers at the University of Pittsburgh frequently collaborate with external investigators and institutions. In an effort to reduce duplicate submission and oversight by multiple IRBs for the same protocol, the University of Pittsburgh IRB offers reliance agreement opportunities. Reliance agreements are arrangements between institutions allowing the IRB of one institution to rely on the IRB of another institution for review of human subjects research. Effective January 25, 2018, the National Institutes of Health mandated the use of single IRBs as a contingency for funding of multi-center studies.
- Single IRB Review: a legal arrangement that allows one IRB to review the research on behalf of other engaged institutions.
- IRB of Record: the IRB that reviews and makes required regulatory determinations (Reviewing IRB)
- Relying Institution: institution that cedes IRB responsibilities to the IRB of Record
- 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.
It’s important to remember that reliance agreements for single IRB review are used to cede ONLY the IRB review of protocols. All institutionally required ancillary reviews must still be obtained locally. For example, Conflict of Interest, Radiation Safety, Stem Cell, IND/IDE oversight will still require local review and approval regardless of ceding IRB review.
The IRB recommends that investigators begin discussions with the University of Pittsburgh IRB at the time the grant is being written. The procedures below outline the steps to be taken when requesting that IRB review be ceded to an IRB at another institution or when requesting that the University of Pittsburgh IRB serve as the IRB of record for external sites.
Requests for ceding IRB review to an external IRB:
- Complete the form “Application for an External Institution to Serve as IRB of Record” and submit to firstname.lastname@example.org. 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.
- Reliance agreements vary by study. Roles and responsibilities of each site will be specified in the agreement. This includes defining the reporting responsibilities for unanticipated problems as well as responsibilities for monitoring the study.
Registering external studies in OSIRIS AFTER reliance agreement has been executed
All studies approved by external IRB’s need to be registered in OSIRIS. This allows for required institutional ancillary reviews to occur and also allows the IRB to maintain a record of the research being conducted at this site.
- Create a new study in OSIRIS by clicking on New Study. In section T1.0, click on External IRB of Record. Studies will be assigned a number beginning with EXT.
- In section EXT1.0, please upload the study documents approved by the external IRB, including the most current version of the multicenter protocol, the Pitt-specific consent form, and any recruitment materials and data collection forms.
- The External IRB expiration date is entered into EXT2.1 of OSIRIS and will become the expiration date of the study.
- Because the University of Pittsburgh is not the IRB of record, all modifications, unanticipated problems, adverse events, and continuing reviews are reviewed by the external IRB of record only. Continuing Reviews (Renewals) are not submitted to the UPitt IRB.
- The EXT study registration in OSIRIS is required to be updated annually at the time when the external IRB of record approves the continuing review (renewal) of the study. For the annual update of the study registration in OSIRIS, you are required to upload the following documents into section EXT1.0: IRB of Record’s approval letter for continuing review, most current version of the protocol and most current version of the local consent form.
- The only other times you are required to update the EXT study registration in OSIRIS are (a) change in PI (which must be accompanied by the single IRB’s approval of the change in PI); and, (b) Determinations by the single IRB of events meeting definitions of serious or continuing noncompliance and/or unanticipated problems involving risk to subjects or others that required reporting to federal agencies (FDA, OHRP, sponsors) by the single IRB of record.
Requests for Pitt to serve as the single IRB of Record:
- Complete the form “Initial Application for Pitt to Serve as the IRB of Record” and submit to email@example.com . 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 can be submitted via firstname.lastname@example.org.
- After your information is received and reviewed by the IRB regulatory division, you will be contacted to schedule additional meetings to discuss the details of the study and the study sites. Legal counsel and the Institutional Official may be involved in the decision making process and in drafting the reliance agreement.
- A draft of the Reliance Agreement will then be sent to all external site PI’s and IRB Representatives with a request to provide any desired revisions to the agreement. Once all requested revisions are received from all sites, a phone meeting may be scheduled with all external sites to discuss requested revisions and to get the Agreement into a final state that is acceptable to all participating institutions.
- The final version of the Agreement will then be sent to all sites for signature by their PI and appropriate officials and returned to email@example.com. The Pitt Institutional Official will then sign the agreement and final, signed copies of the Agreement will be returned to all sites. Once the Single Site protocol has been drafted, the UPitt IRB will also upload the final agreements into the OSIRIS system.
- Reliance agreements vary by study. Roles and responsibilities of each site will be specified in the agreement. This includes defining the reporting responsibilities for unanticipated problems as well as responsibilities for monitoring the study. At this time, the local investigator will be the responsible party for submission of the protocol in OSIRIS, submission of reportable events, and disseminating information to the external sites.
- Create a new study in OSIRIS by clicking on New Study and submit the OSIRIS application following usual procedures.
- The submission should include template consent forms and recruitment materials that, once approved by the UPitt IRB, will be distributed to the external sites for them to edit to include local information such as letterhead, site investigators and local compensation for injury language (if applicable). Once the external sites have revised the templates and returned them to the UPitt study team, a Modification must be submitted to the UPitt IRB to get the final version of these documents approved for use.
- The Pitt PI will be responsible for disseminating information across the external sites.
- Each external institution will have local policies about what their investigators must provide to their local Relying IRB when ceding review to the UPitt IRB. External investigators should discuss these requirements with their local IRB and comply accordingly.
- At the time of annual renewal, submit summary information for all sites through OSIRIS. The UPitt IRB will review following usual IRB policies and procedures.
- Submit modifications and reportable events for all sites as usual through OSIRIS and disseminate the information to external sites.