CHOP currently has master reliance agreements with the University of Pennsylvania, the National Cancer Institute Pediatric Central IRB, and with a consortium of pediatric institutions. The exact procedures for implementing each of these agreements vary and in some cases are still being refined.
Consent Form Requirements when Relying on an External IRB
Regardless of the agreement, when CHOP relies on an external Reviewing IRB, the approved consent form that will be used at CHOP must conform to institutional requirements. The requirements involve the following elements:
- Identification of CHOP as a research site;
- Inclusion of a CHOP contact for Emergencies;
- The HIPAA language must include CHOP as one of the institutions that will have access to PHI;
- The name and contact information for the CHOP investigator needs to be provided for withdrawal of permission;
- Contact information for the CHOP Office of Research Compliance must be included for subjects' questions;
- If injury compensation language is included in the consent form, then it must match CHOP's institutional requirements;
- The signature page must make clear that the subject is agreeing to allow CHOP to use and share health information (and not just the Reviewing IRB’s institution.
CHOP and Penn have created documents (below) that include their respective institutional requirements. The CHOP IRB cannot issue final approval to rely on an external IRB until the consent form includes all institutionally required elements. When CHOP serves as the IRB of record, the consent forms issued to the relying sites will incorporate the Relying Site's requirements.
- CHOP Consent Form Requirements: Instructions for the Reviewing IRB
- Penn IRB | Reliance Agreement Guidance – Requirements for External Consent Templates.
Master Reliance Agreements: Determination Forms
Penn-CHOP Determination Form
The Penn-CHOP Determination Form should be completed by the CHOP or Penn investigator requesting that their home institution's IRB serve as the IRB of record (Reviewing IRB). The signed and completed determination form should be included with the IRB application to whichever Institution (CHOP or Penn) that is being proposed to serve as the Reviewing IRB. If that IRB agrees to serve as the Reviewing IRB, a copy of the signed determination form will be forwarded to both the PI and to the Relying IRB.
For those interested, the Penn-CHOP Master Reliance Agreement that governs the relationship and interactions between the IRB at CHOP and the IRB at Penn is available for download and review.
Master Common Reliance Agreement
CHOP executed a Master Reliance Agreement with Boston Children's Hospital and Cincinnati Children's Hospital in 2013. In 2014 that agreement was revised and implemented as a Master Common Reliance Agreement, initially with 8 institutions as signatories, all of which were sites under a PEDSnet grant. Boston, Cincinnati and CHOP were again three of the institutions. That agreement is open for other institutions to sign on. As of January 30, 2017 there are 21 signatories to the Master Common Reliance Agreement. The list of institutions is available on the IRB Reliance Agreements page.
For multicenter studies that are conducted under the Master Common Reliance Agreement, the Reviewing IRB is responsible for forwarding a completed Master Common Reliance Agreement Determination Form v. 1-26-2017 to the Relying site(s). This form may only be used with one of the participating sites that are signatories to the agreement.
Single Study Master Reliance Agreements
CHOP Standard IRB Reliance Agreement
When CHOP serves as the Reviewing IRB and the Relying Site is not a signatory to one of the several Master Reliance Agreements, the standard CHOP Authorization Agreement template should be used. The typical situation is where the CHOP PI is the overall study PI and the PI is requesting that the CHOP IRB serve as the Reviewing IRB for one or more Relying Sites. The CHOP IRB will assume this responsibility provided that the other site is registered with OHRP and has an FWA and agrees to the delegation of responsibility as outlined in the agreement.
When another external site's IRB proposes to serve as the Relying IRB, their standard Reliance Agreement is usually used. However, some IRBs do not have an standard Reliance Agreement. In these situations, the CHOP standard Reliance Agreement may be used as is, or in modified form. The external Reviewing IRB must sign the IRB Authorization Agreement before it is sent to CHOP for signature. The investigator should consult the IRB Director and request that she contact the Reviewing IRB to negotiate the agreement.