Who is responsible for ensuring that the language in an IRB-approved consent document about subject injury is consistent with the language in the grant/contract supporting the research study?
Because the Reviewing IRB will not be involved in the funding contract negotiation between the Relying Institution and the sponsor, it is the Relying Institution’s responsibility to review the contract language on subject injury against the consent that the reviewing IRB has approved for its site and make sure that they are consistent. Alternatively, the Relying Institution can negotiate a clause in its funding agreement that makes the sponsor effectively responsible for inconsistencies by saying that the consent form will control (if it offers broader protection than the contract).
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