The SMART IRB Agreement requires a Relying Institution to ensure consistency between the approved research study protocol and consent form with the provisions of any applicable grant or funding contract for the study regarding financial coverage for research-related injuries. As an alternative, the Agreement requires the Relying Institution to ensure that in the event of any inconsistency, the approved protocol and consent form, if more protective of subjects, will control. Why does the Agreement place this responsibility for ensuring consistency with the Relying Institution, and what does it mean to ensure that the protocol and consent will control?
The Agreement places this responsibility with the Relying Institution because the Reviewing IRB and Reviewing IRB Institution will generally not be involved in the funding application or funding contract negotiation between the Relying Institution and the sponsor. The Relying Institution is often in the only or best position to review and negotiate the grant or contract language on financial responsibility for coverage of subject injuries as necessary to meet any requirements of the IRB and of its own institution. Aside from reviewing both the grant/contract and the protocol/consent and making sure the language in each is consistent in describing the coverage, another option is for the Relying Institution to negotiate a contract provision with the sponsor that says that to the extent there is any inconsistency, the protocol/consent language will control (the presumption behind this approach is that the protocol/consent language will generally be more protective of subjects than any contract language on the topic). This alternate approach puts the burden of a failure of consistency on the sponsor.