Why doesn’t the insurance provision in the SMART IRB Agreement obligate Participating Institutions to carry specific types or amounts of insurance coverage in connection with their participation?
SMART IRB seeks to facilitate broader participation in reliance relationships and to maximize flexibility of choice for participants. Consistent with these goals, the Agreement sets a basic expectation that Participating Institutions will have insurance coverage for their various activities (including, as applicable, the conduct and review of research), but it does not dictate the types of policies or minimum coverage levels that may accomplish this coverage.
The Agreement recognizes that different types of institutions may insure against research-related risk differently, depending on their organizational structure, the size and nature of their research program, and their relationships with their personnel and other individuals (including IRB members) who are involved. In addition, some institutions have self-insurance programs or limited coverage based on status as public or quasi-public entities, state law immunities, and other factors. The Agreement provides that Participating Institutions may obtain documentation of any other Participating Institutions' insurance coverage prior to determining whether to participate in a ceded review with those institutions. Thus, a Participating Institution can obtain the information it needs to make a study-specific decision. It is not obligated to participate in any ceded review. A Participating Institution can also agree with another Participating Institution to waive the basic requirement to maintain insurance coverage on a study-specific basis if they determine that is appropriate.