Why doesn’t the SMART IRB Agreement have an indemnification provision?

A central goal of SMART IRB is to broaden participation in reliance relationships and to help reduce potential barriers to participation. In recognition that certain types of entities, including public, quasi-public, and smaller private organizations, might find an indemnification obligation to constitute such a barrier, the Agreement does not mandate that Participating Institutions indemnify one another in connection with their activities. In addition, in light of the current open regulatory proposals regarding direct liability of IRBs and the possibility of further guidance or clarification from regulatory authorities regarding the respective responsibilities of reviewing IRBs and relying institutions, the Agreement avoids enacting an apportionment of liability that may not reflect where common understanding ultimately lands. However, in recognition that some institutions may wish to negotiate the allocation of liability among participants in advance of these developments, the Agreement does expressly provide that Participating Institutions are free to request and make agreements with other Participating Institutions for indemnification in connection with the covered Research as they deem appropriate.

It is important to be aware that the practical value of indemnification provisions in avoiding litigation and providing an immediate source of recovery may be limited, particularly in the context of a developing area such as IRB reliance agreements; participants may end up litigating about the interpretation and application of the indemnification clause along with the underlying claims for liability.