If my institution or an institution with which we are involved in a ceded review terminates participation in SMART IRB, are there any ongoing rights and obligations? What happens to any research that is still under ceded review at the time of termination?
When a Participating Institution’s participation in SMART IRB terminates, certain rights and obligations "survive" the termination. These rights and obligations are listed in the SMART IRB Agreement, and include: cooperation in investigations and reporting of noncompliance and problems, recordkeeping, confidentiality, and use of name. With respect to any research study/ceded review that is ongoing at the time of termination, the Agreement does not mandate a particular outcome, but the involved Participating Institutions agree to work together to determine the effect of the termination on such activities. The goal would be to transfer oversight of any ongoing research study(ies) to another IRB as soon as possible and to minimize any disruptions to such studies.
For covered Activities in the scope of the SMART IRB Version 3.0 optional Indemnification Addendum, all the terms and obligations in the Indemnification Addendum will survive any termination of the Indemnification Addendum, either in its entirety or with respect to the participation of a particular Indemnification Participating Institution.
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