No. Use of the SMART IRB SOPs is strongly encouraged, but not required. SMART IRB acknowledges that: 1) some institutions have existing policies and procedures that they apply or prefer to apply to IRB reliance relationships and 2) in some cases institutions are required as part of funding conditions or participation in clinical trial networks or other programs to use a particular set of policies and procedures to govern the reliance relationship. SMART IRB can still be used to support and document reliance in these situations. Participating Institutions may use their own policies and procedures for the reliance relationship if doing so would not render them in violation of any term of the Agreement, and must agree that if a provision of their own policies and procedures conflicts with a term of the Agreement, the Agreement will govern. For example, if a Participating Institution’s policies and procedures prohibit disclosure of IRB minutes to an institution, the Agreement’s provision regarding access to minutes must apply. However, in the instance when a Participating Institution is required by funding conditions or participation in a network/program to use particular policies and procedures for reliance, those policies and procedures will override any conflicting requirements of the SMART IRB Agreement. In all cases, Participating Institutions involved in a research study under the Agreement must communicate in writing with one another regarding what policies and procedures will apply to such study.
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