![]() IRB decisions may only be made by IRB board members following the exempt, expedited or full board procedures. The mission of the institutional review board is to protect the rights and welfare of human subjects enrolled in research. In some instances, the sponsor/CRO may also require approval. Site-specific ICF revisions: If a site submits a request for additional site-specific revisions, an IRB member must review the requested revisions to determine their appropriateness.The site must provide satisfactory resolution of the identified issues before approval process completion. If concerns are noted or the compensation for participation information is unclear, an Advarra representative will contact the site. IRB concerns with site submission information: Upon review of additional sites conducting a previously approved protocol, the IRB may note an area of concern with the site’s responses on the submission documents. ![]() Approval documents will not be sent to sites until the ICF is finalized.
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