Jurisdiction & Purpose

This committee is established to review proposed and ongoing research programs in order to comply with policies established by the Department of Health and Human Services (Title 45, CFR, Part 46) and SEKESC for the protection and safety of human subjects used in biomedical and behavioral research. SEKESC-IRB has the authority to approve, modify, and disapprove all research activities in accordance with (IAW) 45 CFR 46.

This document serves as SEKESC’s assurance which contains the written policies and procedures to be followed by the SEKESC-IRB, departments and staff when conducting research involving human subjects.

The SEKESC-IRB grants authority to individual Directors and/or the Center of Community Supports at Greenbush Research and Evaluation Division to determine (1) whether the proposed activity constitutes review by the SEKESC-IRB according to the definitions of “research” and “human subjects” as defined by 45 CFR 46.102(e)(l), and (2) whether research involving human subjects is exempt from IRB review as defined by 45 CFR 46.104(d) (as outlined in Review Criteria), during the initial application process. The SEKESC-IRB is the final institutional authority in determining approval and disapproval of all applicable research involving human subjects, regardless of funding source or support. All research involving human subjects covered by this assurance will not be conducted until the SEKESC-IRB has reviewed and approved the research protocol and informed consent requirements IAW §46.111, §46.116, and §46.117.