104 CMR 31.04 - Institutional Review Board (IRB)

(1) IRB. The IRB shall be guided by the ethical principles regarding human subject research set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The "Belmont Report").

(2) IRB Operations and Review Process. The IRB shall operate in compliance with and review research in accordance with the requirements and standards set forth in 104 CMR 31.04(2)(a) through (g):

(a) 45 CFR Part 46 and 21 CFR Parts 50 and 56;

(b) M.G.L. c. 94C;

(c) applicable state laws relating to the use and disclosure of personal data;

(d) 104 CMR 31.05;

(e) Health Insurance Portability and Accountability Act of 1996 (HIPAA, Pub.L. 104-191, 110 Stat. 1936, enacted August 21, 1996); and 104 CMR 27.17: Records and Records Privacy and 28.09: Records and Record Privacy;

(f) if the research is supported by a federal department or agency, the additional human subject regulations and policies, if any, imposed by the supporting department or agency; and

(g) applicable procedures and guidelines developed by the IRB.

(3) Membership. The Commissioner shall appoint the members of the IRB as required by the standards set forth in 104 CMR 31.04(2). If the IRB reviews research involving minors, it must have one or more members knowledgeable about and experienced in working with children. A member may be removed at any time at the discretion of the Commissioner.

Notes

104 CMR 31.04

Amended by Mass Register Issue 1326, eff. 11/18/2016.