Section 180.06 - Medical ResearchInmates within the custody of the Department shall be permitted to participate in medical and pharmaceutical research. 103 CMR 180.00 policy permits inmate participation in medical or pharmaceutical research. Institutions electing to participate in such biomedical research shall be in compliance with all state and federal guidelines.
(1) All proposals for clinical trials under 103 CMR 180.00 shall be submitted to the Deputy Commissioner of Clinical Services and Reentry for review and approval. Such trials must also be reviewed and approved by the Lemuel Shattuck Hospital Institutional Review Board (IRB). A copy of all proposals shall be kept on file in the Department's Research and Planning Division;(2) All proposals for clinical trials under 103 CMR 180.00 must conform to the requirements of the Code of Federal Regulations ( 45 CFR 46, et. seq., Protection of Human Subjects), establishing special provisions which protect prisoners involved as human subjects in research activities, and applicable state law;(3) All clinical trials under 103 CMR 180.00 shall be conducted within conditions approved by the Deputy Commissioner of Clinical Services and Reentry. The Health Services Division shall establish policies and procedures consistent with 103 CMR 180.00. (See 103 DOC 662: Clinical Trials and Medical Research Involving Inmate Participation, available at http://www.mass.gov/doc/policy).(4) Nothing in 103 CMR 180.00 shall be construed as affording any inmate a protected right to participate in clinical trials or as creating any private right of action to enforce the provisions of 103 CMR 180.05 not otherwise available by law.(5) Research that is comprised of both a medical and a social science component shall be submitted to the Research and Planning Division for review. The Executive Director of Strategic Planning and Research shall determine if any areas of the research require review by the Deputy Commissioner of Clinical Services and Reentry. If the determination is yes, both shall review the areas of research pertaining to his or her area of expertise and then make a joint recommendation to the Superintendents and the Commissioner.Amended by Mass Register Issue 1338, eff. 5/5/2017.