Office of the Commissioner IRB
|Issue Date:||October 30, 2001|
|Effective Date:||October 30, 2001|
Designated Area of Responsibility: Research and Grants
A. Policy Statement
The purpose of this policy is to specify the manner in which research proposals will be reviewed and acted upon; in order to protect the rights and welfare of human research subjects participating in research conducted, sponsored, approved or otherwise subject to regulation by the State of Connecticut Department of Mental Retardation (DMR); and in order to comply with Title 45 Code of Federal Regulations, Part 46, Protection of Human Subjects.
Compliance with federal regulations for the protection of human subjects is required whenever biomedical or behavioral research is conducted or supported by the federal government or whenever research is subject to regulation by the Food and Drug Administration. It is the policy of DMR to apply the same standards of review to both federally and non-federally funded research projects.1
Note: All studies involving human subjects or records pertaining to them should be assumed to require Office of the Commissioner Institutional Review Board (IRB) review until determined otherwise. If there is any question if IRB review is required, the question should be submitted in writing to the Chairperson of the IRB.
This policy applies to all researchers, including DMR employees or agents, who a) intervene or interact with living individuals for research purposes; or b) obtain individually identifiable private information for research purposes. Agents include all individuals performing DMR designated activities or exercising DMR delegated authority or responsibility. This includes DMR contractors or their staff and other non-DMR researchers (e.g., faculty, staff, graduate students, undergraduate students).
- DMR Office of the Commissioner Institutional Review Board (IRB) Procedure, (October 30, 2001)
- Processing Requests to Conduct Research Involving Human Subjects (October 30, 2001)
- National Institute of Health, Office of Extramural Research, Office for Protection from Research Risk, Protecting Human Research Subjects, Institutional Review Board Guidebook (1993)
- Protection of Human Subjects, Title 45 C.F.R. Part 46 (1991)
- Institutional Review Boards, Title 21 C.F.R. Part 56 (1981)
- Protection of Human Subjects, Title 21 C.F.R. Part 50 (1980)
- Section 45a-677 CGS, as amended
1 Department of Health and Human Services (DHHS) regulations relating to the protection of human subjects are codified at Protection of Human Subjects, Title 45 C.F.R. Part 46 (1991) and are enforced by the Office of Human Research Protection (OHRP). The U.S. Food and Drug Administration (FDA) regulations are codified at Protection of Human Subjects, Title 21 C.F.R. Part 50 (1980) and Institutional Review Boards, Title 21 C.F.R. Part 56 (1981). FDA regulations primarily apply to clinical investigations and the development and approval of drugs, biologics and devices.