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Human Subjects Research

Human Subjects Research

Role of the Institutional Review Board for the Protection of Human Subjects (IRB)

The IRB is responsible for protecting the rights and welfare of human subjects in research conducted by all members of the campus community. Research is defined as an activity that is a systematic investigation designed to develop or contribute to general knowledge. The IRB ensures the safe and ethical treatment of all human subjects and is guided by the ethical principles regarding all research involving humans as subjects set forth in the Belmont Report and by federal requirements. Federal requirements for the protection of human subjects can be found in the Code of Federal Regulations in Title 45, Part 46; the Belmont Report has been captured in the code. The University of Massachusetts Dartmouth will meet the requirements set forth in Title 45, Part 46 of the Code of Federal Regulation (45 CFR 46) for all research without regard to source of funding, including internally funded research and research conducted by students. The IRB must review and approve all work to be done with human subjects prior to the work commencing. Work completed without approval cannot be published. Ongoing work must be reviewed by the IRB on at least an annual basis. Any changes in protocol including renewals must also be approved by the IRB prior to implementation. The regulations also deal with specific sensitive populations and acceptable exemptions. Exemptions must also be approved by the IRB. The Office of Research Administration should be contacted at any time an investigator is not sure the research involves human subjects as defined by the code, or is considering a change in protocol.

For more information, please visit the Institutional Review Board.

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