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Research on human subjects is governed by a number of federal regulations including:
(2) CFR Title 45 (Public Welfare) Part 5b - Privacy Act Regulations 3) Public Health Service Act 42 U.S.C. S241 (d) - Protection of Privacy of Research Subjects See the U. S. Office of Protection from Research Risks website (http://www.nih.gov/grants/oprr/oprr.htm) for access to these documents and good resources and links on human subjects and animal research regulations, protocols and alternatives. The main goal of these regulations is to insure that human research subjects are fully informed of the risks of being involved in research projects and given consent to the procedures knowing the risk (known as informed consent).
Informed consent should be obtained for all minors and for adults when more than minimal risk is involved in participating in the project. Minimal risk is defined as the probability of harm or discomfort anticipated in the research.
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