Phone: 616-331-3197
Fax: 616-331-6830
HRRC
hrrc@gvsu.edu

301C DeVos Center
401 Fulton Street
Grand Rapids, MI 49504

Federal Regulations and Guidance

Human Subjects Research


There are multiple federal regulations governing human subject protections in research activities. The majority of research is covered by three sets of regulations: the Health and Human Services, the Food and Drug Administration, and the Department of Education. There is a great deal of overlap in the relevant regulations, but they are not identical and in a limited range of cases important differences exist among them. The main federal office for providing guidance on the regulations is the Office of Human Research Protections (OHRP)

Title 45 Part 46 contains the relevant Federal Regulations regarding Human Subjects Research.  The Office for Human Research Protection (OHRP) provides these regulations for reference purposes.
Index of Federal Regulations: Title 45 Part 46


The OHRP also provides "Guidance".  Guidance exists to assist in interpretation of regulations in some subject areas.  Other subject areas may have partial guidance, or none at all.
Federal Regulation Policy and Guidance


International Human Subjects Protection Regulations (pdf)


Office for Human Research Protection Questions and Answers



Belmont Report


On July 12, 1974 the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.  In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definitions of informed consent in various research settings.

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.  It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years.  It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.
  Last Modified Date: November 24, 2008
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