Research Involving Human Subjects

“Research involving human subjects,” as defined by Federal regulations, includes any systematic investigation that is designed to develop or contribute to generalized knowledge, and which uses living humans or identifiable private information about humans. Examples of “research involving human subjects” conducted at UC Davis are drug/device comparison trials, disease prevention studies, ethnographic interviews, psychology experiments, and curricular evaluation studies.

Policy

In accordance with the Federal Policy on the Protection of Human Subjects (DHHS Policy 45 CFR Part 46, FDA Policy 21 CFR Parts 50 and 56), UC Davis is responsible for the protection of the rights and welfare of human subjects in research conducted by, or under the supervision of faculty, staff or students. To conduct this responsibility effectively, the University maintains Institutional Review Boards (IRBs) to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects.

Additional information is available from the IRB Administration website.

Responsibilities of Instutional Review Boards

It is the function of the IRBs to:

  1. Determine and certify that all projects reviewed by the IRBs conform to the regulations and policies set forth by the United States Department of Health & Human Services and the Food & Drug Administration regarding the health, welfare, safety, rights, and privileges of human subjects; and,
  2. Assist investigators in complying with Federal and State regulations.
Responsibilities of UC Davis Institutional Review Board
  1. UC Davis, as part of its Multiple Project Assurance (the license from the NIH to function as an IRB), has agreed to protect the welfare of all human subjects involved in research, whether or not the research is conducted or supported by a Federal department or agency. Therefore, the UC Davis IRB has jurisdiction over all human subject research conducted at this institution and does not recognize any exemptions.
  2. The UC Davis IRB has the responsibility of reviewing all human subject research:
    1. Sponsored by UC Davis.
    2. Conducted by any UC Davis employee or agent in connection with his or her institutional duties.
    3. Conducted by any UC Davis employee or agent using any property or facility of UC Davis.
    1. That involves the use of UC Davis non-public information to identify or contact human research subjects
Resources

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