Experiments involving human subjects must conform with the Federal Policy for the Protection of Human Subjects (United States Office of Science and Technology Policy) and in the Declaration of Helsinki and be approved by a local Institutional Review Board. Approval by the latter must be indicated in the text as part of the Methods section. Clinical trial numbers and registration dates should be included in submissions (usually in both the abstract and methods sections).
- Declaration of Helsinki. (Adopted in 1964 by the 18th World Medical Assembly in Helsinki, Finland, and revised by the 29th World Medical Assembly in Tokyo in 1975.) In: The Main Issue in Bioethics Revised Edition. Andrew C. Varga, ed. New York: Paulist Press, 1984.
- Federal Policy for the Protection of Human Subjects; Notices and Rules. Federal Register. Vol. 56. No. 117 (June 18, 1991), pp 28002-28007.
- Office for Human Research Protections (OHRP) Human Subject Protections (http://www.hhs.gov/ohrp/)
