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 as revised in 2013 and be approved by a local Institutional Review Board. Compliance with the former and approval by the latter must be stated in the cover letter and indicated in the Methods section of the article or in a separate section at the end of the article.
Informed consentFor research involving human subjects, including registry reviews and retrospective cohort studies for example,
authors must state that informed signed consent has been obtained from all subjects or provide an explanation as to why consent was waived either in the Methods section or in a separate section at the end of the article.
- Helsinki Declaration as revised in 2013 (wma.net/policies-post/wma-declaration-of-helsinki-ethical-princip...).
- 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 (hhs.gov/ohrp).