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. Compliance with the former and approval by the latter must be stated in the cover letter and the approval number must be provided in the Methods section of the article.
- Helsinki Declaration as revised in 2013 (http://wma.net/policies-post/wma-declaration-of-helsinki-ethical-princip...).
- 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/).
When patient informed consent is required, beginning with Volume 7, Issue 1, we require that the authors archive the consent and provide the journal with a written statement that attests they have received and archived written patient consent.
