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 or in a separate section at the end of the article. However, because of the legacy pipeline after introduction of this policy, the inclusion of approval numbers will not be manifest consistently in all published articles before Volume 7, Issue 4.
Informed consent
For 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. However, because of the legacy pipeline after introduction of this policy, this change will not be manifest consistently in all published retrospective studies before Volume 7, Issue 4.
Ethical considerations, compliance and protocol approval
Compliance with guidelines on human experimentation as well as protocol approval by a local Institutional Review Board should be stated and the approval number should be provided, either in the Methods section or in a separate section at the end of the article. Clinical trials should include the full protocol as a supplement. Studies involving human subjects that are exempt from approval by an Institutional Review Board should mention this in an Ethical Considerations Statement, either in the Methods section or in a separate section at the end of the article. However, because of the legacy pipeline after introduction of this policy, the inclusion of approval numbers and statements of exemption will not be manifest consistently in all published articles before Volume 7, Issue 4.
- 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/).
