Human Subjects

Authors of manuscripts describing research involving human subjects must obtain review and approval (or review and waiver) from their Institutional Review Board (IRB) prior to manuscript submission. Authors of manuscripts that describe multisite research must obtain approval from each institution's IRB. Documentation of IRB status must be made available upon request. In the event that institutional review boards or committees do not exist, the authors must ensure that their research is carried out in accordance with the Declaration of Helsinki, as revised in 2013. A statement of IRB approval or waiver (and reason for waiver) or a statement of adherence to the Declaration of Helsinki must be included in the Materials and Methods section (or at the end of the text for shorter article types: e.g., announcements, short-form papers, etc.).

Authors of manuscripts describing research involving human subjects must also ensure that the research described in their manuscript and that publication of their manuscript is and would be in compliance with all applicable laws within their locality.

Informed consent for publication is not needed if the patient cannot be identified from any material in a manuscript. In the absence of informed consent, identifying details, such as patient initials, specific dates, specific geographic exposures, or other identifying features (including body features in figures), should be omitted, but this must not alter the scientific meaning. Important information that is relevant to the scientific meaning should be stated so that the patient cannot be identified, e.g., by stating a season instead of a date or a region instead of a city. If a patient can be identified from the material in a manuscript, all efforts should be made to obtain informed consent to publish from patients or parents/legal guardians of minors. Informed consent requires that the patient have the opportunity to see the manuscript prior to submission. The written consent must state either that the patient has seen the complete manuscript or that the patient declines to do so. Patient consent should be archived with the authors and be available upon request. A statement attesting to the receipt and archiving of written patient consent should be included in the published article.

Animal Subjects

Authors of manuscripts describing research involving animal experimentation must obtain review and approval (or review and waiver) from their Institutional Animal Care and Use Committee (IACUC) prior to manuscript submission. Authors of manuscripts that describe multisite research must obtain approval from each institution's IACUC. Documentation of IACUC status must be made available upon request. In the event that institutional review boards or committees do not exist, the authors must ensure that their research is carried out in accordance with the International Guiding Principles for Biomedical Research Involving Animals, as revised by the International Council for Laboratory Animal Science (ICLAS) and the Councils for International Organizations of Medical Sciences (CIOMS) in 2012. A statement of IACUC approval or waiver (and reason for waiver) or a statement of adherence to the Guiding Principles must be included in the Materials and Methods section.

For more information, please see the ORI module on human subject research and the COPE guidelines.