Protection Of Research Participants

This excerpt has been taken from the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. (http://www.icmje.org/recommendations/browse/roles-and-responsilities/protection-of-research-participants.html).

When reporting experiments on humans, authors should specify whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 2008, or similar. If there is any doubt as to whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the questionable aspects of the study.

Patients have the right to privacy and should not be violated without informed consent.

Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) provides written informed consent for publication. For this purpose, informed consent requires that an identifiable patient be shown the manuscript to be published. Authors should disclose whether any potential identifiable material is available on the Internet and after publication in print. Patient consent should be written and archived with the journal, the authors, or both, as required by local regulations or laws. Local laws may vary from region to region, and journals should establish their policies with legal guidance.

Unnecessary details of identification should be omitted. If anonymity cannot be maintained, informed consent should be obtained. For example, masking the eye region in photographs of patients is inadequate anonymity protection. When removing identifiers, authors should ensure the provision of assurances, and editors should ensure that such changes do not alter the scientific meaning.

The requirement for informed consent should be included in the journal's instructions to authors. When informed consent is obtained, it should be noted in the published article.

When reporting experiments on animals, authors should indicate whether the care and use of laboratory animals were in accordance with institutional and national standards. Further guidance on animal research ethics can be obtained from the International Association of Veterinary Editors Consensus Author Guidelines on Animal Ethics and Welfare.