Protection of human subjects and animals

Research involving humans

As stated in the Uniform Requirements of the International Committee of Medical Journal Editors (ICMJE): “Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that the patient be shown the manuscript to be published.

When reporting experiments on human subjects, authors should indicate 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 1975, as revised in 2000 (5). If doubt exists 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 doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed. [International Committee of Medical Journal Editors (“Uniform Requirements for Manuscripts Submitted to Biomedical Journals”)  February 2006].

Research involving animals

All studies involving non-human primates must be performed in accordance with the recommendations of the Weatherall report “The use of non-human primates in research”. Experiments involving vertebrates or regulated invertebrates must be carried out within the ethical guidelines provided by the authors’ institution and national or international regulations. Where applicable, a statement of ethics permission granted or animal licenses should be included. If animals were used but ethical approval was not required, a clear statement should be included stating why this approval was unnecessary.

In all cases, a statement should be made to confirm that all efforts were made to ameliorate any suffering of animals and details of how this was achieved should be provided. We also strongly encourage all authors to comply with the ‘Animal Research: Reporting In Vivo Experiments’ (ARRIVE) guidelines (2014), developed by NC3Rs (2014) to improve standards of reporting, ensuring that the data from animal experiments can be fully scrutinized and utilized. The relevant information outlined in these guidelines should be included in the appropriate section of the article.

Updated May 5, 2015

67 thoughts on “Protection of human subjects and animals”

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