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Academic Medicine:
doi: 10.1097/ACM.0b013e318198c40f
From the Editor

Ethical Approval for Studies Involving Human Participants: Academic Medicine’s New Policy

Kanter, Steven L. MD

Free Access

It is important for readers to know that human participants in any study reported in Academic Medicine have been treated in accordance with contemporary ethical standards. Consequently, the journal has added a new requirement: For studies involving human participants (including students, residents, and faculty), it is the author’s responsibility to state in the manuscript information about ethical approval for the research (preferably in the Method section). This information should include but not be limited to the name of the approving committee (e.g., institutional review board, research ethics board) and the name of the institution at which approval was granted.

Authors who do not have access to a formal ethical approval process must provide information in the manuscript about the treatment of human participants, including

* how risks to human participants were minimized,

* why the risks were reasonable in relation to anticipated benefits,

* how the selection of participants was equitable,

* whether adequate procedures were in place to ensure the privacy and confidentiality of participants,

* the plan used to monitor the data and safety of the participants,

* how informed consent was sought and documented,

* if applicable, what safeguards were used to protect vulnerable populations, and

* other relevant information.

(The list above is based on information in the U.S. Code of Federal Regulations concerning criteria for approval of research by an institutional review board.1)

It is the responsibility of these authors to ensure that their studies have been conducted in accordance with the latest version of the principles of the Declaration of Helsinki (http://www.wma.net/e/policy/b3.htm). Also, it may be useful for authors to consult the statements on ethics of the American Educational Research Association, the American Psychological Association, the American Sociological Association, and/or other national and international organizations.

There are several reasons why the journal’s new policy is important. First, Academic Medicine is one of the journals that follows the Uniform Requirements for Manuscripts Submitted to Biomedical Journals maintained by the International Committee of Medical Journal Editors. Section II.F of that document states that 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 (http://www.icmje.org).

The World Association of Medical Editors (WAME) supports this position and offers explicit guidance for individuals working in countries or institutions without ethics committees. WAME recommends that documented review and approval from a formally constituted review board (institutional review board or ethics committee) should be required for all studies involving people, medical records, and human tissues. For those investigators who do not have access to formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. If the study is judged exempt from review, a statement from the committee should be required (http://www.wame.org/resources/publication-ethics-policies-for-medical-journals).

The Council of Science Editors reinforces the idea of ethical approval for research involving human participants, and goes a step further by stating in their White Paper on Promoting Integrity in Scientific Journal Publications that all journals should require formal verification that human subjects research on which a submission is based was approved by an institutional review board or complied with the Declaration of Helsinki and that the researchers conducted the study according to acceptable research standards, including obtaining informed consent (http://www.councilscienceeditors.org/editorial_policies/white_paper.cfm).

Second, in studies that involve students or residents as human participants, it is especially important to treat them with the same ethical consideration that we expect them to use when treating their own patients or study participants. Medical school faculty are important role models for students and residents at critical formative junctures – times when students and residents are formulating notions of how to treat patients, participants in clinical trials, and more junior learners. Experiencing the informed consent process as a study participant can provide a student or resident with an invaluable, first-hand learning experience that supersedes book learning or studying a Web-based module.

Third, if human participants in a study were not treated in accordance with an accepted set of ethical standards, it may introduce additional variability and potentially affect the generalizability of study results.

Fourth, adhering to currently accepted standards of ethical treatment in research involving human participants is essential to preserve and sustain the public trust.

Fifth, journals have a moral imperative to foster work that was done according to the best ethical guidance of the time. It is worth noting that notions of ethical conduct are a function of the times we live in, contemporary mores, personal and professional values, belief systems, and scientific knowledge and potential. The journal’s professional staff and I recognize that it is important to stay abreast of current thinking and to have a process to examine journal requirements on a regular basis.

And finally, I believe that journal editors have an opportunity—indeed, a responsibility— not only to support current ethical guidelines, but also to advance thinking about the protection of human participants in research. The way in which investigators treat other human beings who participate in research studies is an important reflection of our values, a measure of our civility, and ultimately a statement about our humanity.

Steven L. Kanter, MD

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Reference

1 Code of Federal Regulations, Title 45, Public Welfare. Department of Health and Human Services, Part 46, protection of human subjects, subpart A, section 46.111, criteria for IRB approval of research. Available at: (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Accessed December 5, 2008.

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Ethical Approval for Studies Involving Human Participants

From Academic Medicine’s Editorial Policy, Publication Ethics, and Complete Instructions for Authors, available in full at (http://journals.lww.com/academicmedicine/Pages/InstructionsforAuthors.aspx).

Academic Medicine’s policies regarding the treatment of human participants follow those of the International Committee of Medical Journal Editors (ICMJE) (http://www.icmje.org). For studies or evaluations involving human participants (including students, residents, and faculty), it is the author’s responsibility to provide details of ethical approval for the research in the manuscript (preferably in the “Methods” section), including but not limited to the name of the approving committee (e.g., Institutional Review Board, Research Ethics Board) and the name of the institution at which approval was granted. (Please note that at many U.S. institutions, a decision of “exempt” must be made by an Institutional Review Board or an individual designated by the institution, but may not be made by the investigator.)

Authors who do not have access to a formal ethical approval process must provide information in the manuscript about the treatment of human participants. The following should be addressed:

* how risks to human participants were minimized,

* why the risks were reasonable in relation to anticipated benefits,

* how the selection of participants was equitable,

* whether adequate procedures were in place to ensure the privacy and confidentiality of participants,

* the plan used to monitor the data and safety of the subjects,

* how informed consent was sought and documented,

* if applicable, what safeguards were used to protect vulnerable populations, and

* other relevant information.

It is the responsibility of the author(s) to ensure that studies have been conducted in accordance with the latest version of the principles of the Declaration of Helsinki (http://www.wma.net/e/policy/b3.htm). Also, it may be useful to consult the statements on ethics of the American Educational Research Association, the American Psychological Association, the American Sociological Association, and/or other national and international organizations.

© 2009 Association of American Medical Colleges

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