Editor’s Opinion: Why Institutional Review Board Approval

  Rules, regulations, and laws most often are promulgated as a reaction to one or multiple events, mishaps, or problems. One such requirement involves ensuring the protection of research participants. In accordance with international standards, information about how study participants were protected must be included in all manuscripts submitted to Ostomy Wound Management.¹ As with many other rules, regulations, and laws, it is not unusual to wonder why we have to adhere to them or why they exist in the first place. Why, some authors wonder, can my manuscript not be published because I did not obtain Institutional Review Board approval? It was “just” a….. (fill in the blank).   The impetus for the development of Ethical Guidelines in research is well documented, starting with the records of the 1949 Nuremberg trial.² The atrocities committed by physicians and nurses in the name of science led to the Universal Declaration of Helsinki in 1964. Unfortunately, prisoners in German concentration camps were not the only, or the last, to suffer in the name of research. Revelations about horrible experiments conducted during World War II in Japan³ followed, as well as information about one of the most well-known unethical studies conducted in the United States for the purpose of “understanding the natural progression of syphilis” — the so-called Tuskegee study.⁴ Unfortunately, the list does not end here, and unethical experiments continued well after the Universal Declaration of Helsinki was signed and even after it was adopted by the World Medical Association in 1964. Eventually, the Belmont Report titled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”⁵ was published in 1979, and the US Department of Health and Human Services Office for Human Research Protections contains detailed guidance for new and experienced researchers alike (see: www.hhs.gov/ohrp/index.html).

  The bottom line is that it is our duty to protect individuals, because there is always a power imbalance between patients/prospective study participants and medical professionals. Therefore, it is important to remember the three basic principles: 1) Respect for Persons, 2) Beneficence, and 3) Justice. Researchers, journal editors, and manuscript reviewers rely on the work of Institutional Review Boards to make sure all guidelines to protect study participants are met, including their review of patient consent procedures, determination about the level of review, or that a study is exempt from review. No one wants to be complicit in the conduct or dissemination of potentially unethical studies or practices. No one wants to see the past repeated … which is why it is important to remember it.

This article was not subject to the Ostomy Wound Management peer-review process.

1. International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals; Roles and Responsibilities of Authors, Contributors, Reviewers, Editors, Publishers, and Owners: Protection of Research Participants (2013). Available at: www.icmje.org/roles_e.html. Accessed September 10, 2013.

2. Harvard Law School Library. Nuremberg trials project. Available at: http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=bibliogr. Accessed September 10, 2013.

3. Harris SH. Factories of Death: Japanese Biological Warfare, 1932-45 and the American Cover-Up, 2nd ed. New York, NY: Routledge;2002.

4. Centers for Disease Control and Prevention. U.S. Public Health Service Syphilis Study at Tuskegee. Available at: www.cdc.gov/tuskegee/timeline.htm. Accessed September 17, 2013. 5. U.S. Department of Health and Human Services. The Belmont Report. 1979. Available at: www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. Accessed September 19, 2003.