Institutional Review Boards and Peer-Reviewed Publication.

Abstract

Health Environments Research & Design (HERD) requires authors to provide a copy of an approval letter from an Institutional Review Board (IRB) when the study involves human subjects. Some authors from countries outside of North America, or from nonacademic roles in practice, may have little or no experience with an IRB and wonder how to meet the journal's requirements.The Code of Federal Regulations, Title 45, of the Department of Health and Human Services (DHHS) outlines the basic policy for the protection of human research subjects (http:// www.hhs.gov/ohrp/humansubjects/guidance/45cfr 46.html). Essentially, all research and evidencebased practice projects that are conducted in academicsettingsorinhealthcareorganizationsare subject to this Code, requiring a review of the research proposal and its methods by an IRB, ethics board, or an administrative review board at the organization.Abuses of Human Subjects in the Past Have Led to Formal ProtectionsThe sad history of research that tragically abused human subjects ultimately led to the imposition in the United States of IRBs and ethics boards. The 20th century included a number of prominent examples of abuse, as was the case in which Nazi and Japanese physicians conducted cruel and inhumane experiments on living persons during World War II. In the United States, the long running Tuskegee Syphilis Study (1932-1972) conducted by the U.S. Public Health Service (Centers for Disease Control and Prevention, 2013) examined the natural progression of untreated syphilis among African American men without their knowledge. The subjects believed they were receiving free treatment. Radiation experiments on unsuspecting citizens were conducted by the U.S. government during the Cold War. The Soviets may have done the same thing. The Central Intelligence Association (CIA) is known to have been involved in mind control studies that included brainwashing and administration of experimental drugs without consent.Government-sanctioned abuses were not the only problems. Controversial projects were undertaken by faculty at universities. Prominent examples include the studies of obedience to authority by Yale psychologist Stanley Milgram involving the apparent administration of electric shocks by student subjects to other students to test the dangers of obedience to authority figures (Encina, 2004; Milgram, 1974). Professor Philip Zimbardo (Cherry, 2014) at Stanford studied behavior of students assigned to roles as prisoners or guards in a mock prison in the basement of the psychology building. This notorious experiment led to physical torture and psychological abuse of the student prisoners from the student ''prison guards.''The National Research Act and Belmont ReportThe National Research Act of 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In response to outrage over the Tuskegee study that had ended in 1972, it proposed development of guidelines for human subject research and to regulate human medical experimentation. Four years later, the Commission issued the Belmont Report (Department of Health & Human Services, 1979) that summarized guidelines for research involving human subjects based on ethical principles. The following three core principles were identified by the Belmont Report: (1) respect for persons, meaning their respected autonomy and consent; (2) beneficence or not doing harm while maximizing benefits; and (3) justice, meaning fair administration of reasonable, nonexploitative, and well-considered procedures. The three primary areas of application are informed consent, assessment of risks and benefits, and selection of subjects.The Belmont Report has led to the formalization of ethics boards that may have existed, as well as the creation of new entities. Federal regulations now set out requirements for the membership and composition of IRBs, ethics boards, or administrative review boards, including provisions for diversity in experience, expertise, and institutional affiliation. …