Academic journal article
By Valutis, Stephanie; Rubin, Deborah
Journal of Social Work Education , Vol. 46, No. 2
REGULATION OF RESEARCH for the protection of human subjects is not new, but its evolution and interpretation continue to be a challenge for those involved. The contemporary regulatory history began with the Nuremberg trials (Drewry, 2004; Fogel & Ellison, 2005; Gordon & Prentice, 2000; Hamilton, 2005) where medical researchers of the Third Reich were tried for abuses against humans in the name of science. An outcome of the trials was the creation of the Nuremberg Code in 1947, the first of a number of regulatory documents meant to protect human subjects from abuses in research (Grigsby & Roof, 1993; Hamilton, 2005). The purpose of the code was to provide a professional guide to ethical research practices, which included, for example, the need for informed consent (Fogel & Ellison, 2005; Grigsby & Roof, 1993). The Nuremberg Code did not, however, have the force of law or sanction; instead it was a voluntary guide, similar to a professional code of ethics for those conducting research with human subjects in the medical field (Grigsby & Roof, 1993). Even then, there was controversy about the need, specificity, and interpretation of such a guide (Gordon & Prentice, 2000). In 1964 the World Medical Association built on the Nuremberg Code and created the Declaration of Helsinki (Drewry, 2004; Gordon & Prentice, 2000), which added that "all human research subjects are to receive the best treatment available at the time, and the interests of individual subjects shall have priority over the interests of society" (Drewry, 2004, p. 107-108).
Despite these efforts, mistreatment of human subjects continued. The Tuskegee Study is a well-known example of egregious violations of human rights and the public outcry over these violations in the United States (Centers for Disease Control and Prevention, 2008). In response to growing public concerns about medical research (Drewry, 2004), Congress passed the National Research Act of 1974, which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission's purpose was to explore the protection of rights and the well-being of human subjects in research. The resulting 1978 Belmont Report set ethical standards for research with human subjects based on three principles: "respect for persons, especially those with diminished autonomy; the obligation not only to avoid harm but also to maximize benefits; and for research to be just" (Hamilton, 2005, p. 192). The National Research Act also mandated the establishment of institutional review boards (IRBs) to review federally funded research that involves human subjects (Drewry, 2004; Grigsby & Roof, 1993; Hamilton, 2005). Using the principles of the Belmont Report, the U.S. Department of Health and Human Services developed guidance for the Code of Federal Regulations titled Protection of Human Subjects (Title 45, Part 46); this codification, the first to organize and classify such protection, is also known as the Common Rule (Hamilton, 2005). With the establishment of the CFR, the regulations for ethical and safe research with human subjects changed from guidelines to an enforceable federal directive (Grigsby & Roof, 1993).
This brief description of the evolution of the IRB and the regulation of human subject research provides a basis for the discussion of several relevant issues for social work research. First, regulations for human subject research began in medical research (Grigsby & Roof, 1993). Social science research was later included under these guidelines, as was any research involving human subjects (Drewry, 2004). Hamilton (2005) argues that the regulatory guidelines rooted in medical research are not easily applied to social science research, stating, "The rules are not right or wrong, but irrelevant" (p. 193) to many types of social science research. This is not to suggest that social scientific research is immune to unethical methodologies or to potential harm to human subjects, as is evident in studies such as Milgram's on obedience in 1963 (Drewry, 2004). …