Academic journal article Research and Theory for Nursing Practice

The Concept of Vulnerability and the Protection of Human Subjects of Research

Academic journal article Research and Theory for Nursing Practice

The Concept of Vulnerability and the Protection of Human Subjects of Research

Article excerpt

This article provides an overview of the concept of vulnerability through the lens of the U.S. federal regulations for the protection of human subjects of research. General issues that emerge for nurse researchers working with regulated vulnerable populations are identified. Points of current controversy in the application of the regulations and current discourse about vulnerable groups are highlighted. Suggestions for negotiating the tension between federally regulated human subject requirements and the realities of research with vulnerable subjects are given. The limitations of the designation of vulnerable as a protection for human subjects will also be discussed.

Keywords: vulnerability; human; research; protection; federal regulations

As nurses we use the term vulnerability often and with ease, assuming a universal meaning for, and acceptance of, the concept as a fundamental variable in health outcomes. Yet it is only recently that nurse scholars have begun to explore and develop robust theory related to the vulnerable and vulnerability (Rogers, 1997; Sellman, 2005; Spiers, 2000; Sutton, Erlen, Glad, & Siminoff, 2003). The intersection of clinical notions of vulnerability with federal regulations designed to identify and protect members of vulnerable populations who may become subjects of research is an important area of awareness for nurse researchers and presents significant challenges (Anderson & Hatton, 2000; Chang et al., 2004). Nurse researchers, arguably because of their broad clinical backgrounds that cut across race, class, and culture, are frequently in unique positions to access members of vulnerable communities more readily than nonclinical researchers or other health professionals. Further, as the most trusted of health professionals, nurses are culture carriers for sensitive, community-supported work that enhances our ability to access vulnerable groups, improve knowledge of their needs, and provide responsive care for them. This article provides a brief overview of the ethical foundations of U.S. federal regulations designed to protect human research subjects, identifies the vulnerable groups defined in the regulations, and reflects on the status of protection for vulnerable groups at this time.

VULNERABILITY IN THE U.S. FEDERAL REGULATIONS

When the human subjects' regulations to which we currently subscribe were proposed, many research abuses had already been exposed and were abhorrent to the research community and to the general public. These abuses were particularly difficult for society to understand as they occurred with people who, as a class, were perceived to have less ability to influence their own outcomes. Recent analysis has suggested that the problem was one of people treated as objects to provide ends for new knowledge development rather than individuals whose participation in research helped to provide the means for research to occur (Corbie-Smith, Thomas, & St. George, 2002; Wasserman, Flannery, & Clair, 2007). Some examples of study abuses that lead to the development of our current regulations for protections of human subjects include the well-known Tuskegee syphilis study and the Willowbrook State Institution hepatitis virus study (Rothman, 1982).

We should not become complacent. Research findings can have direct impact on public attitudes and policies directed toward individual research participants, their families, and communities (Fisher, 1997). "The public's perception of research ... is shaped by the way research is conducted" (Dunn & Chadwick, 1999, p. 13), and issues regarding public distrust of research participation continue to come forward (Center for Research and Study on Clinical Research Participation, 2007). Investigators can help move research agendas for vulnerable groups forward when they win, and maintain, the confidence of vulnerable participants.

THE FEDERAL REGULATIONS

The federal regulations of Health and Human Services (HHS) (Title 45 Code of Federal Regulations Part 46 [45CFR46]) have four subparts or sections. …

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