for research involving human participants1 (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). I use as a framework for policy analysis the Federal Policy for the Protection of Human Subjects (U.S. Department of Health and Human Services, 1991), also known as the Common Rule. My analysis reviews general issues relevant to research on elder abuse and neglect. Because states vary in their approaches to regulating disclosures of private information, professional reporting duties, nursing home operations, and other relevant topics, issues raised by individual research projects must be separately evaluated by local institutional review boards (IRBs) and attorneys.
The Belmont Report describes the characteristic features of research involving human participants and articulates three ethical principles that apply to such research. These principles are (1) respect for persons, (2) beneficence, and (3) justice. The principle of respect for persons underlies the requirement for informed consent to study participation. The principle of beneficence underlies the requirement to evaluate and balance risks and expected benefits in human studies. The principle of justice addresses fairness in selection of research participants. Provisions in the Common Rule incorporate these Belmont Report principles and requirements.
Institutional review boards rely heavily on the Belmont Report and Common Rule when they evaluate research proposals. Thus, studies on elder abuse and neglect must take into account the concepts and considerations in these documents. Although the Department of Health and Human Services has adopted additional regulations to cover certain populations deemed especially vulnerable in research, it has no special regulations governing research involving older persons, persons with impaired decision making capacity, or residents of nursing homes and other institutions. Various individuals and groups have, however, made recommendations addressing ethical issues with particular relevance to these populations.
In addition, the Common Rule contains a few provisions that specifically bear on vulnerable populations in research. The Rule directs IRBs to “be particularly cognizant of the special problems of research involving vulnerable populations” and to ensure that “[w]hen some or all of the subjects are likely to be vulnerable to coercion or undue influence, . . . additional safeguards have been included in the study to protect the rights and welfare of these subjects” (1991:28,016). The Common Rule advises IRBs that regularly review research involving a vulnerable subject population to consider including “one or more individuals who are knowledgeable about and experienced in working with these subjects” (1991:28,015).