mised before granting requests to withhold information from prospective participants in elder abuse and neglect studies.
Choices to participate in research on elder abuse and neglect should be capable, informed, and voluntary. When someone is unable to make valid decisions to participate, researchers should obtain the capable, informed, and voluntary permission of a relative or other individual concerned with protecting the incapable person’s well-being. Researchers should also seek the willing cooperation of the decisionally incapable person. Departures from these rules require compelling justification, including a showing that research interventions will not expose participants to significant risk.
The Belmont Report describes two dimensions of the beneficence principle in research. One is to avoid harm to study participants, and the other is to maximize possible benefits and minimize possible harms. Risks to research participants cannot be completely avoided. Instead, those evaluating the ethics of proposed studies must “decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be forgone because of the risks” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:4)
Two Common Rule provisions incorporate the beneficence principle. The first provision directs researchers to minimize risks to participants through the use of procedures that are “consistent with sound research design,” do not impose “unnecessary risks,” and, when possible, are “already being performed on the subject for diagnostic or treatment purposes” (1991:28,015). The second provision requires researchers to justify any unavoidable risks by discussing the benefits a study is expected to produce. According to the Common Rule, risks must be “reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result” (U.S. Department of Health and Human Services, 1991:28,015).
To apply the beneficence principle in research, investigators and IRBs must first determine the risks and potential benefits presented by specific studies. The Belmont Report directs study reviewers to be systematic in evaluating potential harms and benefits:
The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts