groups support a sliding-scale approach to evaluating a person’s capacity to decide about research. According to this approach, capacity standards may be lower in research presenting comparatively low risk, while a higher level of decisional ability should be required for research that presents comparatively high risks, particularly when the research fails to offer participants the prospect of direct benefit (NBAC, 1998:24).
The assessment process itself can be conducted using a variety of methods. The simplest method is to ask prospective participants to describe briefly and in their own words the basic study information noted above (Wendler and Prasad, 2001). Richard Bonnie has suggested as options “specially tailored follow-up questions to assess subject understanding, videotaping or audiotaping of consent interviews, second opinions, use of consent specialists, or concurrent consent by a family member” (1997:110). The device of concurrent consent is often adopted in dementia research when prospective participants have uncertain or fluctuating decisional capacity (High et al., 1994). This will not always be an option in studies on elder abuse and neglect, but it could be feasible in some such studies. Another suggestion is to adopt a two-part consent process, in which relevant study information is presented and the prospective participant is then asked questions about the study. If the individual exhibits a lack of adequate comprehension, the information is presented again, and the individual is reexamined (Ratzan, 1985). Such a process can detect individuals with problematic memory or other incapacitating cognitive deficits.
The capacity examination should enable researchers to ascertain when someone lacks the requisite abilities to make an autonomous choice about study participation. For people who appear to have adequate decision-making capacity, the next step is to ensure that they actually understand the significant information relevant to becoming a study participant.
People deciding to enter a study should understand certain facts. The Belmont Report lists the following general items essential for investigators to describe: “the research procedure[s], their purposes, risks, and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:5). The Report describes the following risks, each of which is specifically relevant to elder abuse and neglect research: “psychological harm, physical harm, legal harm, social harm, and economic harm” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:7).