Conducting Research For The Good Of Elderly Persons

The principle of beneficence requires that investigators maximize benefit and minimize harm to human research subjects. This principle also demands that investigators protect subjects from exploitation. Indeed, the Belmont Report states that ''the appropriateness of involving vulnerable populations in research should be demonstrated'' (The Belmont Report, 1979).

Elders, especially those with diminished cognition and living in nursing homes or other institutions, are vulnerable to exploitation (e.g., they may be viewed as convenient subjects for research). Investigators and proxy decision-makers have a duty to protect potential research subjects, especially those who lack decision-making capacity, from harm. Persons who lack capacity should not be enrolled in research studies that provide no benefit to them or to persons with similar conditions, expose them to undue risks, or disrupt their normal routines (Bell et al., 1987).

Beneficence requires that elders be included in research studies. Lack of research involving elderly human subjects leads to inadequate clinical care of elderly patients (Cassel, C., 1985). In fact, the results of clinical trials and other studies involving younger human subjects are often extrapolated to elders. However, changes associated with normal aging (e.g., altered drug metabolism, reduced glomerular filtration rate, etc.), comorbid illnesses, concurrent use of medications, and other factors make the extrapolation of the results of studies involving younger subjects to elders risky (Bell et al., 1987).

Participating in research has a number of benefits aside from direct medical benefit to the individual elderly subject. These benefits include deriving meaning and purpose from the altruistic act of being a research subject, socialization, remuneration, and other benefits. Notably, in a study (Kaye et al., 1990) of elders, those who consented to being research subjects had more positive feelings about being a research subject, helping others, and finding out about problems as a means of passing time compared to those who did not consent. Reasons for participating included interest in the project and benefiting others. This study and others (Leader, M. and Neuwirth, E., 1978; Lipsitz et al., 1987) have also found that elders are more likely to participate in research that directly benefits them and less likely to participate in research that offers no direct benefit.

The principle of beneficence suggests that investigators avoid involving vulnerable elders in research. Yet, many elders suffer from conditions that not only leave them vulnerable, but also have a predilection for elders (e.g. dementia). Ideally, research of such conditions would involve subjects with those conditions. However, if vulnerable elders are excluded from research in order to avoid harm, then these elders would never benefit from research. Indeed, prohibiting research involving vulnerable elders may in fact cause significant harm by not allowing discovery of new knowledge that would help them (Ratzan, R., 1980).

Unfortunately, investigators who conduct studies involving elders infrequently or imprecisely describe ethical considerations (e.g., IRB processes, consent, decisional capacity, funding sources, and confidentiality) in their research reports even when the research involves vulnerable persons (Lane et al., 1990). It is imperative that investigators describe these considerations in their protocols and research reports.

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