Just Involvement Of Elders In Research

The burdens and benefits of research should be distributed equally, and elders should not bear burdens or receive benefits more than other age groups. Nevertheless, elders may be unjustly included or excluded from research studies. Investigators may find elderly residents of nursing homes and other institutions convenient subjects for research. In fact, before the 1970s, nursing homes were common sites for research primarily because of convenient access to captive subjects, most of whom were elders (Cassel, C., 1985). Furthermore, nursing home residents were commonly used for experiments that were not directly relevant to their own illnesses or elders in general (e.g., the Jewish Chronic Disease Hospital study). Instead, the selection of research subjects should be based on the needs of the study, not the convenience of the investigator or the accessibility of subjects.

The National Commission examined the issue of conducting research involving institutionalized human subjects. The Commission noted that investigators should preferentially involve subjects who are living freely in the community rather than those living in institutions. The Commission also stated that the convenience of subjects is not sufficient rationale to conduct research in an institution (Cassel, C., 1985).

On the other hand, elders, especially the oldest-old (age >85 years), have been unjustly excluded from research studies (Sachs, G. and Cohen, H., 2003). For example, a review of original research papers published in four journals during 1996 and 1997 found that one-third of the studies unjustifiably excluded elders (Bugeja et al., 1997). Another study of research protocols on topics relevant to elders that were submitted to a hospital ''ethics committee'' (institutional review board) found that a majority of the protocols had unjustifiable upper age limits (Bayer, A. and Tadd, W., 2000). A study of human subjects consecutively enrolled in 164 study protocols of an oncology study group found substantial underrepre-sentation of elders (Hutchins, L., et al., 1999). A recent review of 59 randomized controlled trials between 1985 and 1999 of interventions for congestive heart failure (a disease that afflicts elders more than any other age group) found that elders were underrepresented in the trials (Heiat et al., 2002). Other studies have had similar results (Morse, A., et al., 2004; Avorn, J., 1997). Elders bear more illnesses, use more medications, and experience more deaths than any other age group. Hence, investigators should not exclude elders from research studies and should include enough elders in order to generate valid results that can be generalized to elderly populations.

Investigators may be tempted to exclude elders from research for a number of reasons. For example, investigators may avoid elders with impaired decision-making capacity because involving proxy decision-makers is time-consuming and costly (Bugeja et al., 1997). Investigators may be unwilling to enroll elders in research studies because elders are more likely to have sensory deficits, mobility issues, comorbid illnesses, and other confounding variables. Conducting long-term studies involving elders is difficult because of their relatively high mortality rates (Sachs, G. and Cassel, C., 1990). Finally, compared to other age groups, elders are less willing to participate in research studies (Kaye et al., 1990; Sachs, G. and Cassel, C., 1990). Nevertheless, while these reasons for excluding elders from research are not trivial, investigators should make efforts to address them in order to conduct valid research, the results of which can be generalized to elderly populations for their benefit.

Injustice also occurs when elders are excluded from their fair share of the benefits of being involved in research. These benefits include altruistic feelings of meaning and purpose associated with being a research subject, attention and socialization that accompanies being a research subject, medical supervision and other benefits (Cassel, C., 1985; Sachs, G. and Cassel, C., 1990).

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