Changing Views Of Research

As research progresses and the beneficial results of research protocols become known, the view of research as essential and beneficial activity is becoming more common. Perhaps one of the best examples of the benefit that research can provide for elderly nursing-home patients is associated with studies of physical-restraint use (Miles & Myers, 1994). Physical restraints were, and in some situations still are, commonly used in nursing homes. Their use was based on the best of intentions: preventing falls, limiting injuries to patients prone to wandering, controlling aggressive patients, and maintaining appropriate posture (Miles & Myers, 1994). After a few tragic problems, research was undertaken to quantify the alleged benefits of physical-restraint use. The research showed that restraints were actually associated with increased injuries, agitation, physical deconditioning, and death. Research demonstrated that devices once accepted as good medical care were harmful to vulnerable people and were used inappropriately more often than they were used appropriately. Other research studies designed to assess whether there were harmful effects associated with reduction in restraint use showed no increased risk of falls.

Before the early 1980s, the value of physical restraints was virtually unquestioned; they were common practice. By the end of the decade, the evidence against restraint use was so compelling that the federal government passed legislation aimed at severely limiting their use as part of the 1987 Omnibus Budget Reconciliation Act (OBRA). The clear lesson associated with this experience is that without the unbiased eye of research, harmful but well-intentioned care might have been allowed to continue.

The growing recognition of uncertainty in medical decision making has also contributed to growing confusion about clinical research. Research is simultaneously being described as a right and unethical. Comments like ''ethicists and institutional review boards must sincerely consider whether disdained and vulnerable people are being substituted for experimental animals'' (A. Novick, 1991, p. 126) are still common, but perhaps less justified. However, for many conditions for which treatment alternatives are lacking (e.g., AIDS), research trials are increasingly seen as a scarce resource that must be allocated fairly. Participation in research is now being viewed as a right that should be fairly distributed across all sectors of society rather than as an altruistic act or, perhaps, a societal obligation. While formerly, members of minority groups, the handicapped, prisoners, and other disenfranchised groups used justice-based arguments to support their claims that they should not be asked to be research subjects (the basis for the value of voluntarism), these same groups are now using justice-based arguments to support claims that they should not be denied the right to participate. Carol Levine (1988) sums up this tension nicely: ''The shortage of proven therapeutic alternatives... and the belief that the trials are in and of themselves beneficial have led to the claim that people have a right to be research subjects. This is the exact opposite of the tradition starting with Nuremberg—that people have a right NOT to be research subjects'' (p. 172).

Yet this transition is by no means complete. The following example illustrates the harsh and often contradictory light under which research protocols are currently examined: Work in prevention of falls in the elderly led to the observation that recent hospitalizations were a major risk factor for subsequent serious falls (Department of Health and Rehabilitative Services, 1990). This was entirely consistent with research showing that prolonged periods of bed rest (often experienced by hospitalized elderly) result in physical deconditioning that is, in turn, a major risk factor for falls (e.g., Sattin, Rodriguez, DeVito, Lambert-Humber, & Stevens, 1991; Simonsick et al., 1993). Physical therapists informed us that although they believe that physical rehabilitation can effectively remedy this problem, Medicare does not currently reimburse for rehabilitation after hos-pitalizations unless there is a specific motor deficit. While Medicare's policy contradicts much conventional wisdom, the policy is justified because general rehabilitation has not been scientifically proven to benefit the elderly. In truth, the benefit of rehabilitation immediately after hospitalization has never been directly studied. Our group at the University of Miami sought to fill the gap and obtain necessary data to change Medicare's policy. To do this, we proposed a randomized trial to examine the effect of physical rehabilitation after hospital-ization for elderly people.

According to our study protocol, elderly persons who consent and whose physician approves would be randomized to usual care (whatever posthospital services their physician orders) or rehabilitation. Our study was criticized by one reviewer because randomization to the control group would unfairly deny someone a treatment believed to be beneficial, and that is unethical. A different reviewer criticized the study because randomization to the rehabilitation program (the intervention) might place subjects at unjustifiable risk, and that is unethical. We were totally unsure how to respond to our critics. The two critiques are a perfect example of the inconsistent way in which ethical evaluation of medical research is viewed. While both reviewers agreed that it was unethical to randomize subjects, one believed that harm was associated with being in the control group, while the other felt that the harm was being in the treatment group. Our experience illustrates the difficulty that can be faced when requirements for proving the efficacy of accepted therapy are reviewed by people who think that such evaluations of accepted therapies are unnecessary and by people who mis trust human-subjects research in general. Researchers are caught between these conflicting views and often find it difficult to conduct studies aimed at verifying things that are accepted but never proven.

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