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Ethics and Regulation of Clinical Research.

Ethics and Regulation of Clinical Research

It has been more than twenty years since the initial surge of scholarly work on moral issues in human research. Indeed, IRB: A Review of Human Subjects Research, the only journal devoted exclusively to moral and regulatory issues in human research, has now been in existence for nearly a decade. Most issues have recieved extensive analysis. Nevertheless, the field has room for much creative growth, and these volumes suggest directions for future inquiry.

Lawrence Altman's Who Goes First?, on self-experimentation, rectifies the surprising neglect of this fascinating aspect of human research. Altman examines self-experimentation by medical researchers in such diverse fields as surgery, infectious diseases, respiratory physiology, cardiology, and hematology from the nineteenth century to the present.

Altman has ably utilized his dual skills as a physician and professional journalist. He carefully explains the state of medical knowledge at the times each set of self-experiments was performed and the existing social needs that stimulated the investigation. The experiments themselves are described in considerable detail. As any good journalist, Altman also uses multiple sources to build his accounts of the experiments, including reports in academic journals, secondary historical sources, diaries and letters of the experimenters, and personal interviews with investigators, family members, and colleagues. He outlines clearly the results of each series of self-experiments for the advancement of medical knowledge. Moreover, he is an excellent storyteller who is able to rivet the attention of his reader.

However, Altman seems overly disposed to universally judge auto-experimentation as a noble tradition. Depending on circumstances, our moral assessment may vary tremendously. We may consider some auto-experiments to be morally required. For example, situations occur in which self-experiments can provide information about the technical feasibility of research interventions or the subjective experiences of subjects helpful in designing protocols. Alternatively, self-experiments that carry serious risk of harm, but may yield significant medical knowledge, might be neither morally required nor prohibited; although their performance is morally praiseworthy, of other auto-experiments we must conclude that they are morally wrong. This might be because the degree of risk is unacceptable, the significance of the knowledge to be gained is questionable, or the experimenter has prior moral obligations that will not be fulfilled if he or she is harmed. For example, some self-experimenters have had spouses or children who were not consulted prior to their experiments and whose interests were seriously compromised by their injury or death.

Thus it remains for other investigators to subject the tradition to critical moral assessment. In fairness, it should be emphasized that Altman's primary purpose is to bring to life the remarkable history of auto-experimentation, and this he does in admirable fashion.

While Altman's work leaves us in search of a moral framework within which self-experimentation might be scrutinized, Veatch's The Patient As Partner is intended to implement a general moral theory for assessing the whole field of human research. The book brings together many of Veatch's most important essays on human research, but also includes original material developed for this volume. Veatch reviews his general theoretical approach as developed in A Theory of Medical Ethics and examines the implications of the key principles of respect for personal autonomy, beneficence, and justice for human research, subsequently applying his theoretical commitments to specific issues. He goes on to assess the regulatory process itself, explore a number of research practices that raise thorny moral problems--for example, the use of disadvantaged subjects--and investigate some special research contexts, such as research on the brain dead. While the volume suffers from some repetition in the discussions of specific issues, the selection and sequence of essays has resulted in a well-organized and comprehensive presentation of Veatch's approach.

The basic metaphor Veatch uses to capture his view is "the patient as partner", an elliptical stand-in for his strategy of ranking moral considerations at the level of general principles. According to this approach, nonconsequentialist moral principles, such as respect for autonomy and justice, have precedence over the consequentialist principles of beneficence and nonmaleficence. This means that the nonconsequentialist principles must be satisfied in full before good consequences can be considered in determining conduct. Applied to human research, this account implies that principles such as respect for autonomy and justice set non-negotiable constraints on the conduct of research activities. Investigations that fail to satisfy these limitations are impermissible, no matter how significant the anticipated good consequences or how minor the infringement of nonconsequentialist principles.

Veatch's general approach has an elegant simplicity, making it attractive at the theoretical level. However, as the implications unfold, an unacceptable rigidity appears in Veatch's ranking of moral principles. For some research practices, Veatch's conclusion that they are impermissible does not square with our moral intuitions. In other places, he avoids the latter problem only by employing logical devices inconsistent with his general theory.

These problems are illustrated by his application of the principle of respect for personal autonomy. The principle requires that the decisionmaking capacity of persons be properly acknowledged prior to their participation in human research. According to Veatch, this might be accomplished in three ways: By "explicit consent," in which subjects agree to participate after full disclosure of information deemed relevant according to the reasonable person standard. By "blanket consent," in which potential subjects agree prospectively to later involvement in a certain category of research activities (e.g., studies using their medical records), without receiving specific information about the anticipated studies. And finally, where explicit or blanket consent are not practicably possible, respect for autonomy might allow a process of "construed consent." This strategy requires determination by the IRB that, for specific subject populations and particular research studies, reasonable persons would be willing to participate without giving explicit or blanket consent.

The problems emerge as this fleshed-out position is applied to specific research practices, such as the use of deception or the examination of medical records. One horn of the dilemma is that, if we uniformly require explicit or blanket consent, some unobjectionable research studies become impermissible.

To permit some innocuous forms of deceptive research and access to medical records, Veatch introduces the device of "constructed consent." This creates the other horn of the dilemma, since the strategy does not square with his own theoretical assumptions. He goes astray by inappropriately extending use of the reasonable person standard, originally introduced as a mechanism for determining what types of information must be disclosed to subjects. Veatch suggests that it can be used to determine whether a subject's consent is required. This fails to square with his insistence elsewhere that we respect the autonomy of persons only if we query them about their willingness to participate in the research (p. 104).

Veatch's difficulty in finding theoretical room for many innocuous (and highly beneficial) research studies can be traced back to the rigidity of the basic theory. While the challenges us with a systematic analysis of moral problems posed by human research, his analytic framework falters by presupposing the universal priority of nonconsequentialist principles for dealing with situations in which moral factors must instead be sensitively balanced.

Robert J. Levine's volume on clinical research, Ethics and Regulation of Clinical Research, sharply contrasts with Veatch's work in that he disavows general priority rankings. Rather, the insists that "Ethical reasoning should begin with multiple basic ethical principles...each of which in the abstract has equal moral force" (p. 12). Moreover, he admits that there are many moral issues in clinical research about which he has not reached settled conclusions.

The book begins with an overview of basic moral concepts and principles applicable to clinical research. The immediately following chapters examine the implications of the principles of beneficence, justice and respect for personal autonomy for research design, selection of subjects and informed consent. The middle section of the book explores various problematic research practices, such as randomized clinical trials, studies employing deception, and research using medical records. The later portion of the volume examines issues generated by the use of "disadvantaged" subject populations, such as children, prisoners, and those institutionalized as mentally infirm. A final chapter analyzes in considerable detail issues regarding the operation of institutional review boards.

This book is a superb achievement, something perhaps only Levine could have written. Discussion of specific issues is helpfully located within the historical framework of professional codes, reports of the National Commission, and earlier government regulations. In addition, Levine consistently presents a balanced and thorough introduction to competing views about specific issues, drawing upon his impressive command of the literature. The volume is generously sprinkled with many case examples, which provide helpful illustrations of the moral issues. Moreover, the discussion has a highly practical focus, in that Levine struggles to find workable solutions to moral problems that show regard for competing moral considerations. Finally, the book contains a rich and extensive bibliography, which provides a useful entree to the most important literature on moral issues in clinical research.

It is difficult at times, however, to trace the general balancing of moral considerations that informs Levine's treatment of different issues. For example, in discussing research on medical records, he claims that notifying incoming patients of the possible use of these records in research is usually sufficient to satisfy the requirements of respect for personal autonomy and preserve the welfare interests of identifiable subjects. He appears to assume a more stringent view in his analysis of research employing deception, however. In an epilogue to the chapter addressing the latter issue, Levine states his opposition to this type of research. Although he builds his case by citing several studies in which the welfare or privacy interests of subjects were seriously compromised, this fails to indicate the basis for disallowing less controversial investigations. Levine is clearly concerned about the indirect effects of deceptive research on the integrity of investigators and the trust of lay persons in the research enterprise. But without further clarification, it is difficult to trace the precise balancing of moral factors that informs the different assessment of these practices.

Taken as a group, these three volumes suggest fertile directions for future scholarly work on moral issues in human research. Altman's work clearly suggests that a comprehensive account cannot fail to assess self-experimentation. Difficulties in Veatch's analysis suggest that universal priorities cannot be profitably set at the level of principles. Following the National Commission, Levine endorses the most promising theoretical approach of seeking a sensitive balance among the various moral considerations implicated in the conduct of clinical research.

Robert J. Levine. Baltimore: Urban & Schwarzenberg 2nd ed., 1986. 452 pp. $45.00, cloth.
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Author:Ackerman, Terrence F.
Publication:The Hastings Center Report
Article Type:Book Review
Date:Oct 1, 1988
Words:1752
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