Academic journal article Northwestern University Law Review

Introducing a New Paradigm for Ethical Research in the Social, Behavioral, and Biomedical Sciences: Part I

Academic journal article Northwestern University Law Review

Introducing a New Paradigm for Ethical Research in the Social, Behavioral, and Biomedical Sciences: Part I

Article excerpt

"The first, indispensable steps in any philosophical inquiry are liable to seem entirely negative, both in intention and in effect. Distinctions are made, objections are pressed, accepted doctrines are found wanting, and such appearance of order as there was in the field is destroyed; and what, asks a critic, can be the use ofthat?

"In immediate effect, the philosopher 's initial moves do certainly tend to break down rather than build up analogies and connections. But this is inevitable. The late Ludwig Wittgenstein used to compare the re-ordering of our ideas accomplished in philosophy with the re-ordering of the books on the shelves of a library. The first thing one must do is to separate books which, though at present adjacent, have no real connection, and put them on the floor in different places: so to begin with the appearance of chaos in and around the bookcase inevitably increases, and only after a time does the new and improved order of things begin to be manifest . . . ."

- - Stephen Toulmin, The Uses of Argument 253 (1958).

INTRODUCTION

During the past thirty years, considerable attention and resources have been focused on the ethics of research involving human participants.1 The ethical principles currently employed by regulators and ethics committees to govern human research are derived from the work of the National Commission for the Protection of Human Subjects in Biomédical and Behavioral Research. The National Commission was established by the National Research Act of 1974 in response to public concern about unethical biomédical experiments. Two experiments were particularly troubling. One experiment involved injecting children at the Willowbrook State School for the Retarded with a form of hepatitis.2 Another experiment studied the course of syphilis in several hundred African-American men and failed to treat these individuals after the subsequent discovery of penicillin.3 The National Commission was charged with reviewing the system of Institutional Review Boards ("IRBs") that perform ethical review of research, identifying basic ethical principles for research with human participants, and recommending ways to ensure that research followed those principles. The commission consisted of three physicians, three attorneys, two bioethicists, one biologist, one physiological psychologist, and one community member who was president of the National Council of Negro Women, and hence also cognizant of minority issues. The commissioners, with the aid of staff members, derived a set of principles (beneficence, respect for the autonomy of persons, and justice) as set forth and discussed in the Belmont Report (named after the location where this group convened).4

The Belmont Report-the presumptive basis on which the entire enterprise of research ethics is based-has received little serious scrutiny during or since its inception. Conceptually, Belmont occupies a unique position: because it is outside traditional disciplines that deal with issues of morality and moral reasoning-e.g., moral philosophy, social and political philosophy, legal ethics, and anthropology-it appears to be unassailable to judgments from those disciplines. Yet, despite this separation from these more traditional disciplines, Belmont relies on their principles, without necessarily being sufficiently informed by them. Indeed, Belmonfs influence is nearly hegemonic in that, within IRBs and the broader research ethics community, all discussions must start (and sometimes end) with it in order to be considered morally legitimate. Belmont is treated as immutable to appeals to the philosophical requirements of the principles upon which it claims to be based. Moreover, within its implementation, it straddles a line between normative and practical ethics, leaving both unsatisfied.

The federal regulations governing research on human subjects5 draw from and underscore Belmont' s principles-in particular, the respect for autonomy via an informed consent procedure and the protection of human subjects from harm via a presumed risk-benefit assessment on the part of investigators and IRB members. …

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