In Loco Parentis Minimal Risk as an Ethical Threshold for Research upon Children

Abstract

While respect for rights is hallmark of a liberal society, responsibility toward vulnerable persons unable to care for themselves or even speak on their own behalf is mark of a humane society. And within broad field of social ethics, bioethics in particular must focus upon such responsibilities: to very old and very young, those muted or rendered incoherent by illness. Yet delineating nature of that responsibility has proven to be among most vexing problems bioethics has faced. Agreement in principle upon touchstone of responsibility toward incompetent is elusive. Should we act in their best interests, or as they would have directed us to act? More difficult still is application of such a standard, as when we attempt to describe what is required by best interests of a particular handicapped newborn. Most difficult, perhaps, is application of a standard under conditions of risk and uncertainty, when our ethical calculus, ill-grounded as it is, is put to work on shifting and statistically ill-defined values. The ethics of clinical research in children seems tailor-made for addressing these moral quandaries. Is it ever ethical to expose children to risks associated with research? If it is, what are ethical limits to such risk? How can a specific threshold to research risk be formulated, justified, and applied? These questions have preoccupied pediatric researchers and others for many years. Recent revisions of United States regulations regarding research with human subjects and formulation of a common applying to all federal departments involved with human research make it necessary to examine these questions.[1] The new definition provided in common states, Minimal risk' means that probability and magnitude of harm or discomfort anticipated in research are not greater in and of themselves than those ordinarily encountered in daily life, or during performance of routine physical or psychological examinations or tests.[2] Finding that a research study poses only 'minimal risk' has some important procedural consequences for review. In this paper, though, we will focus upon another role: 'Minimal risk' is concept used in American regulation to serve as an anchoring measure of allowable risk (or--the other side of coin--relative safety) in clinical research. The critical threshold of risk that may not be surpassed (short of special federal approval) is in fact one level higher: 'minor increment over minimal risk.' However, since rule offers no independent definition or specification of 'minor increment,' attention must first be focused upon its anchor, 'minimal risk.' Similar measures may be found in other national guidelines concerning ethics of human research as applied to children and other persons without capacity to consent. Canada's Medical Research Council, for example, sets the risks of everyday life as relevant measure, and report concerning ethics of research on children prepared by Great Britain's Institute for Medical Ethics employs term 'negligible risk,' understood to be similar to 'minimal risk.'[3] Because United States regulations are both most familiar and most developed statements of problem, they will serve as focus for our discussion; however, our comments may well be applicable to these other national frameworks. 'Minimal risk' seems to raise more questions than it solves. This paper deals with a number of those questions: Do all forms of research upon children require use of a threshold like 'minimal risk'? What is meaning, use, and justification of 'minimal risk'? To what criticisms is concept vulnerable, and what problems arise in its application? We will deal with these questions with conviction that even if final answers remain elusive, clarification must be attempted. The many thousands of members of research ethics committees internationally that employ 'minimal risk' or a similar concept must develop some shared understanding of what it means. …