Recent FDA regulations waive the informed consent requirement in life-threatening situations for emergency research with human subjects who cannot give informed consent and do not have legally authorized person immediately available to represent them. The FDA recognizes that granting such waiver is a serious matter and this is indeed the case. The problems with the regulations, however, do not reside in the exception to the informed consent requirement. While the principle of self-determination in the conduct of human experimentation should not lightly be set aside, I have always believed that principles must have exceptions as long as they are rigorously justified and most narrowly drawn. A waiver of informed consent in the situations encompassed by the regulations can be justified and my reservations are not that waiver was granted. But I have many problems with the ways in which the regulations were drafted. Here I intend to address only two: (a) the obfuscation of the research/therapy distinction and (b) the vast and vaguely defined discretion granted to IRBs in administering these fateful regulations. The Research/Therapy Distinction In my writings I have argued that the informed consent dialogue in research with competent patient-subjects must be stripped of the illusion,) which misleads patient-subjects into believing that they are receiving the most advanced and beneficial treatments available, when instead they are being asked to serve the interests of science. In this instance, since patient-subjects are incapable of giving their consent, the FDA misleads the public at large by emphasizing too much that the abrogation of informed consent is in patients' direct therapeutic interests, for this is only partially true. The FDA makes it quite clear that it felt moved to proceed as it did because current rules are making high quality acute care research difficult or impossible to carry (p. 51498). Thus, concerns over the inability to do research loomed large in FDA's mind. But since it also felt that research with unconsenting subjects is serious matter, the FDA emphasized that such research should only be resorted to if support[s] the potential of providing direct benefit to the individual subject (p. 51499). Unless the greatest care is taken, such intentions, frequently advanced, can obfuscate the distinction between therapy and research. And they do so in this instance. Thus, one of my most fundamental objections to the regulation is this: that in its emphasis on therapeutic benefits, the FDA obscures the fact that some of the permissible research activities either hold out no promise for therapeutic benefit or are so vaguely defined that potential therapeutic benefit can be inferred when research is the predominant intent. Research is not treatment, and whenever clear distinctions are not made between the two, the waiver of informed consent becomes problematic because some human subjects are being recruited to serve the ends of others. In the crucial and all too brief paragraph 50.24(a)(1), important words were left undefined and provisions were smuggled in that deserved more extensive elaboration and even elimination: The human subjects are in life-threatening situation, available treatments are or unsatisfactory and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions. (p. 51528) (emphasis supplied) What is the meaning of unproven? Not proven by rigorous scientific evidence, proof physician-investigators so often insist on? Or is the clinical judgment of physicians who have observed therapeutic benefits from unproven treatment sufficient proof? …
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Nov 1, 2009
Federico E Vaca + 3
Open Access
