Editorial: civil rights and the clinical investigator.

Abstract

PERSPECTIVES IN BIOLOGY AND MEDICINE Volume 10 · Number 2 · Winter 1967 EDITORIAL: CIVIL RIGHTS AND THE CLINICAL INVESTIGATOR The two decades since the end ofWorld War II have seen an appropriate emphasis in political thinking and legislation with the aim ofprotecting and extending human rights and personal liberties. The same twenty years have witnessed fantastic developments in biological and medical sciences. The accomplishments of the clinical investigator—the development ofnew diagnostic techniques, the discovery of potent drugs, spectacularadvances in surgical therapy, and the rapid expansion ofknowledge in human physiology—have come so rapidly that the education of the medical student has had to be revised, and the practicing physician can scarcely keep up with progress in a specialty area, to say nothing of a broader field. Fifteen years ago, a very wise man might have been able to predict a collision course between these two apparently unrelated facets of our society: the drive toward preservation of human rights and the advancement in the health sciences. The crash has now occurred. Perhaps it could not have been averted even if anticipated. The best interests of a patient subject ofa clinical research program could be compromised by the zealous investigator spurred by personal ambition and the added incentive provided by research grants from the government and industry. A very few investigators have stepped over the fuzzy line dividing proper conduct from unethical behavior with respect to the preservation ofrights and safety. As a result, the clinical investigating community as a whole stands accused of violating the rights of its patients and research subjects. It will be denied that the entire community has been so accused, but recent actions of the Public Health Service and the Food and Drug Administration (see below) are clear enough. No physician-investigator 137 with pride in the ethical standards ofhis practice could be thoughtparanoid when reacting defensively in today's climate. With the laudable purpose of protecting the citizens' rights, frightened federal administrators have promulgated rulings which apply selectively to patient-doctor relationships in clinical investigation. These regulations may well persuade so many physicians to abandon their careers as clinical investigators that the progress in some aspects of medical research will be seriously retarded. Most investigators will probably attempt to comply, but it should be anticipated that like all unwise rulings these regulations are more likely to lead to disrespect for the law than to achieve the intended purpose of providing protection for the patient and research subject. In implementing the February 8, 1966, resolution ofthe National Advisory Council, the U.S. Public Health Service has established regulations which state in part, "The Public Health Service will require necessary assurances from the grantee institution which sponsors investigations involving human subjects including clinical research. These assurances will cover both the general principles of safeguarding human rights and welfare in the conduct of research and the specific points of the Surgeon General's policy. The assurance should provide explicit information on the policy and procedure it employs for review and decision on the propriety ofplans ofresearch involving human subjects. The descriptions will include the competencies represented in the committees of associates utilized for review, the sources ofconsultants (ifused), the administrative mechanisms by which surveillance is provided for projects involving human subjects—particularly to deal with changes in protocol or emergent problems of investigations, the means of guidance and advice provided for investigators, and the manner in which the institution will assure itself that the advice of the committee of associates will be followed." The Food and Drug Administration has very recently decreed that "informed consent" must be obtained in writing from all individuals receiving experimental drugs, except in those most unusual circumstances in which the health of the patient might be threatened by this requirement . After many years of maintaining an admirable hands-offpolicy while supporting and encouraging medical and biological research in a most effective fashion, the Public Health Service has at last crossed the line and begun to regulate professional conduct in universities, private research 138 Editorial Perspectives in Biology and Medicine · Winter 1967 institutes, and hospitals. The policy of non-interference is now a fiction. The university which has grown at least partially dependent on federal...