[Congressional Record Volume 140, Number 43 (Tuesday, April 19, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: April 19, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                    REMARKS OF DR. ALBERT R. JONSEN

                                 ______


                          HON. GEORGE W. GEKAS

                            of pennsylvania

                    in the house of representatives

                        Tuesday, April 19, 1994

  Mr. GEKAS. Mr. Speaker, I would like to share with my colleagues some 
remarks made by Dr. Albert R. Jonsen, professor and chairman of the 
department of medical history and ethics at Washington University 
School of Medicine, before the Congressional Biomedical Research Caucus 
on Monday, March 21, 1994. The text of Dr. Jonsen's remarks follow:

       The speakers at past meetings of the Congressional 
     Biomedical Research Caucus, and Dr. Jules Hirsch today, have 
     eloquently and convincingly stated the case for the 
     importance of biomedical research as a benefit to society and 
     to individuals. Our society would not be what it is today--
     vigorous, progressive, competitive--had it not benefited from 
     the numerous advances in promotion of health and prevention 
     of disease that come from biomedical research. However, in 
     recent months, a dark side to that research has appeared and 
     has been widely noted in the media. Several months ago, news 
     stories about research on the effects of radiation, carried 
     out during the 1950s and 60s, under sponsorship of the Atomic 
     Energy Commission and later of the Department of Energy, have 
     cast doubt on the integrity of researchers and on the ethics 
     of the research itself. In the last two weeks, the following 
     headlines appeared in the New York Times, ``Agency Faults 
     UCLA Study For Suffering Mental Patients,'' (March 10, 1994), 
     ``U.S. Ethics Questioned by Critics of Vaccine Trial in Italy 
     and Sweden'' (March 13, 1994), and ``Researcher Falsified 
     Data in Breast Cancer Study'' (March 14, 1991). These 
     stories, and many others, have revealed a dark side to the 
     world of research.
       However, this revelation is not unprecedented. In the late 
     1960s and early 70s, a similar series of stories that 
     questioned the ethics of biomedical research appeared in the 
     media. These stories agitated the public, which had until 
     then seen biomedical research as an undiluted good. They 
     aroused the attention of legislators and regulators, 
     who sought to remedy the abuses by law and regulation. 
     They deeply disturbed many scientists, who deplored 
     ethical lapses and also recognized that a tainted 
     reputation could hinder valuable scientific work. Thus, a 
     quarter of a century ago, as again today, significant 
     attention was focused on the ethics of research with human 
     subjects.
       In order to appreciate the current concerns, we must 
     understand one particular event, the accomplishments of the 
     National Commission for Protection of Human Subjects of 
     Biomedical and Behavioral Research. Congress established that 
     Commission by including in the National Research Act of 1974 
     (PL 93-348) the requirement that a group of citizens be 
     formed to recommend to the Secretary DHEW (now DHHS) 
     regulations to safeguard the rights and welfare of human 
     subjects of research and to develop the ethical principles 
     that should govern such research. The idea of such a 
     Commission had been proposed in hearings held by Senator 
     Mondale in 1968, but the idea was pushed into reality by the 
     unusual conjunction of two events. In 1971, the Tuskeegee 
     Syphilis Study, a Public Health Service research project 
     which had excluded 400 rural black men from treatment for 
     syphilis over a thirty year period, was made public. At the 
     same time, studies on the human fetus, done in Finland by 
     American researchers with federal funds, aroused ire. Thus, 
     legislators concerned about civil rights and racial 
     discrimination, and legislators concerned about abortion and 
     right to life, found in biomedical research a common cause. 
     Without that convergence of left and right, I doubt that the 
     National Commission would have come into being.
       The Commission (on which I was privileged to serve) worked 
     for four years. During that time it produced detailed studies 
     of the ethical issues in research, made recommendations to 
     the Secretary on research involving the human fetus, 
     children, incarcerated persons, the mentally incapacitated, 
     and endorsed a system of public and peer review of research 
     for the nation. That system exists today and is, 
     demonstrably, a fair, effective and efficient method to 
     assure that biomedical research meets the ethical principles 
     stated by the Commission: respect for personal autonomy, 
     promotion of benefit, avoidance of harm and fairness in 
     recruitment of subjects. This system has been in place for 
     twenty years. The recent reports of ethically questionable 
     research are the first to appear during that time (the 
     radiation research, of course, was done before the system 
     came into being).
       I propose that the current problems are the result of one 
     important gap in the system of protection of research 
     subjects. The Commission recommended that a standing body of 
     citizens and scientists be established within DHEW, the 
     Ethics Advisory Board, whose function would be deliberation 
     about particularly difficult cases. That body was instituted 
     in 1977; it was discontinued in 1980. Although its name 
     appears in the Federal Regulations, and it has assigned 
     functions in the review of research, it has not existed for 
     fourteen years. This absence essentially blocked certain 
     types of research, such as proposals to study the human fetus 
     and the use of fetal tissue, and made difficult the 
     assessment of many other proposals. The two studies that made 
     the headlines I cited above, vaccine trials and trials of an 
     antipsychotic medication, would have, in all likelihood, gone 
     to that body for review, had it existed. The failure to 
     maintain the Ethical Advisory Board was a political and 
     bureaucratic decision: it has been detrimental to research 
     ethics and to the progress of research itself.
       The Commission's accomplishments mark a before and after 
     point in the history of the ethics of research with human 
     subjects. For over a century prior to its establishment, 
     biomedical research had evolved from exciting but primitive 
     origins to a vast, sophisticated enterprise. The modern era 
     of biomedical research begins in the first half of the 
     nineteenth century. As scientists began to understand health 
     and disease in terms of cellular structure and pathology, to 
     learn more about microbial pathogens, to invent and utilize 
     instruments to measure physical processes, biomedical science 
     advanced from ``trying the unknown,'' to a formal process of 
     investigation. The great French physiologist, Claude Bernard, 
     produced the classic description of that process in his 1865 
     volume, Introduction to the Study of Experimental Medicine. 
     In that book, Bernard not only lucidly exposed the logic of 
     investigation; he also stated the fundamental ethic for 
     investigators. He wrote, ``the principle of medical and 
     surgical morality consists in never performing on man an 
     experiment that might be harmful to him to any extent, 
     even though the result might be advantageous to science, 
     that is, to the health of others.''
       This statement, however, does not take into account that 
     experimentation, which is always to some extent a voyage into 
     the unknown, has its risks and dangers that are almost 
     unavoidable. Strict adherence to Bernard's strict rule, 
     ``harmful to any extent,'' poses a difficult problem to 
     conscientious researchers. Forty years after Bernard wrote 
     these words, one of the most famous medical experiments was 
     hailed for its success and the bravery of its participants. 
     Major Walter Reed had invited a crew of persons, mostly US 
     Army soldiers and a few civilians, to risk serious disease 
     and even death to determine with certainty whether yellow 
     fever was transmitted by mosquitos. When the leading medical 
     educator of the time, William Osler, was asked whether it was 
     not immoral to experiment on man with possible ill result, he 
     answered, ``it is always immoral without a definite specific 
     statement from the subject himself, with full knowledge of 
     the circumstances.'' Reed had done just this, preparing a 
     document for the signature of his volunteers that informed 
     them of the risk of death.
       It is clear, from these historical events and from much 
     other evidence, that the idea of voluntary consent of 
     subjects and the duty to avoid harm was hardly foreign to 
     researchers. At the same time, it was commonly believed that 
     the researchers themselves were the best judges of the 
     ethical nature of their work. A conscientious investigator 
     was the best assurance of ethical investigation. This can be 
     a fragile safeguard against abuse. Certainly, there are 
     unscrupulous investigators, whose sole aim is fame. However, 
     even the conscientious researcher may take a dangerous track. 
     This may happen when persons judge that the social benefits 
     of scientific advance outweigh in moral importance the rights 
     of individuals.
       During World War II, the worst distortion of this view 
     generated the most heinous crimes in the name of research, 
     the Nazi concentration camp experiments. The physician 
     criminals who carried out these experiments were tried and 
     convicted at Nuremburg in 1949 and the famous Nuremburg Code, 
     stating the ethical principles for human experimentation, was 
     first expressed in their judgment. At the same time, a great 
     pressure was building in American biomedical science to solve 
     the medical problems posed by war. The Committee on Medical 
     Research, established in 1941 by President Roosevelt, began 
     an ambitious program of sponsoring research in American 
     universities. Biomedicine became part of the war effort. 
     Here, too, the principle of social benefit overriding 
     individual rights, while hardly taken to the extremes of the 
     Nazis, carried some weight. Wartime medical research, often 
     carried out as classified, did not always scrupulously 
     respect the principles clearly stated by Bernard, Reed and 
     Osler. This attitude carried over, to some extent, to the 
     postwar, cold war years and was manifested in some of the 
     radiation research currently under criticism. The National 
     Institutes of Health continued and accelerated the research 
     sponsorship that had been begun by the Committee on Medical 
     Research and, in its early years, had no definite policy with 
     regard to the ethics of sponsored research.
       It can be said, then, that the culture of medical research 
     prior to the National Commission was one in which the 
     principles of voluntary consent and avoidance of harm were 
     acknowledged. At the same time, the conscience of the 
     individual investigator was the measure and source of 
     judgment on these matters and a bias in favor of social 
     benefit over individual rights, while subtle, prevailed.
       The National Commission preserved the rules of voluntary 
     consent and avoidance of harm as the foundations of research 
     ethics and developed these in conceptual clarity and 
     practical detail. However, it recognized clearly that the 
     conscience of the investigator was an inadequate safeguard, 
     since the investigator who was a physician faced an inherent 
     conflict of interest between care of the patient and the 
     search for new information. The Commission endorsed and 
     strengthened the practice of peer and public review of 
     research that had been a slowly developing policy within 
     the National Institutes of Health during the late 1960s. 
     Other judges than the researchers themselves were to have 
     a say in what might constitute informed consent and risk-
     benefit features of all research protocols. The 
     establishment of Institutional Review Boards at all 
     research institutions brought thousands of participants 
     into the review of the ethics of research, as many 
     scientists, scholars and public members were rotated 
     through these Boards. The private conscience of the 
     researchers and the secret nature of research is now 
     exposed to open and critical discussion. In this light, 
     the ease with which social benefit can be invoked as a 
     justification for slighting individual rights is 
     challenged by critical scrutiny and by a very strong 
     presumption in favor of the protection of the individual. 
     This system, which Dr. Gary Ellis, who is with us today, 
     can explain in detail, had been for twenty years a fair, 
     efficient and effective method of assuring that the rights 
     and welfare of research subjects are protected.
       Yet, we are having problems. Does this mean that the system 
     is cracking? I do not think so. I believe that the problems 
     occur because the system is only two thirds in place. The 
     first third consists in the clear understanding of the basic 
     concepts of the ethics of research and their appreciation by 
     many persons who have participated in the system of review. 
     This is an enormous improvement in quality and quantity over 
     the pre-Commission culture of research. The second third 
     consists in the review system itself, implemented in research 
     institutions and carefully monitored by federal agencies. By 
     for the greater part of the ethical problems, such as 
     inadequacies in informed consent documents and in risk-
     benefit analysis, are caught early and corrected before any 
     human subjects are touched. The final, missing third is the 
     Ethical Advisory Board which has not been in existence since 
     1980. The purpose of this Board, as envisioned by the 
     National Commission, was to provide a forum for the difficult 
     questions that cannot be answered at a local level or by an 
     agency review, but require open, impartial debate. 
     The absence of such a forum has led to obstruction of 
     research, clumsy management of ethical conflicts and the 
     inadequate assessment and explanation of problematic 
     cases. Both of the recent cases that reached the headlines 
     of the New York Times would probably have been considered 
     by the EAB, if the process envisioned by the National 
     Commission has been followed (although the Commission's 
     recommendations on research with mentally incapacitated 
     persons, which might have governed the schizophrenia 
     studies, were rejected by Secretary Schwicker in 1983, the 
     only example of such a rejection). In addition, recent 
     debates over such questions as the distinction between 
     research and treatment that troubles the development of 
     new drugs to treat HIV infection and the inclusion of 
     women in research studies, could have been discussed at 
     the EAB, had it existed.
       During this legislative session, Senator Hatfield submitted 
     a bill to reestablish the EAB (SB 1042). I have heard that 
     this proposal has been assumed into a broader plan to 
     establish a new Presidential or National Commission that 
     Senator Kennedy is now preparing. I do not know the details 
     of that proposal. However, I urge attention to one crucial 
     point. The National Commission for the Protection of Human 
     Subjects of Biomedical and Behavioral Research (1974-78) and 
     its successor, the President's Commission for the Study of 
     Ethical Problems in Medicine and in Biomedical and Behavioral 
     Research (1979-82) were both time limited bodies, constituted 
     to study and recommend resolutions for particular problems. 
     The EAB was intended to be a standing body prepared to take 
     on difficult questions as they arise. The former Commissions 
     drew up broad principles and guidelines; the EAB was to apply 
     these with prudence and flexibility to unanticipated 
     situations. Whether or not we need a new Commission, of the 
     former sort I am uncertain. I am sure that we need an Ethics 
     Advisory Board. I strongly urge that this be done and that 
     the final third of the structure for protection of human 
     subjects be firmly put into place.

                          ____________________