Kurt F. Stone, D.D. is an ordained rabbi and college lecturer, teaching courses in political science, American history, and cinema. Since 1995, he has also worked as a medical ethicist, first for the Cleveland Clinic Florida and now for Schulman Associates Institutional Review Board (IRB). Schulman Associates is considered the leading independent Institutional Review Board dedicated to safeguarding the rights and welfare of clinical research participants. They have reviewed studies in pharmaceutical, bio-pharmaceutical, device, behavioral and data collection research. Schulman Associates was even selected, in March 2016, as the national IRB for the Cancer MoonShot 2020 program.
Dr. Stone, what exactly is a medical ethicist? How did you decide to become one?
From my perspective, a medical ethicist is one who explores, contemplates, and ultimately protects the rights of subjects in medical research protocols. It is our task to ensure that not only are the tests, procedures, and research both medically and ethically justified, but also that subject participants are fully and freely able to give informed consent. The need for medical estheticians to oversee research protocols arose as a result of the “Doctors Trial” at Nuremberg in 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
In Nazi Germany, German physicians planned and enacted the “Euthanasia Program,” the systematic killing of those they deemed “unworthy of life.” The victims included people with severe psychiatric, neurological, or physical disabilities. Further, during World War II, German physicians conducted pseudoscientific medical experiments utilizing thousands of concentration camp prisoners without their consent. Most died or were permanently injured as a result. Most of the victims were Jews, Poles, Russians, and also Roma (Gypsies). Sixteen of the doctors were found guilty. Seven were sentenced to death. They were executed on June 2, 1948.
Needless to say, the world was outraged; something had to be done to ensure that such medical atrocities never occurred again. Eventually, the field of medical ethics came into being; its three core principles – respect for persons, beneficence, and justice – became codified in the “Belmont Report.”
How I “decided” to become a medical ethicist is a quaint tale. In the late 1980s and 1990s, I spent a lot of time as a patient. At one point, I was hospitalized for more than 3 months. As a result, I became rather close with a handful of physicians and surgeons at the Cleveland Clinic, Florida. One doctor, a gastroenterologist, and I became particularly close and often went to baseball games together. At one game, he mentioned that he thought I would make a great addition to the clinic’s “Institutional Review Board,” of which he was committee chair. He explained that my role would be to translate informed consent documents – to turn “medicalese” into readily understandable English. He was confident that I could make a contribution. Well, I went to the first meeting the next week, at which he announced his retirement from the board! He was replaced by my favorite surgeon, who also happened to be a congregant. And so, a new career was born.
What types of people are on your Review Board? Doctors, lawyers, researchers, for example? Do you serve in your capacity as rabbi?
By law, an IRB must consist of physicians and surgeons, bio-engineers, scientists, nurses and at least one, maybe two “community representatives.” Whenever we are called upon to deal with an area of research for which none are expert, we call upon a specialist to go over the research protocol in question. The latter are frequently culled from the worlds of law, academia, and religion. I do not serve in my capacity as rabbi. Rather, my fellow board members (there are 7 of us) look upon me as the group’s thesaurus; the one person who views everything through the eyes of a literate, compassionate patient. Doctors and scientists frequently speak in a language which only they understand; my job is to make it understandable. In order to handle anywhere between 3 and 8 or 9 research protocols a week, I have to do an awful lot of studying. As my mother would say, “My son the doctor” is a doctor in every sense of the term… it’s just that he can’t diagnose or write prescriptions.”
Do you work as a team or do you each submit your individual opinion on a proposed clinical research study? How much of your final evaluation is subjective?
We work as a team. We use a program which permits all of us to see the comments, questions, redactions, or objections of our colleagues in real time. Then, at our meetings (which are done via teleconference), we go over everything we’ve put together individually, present the primary investigator(s) with our findings and either fully approve, conditionally approve, put on hold or, in very rare instances, disallow. Our mandate leaves little room for subjectivity…even though medicine is both an art and a science.
Medical advances would be difficult without volunteers participating in clinical research. How do you proceed when the proposed research participants are children? Are subjects without a capacity to consent ever used in clinical trials?
No child may participate in medical research without parental consent and patient assent. These are embodied in separate documents. Children aged 7-17 are given assent documents written in simple to understand English – or, if needed, in translation into their native language. In some cases, research necessitates using subjects who are not completely compos mentis. In this instance, ethics permit the informed consent document may be signed by an “LAR,” a “legally authorized representative.”
If your IRB disapproves a proposed study, can your client submit it to a second IRB? What are the ethical ramifications of that?
Absolutely not! Any application to any IRB includes the question “Have you submitted this proposal to any other IRB?” Should the research sponsor or investigator lie and check the “No” box and it were to be discovered (not such a difficult thing to do), they could be in big, big trouble – not only in the research/scientific community, but with the National Institutes of Health Office of Human Subjects Research Protections (OHSRP).
When I worked in Paris, I had several clients in the pharmaceutical research field, including a brilliant Greek researcher with whom I had lengthy discussions on the subject of ethics. He told me that just because he could develop a certain drug didn’t mean that he should do it from an ethical viewpoint. He said that in his home country of Greece, “Ethics” was a required subject in high school on a par with History, Literature, Mathematics, and Science. Do you think Ethics should be taught in American high schools?
If I were in charge of creating high school curricula, I would definitely make room for at least one mandatory class in Ethics. It is both intellectually and academically justifiable. However, politically, it would be a struggle; there are simply too many people who “know” that what they believe is ethical and moral, but that anyone who has a different point of view is both unethical and immoral. It’s in the same realm as teaching evolution versus creationism.
How has becoming a medical ethicist changed the way you think?
Having spent the past 23 years as a working member of 2 separate IRBs has greatly increased my wonderment at how brilliant some people are, and how terribly difficult and time-consuming it is to bring a new drug, a new surgical procedure, or a new diagnostic tool to fruition. I am simply in awe of my colleagues. At Schulman Associates, I am proud to report, the vast majority of board members are women…and quite young. Indeed, at many meetings I am the senior citizen!
Is it possible to be ethical without being religious?
Yes indeed. One of the most important lessons I ever learned in my rabbinic studies was this gem of ethical wisdom: “In a place where people aren’t acting like human beings, you strive to be an ethical person.”
An even more difficult question: Is it possible to be religious without being ethical?
Most regrettably, the answer, again, is yes indeed. In science, we speak of phenotypes and genotypes: the former is the set of genes in our DNA which is responsible for a particular trait; the latter is the physical expression, or characteristics, of that trait. In simple terms, one can have deep blue eyes (that’s your phenotype – what is apparent) but still have brown-eyed children (because genotypically, you carry genes for producing brown-eyed kids). In terms of your question, one can go to church or synagogue, pray like the dickens, and eat kosher food (that’s your phenotype – what you see), but can nonetheless lie, swear, cheat on their taxes or spouse, and be a bigot (that’s your genotype – what you truly are).
The best thing I can say about working on an Institutional Review Board is that it gives me the feeling that I’m making a difference. And in this world of ours, it’s a truly rare feeling.
Kurt F. Stone, D.D. – Fall 2017 film appreciation course at FAU LLI Jupiter:
Making Heroes Out of Humans…and Humans Out of Heroes
Mondays, October 16, 23, 30; November 6, 13, 20, 27; December 4, 2017, 7:00-9:00 p.m.
(Full 8 weeks or Last 4 weeks option available)
To register for the full 8 week course, click here.
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