5.4. A Plea to Liberalize the Ethics of Non-Interventional Genetic Research

pp. 59-60 in Bioethics and the Impact of Human Genome Research in the 21st Century

Author: Frank (Yeruham) Leavitt (Ben Gurion University of the Negev, Israel)

Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.
Extremism causes extremism. Past and continuing violations of human rights in the names of scientific and medical progress have led to progressively stricter ethical constraints on research on human subjects. In spite of a not-totally-exemplary record on matters of honesty, the medical profession does have some cause for pride in its self-regulation and respect for autonomy in clinical research.

Ethical constraints, however, can restrict research to the point of danger. Here are some examples. A few years ago there was an international association of medical journal editors to insist on informed consent in all studies, presumably including case studies, even if the study is anonymized (1). The decision was prompted by a published case of anorexia nervosa where the patient was a medical student and the author of the case study was one of her professors. Her fellow students recognized her from the article, brought it to her attention, and she sued, claiming embarrassment. But isn't it going too far to forbid publishing case studies without informed consent? Imagine a case which gives a physician reason to believe that a widely accepted treatment can have previously-unsuspected dangerous side effects. Would you refuse to allow the case to be published just because the patient refuses? I would want to weigh the privacy of one person against the health of many others.

Another example: I have been told that Soroka University Medical Centre, our Faculty's teaching hospital in Beer Sheva, has many thousands of blood samples, which were taken for medical purposes with no request made for consent for research use. We have been learning in recent years that genetic data are going to be an indispensable part of any epidemiological study. Think of the magnificent data base we could get by sequencing these samples! But getting informed consent from these people or their heirs would be a monstrous and prohibitively expensive task. Here the promise of population-wide health benefit is great while the risk of embarrassment is nil because the individual cases would be buried in the statistics.

Another example is class or national embarrassment. There have been many objections to research into genetics of undesirable character traits among minorities. And a few years ago I read newspaper discussions of objections to publishing about genetic diseases which -- like Tay-Sacks, Gaucher and some BRC's -- have a relatively high incidence among Ashkenasi Jews, for fear of causing us to be branded as "genetically defective". As an Ashkenasi Jew, however, I would like to say, first, that perhaps the reason why there are so many Ashkenasi Jewish diseases is simply because there are so many Ashkenasi Jewish doctors, and people like to research what most affects them and their loved ones. Furthermore, if I am healthy then I don't care what people call me. I'd rather the research be done and the cures be sought.

While respect for privacy is emphasized to the point of absurdity, the simple principles of beneficence and non-maleficence can take a back seat. A couple of years ago researchers wanted to check the idea that maybe the low oxygen concentration in jet planes is a cause of Sudden Infant Death Syndrome. Neonates were made to live in a 17% oxygen environment, as contrasted to the normal concentration of 21%. Some were siblings of babies who had died of SIDS, but most were not. So there could be no presupposition that they might benefit from the study. Informed consent was obtained from the parents, but obviously not from the babies. And I submit that autonomy by proxy turns autonomy into a joke.

Nor was there beneficence. Indeed, a baby is not a parent's private property like a bicycle or a computer. Parents have no right to submit a child to any medical intervention, invasive or not, unless it is for the child's clear and important health benefit. And if there had been no reason to assume potential risk, there would have been no reason to do the study. So there was obviously potential maleficence. The amazing thing is that an institutional review board approved the study and the BMJ published it (2).

Our bioethics have gone crazy. In an attempt at sanity let's make some distinctions. A study may be retrospective or prospective, interventional or non-interventional.

Strict ethical restrictions on all interventional studies are in order. When there is any doubt about the competence of the patient -- and this includes psychiatric, pediatric and some geriatric studies -- I suggest that no one in the world has the right to give surrogate informed consent unless there is clear and urgent medical benefit for this particular patient and not just for others. For this reason I object to the clause in the UNESCO Universal Declaration on the Human Genome and Human Rights which allows research on patients who do not have the capacity to consent, even if there is no "expected direct health benefit" if it exposes the patient "only to a minimal risk and minimal burdenif the research is intended to contribute to the health benefit of other persons in the same age category or with the same genetic condition" (3).

Let us remember that even taking a blood sample entails some risk. If someone freely chooses to take a risk for the health benefit of others, one has this right. But I cannot imagine who would have the right to submit a child even to "minimal" risks if there is no clear benefit for that child. Nor do I understand what the framers of the UNESCO Declaration meant by "minimal risk and minimal burden". They do not define the terms. Is, for example, taking a child to a clinic to have a blood sample taken, when the child might have preferred to be swimming or riding a bicycle, a minimal burden or a major one? When we expose children to medical environments without clear and urgent health benefit, are we not conveying a message that turning to doctors (rather than developing natural ways to be healthy) is a normal part of life? Is this a burden or not? How can it be defined?

Prospective studies, both interventional and non-interventional also need strict bioethical supervision. The ethical problem with non-interventional prospective studies, of course, is that when a danger to a patient or population is suspected, one cannot intervene without risking the scientificity of the study. The Tsukeegee study was evil precisely because it was non-interventional.

Retrospective non-interventional studies are another thing. Here the major ethical risk is to privacy, which is a small matter when compared to the public health potential of large epidemiological genetic data bases. And the more that medical records are computerized, the more it will be a technical matter to reduce to a minimum the risks to individual privacy. So I propose an extreme liberalization of the ethics of non-interventional retrospective studies.

But I would like to make an exception. Perhaps my own, non-scientific, personal tastes are involved here. But I have never been able to take privacy as an overriding ethical value. But I do take justice seriously. I suspect that suits to prevent the use for genetic research of tissue samples which were taken for medical purposes are more. financially than ethically motivated. The motivation may be simple greed, as one may suspect is the case in some litigation-happy Western countries. But when research is done in developing countries among impoverished, malnourished and medically deprived populations, then the rights of these people to a share in the profits of the research must be guaranteed, no matter how harmless and non-interventional the research may be.

I have been asked why I think ethics should be different for people in developing countries. In my opinion the needs of medically deprived impoverished peoples are so great that their demands for a fair share should be taken much more seriously than claims by litigious well-fed westerners. Of course all this depends on whether indigenous people really want a share in profits. Some people are quite happy with a simple life. It does not hurt to inform them of alternatives. They are finding out anyway. But it would be a kind of imperialism to force our greedy values on them.

References

1) International Committee of Medical Journal Editors. Protection of patients' rights to privacy. BMJ (1995) 311:1272.

2) Parkins KJ et al. Effect of exposure to 15% oxygen on breathing patterns and oxygen saturation in infants: interventional study. BMJ (1998) 316: 887-894.

3) Eubios Journal of Asian and International Bioethics 8 (1998) 4-6.

Please send comments to Email < asianbioethics@yahoo.co.nz >.

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