Human Subjects I read with interest the Ex Libris article "Doing Research on People"

By | February 8, 1988

Human Subjects

I read with interest the Ex Libris article "Doing Research on People" (November 16, 1987, p. 23) by Ruth Macklin. I was very disappointed by the tone and approach she took. Perhaps some of this suffered from the space limitations in which she was forced to work, and I hope to one day read the book. However, the article is all that many people may get to see. Since she has a very important and visible role in a major medical college, herr attitudes undoubtedly will influence others. Thus, I think that the ambiguity and imprecision in the piece should be resolved.

should not have to resort to the circumlocu tion of"hav(ing) an interest in the success of the research." Most research is not succes ful in coming to an unambiguous answer Requiring a personal interest in success as a condition for participation would greatly re strict research. Altruism, curiosity or just plain good will should be enough.

To begin with, the title is offensive. If I first thought it was an editor's choice, I rapidly was convinced otherwise by the first two sentences, in which Macklin talks about the "use" of patients as research subjects and "experimenting on patients." Except in instances of diminished responsibility, where fully informed consent may not be possible, most human clinical research is done with patients rather than on patients. Although some may consider this a minor distinction, it represents the attitudinal difference between what is described in her horror-story examples and what should be taking place in medical research today.

I fear that if Macklin is teaching the 'research on' metaphor to students, she is perpetuating the paternalism of an old-style medicine that is long gone. There is a participative aspect in clinical research and clinical care that goes beyond informed consent and extends into the realm of modern- day medical practice. "On" implies an imposition of a physician's will upon another person that just is not the norm today.

In addition, MackIm's discussion of beneficence and Kantian imperatives in non-therapeutic research with persons fails to distinguish between healthy volunteers and patients. In addition, patients-people who have a therapeutic relationship with a physician--should be permitted to give consent to nontherapeutic research by another investigator. In that case, they stand in the same light as any other volunteer.

I am concerned with therapeutic and non therapeutic medical research on a daily basis and I find MackIn's exposition less than helpful in creating a broader understanding of what it is all about.

--Marvin E. Jaffe
2100 Packard Ave.
Huntingdon Valley, PA 19006

I had no hand Whatever in making up the title of the Piece. The article was excerpted from my book Mortal Choices from a chapter entitled "Experimenting on Human Subjects" I can only presume Jaffe finds that title equally offensive since it uses the preposition "on." This appears to be a verbal quibble. Even when fully informed consent is obtained, the research is still done on human subjects, not with them. One does research with one's collaborators.

The point of the chapter is to illustrate how carefully clinical research can be conducted by adhering to the precepts of voluntary informed consent. The "horror stories" are intended to show that it wasn't always that way in medicine. And, I suspect, in many centers there are significant lapses from the idea of properly informed consent.

Jaffe's fear that I am teaching the "research on" metaphor to my students is unwarranted. First of all I don't teach metaphors, whatever that might mean. More important, I find myself defending clinical research that many students find horrifying when they first come on the wards or read about the research. They ask, "How can re search be conducted ethically, especially when acutely ill patients serve as subjects? Is it ethical to use placebos? Won't patients consent to any research maneuvers their own doctor asks them to undergo?" and so forth.

Jaffe's charge that I am perpetuating the paternalism of an old-style medicine that is long gone is surprising. I find that paternalism everywhere, but I try to do little to perpetuate it. Jaffe must work in a very enlightened setting if that brand of paternalism is nowhere in evidence.

I'm sorry Jaffe found my exposition less than helpful in creating a broader understanding of what medical research is all about. My aim was, indeed, to foster that understanding. It may well be that medical research is conducted differently in different places and by different people. I can recommend the publication IRB A Review of Human Subjects, published by the Hastings Center. A number of the issues Jaffe raises have been addressed in its pages over the years.

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