Return to Nicholas Johnson main Web page

The Limits of Human Subjects Research

Nicholas Johnson and Dr. Michael Flaum Comments on
Gayane Torosyan's "Week's End"

Iowa City, Iowa

November 9, 2003

* * *

Gayane Torosyan [GT]: Mr. Johnson begins by talking about the evolution of the standards of research ethics.

Nicholas Johnson [NJ]: There have always been ethical standards applied by those who do research involving human subjects. Indeed, the ethics of many of the early studies compare very favorably with today’s ethical standards. But in the early Twentieth Centry there were really no ethical standards as such in place in the form of a formal document or international agreement.

The current standards from the National Institutes of Health, which is the primary administrative body on this, provide that it is okay to have risks to human subjects under some circumstances; that is, if the benefits and the importance of the knowledge that come from the study outweigh the risks.

GT: Dr. Flaum, how is it in your area?

Dr. Michael Flaum [MF]:  This really is a moving target and even in the short amount of time that I have served on the IRB [Institutional Review Board], we are talking five or six years, the criteria continues to evolve and change and it’s a much more stringent atmosphere today than it was when I began with the IRB.  In terms of the distinction between psychological and medical, frankly we have two separate boards, one deals with more of the medical and one the psychological, and I don’t have expertise on what that distinction really is.  But my sense is that there are far more similarities than differences, and that the rules on human subjects research are basically fairly general.

GT:  What’s the standard? What’s the normal procedure?  Do people volunteer, as we hear sometimes, “Volunteers are needed for studies to detect lung cancer before symptoms appear"?  And it seems like those experiments would benefit the patient as well. First of all, if it is detected, if a cure is found, the person would be the first one to receive that treatment.

NJ: This becomes an issue when you’re testing the new pharmaceuticals on a population and some of them are getting a placebo and there comes a point at which the ethical standard would suggest that one ought to call off the experiment and give those who’ve been receiving the placebo the medicine, knowing that it will, in fact, do them some good.

The primary standard of the World Medical Association was not in existence until 1964. And from 1964 on, there are some examples of studies that were undertaken or approved that certainly today we would look back on and question. And bear in mind that these are after these standards are in place, not before they were in place.

Within this last 5-year period at Johns Hopkins – Johns Hopkins is the largest recipient of Federal funding for purposes of human subjects research – a study was done with regard to asthma. The subjects were injected with a chemical drug in powdered form that had not been approved for that use, and for which there were risks, it was a deliberate effort to do harm to the subjects and to see whether or not they could recover from this. The subjects were told that there were some risks, but they were not told that death was one of those risks, and one of the subjects died.

Now, it’s interesting that not a lot was made of that by the media. So far as I know there are no law suits that have been filed, there was no excoriation of Johns Hopkins. And that actually involved the death of a subject, which one would think is probably one of the more severe consequences that can come to a subject in human subject research.

And I know, Michael, you’re involved, or could be involved, in research that can’t be done because of current ethical standards.

MF: The area of research interest of mine is schizophrenia.  And one thing I can tell you that we know almost nothing about is real paranoia within schizophrenia because, by definition, there is an inherent bias in screening out a certain type of person who is not going to be willing to participate in these kinds of studies.

GT: Are you saying that there is a downside?

MF: Oh, absolutely, and I’ll give you an example of another population that I’m interested in, that I think we just don’t know anything about, and that’s prisoners.  Prisoners were used as populations of convenience for a long time.

As a matter of fact, anti-psychotics, which have been around for about 50 years, were discovered serendipitously. But, what has happened – and Nick said before that the pendulum has swung too far – because prisoners were populations of convenience for so long, and because it is clear that that is not okay in our current thinking, we’re now having a very difficult time arguing for the inclusion of prisoners.

GT: And when I was doing human subjects research, I had to mention that my subjects were doing their normal work and they gave me their consent. As a journalist, I could go interview any person. But for me to interview the same person as a researcher would be restricted.  Now, how do you view this?  Is that pushing a little too far?

NJ: I think so.  Particularly when a journalist who is functioning as a journalist  can ask all the same questions.  It’s a little silly, maybe, to impose on that person, when they are in the role of researcher, standards that do not apply to them as a journalist when they are actually wearing both hats.

GT: Now, what are the consequences of these issues on future funding of research?

MF: They are enormous. There are a lot of well intentioned people who really believe that it would be unethical to do any kind of research on, say, higher primates like chimpanzees. There are people who lower the bar; they say not only chimpanzees, but you shouldn’t be doing it on mice or rats.  The truth of the matter is, if we didn’t do this kind of research on any animals, the effect on our ability to progress scientifically would be extremely dramatic. We as a culture have to look at the long term risk-benefit balance of the resetting of that bar, and it is not something that is ever going to be clear.

GT: UI psychiatrist Michael Flaum and UI law professor, Nick Johnson.  This is "Week’s End."  I’m Gayanne Torosyan.

* * *