I am a member of the philosophy department at the University of Louisville and have a PhD in philosophy and an STL in theology with, therefore, considerable training in ethics. With that in mind the vice president for research asked me to sit on the university’s IRB, more than 30 years ago, and I have served continuously ever since, quite willingly.

The free lunch that is served at the noon meetings! Well, er, also the opportunity to both keep abreast of the latest developments in the social and natural sciences, and to engage in meaningful debate with dedicated and bright colleagues on some of the most complicated ethical questions raised today.

I have no iPod; I don’t visit any websites on a daily basis; and my after-hours guilty pleasure must remain a secret to all but the CIA and FBI, and of course to the little old lady who lives down the block and who knows everything that is going down. The answer: I love to read novels set in historical periods: surcease from current cares.

Actually, the university here enrolls all members of the IRBs in PRIM&R. It pays the membership, and I am happy that it does this. I am also happy to say that it is just one example of the comprehensive and generous dedication—let us not forget the lunches!—of my university to the work of our IRBs.

The greatest benefit I derive from PRIM&R is the education and inspiration obtained at the annual conference. That is truly an impressive group of people with which to associate, and the PRIM&R staff is super competent and available. I suspect that our office director and staff benefit from the organization in a myriad of ways of which I am ignorant.

An ethicist, not a lawyer. The one disappointment that I have had with the annual conference and with many of the panels is the lack of trained ethicists as speakers. I have never quite understood why the feds, in defining what areas of competency must be represented on an IRB whose principal duty is to render judgment on the ethical uprightness of a given protocol, omit a requirement for at least one member formally trained in ethics.

Everyone has a sense of (personal) morality, but that is no substitute for a rationally derived understanding of ethical principles and their coherent application. The lawyers tell us what the law is; the ethicists tell us which laws we must obey when we are protecting human subjects and what conduct is appropriate even when the law is silent. So I would like to see much more time dedicated to ethicists as keynoters (and panelists) weighing in on some of the more complex moral issues in current research. Hopefully, the IRB members and the law-makers will listen and learn.

What do you believe is a key challenge facing the field of research ethics?

There are several key challenges facing the field of research ethics today, and they have shifted in the 30-plus years I have sat on IRBs. Were I to single out one of the more serious issues, I would point to the increasing influence of money in the system. The huge sums involved are just about to overwhelm the system. Central IRBs are under huge pressure to judge protocols favorably; investigators’ livelihoods (tenure and promotion in universities) are tied up with bringing in bigger and bigger bucks for their institutions, and this means increasing pressure to please sponsors. How many times do we hear at in IRB meeting: “If we require this change, the sponsor will get mad and the investigator will lose the study!”

Money is driving the system of review to an extent and in ways unimagined 30 years ago, and I see little evidence that things will improve. IRBs have to get together on the national level in order to speak with one voice. For example, it is arguable that at some point sponsors of research should have to be required in all cases to pay for injuries incurred as a direct result of a subject’s participation in research. It is hard to imagine the pharmaceuticals allowing the feds to require this; but if that were a position agreed to on a national level by IRBs, sponsors would be unable to shop the system. If I were a young person (with a few years’ experience on an IRB learning the ropes), I would think seriously about the merit of dedicating a good portion of my time to organizing the IRBs in this country. As things stand now and in the foreseeable future, it looks as if sponsors have far too much weight in determining the outcome of IRB reviews. Money is a powerful force, and there has to be an even more powerful counterforce, if ethics is to secure its proper role.