Just this morning I had a great meeting with my prof regarding my thesis. I showed him the outline for my thesis and we put together a schedule for completing it. He even gave me a few references to go on in terms of researching the topic. I’m starting to feel good about it.
I’ve had a number of people asking me what my thesis is about, so here it is in brief:
There are restrictions that institutions place on the sorts of human research that can be done, and the justification for such restrictions are usually given in terms of subject harm or benefit. Unfortunately, such justifications are paternalistic. By that, I mean there is a sense in which, if someone wants to engage in a very risky research protocol as the subject, what right does the institution’s ethics board have to stand in her way?
That said, there is also a sense in which we do not want human research to just be a free-for-all house of horrors, where anything goes. My thesis is that we should rather justify human research subject protections in terms of protecting the integrity of the human research project as a whole.
So, in colloquial terms, I’m suggesting that rather than saying, “We won’t let you do that risky research because we know better than you what ends you should be pursuing,” rather we should say something more like, “We won’t allow such risky research because allowing such research to go on would make the human research enterprise look sketchy.”
An interesting application of this thesis is in the area of phase IV human research studies. A phase IV study is one that occurs after the drug is already approved for use, and it is essentially a marketing study. The drug company wants to see how to best market the drug to doctors and patients. Often it is even the marketing division of the drug company that applies for the phase IV study.
Ethicists have generally been trying to criticise phase IV studies on the basis of some sort of risk that it may pose to the research subjects. This position is difficult to hold because really, the drug has already been approved for use on humans. I will argue that it is much more defensible to say that such studies are unethical because they do violence to the integrity of human research.
Et voilà. My thesis. All I have to do now is write 80 pages on that, and I’m golden.