* Lawrence Corey, M.D.
o President and Director
Fred Hutchinson Cancer Research Center
o Principal Investigator
HIV Vaccine Trials Network
o Professor, Laboratory Medicine and Medicine
University of Washington
* Robert M. Califf, M.D.
o Vice Chancellor for Clinical Research
o Professor of Medicine
Duke University Medical Center
Duke Translational Medicine Institute
* Susan E. Lederer, Ph.D.
o Robert Turell Professor of History of Medicine and Bioethics and Chair, Medical History and Bioethics
University of Wisconsin School of Medicine and Public Health
* Dan W. Brock, Ph.D.
o Frances Glessner Lee Professor of Medical Ethics, Department of Global Health and Social Medicine and Director, Division of Medical Ethics
Harvard Medical School
* Eric M. Meslin, Ph.D.
Indiana University Center for Bioethics
o Dean (Bioethics) and Professor of Medicine, Medical and Molecular Genetics, Public Health, and Philosophy
IU School of Medicine
Indiana University-Moi University Academic Research Ethics Partnership
“So Eric, as you were saying, you had one more point.”
“Yes. Well this actually follows so you can consider it one point, if you want. It is a subordinate clause from the first point.
I can say with complete humility that virtually every commission has tried its best to see its findings implemented and with very few exceptions, I have seen that happen.”
” What I would say is that I think one critique of bioethics that has grown has been the narrowness of its focus. And in some ways informed consent and I know this is a caricature but hold with me, you know, it was like a band-aid for all the problems with, and it turns out not to resolve them, not surprisingly.
So I guess if I had one thing to suggest, it would be to broaden the focus on the socioeconomic realities. I mean, for example, I don’t want to make another requirement but listening to the conversation earlier sort of like, I mean some of those plans for global research sound fabulous but the question to me is not if the money runs out, it is when. And it seems to me if we look at the past, a lot of bad decision making comes when the financial realities change dramatically and there is not contingency plan.
So I mean, I would like to put in a plea for planning not just for aftercare of the subjects but, you know, some sort of plan for when your funding source dries up completely and what are you going to, you know, how are you going to scramble? I mean, maybe people do take that into account but certainly they did not do so historically.”
“Well, the alliteration promise and peril is a little challenging but it is fun to try.
I think the perils are pretty obvious when you talk about exploitation and the selection of sites on the basis of lowered barriers, the kinds of things we were talking about before. There are reasons beyond just human subjects protection and why going somewhere with a lowered barrier is a bad idea. It is bad economically. It is bad politically. It is bad for a whole bunch of reasons. But what we don’t tend to think about is what the opportunities are for going elsewhere. And if we can get out of our mind the idea of that model of the opportunistic pirate who is going elsewhere and think that there may be reasons of international partnership and collaboration where we are now seeing not only more studies going on elsewhere, but foreign investigators have increased dramatically as a function of both FDA-sponsored studies and PIs or co-PIs at the NIH. So there are great advantages to “off-shoring.””
“Sure. Three tools. One is training and education. We have actually moved quite far down the road in training investigators about research ethics. It used to be you had to go online and take an NIH course, get 70 percent and satisfy your institutional requirements. We are now making some progress along those lines. The cooperative institutional training initiative, the online module program run out of the University of Miami and the University of Washington, now has probably a thousand institutional subscribers around the world. There is some evidence that it is actually having an impact. So that is tool number one.
Tool number two, which was alluded to in the NBAC report, and I think would be very helpful if you wanted to push this ball down the road to the NIH, is providing the administrative and financial tools to foreign countries to use indirect costs at a rate commensurate with what U.S. institutions do.
I could just give you one example. At Moi University in Kenya, they aren’t allowed to use any of their indirect cost recovery to support their institutional research ethics committee. They have to do it out of regular funds. Not allowing an institution the tools to carry out the review that they are actually required to undertake is something that frustrates researchers and sends them elsewhere. So that is two tools.”
” I have a question for all of you and it has to do with informed consent, which I realize is one of Christine’s seven sacred elements of ethical research. But I wonder about rethinking it in the context of this particular mission that we have in the following way.
At the end of the day, one of our responsibilities as researchers is to ensure that we shift some of that responsibility to informed consent to the subject. Right? I mean, ultimately that is one of the things that we are supposed to do.
I have a concern that gets to Dan, your comment about exploitation and Susan your comments about broadening the focus on socioeconomic realities that really the ethical purpose, the moral purpose for informed consent is not to secure the consent so that I can go forward, but it is to inform.
I worry about the capacity of some places where it will be important and already is important to do research of the individuals there actually to be fully informed. And how do we measure that and how do we go about ensuring that we can inform in places where, you know, rates of literacy are under five percent and where perfectly adequate social behaviors and social understandings for that community may lack the, I hate to use the word sophistication because it sounds pejorative, but for this purpose may lack the sophistication to enable us to actually get informed subjects, not just check off on informed consent.”
Well, Dan you have written a lot about informed consent so why don’t you try to answer that?
” Unfortunately, I am afraid that is correct.
A similar question can arise not even in the developing world context where medical students, for example, when you start talking about informed consent with them, there is always a certain number of skeptics in the group who say, well patients, often they are talking about patients as opposed to research subjects, well they can’t really understand it as well as we do. They would have to go to medical school and do a fellowship and so forth to really understand it. And the right response to that I think is you have to think about what it is that in that case a patient, but in other cases, a research subject, needs to understand. There will certainly be many things that the investigator understands that the research subject doesn’t understand but also has no need to understand.”
“Let me stop you there. I am just curious. Please, who makes that judgment? Is it the pharmaceutical company that is sponsoring the research? Do we look to third parties to do that? Who makes that?”
“IRBs typically step in to this, in terms of what needs to be a part of the consent process and often the forms but and there is reasonable disagreement about this.
I think what a subject wants to know and for that matter what a patient wants to know is basically what is going to happen to me. What are they going to do and what is going to happen to me, and how might that matter in my life?
Now, I think that is something that even unsophisticated and not very educated people can understand if the information is given to them, I am inclined to say in an understandable form, but nevertheless.
So I think if we think about what we want people either in clinical medicine or in research to understand as a part of their giving informed consent, then I think people are more capable of it than I guess I took your question to suggest.”
” I actually agree with the point and it actually gets — I want to be a little bit provocative when asking could it ever happen again. This is the only time I will mention the other NBAC report focusing on human subjects research.
We still have an incompletely covering federal oversight system. So when you say could this ever happen again, the answer is of course it could if it was conducted by researchers who were not federally funded or who had no intention to market or license a drug or a device by the FDA. It could happen today. It might be happening today. That may not be the sound bite you want for the meeting but the point is if you are concerned about whether Guatemala could happen again, which of course is several studies and not just one, could happen again in the United States, the answer is, it probably could but you might not know about it. We might not know.
But could it happen within — under the umbrella, under the Common Rule? Less likely. Those agencies that are not signatory to the Common Rule? Probably not because they almost all follow it in spirit anyway but we still don’t have complete harmonization between the FDA and the Common Rule.
So before we — I mean I am a complete believer in your question. None of us should sit here and say could it happen here and answer well, it might. Ethically it ought never to happen. We have protections in place but we have a leaky system.”
“So you have described a framework. Many of you have described a framework that goes from investigators, community engagement, goes all the way up through national regulatory or normative bodies and to an international something that would exist that would actually change this debate from what my Nigerian colleagues would say just grammar to actually action.”