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New OHRP director on new priorities, changes
Q&A with Jerry Menikoff
The Office for Human Research Protections (OHRP) of Rockville, MD, announced in October, 2008, that Jerry A. Menikoff, MD, JD, is the new director. Menikoff also has served as the director of the Office of Human Subjects Research and has worked as a bioethicist at the National Institutes of Health (NIH). Prior to his NIH appointments, Menikoff was a chair of the human subjects committee and the hospital ethics committee at the University of Kansas Medical Center.
IRB Advisor asked Menikoff to discuss his vision and priorities for OHRP in the next few years, as well as how he thought the new Obama/Biden administration might impact human subjects research regulations. This question-and-answer story contains some of his answers to questions about OHRP's new directions and any anticipated changes.
IRB Advisor: Would you please explain your goals and vision for OHRP? What do you feel would be a good direction to go during your tenure?
Menikoff: I'd say my vision ties into why is OHRP here in the first place and that OHRP has this unique role. We're trying to make sure that people who are taking part in research are going to be adequately protected. That's the major goal OHRP has. But at the same time, we clearly have to make sure we're not applying the rules in an inappropriate manner. There has to be a balance in how OHRP applies its purposes. There has to be adequate protections in terms of the subjects, and at same time we're not over-regulating, not applying the rules in a manner that it inadvertently creates major burdens to research while not in any significant way adding protections to subjects.
IRB Advisor: That's been a complaint of a lot of research organizations that IRBs are so busy now because of the perceived increased regulations and media scrutiny. Is that the trend you're addressing?
Menikoff: Partly, yes. It certainly has gotten some attention, and it's appropriate that there be some response to the concerns. In a sense, what OHRP is dealing with is not that different from scenarios we see in applying other regulations in other areas. But any regulatory agency shouldn't be losing sight of why the regulations are there in the first place. And the regulations that OHRP administers are clearly there to protect research subjects. So OHRP should be making sure to the extent possible that happens and that it happens in an appropriate manner. Any administrative agency has limited resources in terms of fulfilling its goals and the constituency it deals with out there, in terms of making sure the regulations are adhered to, also have limited resources. We only have so much time in day; there's only so much effort we can expend; there's only so much money in terms of personnel, etc., etc.
Getting back to that, in terms of balancing, on one hand OHRP should be making sure that IRBs and others involved in protecting subjects know how to best apply their limited resources. So, for example, there are certainly studies out there that are very, very low risk. Generally, you can take any study out there and you could certainly expend more and more effort making sure that there are adequate protections in that study. But you don't necessarily get more benefits out of expending more and more effort — in terms of protecting research subjects. So everybody involved — OHRP, IRBs, the administrators, PIs, everybody—should be applying the rules in a reasonable manner. That includes not spending more time than is appropriate on a very, very low risk study where the regulations themselves suggest that not a lot has to be done to adequately protect the research subjects of that study.
That certainly is getting into the theme that investigators and others are complaining about.
Also, by recognizing the need to not spend too much time on very low-risk studies, there's a very beneficial effect of freeing up time and resources to spend on parts of the system that perhaps are not getting enough attention—studies that are much riskier and that may involve life or death issues.
IRB Advisor: OHRP has started to publish correspondence about IRB reviews and some findings on your web site. Could you please explain what this new transparency might mean for IRBs?
Menikoff: This started before I got here. Informally, everything I've heard has been very, very positive. This totally fits my goal. So it's great to come here and fit into a theme that OHRP is already doing with increased transparency.
There is some degree of concern on the part of some of OHRP's constituencies. These researchers, even research subjects have said that OHRP's positions on some issues are not clear. Some people are just nervous in general about dealing with a regulatory agency. So even though OHRP by and large has been quite open in responding to requests for information about its policies or about applying a policy to a particular study, some people just don't like to call or ask the question. They think you might show up on some regulator's radar screen and you might say the wrong thing during an email or phone call.
The result is that by not giving guidance in one area or another, you could have people inappropriately not doing the important research. They could do that research, and it might not be problematic at all. It could be totally consistent with regulations and subjects could be adequately protected, and OHRP might not have a problem with that. So this increased transparency could lead to what some people think is a paradoxical effect: by putting more guidance out there you actually enable people to do things they previously didn't think they'd be able to do.