Federal Perspectives on Research and Human Subjects Protection

Linda Bartoshuk
Menikoff

Jerry Menikoff is Director of the Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (HHS). OHRP leads the department’s efforts to ensure the protection of the rights, welfare, and well-being of subjects involving in research conducted or supported by HHS.

Menikoff previously served at the National Institutes of Health as the director of the Office of Human Subjects Research and as a bioethicist. He has written extensively on research and human subject protections, including several books and numerous journal articles, over the past fifteen years. Previous to his NIH appointments, Menikoff served for nine years as the chair of the human subjects committee and the hospital ethics committee at the University of Kansas Medical Center. His educational background includes an MD from Washington University and law and public policy degrees from Harvard. In addition, Menikoff has held academic positions in schools of law at the  University of Chicago and Hofstra University.

Menikoff recently talked to APS Director of Government Relations Amy Pollick about institutional review boards (IRBs) and psychological science research.

Open to Questions

Amy Pollick (APS): Many in the behavioral science research community feel that OHRP needs to state its commitment to help researchers work with their IRBs, and that the agency should answer questions from anyone about the appropriateness of the behavior of their IRBs. Hearing the message that you are open to working with both IRBs and with researchers would make a difference.

Jerry Menikoff: We are in favor of working with the IRB and research communities to make sure research can get done correctly. If you are at an institution whose IRB is making particular decisions that you think are not mandated by the regulations, we are happy for you to bring a question to us and say, “Our IRB does X and Y – is this required by the regulations?” We can give you guidance about what the regulations mean. It’s not our purpose to fault the IRB for doing something. Some IRBs may go beyond the regulations and ultimately it is for the institution to decide whether or not it wants that to happen; institutions can have differing degrees of protection. On the other hand, it could be that an institution does not know that its IRB is over-interpreting the regulations, that it is enforcing the rules in a stricter manner than the federal government or OHRP requires. So we are happy to say the regulations don’t require your IRB to say or do X or Y, and then it’s up to the institution to say, “Okay, we are going to talk with our IRB”.

We are extremely open to answering questions. We will answer anonymous questions from people who are afraid of dealing with regulatory agencies or who may say something that unintentionally reveals their research institution. They can just call us up and say, “We prefer not to say who we are” and we will not take down the caller’s information. We’ll also accept an e-mail query from anyone.

APS: Does OHRP get many official complaints?

JM: We get more unofficial complaints about the regulatory burden— from people writing articles, from people going to meetings where the big issue is IRBs dramatically slowing down important research. That message is clearly out there and we hear it. If you think your IRB is over-interpreting the regulations, feel free to contact us with a particular example of what the IRB did and we will be happy to tell you if the regulation requires that to be done. We live in a world of limited resources so an IRB that is spending a lot of time giving much stronger protections to low-risk research than what the regulations require probably will not have the resources to be spending the time on the more risky research, the things that require them to pay greater attention . Just as an ethical matter, the IRB may not be doing the best job in terms of protecting your subjects.

We are revamping our website, which we expect to go up this fall, and are planning a top 10 FAQ section. If people could provide specific information — specific recurring things  IRBs are doing that appear to be inappropriate — it would be great to let us know about it so we could clarify it. It’s a lose-lose situation if IRBs are doing things that aren’t required by regulations because they think they are required by regulations. Once again we are very willing to field inquiries if it comes from a researcher, administrator, or the IRB itself so that they know that the regulations don’t require you to do X.

Learning by Example

APS: Will the new website include a set of case studies of specific examples or hypothetical scenarios of possible IRB decisions? Will there be guidance on international research?

JM: The new website is going to collect and organize the information we have there now and put it in a more user-friendly format. Again, in line with our openness, if you have case examples that you think would be worthwhile for OHRP to review, I would encourage you to get people together and to submit them, not with the answers, but with the questions and we would consider posting those as FAQs.

Regarding international research, the regulations by and large work for these kinds of studies; if you are a federally-funded study, you are subject to the same regulations that any study conducted within the United States would be subject to. What that may mean is that you recognize that the regulations are flexible and how they might be applied by an IRB in another country or culture. For example certain countries have rules for IRBs and the concept of consent. You may be dealing with a country that doesn’t [typically] sign papers or something like that. In China, for example, many parents have moved to the city to work and left their children with grandparents. Then, the issue arises about who gives consent for a research study. Here you may just need to make a common sense decision: if the grandparent would be permitted under Chinese laws to make medical care decisions and take the child to the hospital for medical treatment you can likely conclude that they would be able to make the appropriate decision for participation in a study.

About a quarter of the IRBs that are registered on our database are from outside the United States, and lots of foreign institutions have FWAs [Federal Wide Assurances]. When I was at NIH many entities would get FWAs in order to collaborate with the NIH; it wasn’t very hard to obtain one.

The Council of Europe (CoE) is a group of 47 countries and what it does, among other things, is to develop proposed laws that each member country can decide whether or not to implement.  The CoE now has a working group that is tackling the question of what protections should apply when a developed nation conducts research in a developing nation.

Communicating About Risk

APS: One problem with behavioral science research is IRBs making gut-level decisions about risk. IRBs need data on consequences of supposedly risky studies. What has been especially useful from studies of trauma is follow-up data on participant experiences because IRBs will sometimes automatically rule out such studies, feeling that even if you interview them a week after the traumatic experience you will have them re-experience the trauma and that’s just not the case, as scientists at the University of Tulsa have shown. We are trying to get that data into the hands of IRBs. How can OHRP help spread this information?

JM: OHRP is behind you on that point. We are certainly open to communicating information about risks. Obviously, IRBs should be using appropriate information to determine risk levels. I think it’s wonderful that groups are collecting this information and determining what actually are the risk levels. I remember there was a discussion at one of the recent Public Responsibility in Medicine and Research (PRM&R) meetings where a researcher was discussing his problem with getting a protocol approved. He was doing some sort of benign research like studying smoking and smoking cessation. It involved exposing healthy subjects to nicotine for an hour or so and seeing their physiological response. The IRB asked, “Won’t some of the subjects take up smoking after this?” (Because they had exposure to nicotine they could become nicotine addicts.) It was hard for him to address that concern until he discovered that another researcher had done a number of studies where that researcher exposed healthy subjects to far more nicotine than he was going to. Now that the information was out there he was able to say to his IRB, “Look, this is not a problem. These people are not going to get addicted because it’s a minimal risk study.”

APS: But if an IRB is starved for resources and the researchers don’t necessarily know about existing data, then what?

JM: Exactly. We are happy to inform researchers if we are aware of appropriate resources. You would have to call us and we wouldn’t necessarily tell you how to categorize a certain risk but we could tell you, if we are aware of it, how other IRBs have dealt with it and if we know somebody who collected data on how risky it was we’d refer you to that researcher. At the moment, OHRP doesn’t have much information of this nature, but hopefully it will grow over time. IRBs should have as much information in front of them as possible so they can make the best decisions about risk. We are well aware that people who tend to deal with regulatory matters sometimes can be risk-averse in the sense that they will imagine lots of risks when in reality things might not be that risky.

Student Research

APS: Let me switch to student research. We’ve seen so much variability in how institutions handle research done by students, especially psychological science research. Since these studies rely on a pool of undergraduates that comes and goes so quickly the IRB holdups become very problematic for this community. Can you clarify what the regulations say about student research that is not meant to contribute to “generalizable knowledge”?

JM: If the work doesn’t meet the definition of research as it appears in the regulations (which can sometimes be tricky to figure out) then IRBs are not required to review it. This is getting back to our earlier issue. But an institution could decide that, nonetheless, this is an activity that needs some oversight. OHRP has basically no position on what institutions can do in terms of providing protections for activities that happen which don’t fall within our jurisdiction — that is, they aren’t research, as defined by the regulations.

APS: Ultimately it comes down to the institution’s decision on what sort of protection they want.

JM: There will be times when over-protection can be a bad thing. Doing research, sometimes even risky research, can be a good thing if it’s answering an important question. We shouldn’t be doing things so that we slow down important research without at the same time obtaining significant protections to people as the trade-off. If the types of risks we are talking about are very low, there is little justification for putting in place protections that are substantially delaying research. These are perfectly appropriate trade-offs to be considering. Once again, OHRP doesn’t have any authority to do anything about this, but I’m saying as a reasonable person that people should be thinking about trade-offs between slowing down research and doing things that aren’t doing very much towards protecting subjects.

As the director of OHRP I want to send the clear message that we are not trying to slow down or discourage potentially crucial research from being done because of excessive regulation.

IRB Behavior

APS: Switching topics a bit: I think we have all heard about the time lag that can happen during IRB review — is this a major cause of delayed study approval?

JM: If you look at the amount of delay due to IRB actions and then refine it, you see how much of that is time when the IRB is waiting for the investigator to respond. Getting to your earlier point about reasonableness I think IRBs need to be reasonable in figuring out whether the changes they are making are actually going to be genuinely beneficial to the research subjects. Correcting grammar and spelling errors probably doesn’t do a lot to actually increase protection. IRBs should think about that when reviewing.

We have done site visits to IRBs and talked to staff and administrators about times when they would try and talk to higher-ups to inform them that they needed more staff and resources. Sometimes you realize that the IRB was doing an extraordinarily intensive review of expedited studies so that they were coming up with, hypothetically, let’s say 50 problems or corrections that needed to be made, and then it would get sent back to investigators and bounce back and forth and take a long while for investigators to answer all 50. We’re not necessarily going to tell the institution it  needs to give more staff or resources to the IRB because the IRB was doing things that went beyond what was required. Low-risk studies shouldn’t be getting the kind of intensive review that frequently comes up with 50 points to change. There is a reason they are expeditable in the first place.

APS: While OHRP cannot directly fund research on IRB behavior, how would you like to see that research funded through NIH, through NSF, or through any other organization?

JM: The more research the better. Empirical data is important and useful to have just in general. In one of the SACHRP meetings it was noted that NIH, through the Office of Science Policy, is undertaking to fund a number of bioethics issues.

APS: Your comments resonate with what Susan Fiske, a Past President of APS who is a social psychologist at Princeton University and chair of her IRB, says about bringing a promotion focus to IRBs for better research [Editor’s Note: See Fiske’s article “Institutional Review Boards: From Bane to Benefit” in the January 2009 issue of Perspectives on Psychological Science for more information.]

JM: Most people think of OHRP as being a primarily a compliance agency but I hope people also view us a resource for guidance. Hopefully the rules are appropriate and not unnecessarily burdensome to the researchers. We still need to make it clear to people about what you need to do to comply so researchers can end up in a win-win situation: they can do the research, fully compliant with the regulations, without any inappropriate regulatory burdens.

Observer Vol.22, No.8 October, 2009

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Comments

I am a behavioral scientist and until recently I have not been asked to provide others with raw (unanalyzed) research data. This is now changing as so many people want to populate their evolving databases. My training is not to share such data, but I think things may be changing.

Can you point me to any societal or other guidelines on if or when anonymous data from behavioral science subjects can or should be shared with other researchers (and others.)

Thanks.

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