On this last episode, we look back on 23 years of joyous, difficult and always informative conversation.
Clinical trials and other human research studies can play a vital role in developing new drugs, medical therapies and public health strategies. They also raises complex ethical questions about privacy, consent and researcher motives. “The Common Rule” sets out ethical guidelines for research funded by the federal government. But many scholars say those rules– last revised 20 years ago– are hindering research across academia, including social sciences like anthropology and history. We examine efforts to update the “Common Rule.”
- Jerry Menikoff Director, Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
- Kathy Hudson Deputy Director for Science, Outreach, and Policy, National Institute of Health (NIH)
- Zachary Schrag Associate Professor, Department of History and Art History, George Mason University; Author, "Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009" (Johns Hopkins)
The panelists answer a caller’s question about what might have happened to a mandatory DNA sample he had to give when he was incarcerated some years ago:
What Do You Think
- Have you participated in a medical trial or research study? Did you feel that you were adequately consulted and that your privacy rights were respected?
- Have you presented a research proposal to an Institutional Review Board?
- Should historians and anthropologists be subjected to the same review process as biomedical researchers?
Send us a tweet us @kojoshow, post a comment below, or call us during the show at 800 433 8850.
What Does “Ethical” Research Look Like in the 21st Century?
Today, most human research in the United States is subject to the Common Rule. Established in the 1970s, after revelations about the Tuskegee Syphilis study, the Common Rule requires institutions receiving federal-funding to establish policies that ensure ethical research protocols and protect human participants.
Revising the Common Rule: New Rules for a Changing Landscape
This year, the Office for Human Research Protections at the Department of Health and Human Services proposed major changes to the Common Rule. In July, proposed changes are aimed at reducing red tape and strengthening protections for participants. But experts in a variety of academic disciplines are worried the new rules will adversely affect their work.
Researchers complain that the current framework are inadequate for today’s technological and ethical landscape. In the two decades since The rules were last revised, major advances in DNA applications and digital record keeping have transformed biomedical research. But they have also raised thorny questions about privacy and consent.
From no consent to Informed Consent to “Re-Consent”
Henrietta Lacks died of cervical cancer in 1951. But the HeLa cell line—derived from cancer cells taken without her consent— would serve as an important research tool in subsequent decades. By today’s standards, those research practices raise serious ethical red flags.
Under the current system, researchers must acquire “informed consent” from trial participants, explaining the risks and benefits of participation and exactly how their blood, tissue and other data will be used. But what happens to all of that data after a study is completed? Researchers can often use old samples in new research without permission, if the identity of the donor cannot be determined. But controversies have emerged about whether “informed consent” should extend to these studies (re-consent).
Starting in 1990, members of the Havasupai Indian tribe participated in an Arizona State University study examining the genes associated with Type 2 diabetes. However, they later learned that researchers were using their blood samples for other studies. Their samples were used in a study exploring genetics and schizophrenia—a taboo subject within the tribe. Researchers also used the DNA to trace the tribe’s geographic origins to Asia, contradicting traditional Havasupai origin stories. The case was settled in 2010.
Patients and Participants Want More Control
While no consensus currently exists around the consent / re-consent issue, patients and participants clearly favor more control over their data. A study in Journal of Empirical Research on Human Research Ethics found that the vast majority of donors want researchers to ask permission to use their data in other contexts: 90% of donors thought it was important that they were asked for permission before their data was shared. But a large majority of donors (86%) still opted to give consent for their data to be released.
Too Much or Too Little Consent?
Proposed changes to the Common Rule would strengthen informed consent protections involving “secondary use” of data and biospecimens. But researchers are divided about whether the rules impose too much or too little protection for participants. Some researchers and clinical trial administrators worry that the rule change could place unfair financial and logistical burdens on scientists. Dr. William E. Grizzle, a professor of pathology at the University of Alabama at Birmingham, told Clinical Trial Admnistrator:
- They’re asking us to consent 30,000 to 50,00 patients a year… We estimate it would take three or four fulltime individuals who would do noth ng but informed consent, costing us up to $300,000 more to be able to continue the doing the research at the level we’re currently operating” (“Common Rule tissue changes elicit objections” November 1, 2011– paywall ).
Another researcher predicted that the medication pipeline would grind to halt without access to thousands of tissue samples.
On the other side, Krishanu Saha & J. Benjamin Hurlbut argue protections are too weak in the new proposed rules:
- The changes encourage blanket consent— asking donors to authorize virtually everything… telling donors next to nothing about how and for what purpose their donation will be used. Although this may reduce administrative complexity, we believe it will decrease, not increase public involvement in biobanks and fail to deliver on its ethical aim of better protecting participants’ rights.
Should Historians be Subject to the Same Rules as Pathologists?
The Common Rule framework was designed with drug trials and medical research in mind. But anthropologists, oral historians and other social scientists often have to submit their research proposals to Institutional Review Boards for approval. Many researchers complain the process has become a major obstacle to academic inquiry.
Social science organizations have raised concerns that the proposed rules could make things worse. They say important academic work– like recent revelations that American research scientists deliberately infected research subjects in Guatemala with Syphilis in the 1940s– would not come to light under new data collection and consent rules. The Guatemala abuses were uncovered when a historian accidentally came across notes in an archive.
MR. KOJO NNAMDIFrom WAMU 88.5 at American University in Washington, welcome to "The Kojo Nnamdi Show," connecting your neighborhood with the world. The Havasupai Indians believe their blood is sacred, but the small native American tribe located deep within the Grand Canyon is ravaged by high rates of type 2 diabetes, so beginning in the 1990s, they agreed to submit blood samples to find genetic clues about the disease. The document they signed allowed researchers from Arizona State University to use their blood for other purposes, but the Havasupai were shocked when they found out exactly how their DNA was being used.
MR. KOJO NNAMDIYears after the diabetes study, researchers were using their genes to explore schizophrenia and contradicting the tribe's traditional origin stories. Today, most research involving human research is subject to strict government mandated ethical guidelines, whether it's a DNA study or clinical trials, even oral history projects are subject to the guidelines commonly known as the "Common Rule." But the rules were last updated in 1991 before the days of advanced DNA applications and internet platforms. This year, a panel of experts began the complex work of updating the "Common Rule."
MR. KOJO NNAMDIJoining us to discuss this are two members of that panel. Jerry Menikoff is director of the Office of Human Research Protections at the Department of Health and Human Services. Prior to his work within government, Dr. Menikoff was chair of a human subjects committee and a hospital ethics committee at the University of Kansas Medical Center. Jerry Menikoff, thank you for joining us.
DR. JERRY MENIKOFFA pleasure to be here, Kojo.
NNAMDIAlso with us is Kathy Hudson, deputy director for science outreach and policy at the National Institutes of Health. She also serves as chief of staff to the director of NIH, Francis Collins. She's a molecular biologist by training, an expert on ethical issues around genetic technologies. Kathy Hudson, thank you for joining us.
DR. KATHY HUDSONThank you.
NNAMDIAnd Zachary Schrag, well, you've met him here before. He's a professor in the department of history and art history at George Mason University and author of "Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009." His previous books, this is the one you'll probably remember, include "Great Society Subway: A History Of The Washington Metro." He writes the "Institutional Review" blog, which explores how ethics rules effect researchers in the humanities. Zachary Schrag, good to see you again.
MR. ZACHARY SCHRAGIt's my pleasure. Thank you.
NNAMDIIt's a conversation on the ethics of research with human subjects. We're encouraging you to join by calling 800-433-8850. Have you participated in a medical trial or research study? Did you feel that you were adequately consulted and that your privacy rights were respected? You can call us at 800-433-8850 or you can send email to firstname.lastname@example.org, at tweet @kojoshow or simply go to our website, kojoshow.org, and join the conversation there.
NNAMDIIt was a medical study that shocked the United States and the world. For 40 years, government researchers in Tuskegee, Alabama, studied the effects of syphilis on a group of African-American men without referring them for treatment. To what extent did Tuskegee and the subsequent outcry kick start the creation of these ethical guidelines, Jerry Menikoff?
MENIKOFFIt certainly played a major role. We actually had regulations on the NIH side that predated Tuskegee, but when Tuskegee came along, basically the regulations were expanded, the U.S. government put together a panel, which produced a very famous document called the "Belmont Report." That created three overarching ethical principles and over the years following Tuskegee, eventually we produced a common rule in 1991, which is basically a set of ethical rules that apply to most research that is funded by the federal government and in particular, a number of branches of the federal government.
MENIKOFFThat's why it's called the "Common Rule."
NNAMDIFifteen federal government agencies adhere to this framework of rules called the "Common Rule."
MENIKOFFMore than that now, actually.
NNAMDIMore than that now.
MENIKOFFYeah. It was - in 1991, there were only 15.
NNAMDIWell, clinical trials and other human research has helped eradicate diseases like polio, small pox, helped expand our understanding of genes and DNA and the building blocks of life. The "Common Rule" was updated in 1991, Kathy Hudson, and over the last 20 years, a literal revolution has occurred within the sciences and within communication technology. Has our understanding of what is ethical and what is right kept up with what is possible?
HUDSONWell, the science has certainly changed over the last 20 years in terms of what we can do scientifically and the nature of the risks that are posed to those who are participating in research, so today, we can take a biological specimen and we can sequence the entire genes of that individual for a modest amount of money, about 28,000-fold less than it used to take us. And that will reveal an enormous amount of information about that person, and so the question is, should that person have an opportunity to give their permission for that research.
HUDSONAnd we have, you know, there was a time when we didn't ask people whether or not they wanted to participate in research, we just did it. And we have evolved the rules in the wake of Tuskegee. Certainly, we put in place rules that have served us well over the last several decades. But we now, as research changes its nature with technology and in the volume of research that we're conducting across the country in large multi-sect clinical trials, it's time to modernize and streamline those regulations.
NNAMDIJerry Menikoff, would it be correct to say that the two basic building blocks of the "Common Rule" are institutional review boards, or IRBs, panels of experts and researchers who review and approve every step of the research protocol before it can begin, and informed consent, before they can participate in a study, all participants give all their voluntary informed consent? Correct?
MENIKOFFAbsolutely. Informed consent is sort of the key, the core element of ethical research.
NNAMDIAnd where are we now in the review process, by the way, with the panel?
MENIKOFFWe have gotten comments. There is a 90-day comment period. This is published in the federal register and we've actually gotten lots and lots of comments. We have over 11 -- about 1100 comments and they're from an amazing diversity of groups, some of the leading, you know, scholarly societies in certain fields and many individuals. And I have to say on the part of HHS, we're thrilled that we have so many comments.
NNAMDIZachary Schrag, you wrote a very well received history of the Washington Metro that we mentioned earlier, but that's not exactly the same kind of research as a pathologist trying to figure, oh, our triggers for cancer. But it turns out that social scientists, historians, anthropologists, political scientists, even arguably journalists are actually directly affected by the same rules as that pathologist. You became interested in institutional review boards when your own work began to be affected by these institutions. Can you explain?
SCHRAGThat's right. So as you heard from Dr. Menikoff, these rules were originally written by people at the National Institutes of Health. And they were medical researchers who were sort of imagining that there would be blood drawn or spinal taps taken or that kind of work, but they wrote the rules very broadly to say any kind of interaction might count as research. So when I got a dissertation grant from the National Science Foundation, for which I am very grateful, and I was interviewing people who had worked on Metro, architects, engineers and all the rest, I had all this paperwork.
MENIKOFFAnd I said, yeah, okay, there's a box that says are you doing human subjects research. I guess I am. I am interacting with people. I certainly was. And that sort of lead me down the rabbit hole of these rules because at first, it wasn't so bad. I told the university, I know what I'm doing. They said, fine. Then they said, we really want you to take this online training that has to do with medical ethics, and that got me a little worried.
SCHRAGThen they started asking me to report how many people I'd talked to and how old they were and what race they were. And that got pretty strange because some of these people I'd interviewed on the telephone. I didn't know how old they were or what race they were, for that matter. And then, it just got worse and worse. And a lot of social scientists and historians in particular have had this experience where the rules sound fine when you start getting involved.
MENIKOFFEveryone likes ethics. That sounds good. Informed consent, that sounds great. But when you get into the details, you start wasting your time and at times, are actually told that you can't do work that you think is perfectly ethical and is quite needed for your own research.
NNAMDIYour turn, Kathy Hudson.
HUDSONSo in addition to doing genetics and molecular biology, I also had a stint doing social science research and I sympathize with the dilemma of having work that seems on its face to be -- have no risk inherent in it to the participants. I did a lot of focus groups and interviews and surveys where, by answering the questions, people were basically giving their consent. And yet, when we got caught up in the university bureaucracy and when I tried to collaborate with other institutions, other investigators at other institutions, we ended up having multiple institutional review boards editing the consent documents and ending up in a significant delay in this project that I would argue posed no risk to my participants, and yet we got sort of caught up in the mire.
HUDSONI think that the goal of the revisions that are being proposed now by the administration is really to try to streamline the regulations so that attention is focused on those areas where there are significant risks to participants and to really protect research participants and eliminate unnecessary bureaucracy and time-wasting convoluted schemes wherever we can.
NNAMDIIndeed. Jerry Menikoff, where does social science research fit into this review?
MENIKOFFWell, so it's important to realize from the beginning, under these rules, the rules look at different studies in different ways. They're not imposing exactly the same sets of requirements in all types of studies. There were categories called full review where you have to have the entire IRB review of the study. Then, there's expediter view where one reviewer could review and then there are studies that are actually called exempt, that they're actually not subject to most of these rules.
MENIKOFFAnd what our proposals right now are looking at are maybe we can improve the system even a little more, in terms of, again, as Kathy was noting, better focusing the greater administrative effort, the greater reviews on the studies that impose greater risks to people, which is not say that you might not want certain protections in terms of privacy. If a study involves asking people for very, very private information that they don't want the public to get, you might have the reviewer subject to some rules, but is there a way of doing that in a better, more effective, more efficient method so that we could save the great bulk of the efforts for the studies that really impose very, very complicated substantial, perhaps life and death risks.
NNAMDIHere is Heidi in Washington, D.C. Heidi, you're on the air. Go ahead, please.
HEIDIHi. Thank you to all the participants. I'm actually the chair of the IRB for social and behavioral sciences at Georgetown and I'm following the process of devising the "Common Rule" and its applicability quite closely. I've read Professor Schrab's book and learned a tremendous amount from it.
HEIDII have -- but I do want to make two important points. One is that nobody likes being regulated so - but I'm a philosopher and a lawyer. I teach torte law and theory of tortes. No pharmaceutical producer likes being subject to tort litigation. Likewise, nobody likes having other people review their work for ethical concerns. It's just, you know, it's one more step to go through. It should certainly be streamlined. But the reason we do this is because people who look at their own work in whatever field they're in, often think it doesn't pose any risk.
HEIDIAnd that's a quite sincere belief on their part. But they may not be in the best position to access that. And secondarily and very quickly, I would say that with regard to social and behavioral sciences, whatever the history of the development of the regulations is, there's no reason that they cannot be applied with great sensitivity to (word?) areas, particularly in an era where technology, invasion of privacy and respect for the perspective of research participants like the American Indians Kojo mentioned at the beginning of the show, have become increasingly important.
HEIDIWe have more expanse of (word?) autonomy and privacy than we once did and more ways for researchers to encroach on them. Therefore, I think we need to make sure that in streamlining the new procedures, we don't throw the baby out with the bathwater.
NNAMDIThank you very much for your call, Heidi. What's your last name?
HEIDIFeldman, "F" as in "Frank," E-L-D-M-A-N.
NNAMDIThank you very much for your call. You too can call us at 800-433-8850. By way of example, Zachary, Americans have long been aware of the Tuskegee studies. But in recent years we learned about another government sponsored syphilis study in Guatemala, which in some ways was actually more shocking and almost forgotten because the Guatemala experiments involved intentionally infecting prisoners, soldiers and the mentally ill with syphilis.
NNAMDIA lot of social science advocacy groups claim we would never know about the Guatemala story if the proposed rules or if the common rules were in effect -- the common rule was in effect. Could you please explain?
SCHRAGWell, sure. The caller from Georgetown claimed that there was no rule that the same real -- no reason the same rules could not be applied to social and humanities research as could be applied to medical research. And I would disagree there in part because the medical ethics rules are based on the rules of medicine, including the idea that one cannot harm a patient. And that's been applied to the idea that one should not harm a research participant.
SCHRAGHistorians, journalists and sometimes sociologists as well, for example, very often want to write critically about the people they study. Informed consent is fine. You know, you tell people you're being interviewed. But we do not have an ethical duty to avoid embarrassing people and even bringing people to criminal justice if they're done something wrong.
SCHRAGSo the Guatemala case -- and I'm very proud to have edited the article that brought that to light -- is an example where the historian is really concerned with the truth and not particularly concerned with embarrassing people who may have done something wrong.
HUDSONSo can I add to that?
HUDSONThis was a fascinating historical finding with these documents uncovered at a university archive. The gentleman who was involved in doing the study in Guatemala who led it, Dr. John Cutler, had also been involved in the Tuskegee study, in Sing Sing and a number of really horrible horrific unethical experiments in the United States. This is the only documented unethical set of experiments overseas that we were able to uncover.
HUDSONI don't -- I think that the important part here is that the people who were the victims of that research in Guatemala, their photographs were included in those records. Their names were included in those records. And the fact that those individuals had been victims of research one time shouldn't mean that they should be subjected and exploited again.
HUDSONAnd so I was very happy to be able to help get those records moved to the national archives where they are now protected and made available actually for researchers, but in a way that protects the privacy of those who may still be living. And there are some people who are still living who were victims of that research.
NNAMDIGot to take a short break. When we come back we'll continue this conversation on the ethics of research with human subjects, and taking your calls at 800-433-8850. You can send email to email@example.com. Is technology outpacing our ideas about ethics and privacy in the sciences and medicine? 800-433-8850. I'm Kojo Nnamdi.
NNAMDIWelcome back to our conversation about the ethics of research with human subjects. We're talking with Kathy Hudson, deputy director for science, outreach and pat the National Institutes of Health. She also serves as chief of staff to the director of NIH. She is a molecular biologist by training and an expert on ethical issues around genetic technologies.
NNAMDIZachary Schrag is a Professor in the Department of History and Art History at George Mason University and author of "Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009." He writes the Institutional Review blog which explores how ethics rules effects researchers in the humanities.
NNAMDIAnd Jerry Menikoff is director of the office for Human Research Protections at the Department of Health and Human Services. Prior to his work within that department, he was the chair of a human subjects committee and hospital ethics committee at the University of Kansas Medical Center. We're taking your calls at 800-433-8850.
NNAMDIBefore I go to the phones, during the 1990s a small tribe of Native Americans in Arizona agreed to participate in a type 2 diabetes study at Arizona State University. More than 200 Havasupai Indians submitted blood samples to researchers who were interested in exploring the genetic origins of the disease. What they did not know was that the researchers would later use these same DNA profiles to study schizophrenia, a highly taboo subject in their tribe.
NNAMDIThey would also use the DNA sample to establish that the tribe came to the region from Asia, a story that conflicts with their beliefs that they came from the Grand Canyon. Their case triggered a lawsuit and settlement in 2010. In that case we saw different values and ethical judgment calls. Would the proposed rules change affect this kind of research, Jerry Menikoff?
MENIKOFFWell, in general that's actually one of the areas that the proposed rule change could have a lot of impact. And that -- the proposal is asking whether or not we shouldn't in fact strengthen our rules in terms of informed consent when we're doing research on bio specimens.
MENIKOFFAnd as current rules for example, all of us probably have, you know, some of our blood sitting in a freezer somewhere in a pathology lab due to clinical care. And under the current rules a researcher's allowed to do research for those studies as long as they're not given the name of that person or their identification. You could do research on those bio specimens without getting their consent. And we're proposing should we perhaps require consent in all those instances.
MENIKOFFSo we are certainly going out to the public on this issue and asking, you know, what about this? Is this a good direction to go in? And it's a complicated area because this is the sort of research that in many ways is certainly less risky than actually randomizing somebody to a new type of treatment in a clinical trial.
NNAMDII'd like to hear your view on this, Kathy Hudson, and yours, Zachary Schrag, but first you, Kathy Hudson.
HUDSONI think the tension here between progressing by medical research and asking people permission was really meaningfully demonstrated in the recent book by Rebecca Skloot, "The Immortal Life of Henrietta Lacks" in which a -- it tells the story of a black woman in Baltimore -- poor black woman in Baltimore whose samples were taken. And ended up those cells grew immortally, as the title says, and have been enormously valuable in research. And yet no one ever asked her, at least not to her memory or her family's memory, whether it was okay that her cells be used in research.
HUDSONAnd I think that asking permission is an enormously important way of showing respect. And that was one of the principles that came out of the initial commission that created the -- what we now call the common rule, was that we should have -- that respect for a person should be central to the participant researcher relationship. And so asking permission is very, very important.
SCHRAGWell, unfortunately if you read the proposed rule that they've come up with for this, it doesn't say bio specimens. It says bio specimens and data. So the same idea that you would ask people's permission to reuse their bio specimens could be applied to something like a survey. So if the Gallup organization calls up people and gets their opinions on the latest Republic debate and ten years later a political scientist wants to use that same data, well guess what? The rules for genetic material might now be applied to social science data.
SCHRAGAnd so this is why however good the intentions are, social scientists are very skeptical about the way these rules are being written. Because we've had 45 years of good intentions and they've produced some very unfortunate and unintended consequences.
NNAMDIHow would you address a situation like the one that Zachary Schrag just described, Jerry Menikoff? Or how could the rules address that situation?
MENIKOFFSure. And, I mean, the rules are actually -- at least what we're talking about possibly doing are more flexible than Professor Schrag notes. In terms of data consent rules would be applicable if, in fact, you need to use identifiers. And an easy way -- so often a social science researcher may not need to have the person's name when it's reused ten, twenty years down the road. In fact, probably in most instances they wouldn't.
MENIKOFFAnd secondly, one way to deal with this we -- our goal is to actually just make informed consent more robust. So one way to deal with it is when you first collect this data it could be a standard practice in the future to just let people know what's going to happen. Hey, we're collecting this data. We may use it for many, many other studies in the future. We're just warning you that we, in fact, will share it with all these other researchers including giving them perhaps your name and other identifying materials.
MENIKOFFIf people are okay with that then that should be fine. If they're not then that raises the question of well, perhaps then you're not being upfront in terms of telling them what you want to do in the first place.
NNAMDIHow clear can that be? Do I read all of the conditions every time I download an app about the things that I'm agreeing to before I click I agree?
SCHRAGYes. This is another problem that goes back through the decades. A lot of these rules again were originally written for research that would be funded by the federal government that's already going through a lot of standard procedures. Through NIH study groups or NSF or some of the other grand procedures where you've got all the paperwork down and the recordkeeping down and you just add a line and that's fine.
SCHRAGBut it would probably not only be impractical but probably unconstitutional to ask the Gallup organization to go through a standard script every time they collect these data. And I think it would be unpractical and very difficult to try to get every survey researcher in the country when you're doing oral scripts and asking people on the phone, may I talk to you, to then try to document exactly what the people said in reply.
SCHRAGSo a rule that works perfectly well for bio specimens may work extremely poorly for survey data or other kinds of information. And that's why, again, we're very skeptical of the attempts to standardize (unintelligible) .
NNAMDIWe have a lot of people who would like to join this conversation -- this conversation. So allow me to start with Adele (sp?) in Baltimore, Md. Adele, you're on the air. Go ahead, please.
ADELEYes. I had -- I want to thank the panel for all that effort in improving the system. I have advocated that there should be proportionality of strictness of the rules based on risks. For example, the current system really, it has, you know, many holes when it deals with children, the mentally ill or let's say returning soldiers with TBI. Whereas the research with surveys and oral history, they should be outright exempt.
ADELEIRB system did not -- was not created for sole purpose to be the only moral arbiter for all our ills in society. Just exempt them. And if they have missteps one in a hundred or one in a thousand let other organs of our society deal with it.
NNAMDIWhat do you think about that, Zachary Schrag?
SCHRAGThat sounds great to me, yes. One of the things to understand is just how odd the IRB system is. There are a lot of things that people can do wrong. In the academic world there's fabrication, there's falsification of data, there's plagiarism. People might grade their students unfairly. They might write unfair book reviews. There are all kinds of things people do that could hurt other people. And we don't say we're going to have a board instituted to make you explain what you're going to do in advance. Rather we wait for you to do something wrong and then we go catch you and we treat it appropriately.
NNAMDIIf however the something wrong is that you have revealed the identity of someone who wanted his or her identity protected, what remedy exists for that in the academic environment as we currently know it?
SCHRAGWell, you could have a disciplinary proceeding within the academy. You could have, I believe, a civil suit for damages if someone felt that their privacy had been invaded. So there are lots of post hoc remedies that one can imagine. And what we don't have is any evidence that the IRBs are particularly good at predicting these harms. So...
NNAMDIAre the IRBs any good at preventing these harms I guess is what my question would be? Because it seems to me that the whole point of I guess going over the rules again is to try to prevent. Kathy Hudson, care to comment?
HUDSONWell, I think it's a really important question. The level to which current IRB protections actually protect participants is a somewhat understudied area. And I would hope that as we put these new rules in place that we can actually try to measure how effective they are in protecting participants in research.
NNAMDIAdele, thank you very much for your call. We move on to Mike in Washington, D.C. Mike, your turn.
MIKEYes. How's everyone on "The Kojo Show" today? And Happy Holidays to you.
NNAMDISame to you.
MIKEOkay. In 1991, I was 17 and I was incarcerated for being in a robbery being at the place. What I wanted to ask about was, one, it was forced consent that I had to submit my DNA sample to the penal institution. And two, during the course of my time, I was told that I would receive good time if I participated in a research study, which actually the good time did not happen, so on and so forth.
MIKESo my two questions are in light of North Carolina's recent ethical challenges how was ethic supplied to places like the penal system where these people are forced to participate in DNA samples. And how can I find out what is being done with my DNA?
NNAMDIAre you referring to the eugenics and forced sterilization stuff that happened in North Carolina?
MIKEWell, because of that that presents the ethical challenge independent of the question that I'm asking. The question that I'm asking is because of the forced consent that I had to give my DNA because I was incarcerated...
MIKE...how do I find out what is happening to my DNA? And because of the challenges ethically that North Carolina has raised, I'm very concerned about what's going to happen with my DNA.
HUDSONSo I think there's two issues, Mike, that you're raising. One is what happened to your DNA and whether or not you can have any control over that. And the second one is the research participation and what sounds like potentially a coercion of research participation, which I will let my fellow panelists address who probably know more about research with prisoners than I do.
HUDSONIn terms of DNA collection from people who are either accused of or who are found guilty of specific crimes, the laws vary from state to state in terms of the DNA that is required or not. In most states where DNA is taken from minors the state law provides that the minor can request that that DNA be removed from the system. And what's happening now, of course, is with shared law enforcement databases that that DNA fingerprint can be shared across the state and across the country.
HUDSONAnd so people can find samples at other crime scenes and be able to match that or be able to even match that it's a relative of somebody who has provided a DNA sample. I believe in most states, but I'm not sure about North Carolina, whether or not you can get your sample withdrawn upon reaching maturity.
NNAMDIJerry Menikoff, can you talk about the course of aspect of this and...
MENIKOFFYeah. So, you know, in terms of, Mike, you're sort of being forced to be in a research study or inappropriately induced to be in a research study by their promising to give you time off, we actually have, at least in the federal side, regulations that are very, very protective of prisoners. And by and large it's -- I don't know the details again of what happened to you and whether or not in fact that study came under the federal rules. It could be that the federal rules don't apply. They don't apply to every single study.
MENIKOFFOne of the major triggers is, is it funded by the federal government. But if it was under the federal rules these protections are fairly robust and they're specifically designed to not put prisoners in the situation of having to volunteer for studies precisely because they'll get time...
NNAMDIMike, you don't know whether there was a federal study involved or not.
MIKEI definitely didn't get that level of detail.
NNAMDIOkay. Well, thank you very much for your call and for posing that issue. We move on now to John in Silver Spring, Md. John, you're on the air. Go ahead, please.
JOHNGood afternoon. Thanks for taking the call. It's been my privilege to have served on several institutional review boards over the years actually since 2002. And I'd like to possibly correct a couple of misunderstandings. One is that there's been an indication that the rules have never been revised since 1991, and that's just not correct. They've been constantly revised since 1991. The -- there is a concern expressed, though really never shown in any of the discussions, that the real problem are the federal rules.
JOHNWhat the problem is, as people like the professor and others relate their experiences, the real problem is is that the IRBs at the respected institutions, the IRBs that have a better view and insight into the professionals who are trying to bring research packages forward, have a better view of these researchers, and as a result know them better. And it's the IRB, not the federal rules, that are placing constraints on these researchers. In addition...
NNAMDIYou're saying that it's not the federal rules, John, that are placing the restraints, but the IRB, but at the same time you're saying the IRB has a quote/unquote "better view of these researchers" which seems to imply...
JOHNWell, it's the IRB -- the IRBs are at the institutions where the research is being done. It is composed often of researchers themselves from within the institution, and so as a result, it's the IRB that is placing constraints on the individuals. The federal rules apply across the entire country to all federally funded research.
NNAMDIOkay. I got your point and I'd like to put you on hold while I take a call from Will in Silver Spring, and have our panelists respond to both of you. Will, you are now on the air. Go ahead, please.
WILLHi there, Kojo. Thank you. I was project manager on quite a large number of medical research studies on tropical diseases in Papua, New Guinea up until about three years ago or so. So maybe what I'm going to be saying now no longer applies. Maybe they've actually -- the NIH in particular has made some changes to these, but a few points that I wanted to bring out from my 13 years in experience in doing that was number one, was that all of these human subjects rules seem to have been designed only for clinical or hospital setting studies.
WILLWhat we were doing was going out in rural areas and studying -- we were trying to, you know, get as many people as were willing in a whole region, you know, from a whole set of villages out there. And so all these rules were just totally onerous for trying to get the individual consent from, you know, several thousands of people. It wasn't like all these clinical trials where you're sitting in a clinic or a hospital. You've recruited a few -- few people with a specific disease, you come in, you meet them one by one anyway. So the rules that we had to follow were like logistically a nightmare.
NNAMDIOkay. And your second point?
WILLSecond point was very culturally inappropriate. These were all rules that were developed in the countries like the USA, maybe Japan, Europe some things. Like our particular setting a country like Papua, New Guinea, totally inappropriate. Like requiring actually written consent where we had to read a six-page document word for word and then, because they were illiterate and nobody knew how, you know, very few of them even knew how to sign their name, you know, having to just have them come down and put an X and then have somebody sign that they were witnessing on this. You know, if you were illiterate and overwhelmed with stuff that there's no way you're going to...
NNAMDIYou and John before you have raised pertinent issues, but we do have to take a break, so I'm going to put you on hold, and when we come back, Will and John, we will have all of our panelists address the issues that you raised. We still have a few lines open. You can call us at 800-433-8850 if you'd like to join this conversation on the ethics of research with human subjects. Should historians and anthropologists be subjected to the same review process as biomedical researchers? Call us, 800-433-8850. I'm Kojo Nnamdi.
NNAMDIWe're talking the ethics of research with human subjects with Zachary Schrag, professor in the Department of History and Art History at George Mason University. Kathy Hudson, deputy director for science outreach and policy at the National Institutes of Health, and Jerry Menikoff, director of the Office for Human Research Protections at the Department of Health and Human Services.
NNAMDIBefore we went to that break, we heard from John and Will who had a variety of issues having to do with this issue, and I'll start with John, since he was the last one we heard from, who was apparently a project manager for studies that were undertaken in Papua New Guinea, and I'll start with you Zachary Schrag.
SCHRAGOkay. So what Will I believe it was told us was a classic horror story to use a term of art, where an IRB imposes some rules that are simply inappropriate such as demanding written signed consent for a group of people who are generally not literate. And we've had horror stories all around the country in U.S.-sponsored research abroad, Dr. Hudson just told one in some terms. We can see it in criminology, we can see it in psychology, we can see it in behavioral economics, we can see it in history.
SCHRAGLots of IRBs making a lot of very poor decisions, and for decades now we've been told, well, that's really the individual IRBs fault. The regulations are just fine. To their great credit, the federal officials have finally come out with this proposal that I think more or less admits that the rules really are problematic, that many times they are quite vague, what is generalizable research, no one really knows.
SCHRAGFor example, what is harm to reputation? No one knows. So there are all these phrases in the rules that are very hard to understand and they've not been updated. If you want to see rules that are updated, you look to Canada where they put out their first set of rules in 1998, revised them twice, and then overhauled them completely in 2010, and since then have offered new interpretations of those rules.
SCHRAGSo a lot of scholars think that we need something more like the Canadian system where rather than just revising these rules every 20 years or every 30 rules we have an expert body of researchers composed of all the fields that are affected that will constantly be offering guidance instead of just haphazardly offering punishment which is pretty much the system we have now. I'd also like to see a system that balances freedom with the protection of human subjects.
MENIKOFFAnd so following up on this point, we're probably agreeing on some of this. We actually are going out there and trying to make the system more effective in particular in terms of doing different things to sort of social research versus other types of research clinical trials. And in terms of Will's point, particularly with regard to cultural issues, one of the questions in our proposal asked the public to comment on the issue of do we need sort of variations in the rules for informed consent and for different cultures, and we're very hopeful that we will eventually come up with a proposal that will look at that, that will say yes, if you're doing something New Guinea or wherever, and people don't like signing forms, that there's a way of documenting that people agree to be in a research without necessarily having them sign a written consent form. So we think it is a good thing that we'll be able to make these changes.
NNAMDIJerry Menikoff, you were one of the people who were critical of the system before you became involved with this process yourself.
MENIKOFFI was critical of the system, and in many ways I was critical of the system in fact on the flip side of things, than in terms of the riskier studies, in terms of clinical trials perhaps we could do a better job in terms of making sure people know what they're getting into when they're making a decision to be in those trials, and in fact, in terms of that sort of thing, I think we need to strengthen informed consent, and that's one of the powerful things we're asking about in terms of these changes.
MENIKOFFMaybe we could do a better job instead of having 10, 15, 20-page consent forms that are full of legalese that are often not very understandable, we could shorten them and get to the core pieces of information that a person really should be thinking about in terms of deciding to be in a trial.
NNAMDIWill, thank you very much for you call. Along the line of the last issue you raised, Jerry Menikoff, allow me to go to Michael in Laurel, Md. Michael, you're on the air, go ahead, please. Hi Michael, are you there?
MICHAELYes. Can you hear me now?
NNAMDIYes, we can.
MICHAELAll right. Yes. Along those exact lines, and you made the comment about the shrink wrap licensing as well, I have recently read a set of licenses called the creative comments that deals with photographs and whatnot, but more importantly they had also developed a human readable language -- not developed, you know, again brought up the idea of human readable language, and they take their licenses which are in some cases several pages long, but reduce them down to, you know, the crux of the matter, a few bullet points, a few simple-to-understand ideas that explain what you're agreeing to or what you have to agree to, and if you want to read to read the legalese, fine, but this is the crux of the matter here, to make it much simpler for people to consent in an informed manner.
NNAMDIIndeed, we got a tweet from (word?) who said, "I'm a cancer survivor, advocate, IRB member. There has been too little focus on the complexity of informed consent and impact on the patient." Kathy Hudson?
HUDSONWell, the critical issue is whether or not the person who is being asked to participate in research actually understands what they're being asked to do and what the risks and benefits of their participation are. And the complexity of the language that is used in informed consent forms, and the length of them is often -- stands in the way of that, and often the best way to make somebody follow along and understand what the consent is, is to have a conversation, and hopefully that happens around the legalistic consent forms that we have now.
HUDSONBut I think that in the proposed rules that we have put forward, we really are focusing on streamlining those consent forms and making them understandable. That's an area where research could certainly benefit us in understanding what is understandable to people in various research protocols.
NNAMDITrying to look at issues that we may not have discussed before. This is another tweet we got. "If parents of a child with cancer are asked to consent for treatment of this child and provide tissue for research, is this coercive?" Jerry Menikoff?
MENIKOFFIt needn't necessarily be coercive. I mean, it's the parents -- I guess the question is are they saying it's coercive vis-a-vis the parents or it is coercive perhaps vis-a-vis the child?
NNAMDIVis-a-vis the child I suspect.
MENIKOFFYeah. That's a difficult issue because if you say you can't do any research relating to children, I suspect we would all be losers, including the children. We make all sorts of decisions for our children, and the question is, do we have appropriate decision makers for the child, and in most instances parents are very reasonable decision makers for their children.
NNAMDIHere is Vidia here at American University in Washington D.C. Vidia, you're on the air. Go ahead, please.
VIDIAHi. Thank you very much for taking my call. I have one comment that is when we do international research -- field research, there are IRB protocols in those countries, and sometimes there are conflicts, especially if you're working on conflict areas. My question is, we do a lot of -- we encourage or master students, graduate students to do field research. If it's desk -- if it is classroom research, they don't really have to get IRB approval, but at the same time, if they need to publish it later, they are perhaps required to get approval.
VIDIASo how is -- that's always been a conflict with us. It has always led to confusion. So how to you deal with certain situations? Because IRB authority is also needed for student research, students who need to -- who want to publish later but is not quite sure as to whether they want to do it right now.
SCHRAGYes, exactly. The rules as they are written now are often arbitrary in odd ways. That again, the -- one of the lead questions is whether the research you're doing is designed to created generalizable knowledge, and no one really knows what that means. You put that question to four IRBs, you're gonna get four different answers. So one of the questions is about classroom research, and that's actually a disagreement from one agency to the next, despite the alleged common rule.
SCHRAGSo one opportunity here with the revision would not be to say we're going to have IRB review depending on whether it's classroom research or generalizable research, but rather, as Dr. Menikoff said, we're going to review things where the IRB does some good, and we're not going to review things where the IRBs can't really predict the risks very well and we're going to try to find other mechanism to protect people in those kinds of projects.
HUDSONCan I add something, Kojo?
NNAMDIPlease do, Kathy Hudson.
HUDSONSo Vidia raised the issue of students doing research, and I think it's important to note that those students need to be appropriately mentored and guided, but also that we need a process where those people can get permission to do human subjects research while they're still students, and not before they will have graduated and gone onto their careers. So it's important that we streamline this process in order to make it not take forever.
NNAMDIThank you very much for your call, Vidia. Will in Silver Spring called back to say one reason we had bad and legalistic implementation was we needed three different IRB approvals, a very long arduous process. How can I have input into the NIH process of trying to revise these rules for overseas studies? Do you make a distinction for overseas studies in the proposals that you're looking at, Jerry Menikoff?
MENIKOFFWell one of the things that the proposal is looking at is basically a study that takes place at many, many sites, and at least in terms of the domestic sites we're considering whether or not there should only perhaps be one IRB of record for all of those sites. The proposal would be a little more flexible in terms of the overseas sites, because the question there is that conditions may be substantially different than in the U.S. in terms of implementing informed consent rules and other requirements.
NNAMDIZachary Schrag, many forward thinking agencies are making their data available to the public over the web whether it's metro schedules or census data or crime statistics. Some of these information sources like the census or the American community are by definition human research projects. If we begin to put the same privacy restrictions on these outlets that we would put on scientific research, isn't there a danger that we would end up with less sunshine and less government transparency?
SCHRAGAbsolutely. And that's exactly the conversation that's been missing is a lot of the people such as some of the IRB chairs who -- or members who called in suggested that we need to protect subjects and that's that, when what we really need to do is some kind of balancing between human knowledge and freedom on the one side, and the protection of human research on the other. Now, there are a lot of ways to do that balancing appropriately. One is to strip out people's names but not necessarily their zip codes, which some versions of the proposals might do.
SCHRAGAnother with the census is we have a 72-year rule, where the manuscript census is locked up for 72 years and then historians get their hands on it and genealogists and all the rest. So some kind of sunset rule for these confidentiality procedures might be quite appropriate here as well.
NNAMDIWe're doing our Tech Tuesday segment tomorrow on interesting new open government projects at the local and state level and ongoing obstacles to open government, so you might want to tune in for that. We're running out of time, but I'd like to go to Barbara in Warrenton, Va. Barbara, you're on the air. Please make your question or comment brief.
BARBARAYes. I just felt that that one question was misunderstand about the consent from the parent for the child.
BARBARAI believe that they meant that the coercion was that the parents had to sign one form for both treatment and research.
BARBARASo they would feel that they had to commit to the research to accept the treatment.
NNAMDIHere's Kathy Hudson.
HUDSONSo the research rules would say that you cannot have treatment conditioned on agreement to participate in research. So if that were federally supported, that would be in violation of the rules. In no circumstance should good treatment be conditioned on participation and research.
NNAMDIThank you very much for your call, Barbara. Kathy Hudson is deputy director for science, outreach, and policy at the National Institutes of Health. She also serves as chief of staff to the director of NIH, Frances Collins. Jerry Menikoff is director of the Office for Human Research Protections at the Department of Health and Human Services, and Kathy Hudson and Jerry Menikoff, obviously this process is not yet finished. We're hoping that we can invite you back once it is.
MENIKOFFThat would be great.
NNAMDIAnd of course, Zachary Schrag, you too. He's a professor in the department of art -- history and art history at George Mason University, and author of "Ethical Imperialism: Institution Review Boards and the Social Studies 1965 to 2009." Zachary, thank you for joining us.
SCHRAGThank you, it's an honor.
NNAMDIAnd thank you all for listening. I'm Kojo Nnamdi.
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