What's the Problem with the IRB?

I've been putting this post off for well over a year, and today, I'm finally getting it out of the way. This will likely be my final post on the topic. I was prompted to revisit the issue after reading this very friendly post from Contexts. This is my take on the problems with the IRB.

Overall, I would argue that IRB's generally do admirably, especially given their circumstances. That's not to say that they are perfect, however. Most importantly, those problems that do exist for IRB's do so simultaneously and interdependently at several different levels. Here are my notes on those:

• Institutional

• The federal government created IRB's, requires that institutions accepting federal funds adopt them, and sets the rules by which they function. It has long been agreed that the federal guidelines are based on biomedical ethical concerns that do not apply to social scientific research (which has exacerbated the cultural and interpersonal issues listed below). Fixes are in the works, but change comes slow through such bureaucracy.
• As the local and public face of the IRB, the IRB chair often becomes the punching bag for those who for whatever reason do not acknowledge the larger constraints that are in place. The IRB chair is the concrete end of an abstract labyrinth.

• Organizational

• My employing institution, and as I understand it most institutions, chronically under-resources our IRB. Here is a short list of some specifics:
• Our IRB has no support staff. All of the administrative work was handled by the chair, and all of the reviews were performed by faculty doing voluntary service.
• Our IRB had no annual budget. That is not to say that the university didn't spend money; it did, on things like a submission system and a small stipend for the chair, but financing was a hidden issue over which the IRB had no authority.
• Our administration only allowed for inadequate course release for the chair, granting only a single course release for an entire academic year.
• Our administration only granted a woefully inadequate stipend for the chair in comparison to the additional work requirements.
• This isn't necessarily about resources (perhaps as human or social capital), but our university was willing to allow a faculty member without tenure (i.e. moi) to serve as chair, a problem for many reason that I won't take up here.

• Cultural

• Academics as a group generally neither respect the need for IRB's nor understand how they function. I think this is partly a function of the type of person who selects into the academe, but mostly, the blame here lies with a failure of graduate programs working with human subjects to adequately train future faculty in the history and ethics of human subjects research. (This hostile culture unarguably exacerbates the interpersonal issues below.)

• Interpersonal

• There are difficult people in the world, and they are over-represented among academics. There are many among us with inflated yet fragile egos.
• internal
• Though the decided minority, IRB members themselves can be surprisingly quite difficult. One can often ignore outside agitators, but it's not as easy to deal with internal contention.
• external
• Every institution has a handful of problem children who are consistently and predictably difficult to deal with. I recall an email exchange with one researcher who complained that the review of his protocol was taking too long, and this was only a week after having submitted his application. When I politely informed him that our IRB had a turnaround time that was on par with peer IRB's, he scolded me and said that our goal should be to be better than our peers. It is said that you can please all of the people some of the time and some of the people all of the time, but in my experience, there are some people who refused to be pleased in this life.

IRB Chair Extraordinaire

So, today I begin my tenure as the chair of our college's IRB. I've written before on IRB's (here and here). Orgtheory has quite a bit on IRB's that's worth checking out as well. In general, I think it is safe to say that social scientists, and likely researchers of virtually all ilks, do an unfair amount of kvetching and gnashing of teeth about IRB's and human subjects committees. I've starting brainstorming about ways to alleviate the causes of the frustration that many of us, including me, experience with the IRB process. So far, I can see two places for improvement. First, most reviews that spend a prolonged amount of time in the machine do so because researchers inadvertently leave out requirements (e.g. supervisor approvals), fail to attach important documents (e.g. informed consent forms), or fail to provide enough detail about their protocol. A little more attention to detail at the front end can dramatically reduce the time to approval. Second, reviewers need to be regularly reminded to be mindful of the level of risk involved in proposed research. Clarification and revision is often unnecessary when it is clear that the protocol will only pose minimal risks to human subjects. We reviewers can often and easily lose sight of our purpose in the haze of our own institutional bureaucracy. I'm going to try to make these points-of-emphasis early in my stint as chair. I'll report back on how it all goes.

A Guiding IRB Principle

Just a quick post today. This IRB chairship is really dominating what passed for discretionary time in previous semesters.

The sole and primary purpose of the IRB is to protect human subjects. Full stop.

An important secondary concern, though, should always be for the IRB to ensure the legitimacy of its own authority within the university by not inflicting undue burdens on researchers that slow the review process unnecessarily. If researchers perceive the IRB as a bureaucratic roadblock instead of as an ethical champion, they are less likely to abide the IRB and its policies, and this has the potential to directly constrain that sole, primary purpose: to protect human subjects.

I don't pretend yet to have an answer to this conundrum, but I think it's a place to begin any discussion.

Pulling Back the Curtain on IRB's

I returned today from an extended weekend of travel. Late last week, I attended a national conference for IRB leaders in Atlanta. (I am the chair-elect of our IRB at Georgia College.) The conference was illuminating in two ways, one generally positive, the other not so much.

First, I heard a few presentations from a representative of the Office for Human Research Protections (OHRP) that were very informative. For example, I now better understand the federal regulations regarding informed consent and when it can be waived. These folks take their work very seriously, and their website really should get a lot more traffic from any sociologist engaging in human subjects research.

Second, however, there was a serious lack of understanding among virtually all of the attendees, presenters, and organizers about the social/behavioral sciences and a general lack of social awareness. As far as I could gather, I was one of only two attendees (out of approximately 50) who was not a bioethicist or in some way attached to a bio-medical IRB. While social research issues did occasionally come up, there was a general dismissiveness of the possible risks associated with such methods. (In some ways, this is understandable for a group of people used to discussing whether or not it is OK to inject a person with potentially lethal substances. As sociologists, afterall, there is no risk of someone bleeding out on the table as there is for those who do medical research, but social risk is nonetheless real and can destroy lives.) On the other hand, the only session specifically on a social research method was presented by a bioethicist with zero firsthand experience in social research methods. The session attempted to tackle social media research (e.g. on Facebook), but all of the discussion and conclusions were woefully behind-the-times. The example we focused on was a researcher hoping to covertly join an online chat room (Do these even still exist?) for cutters. Correctly, several in the audience questioned whether there was a method short of deception that could elicit the same results. Incorrectly, though, they all agreed very quickly that there was. "Why not just interview them?" Practices like cutting are wrought with stigma and are highly deviant. There is a strong argument to be made that deception is necessary and warranted. It's also very difficult to take a presenter seriously who mistakenly calls MySpace "MySite."


Oh, and did you know that instead of including women on an IRB committee it is acceptable to substitute a male OB/GYN because he has an understanding of women's issues and experiences? That was one suggestion in the discussion of a mock IRB on stem cell research in which the organizer failed to include any women.

More on all this soon.

Why I Stepped Down as IRB Chair

After a year at the helm, I stepped down as the IRB chair at my college at the beginning of this semester. I initially and enthusiastically agreed to serve as IRB chair when first asked, as I saw it as an opportunity to serve my university using my unique expertise in research methodology and ethics. While I would be remiss if I did not admit that I also saw it as an opportunity to help my bid for tenure and to raise my status on campus, I lost any illusions of a leadership role on campus two weeks after starting my first job out of grad school, seeing the problems posed by and to administrators. Within weeks of taking over as IRB chair, I learned that the position was not one that required much academic knowledge but instead called for an impossible balance of interpersonal diplomacy and personal fortitude. Being an IRB chair is more about managing the expectations of one's colleagues than anything else. (I plan to detail these issues in upcoming posts.) The IRB, it turns out, is one of academics favorite punching bags, and the chair is the public face of an invisible and misunderstood bureaucracy. As the stress of dealing with difficult colleagues mounted, I came slowly to the realization that I was unwilling to accept dutifully the anxiety that this manifested.

I think that the situation could be framed in two ways. First, one can choose to see this as a personal failing on my part. I simply was not up to the challenge. As the saying goes, if you can't stand the heat, get your ass out of the kitchen. Second, one could instead choose to see this as an issue of cultural and institutional dysfunction, of social structure creating an unreasonable challenge. If you can't stand the heat, perhaps the kitchen has been designed in a way that is not conducive to productivity. (I plan to detail these issues in upcoming posts as well.) While I must admit that there is a chance that I am just individually ill-suited to such a role, ignoring cultural and institutional dysfunction is deleterious. More to come.

IRB Comments on Methodology

The primary purpose of the human subjects committee is to protect the people whom we are studying. It is that simple. (While it is not our intention and should certainly not be our concern, by protecting subjects, we also shield the university from litigation.) Among the things that we need to ensure are the following: all human subjects who are part of research done at or in conjunction with a given institution must consent to participate, must have the ability to refuse to participate and to withdraw their participation, can expect that they will not be exposed to unreasonable risks, and can expect that their identity will be protected as either anonymous or confidential.

Beyond that, it is not the IRB's job to ensure that the research that we review is good research. It should be the policy of IRB's that we should not critique our colleagues' methods. While it can sometimes be tempting to do so, it is problematic for several reasons. First, the IRB is a black box so any animosity that a researcher harbors for her reviewer gets transferred to the board. We do ourselves--and ultimately would-be human subjects--no favors by garnering the contempt of our peers. IRB's are despised enough without us further fanning the flames. Second, we are busy people with competing demands; unsolicited methodological critique should not be another. Finally, we have a duty to be good neighbors. We must respect the training, intelligence, and expertise of our colleagues, and in the case of student research, we must respect the abilities of the student's faculty adviser. Unless you are asked directly for your scholarly opinion, do not give it. Peer reviewers for conferences, university presses, and academic journals as well as annual faculty evaluation committees, department chairs, and tenure and promotion committees are more appropriate bodies for the review of faculty research.

That said, there are some circumstances under which poor research design may spill over into our commission to oversee the ethics of that research. For example, imagine a protocol that proposes to stick subjects with needles to gauge their favorite color. This research design is flawed since it would not be testing what it claimed to be, but since the subjects are being exposed to pain and an increased risk of infection and because the research design is flawed, the pain and risk would be pointless. In other words, the study could be conducted in a less invasive manner with equal or better results. However, not all methodological errors are equally dangerous. A question on a survey that asks, "What is your favorite color? (a) blue (b) bright (c) dull (d) green," might be poorly written but, because it does not expose the participant to any additional risk, it falls outside of our purview.

Southerns 2013

I'll be heading over to the Annual Meeting of the Southern Sociological Society so posting will be limited this week. I will be presenting with my coauthors at 4:00 PM on Thursday in the Fairlie room. Here is our abstract:

The "War on Christmas": Teaching about Christian Privilege

Scholars have begun to recognize a “Christian privilege” (CP) in the vein of “white privilege,” which McIntosh (1988) famously described as being “like an invisible weightless knapsack of special provisions, assurances, tools, maps, guides, codebooks, passports, visas, clothes, compass, emergency gear, and blank checks” (1-2). Blumenfeld (2006) defines CP as the:

…seemingly invisible, unearned, and largely unacknowledged array of benefits accorded to Christians. … This system of benefits confers dominance on Christians while subordinating members of other faith communities as well as non-believers. These systemic inequities are pervasive throughout the society. They are encoded into the individual’s consciousness and woven into the fabric of our social institutions, resulting in a stratified social order privileging dominant (“agent”) groups while restring and disempowering subordinate (“target”) groups… (195).

Several scholars (e.g. Schlosser 2003 and Goodman and Seifert 2010) have constructed lists of CP in line with McIntosh’s list of white privileges. Christians, irrespective to their specific religious practice or tradition, are indiscriminately privileged, just as even the most progressive of whites and men are advantaged by white and male privileges (Clark 2006). Christians can problematically ignore or deny their CP because they have never experienced the oppression that is levied against non-Christians (Schlosser 2003). Further entrenching CP is the supposed diversity of religion in the U.S., which tends to mask the hegemonic force exerted by Protestant Christianity; the assumption of pluralism in fact allows Protestant hegemony to marginalize religions that are not “normal” (Beaman 2003).

To teach this concept to students, we developed an in-class debate about the “War on Christmas” and holiday expressions (“happy holidays” vs. “Merry Christmas,” neutral winter displays vs. religious displays, etc.).

In the exercise, students are told they represent a community group meeting to decide if local businesses should be neutral on holiday greetings. They are divided up to represent different perspectives. The first group is instructed to argue the belief that “happy holidays” and neutral displays represent political correctness gone too far, and that these emphases focus too much on semantics. The second group is to argue that neutral greetings/displays represent inclusiveness of diverse religious backgrounds. Optionally, a third group can argue that the push for neutrality is “reverse discrimination” against Christians.

A debriefing discussion includes if a Christian offended by “happy holidays” is equivalent to a non-Christian offended by “Merry Christmas.” The instructor then addresses the concept of Christian privilege: the idea that “Merry Christmas” or other Christian displays may be intended as neutral is used to demonstrate the pervasiveness of Christianity and the privilege of being in a dominant group. Anonymous polls measure students’ own experiences with Christian privilege.

This exercise can be used in introductory classes or courses on religion, politics, or inequality, related to conversations about the separation of church and state, political correctness, pluralism, and privilege. As researchers in the South, we examine Christian privilege where Christianity is often the norm and taken for granted. Pending IRB-approval, we will implement this exercise in a range of introductory courses across our institutions.

Drop me a line if you'd like to meet up for a beer.

Offline for a While

Heading to Atlanta for a couple days for an IRB conference. Then, I'm off to Los Angeles for a few days to meet my baby niece for the first time. Posting will be limited, if existent, until Tuesday at the earliest.