Tuesday, June 26, 2007

The University and the IRB

The last two months have been illustrative of why people become frustrated with universities. As with any large organization, bureaucracy starts to get in the way of any work. This is usually the result of no one wanting to break any rules or in any other way get "in trouble" with whatever mysterious powers are in charge.

I have been awarded a summer fellowship. That's a good thing. Unfortunately, this also required submitting my research proposal to the Institutional Review Board (IRB), a beast created to protect individual research subjects from exploitation. If you do a basic Web search on IRB and abuses there is a sad trend towards the ridiculous that is being fought by students and professors.

The following is an excerpt from an editorial on IRB "mission creep" and how it affects those of us in the humanities.

Science 9 June 2006: Vol. 312. no. 5779, p. 1441

Mission Creep in the IRB World
C. K. Gunsalus, Edward M. Bruner, Nicholas C. Burbules, Leon Dash, Matthew Finkin, Joseph P. Goldberg, William T. Greenough, Gregory A. Miller, and Michael G. Pratt

The system in the United States for protecting human participants in research engages the earnest efforts of thousands of scientists, community volunteers, and administrators. Through untold hours of service on Institutional Review Boards (IRBs), they watch over the safety of human research subjects. Unfortunately, much of that effort is increasingly misdirected as the system succumbs to "mission creep" that could compromise its central goals. Our IRB system is endangered by excessive paperwork and expanding obligations to oversee work that poses little risk to subjects. The result is that we have simultaneous overregulation and underprotection.

IRBs were established after the 1979 Belmont Report from the Department of Health, Education, and Welfare, with the goal of protecting human subjects involved in potentially risky medical and behavioral research. But IRBs' burdens have grown to include studies involving interviews, journalism, secondary use of public-use data, and similar activities that others conduct regularly without oversight. Most of these activities involve minimal risks--surely less than those faced during a standard physical or psychological examination, the metric for everyday risk in the federal regulations. And IRBs are pressured to review an expanding range of issues from research design and conflicts of interest to patient privacy. These are beyond the scope of research protection and are best left to others.

The IRB system is being overwhelmed by a focus on procedures and documentation at the expense of thoughtful consideration of the difficult ethical questions surrounding the welfare of human subjects, especially as complex clinical trials burgeon. Their work is afflicted by unclear definitions of terms such as "risk," "harm," and "research." Because ethical behavior is difficult to measure, many IRBs rely on stylized documentation over substantive review, out of concern that one case in a thousand could slip through and generate bad publicity or penalties, or potentially shut down research. The result is that many protocols receive exaggerated review, and the paper piles up. Society loses as potentially productive research is discouraged or self-censored.

Ironically, this obsession with paperwork and mechanical monitoring may undermine protection of human subjects. IRB members spend too much time editing documents, marking typos, and asking for more details. One researcher, 10 years into a longitudinal study, was asked by an IRB to remove the term "anemia" from consent forms because participants might not understand it. Such actions, about which we hear frequently, carry a serious risk: They reduce trust in the guidance of IRBs and may alienate some researchers enough to turn them into scofflaws.

I submitted a basic survey on Internet usage to the IRB in mid-May. The survey should have been classified as "exempt" in my opinion. How dangerous is it to ask people if they use a "social networking" Web site or play online games? Clearly, the risks are minimal! (Non-existent, unless you are an IRB committee member?)

My initial IRB request was rejected with a "stipulation letter" demanding I clarify how the identities of survey participants will be protected. It is absurd to think that people with Web sites and online gaming profiles want or need their identities protected. I'm sorry, but it you are online you aren't anonymous without an extreme effort. Plus, the survey doesn't ask for Web addresses or online "screen names."

It was exactly one month between the date I submitted my survey to the IRB and when I received approval to conduct the survey. That's not a lot of time, but it is silly that a basic survey couldn't be approved in a week. Seriously, I don't even think the IRB needed to be involved. If I were a journalist or writer working alone, I don't think anyone would expect me to run the questions by psychologists and lawyers. Then again, maybe a newspaper or broadcast outlet would be just as cautious as the university.
By the time the process was completed, I had submitted three versions of my paperwork. I had to get a department adviser to approve my research, which had already been endorsed by a college dean within the university. I printed 40 pages of paperwork for a survey that won't require half that many pages, and will probably be completed in two or three days.

There's more on the university.... and how frustrating it can be. Oh, well. At least I'm not alone and it isn't a rare problem. I've received dozens of supportive comments after dealing with this process.