Tuesday, December 12, 2006

Introduction

In 1974, Congress passed the National Research Act. This act required researchers in biomedical or behavioral fields who received federal funds and who conducted experiments on humans to submit their work to the oversight of “institutional review boards,” or IRBs. These boards, established by universities, hospitals, and other institutions, were required to judge the ethics of a project before it could proceed. This step, Congress hoped, would prevent researchers from denying treatment to or otherwise harming the people who participated in their studies.

At some point (and I hope to learn more about this history), university IRBs around the nation began insisting that researchers in the humanities and social sciences also submit their projects for review. Ever since, many of those scholars have questioned the legality and wisdom of these demands. This blog is designed to inform the debate over IRBs by collecting breaking news, commentary, and background information on the subject.

I first became interested in this issue in July 2000. I had received a grant from the National Science Foundation to support my dissertation on the history of the Washington Metro. The grant required that if I involved human subjects in my research, I had to get approval from my university IRB. Since the definition of human subjects research seemed to include the oral-history interviews I was conducting, I accordingly gained approval for my research from Columbia University’s Human Subjects Research Committee. I kept that approval active until I had completed my research, which has now been published as The Great Society Subway: A History of the Washington Metro (Johns Hopkins University Press). More recently, I gained the approval of George Mason University’s Human Subjects Research Board for a series of interviews on the history of riot control.

At neither university did the review process do much to aid my research, and, on the whole, I consider the applications to have been a poor use of my time and that of the staff doing the review. Based on my own experience and that of other scholars, I am skeptical of the application of IRB oversight to non-experimental research. On the other hand, I do believe that historians and perhaps other scholars in the humanities and social sciences could learn from IRBs’ practices of mandatory training, careful documentation, and the review of consent forms. I therefore hope to find ways in which scholars in the humanities and social sciences can learn from IRB practices without being subjected to standards and practices never meant for them.

5 comments:

Christopher Tassava said...

Zach -

I just found this blog (perhaps via the AHA's blog; I forget the provenance), and I'm enjoying it.

Though I'm not presently conducting any research which might necessitate IRB approval, I am serving on the IRB at Carleton College by dint of my administrative position here. The work is quite engrossing, but we have come across some situations where the oral history/interview line is at least within sight, if not actually crossed.

This blog will be a useful way to stay informed. Thank you for starting and maintaining it.

Christopher Tassava

David Hunter said...

Zach I likewise just found this blog, and sitting on the other side of the fence (I sit on three research ethics committees which is what we call them in the UK) I'm finding it fascinating to read. I'm personally of the view that all research ought to have some ethics review, and the best form of that review is via a research ethics committee. I agree this will often be a waste of time for the researcher, since often, barring perhaps minor problems with the information sheet there is no real problems with their research. Nonetheless I have seen several social science research applications where the research would have been genuinely unethical if it had been carried out. I'm curious, how would you protect against this research being carried out?

Zachary M. Schrag said...

Thanks for your message.

A good alternative to IRB review is departmental review. This gives researchers the chance to have their projects judged by the ethical standards of their discipline, rather than those of some other social science or, worse, of medical research.

For elaboration of this point, please see my essay, "Ethical Training for Oral Historians," as well as the following posts:

* In Search of Expertise

*Why IRBs Are Not Peer Review: A Reply to E. Taylor...

*My Problem with Anthropologists

You write, "I have seen several social science research applications where the research would have been genuinely unethical if it had been carried out." I would be very interested to learn more about these.

Best,

ZMS

David Hunter said...

I'd disagree on departmental review being best for two reasons.
1. While a committee which has some knowledge and expertise in the area of the project, too much expertise and it becomes too close to the subject matter. This can mean that it misses significant ethical issues because they are standard practice within a specific discipline. To give one example, psychologists often want to give part of their students grade (10%) for being involved in their research. Most RECs I am involved in don't allow this practice because it is felt it is unduely coercive. I imagine if a REC/IRB was entirely composed of psychologists they may disagree.

2. It is important for a REC to be substantially independent from the researcher, but this doesn't happen in departmental review, instead the REC has an interest in the research being let to go ahead.

My university presently runs on a departmental review model, and while I can't name names I have personally seen examples of both of the above issues coming up.

I've written about these problems here:
Hunter, D. 'An alternative model for research ethics review at UK universities' Research Ethics Review. (2006) Vol 2, No 2, 47-51.
(Which unfortunately isn't available online)

and here: Hunter, D. 'Proportional Ethical Review and the Identification of Ethical Issues Journal of Medical Ethics. (2007);33:241-245.

I certainly agree with you that IRBs shouldn't be dominated by medics and medical concerns, they instead should have a wide range of representation. I'm inclined to think though that the baseline ethical issues are similar and while different rules may be appropriate for different disciplines they flow out of the same background.

In terms of examples here are a few, I can't be too specific with details for reasons of confidentiality.

1. Study of sexual attitudes in school children. Asked very probing questions as one might expect, but didn't intend to get parental consent to carry out the research a parallel can be found here: India Research Ethics Scandal: Students made guinea pigs in sex study
No consideration had been given to what might have been done if there was disclosure of harmful behaviour etc.

2. Historian was going to civil war stricken country to interview dissidents about the war, intended to publish identifying comments (without getting consent for this) which were likely to be highly critical of the current regime.

3. Social scientist wanted to understand children's attitudes towards a particular topic. As a blind so that the participant would not know the questions they wanted to answers to, they proposed to use the becks depression index. This contains questions about self harm, future worth and was potentially very distressing, not at all appropriate as a blind.

4. Student wished to conduct interviews with employees of a company on an issue that could significantly damage the companies profitability. No consideration was given to how to best report this information to minimise harm to the company.

I'm inclined to think that any sort of research involving humans can lead to harm whether that is physical, social, financial, psychological or so on. As such the benefits and the risks need to be balanced, and it needs to be considered how to minimise that harm. That I take it is the job of the researcher. However, having sat on RECs for a while it is a job that sometimes the researchers fail at spectacularly, then it becomes the job of the IRB/REC. The difficulty is how, without full review by a properly constituted REC, do you identify those applications that have serious ethical issues?

Zachary M. Schrag said...

Thanks for these examples. I have replied to them in a new posting: IRBs vs. Departmental Review.

Zach