Here is a draft of of my comments. I would appreciate comments on the comments prior to the deadline.
Dear Dr. Carome,
Thank you for the Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs, published in the Federal Register on July 1. I would like to offer some brief comments on this issue.
In tracing the debate over IRB review of the humanities and social sciences as it developed over the past forty years, I have yet to come across anyone who suggests that scholars should conduct research without first receiving training of some sort. The whole purpose of a university is to teach researchers to form their inquiries along lines that will produce the best results, in ethics as well as knowledge. When it comes to human subjects protections, the question is what form of training will produce those results. So far, two general models have been proposed, and I would like to offer a third.
One model demands that every university researcher, regardless of her scholarly discipline or her subject of study, complete a basic, online course in medical ethics and regulatory compliance. The CITI Program, founded by a medical researcher and a medical research administrator, exemplifies this approach. The CITI Program has the great virtue of administrative convenience. A university research office can, in a single memo, declare that all investigators must complete the program, and it can easily monitor that they have done so. But it is not clear that such mandates serve the cause of ethics, particularly when researchers are not conducting medical or psychological experiments. While the program makes efforts at including non-biomedical perspectives, the sections on such disciplines as oral history and anthropology are written by people with no expertise in those fields. The result is that much of the material in those sections is irrelevant, inaccurate, or highly dubious in its interpretations. Such programs also reduce complex ethical problems to simplistic statements to be chosen on a multiple-choice test. While I cannot offer published citations or hard data, I know anecdotally that the requirement to complete such training breeds contempt for the whole review process in many researchers.
In 2002, the Social and Behavioral Sciences Working Group on Human Research Protections pioneered an alternative approach. Rather than preparing the same curriculum for all fields, it devised reading lists specific to each discipline. For example, materials prepared for the American Sociological Association included that association's code of ethics and essays written by sociologists (see http://www.aera.net/humansubjects/courses/asa_notebook.htm). Scholars asked to complete such training are likely to take it far more seriously than a program whose medical origins cannot be disguised. On the other hand, devising a single training regime for an entire discipline will still subject some researchers to a great deal of irrelevant material. For example, an ethnographer may not need nuanced instructions on forming survey questions, nor a survey researcher instructions about participant observation.
Finally, I would like to propose a third model that goes beyond the Working Group's approach. When scholars describe the training that most influenced their ethical decisions, they are less likely to cite general codes and principles than the work of other researchers who faced very similar challenges. Criminologist Michael Rowe put this very well in his essay, "Tripping Over Molehills: Ethics and the Ethnography of Police Work," International Journal of Social Research Methodology 10 (February 2007): 37-48. Rowe wrote,
It is the nature of ethnographic research that the principles contained in methodological textbooks or professional codes of conduct will be stretched and perhaps distorted as they are applied in dynamic situations. Since policing is unpredictable, the ethical dilemmas police researchers might face cannot be easily anticipated . . . If an absolute code of ethics is not feasible, researchers must be prepared to be reflexive in terms of ethical dilemmas and the methodological difficulties experienced in securing informed consent and meaningful access to research subjects. (48)
The best preparation for observing police work, he explains, is reading other accounts of observing police work. I believe this emphasis on specificity would hold true for most qualitative research (and a great deal of quantitative work as well).
I would suggest, then, that rather than impose universal, top-down training like the CITI Program, or even more specific top-down training like the Working Group curricula, OHRP empower researchers to devise their own ethical reading lists of materials most relevant to their work, just as they choose their own methodological models. A researcher seeking IRB certification could present an annotated bibliography, showing that he had investigated the problems he was most likely to encounter and the ways that other scholars had dealt with those problems. Researchers should also be able to use courses and seminars they have completed as evidence of their prepraration.
I assume the goal of any training requirement would be to get researchers to think seriously about the ethical problems they will face. Asking them to research those problems themselves will be far more effective than any multiple-choice test.