Tuesday, August 14, 2007

Evolving Research

Two recent blog postings raise the question of the awkward fit between IRBs' insistence on protocol review and research, such as ethnography and oral history, which begins with no set protocol.

University of Winnipeg professor of politics Christopher Leo poses and then answers positively the question, "Does the Ethics Bureaucracy Pose a Threat to Critical Research?" This provocative essay raises so many key questions that I plan to return to it in future postings. For now, note Leo's description about the evolving nature of his work:

Many researchers concerned with politics and policy stay in regular touch with politicians and public servants and, in the process, ask them questions the answers to which may well be used in future publications. That is an essential part of the research process because regular contact with well-informed people makes it possible for researchers to stay abreast of events and identify important issues as they arise.

So when does a query become a research question and a conversation an interview that requires ethics review? The guidelines are little help in answering that question, but, if we take them literally, they would appear to have taken from university researchers a right that every ordinary citizen enjoys, namely that of picking up the phone and talking to a politician or public servant without applying for bureaucratic permission to do so.

Meanwhile, over at Savage Minds, Alex Golub, assistant professor of anthropology at the University of Hawai’i Manoa (aka Rex), touches on the same question in the posting, "Using informed consent forms in fieldwork." He writes, "In some cases I interviewed people I’d known for years. I’d have breakfast or lunch with them and then schedule the official ‘interview’ for later on in the week."

IRBs that rigidly follow a biomedical model for ethics may insist that research protocols be spelled out in advance--even demanding sample questions. Such demands are inappropriate for the kind of work described by Leo and Golub: keeping in touch with knowledgeable people over a period of time.

An alternative appears in the University of Pennsylvania's Policy Regarding Human Subject Research in the Sociobehavioral Sciences. That policy accommodates such projects by freeing researchers from the requirement to submit "a fixed research protocol":

Evolving Research

Evolving research is a class of research in the sociobehavioral sciences in which the questions that are posed evolve in the course of investigation. An example is ethnography, where research questions may only be clarified after a period of observation and where current findings drive the next steps in the study. This class of research typically involves studying human behavior in non experimental settings, with or without active participation by the investigator; but it can also occur in more structured observational settings (e.g., oral histories, focus groups). In specific cases, such research does not pose more than minimal risk to human subjects and is considered to be “exempt from review,” as stated below. An approved mechanism is necessary for presenting to the IRB a research protocol that will evolve in the course of investigation. This policy institutes such a mechanism via certification.

4a. Research involving only non-interventionist observation of behavior occurring in public (including domains of the Internet clearly intended to be publicly accessible), for which no identifying information is recorded, is exempt from review.

4b. Investigators are allowed to use their certification, as per policy item 1, as a reference for describing evolving research activities to the IRB in lieu of a fixed research protocol.

This policy eliminates the need for investigators doing evolving research to spell out the details of a dynamic research protocol. The IRB can be assured that the research will be conducted in an ethically appropriate fashion, with full protection of human subjects, when certified investigators attest that their pre-registered research plan will be conducted within the ethical framework laid out in the training program for which they are certified.

In other words, if you have shown you know what you are doing, you don't have to get the IRB's approval for specific questions or topics.

I must note, however, that the Penn policy includes this disclaimer: "Note that different studies by the same investigator(s) must be submitted to the IRB as separate research protocols. These must not be viewed as a single study evolving from one investigation into another." I wonder what the Penn IRB would do with someone like Leo or Golub, who has the audacity to keep in touch with people for years.

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