>I am currently in the middle of multiple IRB "issues", to put it mildly >(as current IRB chair on a campus where we are trying to make our IRB >policies a bit more current). The recent list discussion on IRB issues >has opened my eyes to the number of IRB committee members and chairs >lurking around on the list. > >In 45 CFR 46 the definition of "research" indicates that it must be >"generalizable knowledge." Could someone please explain how your IRB >defines this term? > >Thanks, > >Rob
Rob, I think this definition must be taken within the context in which it appears; "(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." In general, we have interpreted this to mean research activity intended for publication or dissemination at professional conferences. Research activities conducted as part of a course requirement intended to teach students how to do research without dissemination beyond the course would not appear to meet the above definition. In general, we would expect the course instructor to provide appropriate oversight of such activity with IRB folks available for consult if the instructor had ethical questions or concerns. I would also expect the department chair/head of a program requiring student research activity to be aware of all such activity (if only through review and familiarity with all course syllabi) and bear some responsibility for what is going on within a department. We have struggled some with such activity (as I suspect have others) since it is often not clear whether the intent of the activity is strictly pedagogical or crosses over as "research designed to contribute to generalized knowledge" (e.g. to possibly be disseminated at student research conferences and/or published in non-reviewed student journals). But, even here one could reasonably argue that the dissemination activity by students is primarily pedagogical to educate students about the mechanisms of scientific discourse rather than to "contribute to the general knowledge base". Such calls are indeed fuzzy and we have generally tried to look at the primary "intent" of the activity. As such,research projects intended for dissemination, including independent study and supervised research activity by students, have typically been subject to IRB review on our campus. Since graduate theses and dissertations are indeed intended to contribute to the "knowledge base" of a discipline, they would meet the above definition and are subject to IRB review. I also believe that the above definition would exclude "in-house research" on a campus conducted solely for institutional purposes (e.g. faculty/staff salary data, alumni surveys, advising/retention data, enrollment management, student/faculty/staff satisfaction with services, program evaluations, etc.) given such information is not disseminated at conferences nor intended for publication to contribute to the "general knowledge" base (e.g. public information about effective advising strategies, student career decision making, effective assessment models, etc. based on or supported by data collected on a campus). Quite often however, research conducted "in-house" on a campus primarily to assess or enhance that particular academy's programs is also presented "off campus" at conferences of Higher Ed Administration. I believe such research would then meet the above definition and be subject to IRB review. A fuzzy area here is when such research is not designed to contribute to the general database (i.e., to be be drawn upon or referenced by others to develop general principles or strategies for higher education administration) but is nevertheless available on that academy's website for inspection or use by anyone with a pc. If institutional data are archived on an open website, does it contribute to a "generalized knowledge database"? We have yet to tackle that question. I hope this helps. I would be interested in hearing how others deal with all of the fuzzy stuff as well. George -- George D. Goedel Professor & Chairperson Department of Psychology Northern Kentucky University Highland Hts., KY 41099-2000 (859) 572-5574 fax (859) 572-6085 [EMAIL PROTECTED] --- You are currently subscribed to tips as: [EMAIL PROTECTED] To unsubscribe send a blank email to [EMAIL PROTECTED]
