Using Students as Educational Research Subjects

Clinical Laboratory Science, Spring 2004 by Goodyear, Nancy

Many clinical laboratory science (CLS) educators are involved with educational research, which frequently involves data, such as students' opinions, information from student records, or information about student performance before and after a curriculum change. This kind of research may be subject to Federal human subjects regulations and Institutional Review Board (IRB) oversight. CLS educators may not be aware of the federal regulations, controversies over application of these regulations to educational research, and possible exemptions that may apply to educational research. Based on literature review and discussion with IRB representatives, this poster will describe the regulations and the ways they may be applied to educational research. The regulations are contained in Title 45 Code of Federal Regulations, Part 46, which lists a series of educational exemptions that apply to activities that are 'normal educational practice'. However this exemption requires interpretation based on the intent of the activity (research vs. program review), and the voluntariness of participation. Voluntariness is important if the researcher gathering data is the same individual who will assign student grades and possibly write letters of recommendation. Confidentiality of student records may also require oversight, even if all data is gathered without identifiers. Exemptions that can be used to streamline the process include expedited review, which requires less paperwork and has a faster turn-around-time, and waiver of consent. In conclusion, CLS educators performing educational research must be aware of how their IRB interprets Federal human subjects regulations and exemptions in order to avoid controversies.

Nancy Goodyear PhD MT(ASCP), University of Washington, Seattle WA