Human Subjects Protection: Does My Project Need to be Reviewed?

Before the review process, researchers must be sure that their project is, in fact, human subjects research as defined by the federal government. In order to qualify as human subjects research, the following must be true. •The participants must be living. Thus, oral history projects fall under the guidelines, but research involving diaries kept in the 1800s does not. •The project is a systematic investigation. That is, it is designed to be a study. For example, instances in classrooms where teachers ask students’ opinions on the material to gauge progress are not research. However, if that same teacher designs a study to evaluate two different methods of teaching the material to see which is more effective this would be research if the third criterion is met. •The project is designed to contribute to the generalized knowledge. To qualify as research, the person conducting the project must intend it to be for dissemination at some level. On our campus, we also review student projects that may not be disseminated but that meet the first two criteria so that students will learn the process of human subjects research and because we have contracted with the federal government to do so. Do I need ethics training? As specified by the federal regulations, all faculty members conducting human subjects research or supervising student research need to complete ethics training. All students conducting human subjects research also need to complete this training. We encourage researchers to complete the CITI program located at www.citiprogram.org