January 2005

Federal regulations define research as; “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102 (d), 1991). The first element – systematic investigation may be characteristic of both research and nonresearch activities. Quality assurance projects, program and course evaluations are examples in which data may be collected and analyzed in a manner identical to that of research projects, but may not be research. “All well-designed medical research involves a systematic approach to investigate a scientific hypothesis, but a systematic investigation is not synonymous with research intent” (Amdur & Speers, 2002, p. 120). The second element - generalizable means the degree of assurance that the findings obtained from the research sample can be extrapolated to the population.

As noted above, systematic investigation and generalizability of results do not necessarily identify research intent. In order to classify a project as either a research or a nonresearch activity, the individual must ask about the intent of the activity. The defining factor frequently used is whether the individual intends to publish the proceedings of the activity or present information obtained from the activity in an academic forum. Although this is not a bad way to proceed, the focus should not be whether the individual wants to publish or present results in the future, but rather would the project be done as planned if academic recognition was definitely not a possibility? (Amdur & Speers, 2002) The question to be asked then is as follows: “Would the project be conducted as proposed if the project investigator knew that he or she would never receive any form of academic recognition for the project, including publication of results in a journal or presentation of the activity at an academic meeting?” The individual’s response to this question can assist in determining research intent.

On occasion, the activity may begin as quality assurance, program evaluation or another type of nonresearch activity. As the project progresses the individual finds that the collected information might be worthy of publication. It is at this point that review by an Institutional Review Board (IRB) must be sought. Many times, projects involving use of data that already exist can be given an administrative review and classified as an exempt project. Classification of the activity as exempt may also depend on the sensitivity and anonymity of the previously collected information. If information is being collected in an ongoing manner and the individual determines that his/her intent has changed to include a research component, other requirements (such as informed consent) may be requested by the Institutional Review Board (IRB).

The system for protecting the rights and welfare of potential research participants depends on the integrity of the individual conducting the activity. To identify research intent, the individual must thoughtfully consider the role of academic recognition in the conduct or performance of the activity.

Amdur, R. J., & Speers, M. A. (2002). Identifying Research Intent. In R. J. Amdur and E. A. Bankert (Eds.), Institutional Review Board Management and Function (pp. 118-124). Sudbury, MA: Jones and Bartlett.

Code of Federal Regulations. Title 45A-Department of Health and Human Services; Part 46-Protection of Human Subjects. Updated August 19, 1991. Retrieved December 12, 2004 from the World Wide Web: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.