There is an apparent need for clarity regarding potential review of activities that may call for Spelman IRB review and or approval. As Co-Chair of the Spelman IRB and at the suggestion of a trusted faculty colleague, I am offering this explanation of how the need for Spelman IRB review is determined. This explanation is intended to supplement the existing directions provided by the Spelman IRB webpage: http://www.spelman.edu/academics/office-of-the-provost/institutional-review-board and to precede a possible discussion at our January Faculty meeting at the pleasure of Faculty Council President, Kathleen Phillips-Lewis.
When considering IRB review for a project, the federal requirements to protect human subjects (28 CFR 46) must involve the following:
1) is the project research?
Research as a matter of Federal Policy is defined as follows: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…”. Typically, this “contribute to generalizable knowledge” is through public presentation or publication.
2) does this research involve human subjects?
The first matter is always, Will this project be considered research? Once that is decided or research is claimed/stated, THEN, it should be determined if the project involves human subjects. If BOTH criteria are met, IRB review is necessary. To be clear, NO research involving human subjects is exempt under federal guidelines.
Please give the decision tree below a look and let me know if this chart needs redesign to improve clarity. There are several other criteria to consider if approval will be provided but these two matters are critical to determine if IRB approval is needed.
Mark E. Lee, Ph.D.
Associate Professor of Biology
BS/MS Neurobiology Program
Spelman College
Atlanta, GA 30314
404-270-5718
http://spelbionews.wix.com/spelbionews