Medical Device Design Projects: When Do Students Become Human Subjects?


Student Research Projects


On April 27, 2017, Andrew Brightman, PhD gave a presentation on whether students designing medical devices and performing research on themselves should be treated as human subjects and follow the same ethical regulations as other studies involving human subjects. The video of the presentation can be accessed with the link above. The presentation lasts approximately 45 minutes and is followed by approximately 14 minutes of discussion.

Additional Resources:

Pritchard, I. A. (2001). Searching for" Research Involving Human Subjects": What Is Examined? What Is Exempt? What Is Exasperating?. IRB: Ethics & Human Research, 23(3), 5-13.

Wilkinson, M. (2008). Ethical review of undergraduate student research in the NHS: evolution of the system could benefit us all. Journal of medical ethics, 34(9), e19-e19.

Edwards, S. J. (2009). Student projects in medicine: a lesson in science and ethics. Accountability in research, 16(6), 285-306.

Gallagher, C. T., McDonald, L. J., & McCormack, N. P. (2014, June). Undergraduate research involving human subjects should not be granted ethical approval unless it is likely to be of publishable quality. In HEC forum (Vol. 26, No. 2, p. 169). Springer Science & Business Media.

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