Do N-of-1 trials need IRB review?

Cen, Ruiqi, Hussain, Azad, Pak, Kirk J., Mitchell, Geoffrey, Nikles, Jane, Gaudreau, Stephanie, Bazzano, Lydia A. and Breault, Joseph L. (2016) Do N-of-1 trials need IRB review?. Journal of Empirical Research on Human Research Ethics, 11 3: 250-255. doi:10.1177/1556264616662560

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Author Cen, Ruiqi
Hussain, Azad
Pak, Kirk J.
Mitchell, Geoffrey
Nikles, Jane
Gaudreau, Stephanie
Bazzano, Lydia A.
Breault, Joseph L.
Title Do N-of-1 trials need IRB review?
Journal name Journal of Empirical Research on Human Research Ethics   Check publisher's open access policy
ISSN 1556-2646
Publication date 2016-07-01
Year available 2016
Sub-type Article (original research)
DOI 10.1177/1556264616662560
Open Access Status Not yet assessed
Volume 11
Issue 3
Start page 250
End page 255
Total pages 6
Place of publication Thousand Oaks, CA United States
Publisher Sage Publications
Language eng
Abstract There is no standard policy regarding the regulatory or institutional approval of N-of-1 trials in the United States. The objective of this study was to examine whether institutional review boards (IRBs) accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) consider N-of-1 trials as meeting the definition of human subjects research (45CFR46.102) and requiring IRB approval. A questionnaire was distributed via email to 170 AAHRPP-accredited IRBs in the United States. Responses were analyzed using statistical and qualitative methods. Nineteen of 59 respondents reported viewing N-of-1 trials as research. Twelve respondents reported having a policy regarding N-of-1 trials, and in all cases, such policies did not consider N-of-1 trials as meeting the definition of research. This topic deserves wider examination in the IRB literature and community to inform policies and guidance as N-of-1 trials become more common in the pursuit of personalized, precision medicine.
Keyword Research ethics
IRB (institutional review board)
Human subjects research
Biomedical research
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

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