title: Do N-of-1 Trials Need IRB Review?
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.
authors.affiliation: Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.
authors.forename: Ruiqi
authors.initials: R
authors.lastname: Cen
authors.affiliation: Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.
authors.forename: Azad
authors.initials: A
authors.lastname: Hussain
authors.affiliation: Ochsner Clinic Foundation, New Orleans, LA, USA.
authors.forename: Kirk J
authors.initials: KJ
authors.lastname: Pak
authors.affiliation: The University of Queensland, Herston, Australia.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Mitchell
authors.affiliation: The University of Queensland, Herston, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Nikles
authors.affiliation: Ochsner Clinic Foundation, New Orleans, LA, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Gaudreau
authors.affiliation: Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA lbazzano@tulane.edu.
authors.forename: Lydia A
authors.initials: LA
authors.lastname: Bazzano
authors.affiliation: Ochsner Clinic Foundation, New Orleans, LA, USA.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Breault
mesh_terms: D001290:Attitude; D035843:Biomedical Research / Q000941:ethics* / Q000379:methods; D026724:Ethical Review; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D057285:Precision Medicine; D035842:Research Subjects; D011795:Surveys and Questionnaires; D014481:United States
keywords: IRB (institutional review board); biomedical research; human subjects research; research ethics