Rethinking ethical oversight in the era of the learning health system.
Ethics
Learning health system
Regulation
Journal
Healthcare (Amsterdam, Netherlands)
ISSN: 2213-0772
Titre abrégé: Healthc (Amst)
Pays: Netherlands
ID NLM: 101622189
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
13
04
2020
revised:
21
07
2020
accepted:
06
08
2020
pubmed:
30
9
2020
medline:
30
6
2021
entrez:
29
9
2020
Statut:
ppublish
Résumé
Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent, and disclosure for low-risk learning activities in all jurisdictions.
Identifiants
pubmed: 32992106
pii: S2213-0764(20)30061-0
doi: 10.1016/j.hjdsi.2020.100462
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
100462Informations de copyright
Published by Elsevier Inc.