A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective.
clinical trial
consent process
ethical review
ethics committees
regulations
Journal
Cureus
ISSN: 2168-8184
Titre abrégé: Cureus
Pays: United States
ID NLM: 101596737
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
accepted:
30
01
2023
entrez:
6
3
2023
pubmed:
7
3
2023
medline:
7
3
2023
Statut:
epublish
Résumé
Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.
Identifiants
pubmed: 36874722
doi: 10.7759/cureus.34433
pmc: PMC9979097
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e34433Informations de copyright
Copyright © 2023, Shetty et al.
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Perspect Clin Res. 2017 Jan-Mar;8(1):2-4
pubmed: 28194330
Perspect Clin Res. 2014 Jan;5(1):6-10
pubmed: 24551580
Indian J Med Ethics. 2018 Jul-Sep;3(3):179-185
pubmed: 29976550
Natl Med J India. 2017 Sep-Oct;30(5):262-265
pubmed: 29916425
Perspect Clin Res. 2018 Jan-Mar;9(1):44-47
pubmed: 29430418
N Engl J Med. 2017 Mar 2;376(9):856-867
pubmed: 28249147
Indian J Dent Res. 2015 May-Jun;26(3):333-5
pubmed: 26275207
Perspect Clin Res. 2016 Apr-Jun;7(2):81-7
pubmed: 27141474
Perspect Clin Res. 2015 Jul-Sep;6(3):159-62
pubmed: 26229752
Perspect Clin Res. 2017 Jan-Mar;8(1):22-30
pubmed: 28194334
Perspect Clin Res. 2014 Jan;5(1):3-5
pubmed: 24551579