Decision making for invasive and non-invasive optional procedures within an acute HIV research cohort in Bangkok.
Clinical research ethics
Decision-making
HIV research
Optional procedures
Research biopsies
Research cohorts
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Feb 2023
Feb 2023
Historique:
received:
09
08
2022
revised:
16
11
2022
accepted:
18
12
2022
entrez:
13
1
2023
pubmed:
14
1
2023
medline:
14
1
2023
Statut:
epublish
Résumé
Clinical research regularly includes required, nontherapeutic procedures to answer research questions. Optional procedures usually offer minimal or no personal benefit and may involve harms and burdens. Members from the Bangkok SEARCH010/RV254 HIV research cohort of individuals acutely HIV-infected are recruited to six optional procedures varying in invasiveness: leukapheresis, genital secretions collection, lumbar puncture, brain MRI/MRS/DTI, colon biopsy, and lymph node biopsy. We surveyed cohort members about their first recruitment for each procedure to examine factors associated with decision making and attitudes about compensation. 406 members (68%) completed the survey. Reported procedure participation ranged from 71% (MRI) to 27% (lymph node biopsy). Respondents underwent 0-6 procedure types (median 3). Ordinal regression indicated that lower perceived HIV impact and HIV remission trial participation were associated with more procedures completed. Reports of decision difficulty varied, and feeling pressured by research staff was low overall. Notably, those who declined procedures and those who underwent more invasive procedures reported greater decision difficulty and perceived pressure. Most respondents felt compensation amounts were appropriate, although opinions differed by procedure, and for some procedures, between people who agreed and declined. There is limited literature regarding consent to and attitudes about optional research procedures. Researchers must consider how to best support voluntary decisions for procedures with little personal benefit, particularly in lower-income or marginalized populations. In this longitudinal research cohort, perceived pressure to participate may be a concern, although our finding of variation in participation rates corresponding to invasiveness is reassuring. Data from different research contexts would provide important comparators.
Identifiants
pubmed: 36636463
doi: 10.1016/j.conctc.2022.101054
pii: S2451-8654(22)00171-5
pmc: PMC9829688
doi:
Types de publication
Journal Article
Langues
eng
Pagination
101054Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2022 The Authors.
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