Informed consent and biological agents in rheumatology and internal medicine.
biological agents
informed consent
mental capacity
rheumatology
Journal
European journal of clinical investigation
ISSN: 1365-2362
Titre abrégé: Eur J Clin Invest
Pays: England
ID NLM: 0245331
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
revised:
19
04
2022
received:
03
03
2022
accepted:
23
04
2022
pubmed:
1
5
2022
medline:
20
8
2022
entrez:
30
4
2022
Statut:
ppublish
Résumé
The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process. The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures. No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off-label use of biological agents usually with no obvious attention to informed consent shortcomings. The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.
Sections du résumé
BACKGROUND
BACKGROUND
The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process.
METHODS
METHODS
The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures.
RESULTS
RESULTS
No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off-label use of biological agents usually with no obvious attention to informed consent shortcomings.
CONCLUSION
CONCLUSIONS
The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.
Identifiants
pubmed: 35488744
doi: 10.1111/eci.13805
pmc: PMC9539695
doi:
Substances chimiques
Biological Factors
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13805Informations de copyright
© 2022 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.
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