학술논문
Informed consent and biological agents in rheumatology and internal medicine.
Document Type
Academic Journal
Author
Mandarelli G; 'Aldo Moro' University of Bari, Bari, Italy.; Iannone F; 'Aldo Moro' University of Bari, Bari, Italy.; Ferracuti S; 'Sapienza' University of Rome, Rome, Italy.; Grattagliano I; Italian College of General Practitioners and Primary Care, Florence, Italy.; Benevento M; 'Aldo Moro' University of Bari, Bari, Italy.; Solarino B; 'Aldo Moro' University of Bari, Bari, Italy.; Ferorelli D; 'Aldo Moro' University of Bari, Bari, Italy.; Catanesi R; 'Aldo Moro' University of Bari, Bari, Italy.
Source
Publisher: Wiley Country of Publication: England NLM ID: 0245331 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2362 (Electronic) Linking ISSN: 00142972 NLM ISO Abbreviation: Eur J Clin Invest Subsets: MEDLINE
Subject
Language
English
Abstract
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: The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures.
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: 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.
(© 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.)
Methods: The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures.
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: 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.
(© 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.)