Informed consent and biological agents in rheumatology and internal medicine
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...
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| Published in | European journal of clinical investigation Vol. 52; no. 9; pp. e13805 - n/a |
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| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Blackwell Publishing Ltd
01.09.2022
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| Subjects | |
| Online Access | Get full text |
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| 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. |
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| AbstractList | BACKGROUNDThe 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. METHODSThe authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures. RESULTSNo 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. CONCLUSIONThe 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. 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. 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. 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. |
| Author | Iannone, Florenzo Ferracuti, Stefano Grattagliano, Ignazio Mandarelli, Gabriele Catanesi, Roberto Ferorelli, Davide Solarino, Biagio Benevento, Marcello |
| Author_xml | – sequence: 1 givenname: Gabriele orcidid: 0000-0003-4887-5108 surname: Mandarelli fullname: Mandarelli, Gabriele organization: “Aldo Moro” University of Bari – sequence: 2 givenname: Florenzo orcidid: 0000-0003-0474-5344 surname: Iannone fullname: Iannone, Florenzo organization: “Aldo Moro” University of Bari – sequence: 3 givenname: Stefano surname: Ferracuti fullname: Ferracuti, Stefano organization: “Sapienza” University of Rome – sequence: 4 givenname: Ignazio orcidid: 0000-0002-3472-9364 surname: Grattagliano fullname: Grattagliano, Ignazio organization: Italian College of General Practitioners and Primary Care – sequence: 5 givenname: Marcello orcidid: 0000-0002-4895-0182 surname: Benevento fullname: Benevento, Marcello email: marcello.benevento@uniba.it organization: “Aldo Moro” University of Bari – sequence: 6 givenname: Biagio surname: Solarino fullname: Solarino, Biagio organization: “Aldo Moro” University of Bari – sequence: 7 givenname: Davide surname: Ferorelli fullname: Ferorelli, Davide organization: “Aldo Moro” University of Bari – sequence: 8 givenname: Roberto surname: Catanesi fullname: Catanesi, Roberto organization: “Aldo Moro” University of Bari |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35488744$$D View this record in MEDLINE/PubMed |
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The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules... The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called... Abstract Background The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of... BackgroundThe need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules... BACKGROUNDThe need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules... |
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