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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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off\u2010label use of biological agents usually with no obvious attention to informed consent shortcomings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/eci.13805","type":"journal-article","created":{"date-parts":[[2022,4,30]],"date-time":"2022-04-30T08:55:35Z","timestamp":1651308935000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Informed consent and biological agents in rheumatology and internal medicine"],"prefix":"10.1111","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4887-5108","authenticated-orcid":false,"given":"Gabriele","family":"Mandarelli","sequence":"first","affiliation":[{"name":"\u201cAldo Moro\u201d University of Bari  Bari Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0474-5344","authenticated-orcid":false,"given":"Florenzo","family":"Iannone","sequence":"additional","affiliation":[{"name":"\u201cAldo Moro\u201d University of 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