Informed consent--practical considerations.
Informed consent is a legal document that summarizes what will take place in a study in a language the study subjects can understand and is the process by which a person decides whether or not to participate in a study. The document is not limited to explaining the intervention or potential risks and benefits but is also the source of understanding why the study is being done and what the particular study will add to what is already known. Overall, informed consent is a document providing important transparency and clarity about the study. While consent forms are mandatory prior to study approval by internal review boards, they are not published as part of study results and are not part of clinical trial registries. The central role of an informed consent document in any study could be vitally expanded and enhanced with inclusion and full disclosure of its content through clinical trial registries and published reports in the literature, bringing improved transparency to the entire clinical trial process. Transparency is important for the maintenance of high standards in clinical research and for public trust of the process, a sometimes underrecognized factor in healthcare initiatives.
Yazici
Yusuf
Y
NYU Hospital for Joint Diseases, NYU Langone Medical Center, New York, New York, USA. yusuf.yazici@nyumc.org
D002986:Clinical Trials as Topic; D032882:Comprehension; D032962:Consent Forms; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D007802:Language; D010353:Patient Education as Topic; D028701:Patient Rights; D012042:Registries; D035842:Research Subjects / Q000523:psychology; D018570:Risk Assessment; D014342:Truth Disclosure