Trends of Informed Consent forms for industry-sponsored clinical trials in rheumatology over a 17-year period: Readability, and assessment of patients’ health literacy and perceptions

Author:

de la Mora-Molina Hector,Barajas-Ochoa AldoORCID,Sandoval-Garcia Leon,Navarrete-Lorenzon Martha,Castañeda-Barragan Edgar A.,Castillo-Ortiz José Dionisio,Aceves-Avila Francisco JavierORCID,Yañez Jose,Bustamante-Montes Lilia Patricia,Ramos-Remus CesarORCID

Publisher

Elsevier BV

Subject

Anesthesiology and Pain Medicine,Rheumatology

Reference44 articles.

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2. Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98

3. U.S. Government Publishing Office. Electronic Code of Federal Regulations, Title 21, Chapter I, Subchapter A, Part 50, Subpart B, Sec. 50.20 [Internet]. Washington, DC: U.S. Government Publishing Office; 2017 [Cited 2017 Oct 16]. Available from: https://www.ecfr.gov/cgi-bin/text-idx?SID=733bd05f4991c3fa75c1692b6997fb67&mc=true&node=se21.1.50_120&rgn=div8

4. Informed consent in clinical research: consensus recommendations for reform identified by an expert interview panel;Lorell;Clin Trials,2015

5. Enduring and emerging challenges of informed consent;Grady;N Engl J Med,2015

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