Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biol Blood Marrow Transplant 2012 Feb;18(2):183-9
Date
10/05/2011Pubmed ID
21806948Pubmed Central ID
PMC3242929DOI
10.1016/j.bbmt.2011.07.022Scopus ID
2-s2.0-84855597249 (requires institutional sign-in at Scopus site) 21 CitationsAbstract
Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the United States (U.S.). The recent development of ICF templates by the National Cancer Institute, National Institutes of Health, and the National Heart Blood and Lung Institute have not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet U.S. federal requirements and pass institutional review board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a 2-column format. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension, and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared with the traditional format on the informed consent process.
Author List
Denzen EM, Santibáñez ME, Moore H, Foley A, Gersten ID, Gurgol C, Majhail NS, Spellecy R, Horowitz MM, Murphy EAAuthors
Mary M. Horowitz MD, MS Professor in the Medicine department at Medical College of WisconsinRyan Spellecy PhD Assistant Provost, Director, Professor in the Institute for Health and Equity department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
Clinical Trials as TopicHumans
Medical Records
National Cancer Institute (U.S.)
National Heart, Lung, and Blood Institute (U.S.)
United States
