title: Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials.
abstract: 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.
authors.affiliation: National Marrow Donor Program, Patient Services, 3001 Broadway Street NE, Minneapolis, MN 55413, USA. edenzen@nmdp.org
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Denzen
authors.forename: Martha E Burton
authors.initials: ME
authors.lastname: Santibáñez
authors.forename: Heather
authors.initials: H
authors.lastname: Moore
authors.forename: Amy
authors.initials: A
authors.lastname: Foley
authors.forename: Iris D
authors.initials: ID
authors.lastname: Gersten
authors.forename: Cathy
authors.initials: C
authors.lastname: Gurgol
authors.forename: Navneet S
authors.initials: NS
authors.lastname: Majhail
authors.forename: Ryan
authors.initials: R
authors.lastname: Spellecy
authors.forename: Mary M
authors.initials: MM
authors.lastname: Horowitz
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Murphy
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D006801:Humans; D008499:Medical Records / Q000592:standards*; D054547:National Cancer Institute (U.S.); D054555:National Heart, Lung, and Blood Institute (U.S.); D014481:United States