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Denzen EM, Santibáñez ME, Moore H, et al. Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biol Blood Marrow Transplant. 2011;18(2):183-9doi: 10.1016/j.bbmt.2011.07.022.
Denzen, E. M., Santibáñez, M. E., Moore, H., Foley, A., Gersten, I. D., Gurgol, C., Majhail, N. S., Spellecy, R., Horowitz, M. M., & Murphy, E. A. (2012). Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 18(2), 183-9. https://doi.org/10.1016/j.bbmt.2011.07.022
Denzen, Ellen M, et al. "Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials." Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation vol. 18,2 (2012): 183-9. doi: https://doi.org/10.1016/j.bbmt.2011.07.022
Denzen EM, Santibáñez ME, Moore H, Foley A, Gersten ID, Gurgol C, Majhail NS, Spellecy R, Horowitz MM, Murphy EA. Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biol Blood Marrow Transplant. 2012 Feb;18(2):183-9. doi: 10.1016/j.bbmt.2011.07.022. Epub 2011 Jul 30. PMID: 21806948; PMCID: PMC3242929.
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Biol Blood Marrow Transplant. 2012 Feb;18(2):183-9. doi: 10.1016/j.bbmt.2011.07.022. Epub 2011 Jul 30.

Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials.

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

Ellen M Denzen, Martha E Burton Santibáñez, Heather Moore, Amy Foley, Iris D Gersten, Cathy Gurgol, Navneet S Majhail, Ryan Spellecy, Mary M Horowitz, Elizabeth A Murphy

Affiliations

  1. National Marrow Donor Program, Patient Services, 3001 Broadway Street NE, Minneapolis, MN 55413, USA. [email protected]

PMID: 21806948 PMCID: PMC3242929 DOI: 10.1016/j.bbmt.2011.07.022

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.

Copyright © 2012 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

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