Open AccessConsent Form Heterogeneity in Cancer Trials: The Cooperative Group and Institutional Review Board Gap
Author(s) -
Shlomo A. Koyfman,
Patricia Agre,
Regina Carlisle,
Lorianne Classen,
Chesley Cheatham,
Joanne Peter Finley,
Nancy Kuhrik,
Marilee Kuhrik,
Toni Kay Mangskau,
JoAnn O’Neill,
Chandana A. Reddy,
Eric Kodish,
Mary S. McCabe
Publication year - 2013
Publication title -
journal of the national cancer institute
Language(s) - English
Resource type - Journals
eISSN - 1460-2105
pISSN - 0027-8874
DOI - 10.1093/jnci/djt143
Subject(s) - readability , institutional review board , bonferroni correction , informed consent , medicine , clinical trial , family medicine , alternative medicine , surgery , pathology , statistics , mathematics , linguistics , philosophy
Cooperative group (CG) provided consent forms (CGP-CFs) undergo re-review and revision by local institutional review boards (IRB) before institutional approval. We compared the relative readability and length of IRB-approved consent forms (IRB-CFs) used at seven academic institutions with their corresponding CGP-CFs. We also assessed the variability of these metrics across our institutions.