Student is co-investigator in Oncology Consent Study published in Science Direct.
Evaluating
the quality of information about alternatives to research participation in
oncology consent forms
David
B. Resnika,
,
Daniel Patroneb
and Shyamal Peddadaa
aNational
Institute of Environmental Health Sciences, National Institutes of Health,
United States
bUnion
College/Mt. Sinai School of Medicine, United States
Abstract
A
careful consideration of the alternatives to research participation is an
essential element of making an informed choice to enroll in a biomedical
research study. While there is general agreement on the importance of informing
prospective subjects about alternatives to research participation, little is
known about how investigators communicate this information. The purpose of this
study was to attempt to assess the quality of information about alternatives
contained in informed consent documents in oncology randomized controlled
trials. Our study indicates that there is room for improvement concerning the
discussion of alternatives to research participation in informed consent
documents in oncology randomized controlled trials. Though most of the documents
in our study met the minimal disclosure standard found in the U.S. federal
regulations, less than a third met the reasonable person standard, a widely
accepted principle endorsed by the common law and various ethics guidelines and
documents. There was a statistically significant difference between the
alternative discussions in local and model forms
(P < 0.0014). The alternatives discussions in local informed
consent documents were more likely to receive higher scores than those in model
consent documents, with an odds-ratio of 3.5 to 1.
