Author: Eva Pastor
Date: 12-04-09 16:28
Source: UPI
URL: http://www.upi.com/Science_News/2009/12/03/Study-Clinical-trial-consent-is-voluntary/UPI-90021259872
Date published: December 3rd 2009
Study: Clinical trial consent is voluntary
Published: Dec. 3, 2009 at 3:35 PM
NEW YORK, Dec. 3 (UPI) -- U.S. researchers say most participants in clinical research studies believe their consent to enroll in the trial was genuinely voluntary.
Professor Paul Appelbaum and Associate Professor Robert Klitzman of Columbia University, along with University of Massachusetts Professor Charles Lidz, assessed people's motivations to participate in research studies. The researchers said their goal was to identify any constraints participants believed limited their capacity to make a choice about participation.
The professors said they developed a 14-item questionnaire to evaluate what they called "voluntariness" and any constraints on voluntariness. They recruited 88 patients who were participants in five areas of clinical research: substance abuse, cancer, human immunodeficiency virus, cardiology and depression.
The scientists said 73 of the 88 participants rated their decisions to enroll in a clinical trial as completely voluntary. Although 31 said they were offered incentives to participate, 26 said the offer was not an important factor in their decision about whether to enter the trial.
"Our findings reveal little evidence of constraints on voluntariness and, when such influences were present, they did not play a significant role in individuals' decision-making process," the researchers reported.
They said the only factors that led some participants to feel more constrained were certain financial incentives, and the participants' own altruistic motivations.
The findings are presented in the journal IRB: Ethics & Human Research.
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