2009 Articles

Voluntariness of Consent to Research: A Preliminary Empirical Investigation

Appelbaum, Paul S.; Lidz, Charles W.; Klitzman, Robert L.

Providing informed consent to participate in research—a primary pillar of the ethical conduct of research—is based on three components: adequate information, a competent decision-maker, and a voluntary decision process . Techniques have been developed to assess the content and adequacy of information disclosures during the informed consent process and the decisional capacity of people recruited to participate in research. But voluntariness of consent has been more resistant to investigation, leaving policy-makers with little guidance for their efforts to insure that prospective research subjects are able to exercise meaningful choice about whether to participate in research.

Given the absence of accepted measures of voluntariness in research settings and the limited amount of available data, our study was designed to develop a more comprehensive approach to assessing voluntariness of consent to research and to generate preliminary data on the extent and correlates of limitations on voluntariness across diverse areas of research.