Formal Assessment of Voluntariness With a Three-Part Consent Process Academic Article uri icon

abstract

  • Informed consent that is voluntary and made by an individual who is knowledgeable and competent is a foundational requirement for protecting human subjects from harm and exploitation that could result from research participation. In 1974 Miller and Willner proposed a two-part consent process that involved disclosure of information and assessment of comprehension. The authors propose a brief third component to the consent process: assessment of voluntariness. Three steps are involved: generate a list of potential coercive influences on the basis of the research population and the study context, develop a set of questions to assess the presence and intensity of the impact of these influences, and identify alternative courses of action should coercion be identified.

author list (cited authors)

  • Stiles, P. G., Epstein, M. K., Poythress, N. G., & Edens, J. F.

citation count

  • 11

publication date

  • January 2011