The individual choice to participate in research (i.e., consent) should be both informed and voluntary. To date, the empirical study of consent has focused on the information (i.e., what a person knows) and decision-making aspects (i.e., how a person processes information) of consent. Few empirical studies examine the voluntary nature of consent, largely because of the lack of an instrument to measure "voluntariness." Absent such an instrument, it is difficult to distinguish between appropriate and "undue" influences on informed consent.
The primary goal of this project is to develop a valid and reliable measure of voluntary consent (called the "decision-making control instrument" or DMCI), focusing on parental decisions about protocol-based treatment of seriously ill children. The project involves three phases. First, we will create a list of candidate items for the DMCI instrument based on focus groups with eligible parents, clinician-investigators, study coordinators and other non-physician clinicians. Second, we will develop a DMCI pilot instrument by administering the candidate items and other selected measures of decision-making preference, coping style and affect to parents who have made a decision concerning protocol-based treatment for their ill child. Third, we will administer the DMCI pilot instrument along with interviews of parents to explore the instrument's ability to capture their own perceptions of the control they exercised over the decision.
