This NSF-funded study was designed to explore the process of monitoring and obtaining informed consent from human subjects. The examination focused on two distinct populations: members of Institutional Review Boards (IRBs) and research participants.
In Year 1 of this 2-year study, the investigators conducted key informant interviews with members of IRBs in order to examine the norms and processes that IRBs use when assessing and monitoring the adequacy of the informed consent process. The sample was comprised of IRB members recruited from throughout the US. The sample included members from all current types of IRBs, namely academic, independent/for-profit, hospital, and community/tribal boards. Research focused on three main questions:
1a: How do IRBs view and assess the consent process?
1b: How do IRB members judge the adequacy and efficacy of their monitoring efforts?
1c: Do IRB members believe that the current approach achieves the goals of protection and voluntarism of human subjects?
The second phase of the study was designed to explore the perceptions, norms, and values that participants bring to the research enterprise and how these factors influence decisions about participation. The examination also explored participants’ perspectives of the consent process including an understanding of information on informed consent documents. The data from the study of IRB members helped identify the themes and issues that were explored with participants of the second phase of the project. The sample for this phase of the study included 50 subjects recruited from throughout the country. All subjects participated in key informant interviews.
The interview instrument for the second study focused on seven major research questions:
2.a. What do research subjects know and understand of the consent process?
2.b. What key information do participants need when invited to participate in research?
2.c. How much information do participants want?
2.d. How do participants interpret what they are told?
2.e What kinds of messages will influence the decision to participate?
2.f. What do subjects’ understanding of purpose, risk, benefit, and disclosure?
2.g. What factors influence subjects’ decision about participation of research?
This study, funded by the National Science Foundation (NSF), was initiated on September 1, 2008 and continued until August 30, 2010.