174269 What do potential research subjects take for granted when they consent to participate?

Tuesday, October 28, 2008: 9:30 AM

Elinor Rae Bock, BA , Department of Psychology, New School for Social Research, New York, NY
James Walkup, PhD , Graduate School of Applied and Professional Psychology at Rutgers University, Piscataway, NJ
While intended to safeguard values of autonomy and respect, informed consent documents are often criticized as opaque, legalistic exercises, more concerned to provide institutional cover than communicate. Efforts to counter this tendency advocate a consent process conceptualized as an engaged dialogue responsive to subjects' information needs. Ironically, “consent as conversation” advocates have not gathered data on these needs, and make little use of empirical descriptions of how conversations work.

Using a conversational presupposition framework, we investigated whether, when considering research participation, people request the information IRBs typically require for informed consent. Of 51 participants approached in a public area and asked to be in a study, about half (51%) asked about the scientific purpose; 37% asked about time required, and 23% asked about the investigator. One person asked about data privacy. Nobody asked about other consent elements: voluntariness, freedom to discontinue, data maintenance, study risks/benefits, or IRB approval. Follow up questions found that many did not ask because they assumed they knew the answer, or did not anticipate the answer would matter to them.

Findings are consistent with conversation theory's claim that listeners do not normally believe speakers should tell them information they already assume to be true. There may be tensions between conversational disapproval of mentioning taken-for-granted information and the IRB requirement that each element of consent be explicitly spelled out for the participant to be considered informed. Implications of empirical studies of the consent process are discussed.

Learning Objectives:
To increase awareness of the "consent as conversation" critique of traditional consent processes. To establish the relevance of empirically-based models of conversation for the consent process To consider to the

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a PhD candidate that has been working Dr. Jamie Walkup on the abstract being presented for two years. I aided in running the study and the data analysis.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.