Project 4: Exploring the Meaning of Consent

 

Surveys have traditionally been exempt from the requirement for obtaining written informed consent from respondents, except when the inadvertent disclosure of their answers would jeopardize their employment, put them at risk of prosecution, or subject them to public humiliation.  Many surveys, however, including surveys of aging populations, request information for which written consent is required, either because they plan to link responses with administrative records, or because the University's or agency's Institutional Review Board deems the survey sufficiently sensitive to warrant the more formal consent procedure.  Even when written consent is not required -- as it cannot be in a telephone survey, for example -- the interviewer is often required to read an introduction that includes the elements of informed consent.  One crucial element in the informed consent statement, whether written or oral, is the level of confidentiality that will be accorded the respondent's answers, since a breach of confidentiality, and possible consequences flowing therefrom, is the major risk to which survey participants are exposed.  This project explores people's understanding of informed consent, including their perceptions of the nature and size of the risks involved, as well as their ideas about the usefulness of the research.  It also explores the relationship between attitudes and behavior:  Are people who say they are more concerned with confidentiality less likely to provide data, especially sensitive data?

The significance of the project arises from several sources.  First, the protections devised by Institutional Review Boards (IRB's) and by researchers should take into consideration the concerns of the participants themselves.  Second IRB's are tending toward increasingly stringent interpretations of the Regulations for the Protection of Human Subjects even for social surveys, even though potential harms of such surveys are very different from those of biomedical studies.  Surveying a representative sample of respondents to social surveys to find out what they understand by risks and harms may help inform such interpretations.  Finally, helping researchers to understand what is important to potential respondents may enable them to better address those concerns and increase willingness to participate.

A series of questions was appended to the Survey of Consumer Attitudes (SCA) as the vehicle for this study.  The SCA is a random sample of the national adult population, replicated every month, which permits cumulation of sample cases until the desired sample size is reached.  The response rate to the survey is around 70%.  Respondents were read introductions to two actual studies being carried out at the University of Michigan (the National Survey of Family Growth and the Health and Retirement Study), with some elements of the introduction systematically varied to affect perceptions of benefit and risk.  Respondents then answered a series of questions to determine what they thought they were consenting to when they agreed to participate, who they thought would have access to their answers, how concerned they are about breaches of confidentiality, what consequences they think would follow a breach of confidentiality, whether the utility of the information offsets the possible risks to which they may have been exposed, and related issues.

Data collection for this project has been completed and data analysis is beginning.

Publications:

Exploring the Meaning of Consent: Beliefs about Risks, Benefits, and Participation in Research