Perceptions, delivery, and understanding of the informed consent process among women participating in a community-based participatory research (CBPR) study of welfare policy and health

With an increased focus on health disparities through the NIH, CDC, and other agencies, there is a need to better engage minority, marginalized, or otherwise disadvantaged groups to participate in scientific research. Given the historical record of ethical violations against marginalized peoples, increasing participation by such groups in research remains a considerable challenge – and one based largely on trust. Despite these parallel realities, there is surprisingly little in the literature describing how women in these groups perceive and understand the informed consent process for participation in research.

This presentation describes one part of an ongoing CBPR study funded by NIH/NINR that utilizes a public health nursing approach to reduce health disparities in women going through a welfare transition program (WTP). Specifically, the results from a descriptive, mail-out survey to n=59 women enrolled in a WTP who participated in at least 1 of 10 focus groups in 2006. Questions related to their perception of, preferences for delivery of, and understanding of the informed consent process for their participation in the focus groups were asked.

A total of n=35 women returned the survey, for a 58% response rate. Among respondents, the majority were black (57%) and the mean age was 32 years. Findings indicate women have definite preferences for the way informed consent should be presented. The majority indicated they were unaware of past research abuses, felt comfortable asking questions during the informed consent process, understood the purpose of the consent, and trusted the researchers would do what was outlined in the consent. Such data are invaluable for engaging disadvantaged women in studies related to health disparities, and suggest some methods for conducting the informed consent process may be more useful than others.