AEGiS-14IAC: Informed consent in a phase II trial of the potential microbicide, CarraguardÃ‚Â®: lessons learned.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Informed consent in a phase II trial of the potential microbicide, Carraguard é «: lessons learned.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1354)

Friedland B, McGrory CE, Magwaza S, Marumo M, de Kock A, Sebola MH, Coetzee N
Population Council, New York, United States

BACKGROUND: Ensuring informed consent and voluntary participation in research is challenging, particularly when conducting complex trials in vulnerable populations. To address this, the informed consent form and procedures were evaluated before, during, and after a Phase II expanded safety trial of the potential microbicide, Carraguard, in South Africa.

METHODS: Independent researchers conducted focus groups and in-depth interviews using guides developed with Population Council researchers. Before the trial, the consent form was pilot-tested in the recruitment communities. Study staff then made significant revisions to the form and developed tools to aid comprehension (flip chart, recruitment script). Once the trial began, further research led the staff to modify existing materials and develop a study booklet with illustrations to further explain the study.

RESULTS: Although the original consent form was written at an 8th-grade reading level, respondents had difficulty reading it and were overwhelmed by the amount of information. Even after significant revision of the form (simpler language; clearer lay out), many respondents could not articulate the primary purpose of the study (safety vs. effectiveness). After the booklet was introduced, nearly all women understood the study purpose and some difficult research concepts, though "placebo" was still confusing to many. Participants also reported that one-on-one counseling sessions aided understanding and reaffirmed voluntary participation.

CONCLUSION: Informed consent is not a one-time event. Making informed consent meaningful requires a range of approaches and tools. Researchers must invest in ongoing assessment of the informed consent process and adapt it to meet the needs of study participants.

Keywords: AEGIS, Informed Consent, Clinical Trials, Consent Forms, Comprehension, Learning, Research Subjects, Ethics Committees, Research, Research Personnel, Research, Research Design, Vulnerable Populations, Counseling, Reading, South Africa, Human, Female, ethics

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