Population Council | Microbicides | Improving the Informed Consent Process in Clinical Trials

PROJECT
Improving the Informed Consent Process
in Clinical Trials

Ensuring truly informed consent and voluntary participation is important for all human clinical trials and is a key component of the Population Council’s work on microbicides. The informed consent process was carefully studied during the Carraguard® expanded safety and acceptability trials in South Africa.

Pilot testing of the original informed consent form among women in the study communities underscored that although the original forms were comprehensive, several main aspects of the study needed to be conveyed more clearly. Working with study staff from the two sites in South Africa, Population Council researchers substantially revised the informed consent process and forms before beginning the actual expanded safety trial.

Throughout the expanded safety trial, the research team continued to work to improve the informed consent documents and process. After the initial pilot testing, the informed consent forms and process were tested again with the first 20 women who were enrolled in the trial. Local qualitative researchers, who were not part of the study team, conducted in-depth interviews with women within 14 days of enrollment and again after the women had been in the study for two months. Women's understanding of the purpose of the study and the steps to be followed were assessed. Based on these interviews, minor modifications were made to the informed consent forms, and a study booklet was developed to explain difficult concepts through pictures and analogies.

A final assessment of the informed consent process was conducted following completion of the trial. This evaluation revealed that the booklet had considerably aided participants’ comprehension of trial concepts. Using findings from this assessment, staff members at the Council and study sites adapted the informed consent forms, enrollment materials, and study booklet for the large-scale efficacy trial recently completed in South Africa. They also developed a 20-minute video to introduce and describe the study to potential participants and the communities in which the trial was taking place. The video visually explains difficult concepts like “microbicide,” “randomization,” and “double-blind," and addresses several themes—voluntary participation, HIV testing, partner issues, gynecologic exam—that were identified as essential to truly informed consent and freely chosen participation.

The materials were made available in three local languages in addition to English: Zulu at the Durban site, Xhosa at the Cape Town site, and Setswana at the Medunsa site.