More than 19,000 men and women, primarily from the countries and populations most affected by the AIDS pandemic, have so far participated in the clinical trials (925 volunteers) and related studies (18,234) that IAVI has sponsored at collaborating research centers.
We consider these volunteers partners—not subjects—in the search for a preventive AIDS vaccine. Research participants receive educational and health benefits. They are often motivated by feelings of altruism, wanting to help themselves, their families and future generations as partners in the search for an AIDS vaccine.
Eligibility for participation in clinical research varies with the particular objectives of the research and the regulatory requirements of the country in which it is conducted. But, in general, volunteers for AIDS vaccine trials must:
Understand the trial’s objectives, associated procedures, duration and the risks and benefits of participation when providing their consent
- Understand that their participation is voluntary and strictly confidential, and that they may withdraw from the study at any time, without penalty
- Meet the requirements for age and health stipulated in the trial protocol and the host country’s regulations
- Agree to HIV testing and HIV risk reduction counseling
- Women must not be pregnant and must use an effective method of contraception over the period defined in the trial protocol
- Understand that it is unknown whether the candidate vaccine to be tested in the trial prevents HIV infection
Protection of volunteers’ confidentiality, health, welfare and human rights are at the core of IAVI’s mission and values. In our work with people, we take guidance from:
- The International Conference on Harmonization’s Good Clinical Practice
- U.S. Federal Policy for the Protection of Human Subjects (The Common Rule, 45 CFR Part 46)
- UNAIDS/WHO documents "Ethical considerations in biomedical HIV prevention trials" (2007) and "Good participatory practices for biomedical HIV prevention trials" (2007)
- The independent ethics committees (also called Institutional Review Boards) established by national governments
- Scientific and regulatory authorities in countries, which review proposed trial protocols, informed consent forms and other study related materials.
- Community advisory boards, which often advise researchers on clinical trial and informed consent processes
IAVI’s research partners also ensure that volunteers are educated about their rights, and that informed consent processes and forms are socially and culturally appropriate. In addition, exit interviews are often conducted with volunteers as part of a continuous quality improvement process, helping to maintain the highest ethical standards in our work with volunteers.