David Alex, Training Officer at YRG CARE, IAVI’s clinical research partner in India, speaking to men in the community to create awareness about HIV/AIDS, Saidapet, Chennai. Photo credit: Anirban Dutta
IAVI and its partners adhere to the highest ethical and scientific standards in the clinical research that informs the development of preventive vaccines, antibodies, and therapeutics. Volunteers are the foundation of IAVI’s clinical trials: their rights, dignity, confidentiality, health, and welfare are always protected.
In preparing for clinical trials and related studies, IAVI and its partners coordinate with surrounding communities to educate volunteers about vaccine research. IAVI also relies on counsel from Community Advisory Boards — groups of community representatives that advise us on various aspects of IAVI’s clinical research studies, such as recruitment procedures and the language used in the informed consent process.
The informed consent process includes a set of procedures and practices to ensure that volunteers clearly understand their rights and responsibilities as participants in clinical research. Trial information is reviewed with volunteers throughout the course of the trial, and informed consent materials and processes used by IAVI and its partners are tailored to local culture. Exit interviews are often conducted with volunteers as part of an ongoing quality improvement process.
Volunteers receive access to high quality medical services while participating in IAVI's trials. Specifically for IAVI’s HIV vaccine trials, these include voluntary HIV counseling and testing (VCT), basic health care, HIV risk-reduction, family planning counseling, and, should the need arise, referrals for HIV treatment or more complex medical problems. IAVI and partners develop and implement procedures for working with vulnerable populations such as women, adolescents, and men who have sex with men in a manner that minimizes the difficulties and social risks associated with participating in HIV vaccine research.
Standards We Follow
IAVI’s clinical research is informed by standard local, national, and international sources, including:
- The International Conference on Harmonisation Good Clinical Practice.
- United States 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 practice: Guidelines for biomedical HIV prevention trials” (2011).
- Independent ethics committees (also called Institutional Review Boards) established by local and national governments, universities, hospitals, etc.
- Scientific and regulatory authorities that review trial protocols, informed consent forms, and other study-related materials.
Toolkits for Research Center Staff
IAVI has published toolkits to provide guidance to individuals engaged in clinical and epidemiological research, including:
Assessment of Understanding Toolkit (Informed Consent)
