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Clinical Research Standards

Clinical Research StandardsSokomoto/IAVIIAVI and its partners adhere to the highest standards of ethics and quality in clinical research in the development of preventive HIV vaccines. Volunteers are the foundation of our clinical trials: their rights, dignity, confidentiality, health and welfare are protected at all times.

In preparing for clinical trials and related studies, we and our partners reach out to surrounding communities to educate participants about HIV vaccine research. IAVI also solicits and takes into account the advice of community representatives on various aspects of our clinical research studies, such as recruitment procedures and the language used in the informed consent process. Community Advisory Boards play a key role in such efforts.

IAVI has instituted procedures and practices to ensure that volunteers clearly understand their rights and responsibilites as participants in clinical research. Trial information is continually reviewed with volunteers throughout the course of the trial, and informed consent materials and processes employed by IAVI and its partners are tailored to local cultural contexts. 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 trials, including 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 works with research partners to develop and implement procedures for working with women, as well as men who have sex with men, in a manner that minimizes the difficulties and social risks associated with participating in HIV vaccine research.

IAVI has published several toolkits to provide guidance to individuals engaged in clinical and epidemiological research. 

IAVI receives guidance in the conduct of clinical research from standard local, national and international sources, including:

  • The International Conference on Harmonization’s 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 
  • Community Advisory Boards, which advise researchers on community issues, informed consent processes and other aspects of their work with volunteers