Ethics of HVTN Trials
Back to HVTN Trial Basics
A number of internationally recognized codes of ethics have been developed since World War II to ensure the protection of human participants in biomedical research. They include:
The Nuremberg Code, 1947
Declaration of Helsinki, 1964 (last updated in October 2000)
The Belmont Report, 1979
The CIOMS Guidelines, 1982 (last updated in 2002)
Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document, 2000
Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials, revised: UNAIDS Guidance Document, 2011
All ethical guidelines for the protection of people in research have the three main principles of autonomy, beneficence and justice at their core:
Autonomy - respect for persons
"The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated so as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him [or her] to make an understanding and enlightened decision." —The Nuremberg Code
Beneficence - benefits outweigh risks
"Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of scientific literature." —Declaration of Helsinki
Justice – selection of participants is equitable
"The selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g. welfare patients, particular racial and ethnic minorities, or groups confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied." —The Belmont Report
How the HVTN addresses ethics
The HVTN works to address many ethical concerns that arise in HIV prevention research. Some of the things we do to address ethical concerns include:
Conducting studies according to scientifically rigorous standards, such as Good Clinical Practice and Good Participatory Practice guidelines, and requiring external review by independent scientists.
Ethics review of all studies by the appropriate regulatory agencies and Ethics Committees in every country where a study will be done.
Incorporating the principles of autonomy, beneficence and justice into the design and conduct of all HVTN studies and all Network policies.
Ensuring substantive community input into the planning, conduct, and follow-up of all HVTN research, as well as at the local level through community consultations with our research sites.
Ensuring that all study participants receive state-of-the-art counseling about how to reduce their risks for HIV infection, including information about new HIV prevention technologies and how to access them.
In Science:
Why is an HIV vaccine needed?
Types of Vaccines
Using Antibodies for HIV Prevention
How HVTN Study Products are Developed
How Vaccines Work