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All ethical guidelines for the protection of people in research have the three main principles of autonomy, beneficence and justice at their core. 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 biomedical HIV prevention trials, (2007)

Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials, revised: UNAIDS Guidance Document, 2011

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 or 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

This principle is the reason that studies include a detailed process of informed consent to fully explain a study and what will be involved, allowing time for questions and time to make a decision about whether or not to join.

Beneficence: Benefits Outweigh Risks

The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In research, beneficence is understood in a stronger sense. Two general rules are used to ensure beneficence in research: (1) do no harm, and (2) maximize possible benefits and minimize possible harms. An explanation of the risks and benefits is part of the informed consent process. The consent process also explains how participant safety will be monitored and protected.

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

The principle of justice guides how participants are selected to participate in research. For example, we would not enroll prisoners just because they would be easy to follow and could attend all of the study visits. Similarly, we do not enroll people from low- and middle-income countries just because it may cost less to do the studies there. The people who are enrolled must come from populations that stand to benefit from the research, and who are able to freely give their informed consent.

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 following Good Clinical Practice and Good Participatory Practice guidelines, and requiring external review of proposed studies by independent scientists.
  • Ethics review of all studies by the appropriate regulatory agencies and Ethics Committees in every country and location 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 likelihood for getting HIV, including information about new HIV prevention technologies such as PrEP and how to access these products.
  • Continually evaluating changes in language, culture, and policy to be sure that HVTN studies are inclusive, respectful, and culturally responsive.