Informed Consent

• Pages: 171-172

Contenidos

• The Issue.
• Legal and Policy Considerations.
• Practice Example.
• References.

Page 171

The Issue

Informed consent, which stems from the ethical principle of respect for persons, is important to protect individuals from the harms of research. It is a process through which competent persons can choose freely whether to participate in research. Obtaining informed consent begins when a participant is first contacted about the study and only ends when the study is complete and participant risks have subsided. Informed consent involves ascertaining an individual's capacity to consent as well as adequately communicating relevant risks, benefits, and rights concerning the research.

In the context of HIV research, concerns about competency, language, literacy, or cultural barriers often arise. Obtaining informed consent may include consent to be tested for HIV and should be accompanied by pre-and posttest counseling. HIV vaccine research may require counseling about the need to take precautions to avoid contracting the infection. Physiological, psychological, and social risks associated with HIV-related research should be carefully explored and explained to participants in ways they understand. Potential benefits of participating in research should also be explained in a way that does not unduly influence an individual's choice.

Legal and Policy Considerations

Pursuant to the Declaration of Helsinki and corresponding legal norms, informed consent is generally required of any person who participates in research, which includes research involving data or biological samples from the participant. Informed consent must meet specific requirements to be valid. The person consenting must be competent. Certain information must be disclosed to the potential participant (e.g., the right to withdraw from the study, potential risks and benefits, or compensation for resulting harms). The consent must generally be documented in writing and renewed every time the research protocol is modified or extended. The entire informed consent process must be approved by an appropriate ethics board. For individuals who lack the capacity to consent (e.g., minors, mentally disabled), a legally-recognized representative may provide consent subject to additional safeguards.

Concerning international research, HIV research may have to adhere to the legal requirements for informed consent in the sponsoring and host countries. Special precautions must be taken to...