- To provide an overview of research ethics: origins, guidelines, principles
- To provide an overview of community engagement: models, challenges, vulnerability and targeted populations
- To examine the dynamics of North‐South research
- To present the concept of standard of prevention and care for trial participants
- To encourage participants to consider the dilemmas presented by the use of ARVs for prevention vs. treatment
- Ethics is a way of understanding and examining what is “right” and what is “wrong”
- 3 key principles of ethics are: Respect for Persons; Beneficence/Non‐Maleficence; Justice/Non‐Exploitation
- Protection of the study participants is the most important responsibility of the researcher
- Research participants will face potential benefits and risks ‐ ethics is about finding the balance between these and ensuring that participants are able to weigh the risks and benefits
- Trial participation does not increase a person’s risk of HIV infection. People will become infected during the trial but not because of the trial. People in both arms should have lower HIV prevalence than people in the general community because of access to the “gold standard” of prevention
- Informed consent is an ongoing process of collaborative communication and decision making throughout the trial, not just the signing of a form
Discussion (slide 5):
Have participants explain what comes to mind when they see these terms:
Discussion (slide 25):
Have participants discuss:
- What are good ways to convey this kind of information to people to ensure that if they agree to participate in a study, they are giving informed consent?
- How do you know if people have understood the information and are making a free choice to participate?
Case study discussion (slide 28):
After reviewing slide 27, have participants discuss questions on this slide:
- In this instance, how should one balance respect for persons with respect for culture?
- Should sexual partners be involved? Are there creative strategies for encouraging partner engagement?
- What might you recommend as an appropriate way to respect both of these values in this instance?
Discussion (slide 85):
After presenting slide 84, have participants read over the handout Thai PrEP Trial‐ Listserv Dialogue. Raise the following questions for discussion:
- Which ethical principles are potentially being violated in the Thai PrEP trial?
- Should the researchers be expected to provide needle exchange when such programs are not available in Thailand?
- How could the trial have been designed to be more ethical?
- What impact do you think these ethical concerns have on the validity of the trial results?
Debate (slide 92):
Divide participants into 2 groups.
- Group 1: Form three arguments for focusing ARV distribution globally on treating people already infected with HIV
- Group 2: Form three arguments for focusing ARV distribution globally as a prevention method with those who are not yet infected
- Plenary debrief: which argument is more convincing and why?
- Consensus statement