Project Summary
One of PCORI’s goals is to improve the methods that researchers use for patient-centered outcomes research. PCORI funds methods projects like this one to better understand and advance the use of research methods that improve the strength and quality of comparative effectiveness research.
What is the project about?
Before people enroll in a research study, they must first learn what the study is about and the benefits and risks of taking part. This process is called informed consent. Informed consent can be a challenge for researchers when the research topic is sensitive or when people may be vulnerable to harm. For example, teens have higher than expected rates of HIV infection. Researchers can’t include teens in studies without a parent’s consent. But teens may not feel comfortable asking a parent if they can take part in an HIV study. If teens don’t take part in studies, researchers can’t learn which treatment and prevention methods work for teens.
In this study, the research team wants to learn if a method called public deliberation improves informed consent for people who are vulnerable to harm or have sensitive health issues. In public deliberation, people learn about an issue that affects their community and work together as a group to develop solutions.
How can this project help improve research methods?
Results may help researchers use public deliberation to deal with sensitive issues around informed consent.
What is the research team doing?
The research team is recruiting 102 people to take part in public deliberations about minors giving consent to take part in HIV research. The deliberations are taking place in Baltimore, San Francisco, and Tampa. Participants include teens, parents or guardians of teens, and community leaders. Other community members affected by HIV or with experience in minor consent for HIV research are also taking part.
The research team is holding deliberations for two weekends in each city. At the deliberations, participants
- Receive information on informed consent for vulnerable groups taking part in HIV studies
- Hear different points of view from experts
- Take part in discussions
- Come up with solutions
The research team is surveying participants before and after the deliberations. Surveys ask about how concerned people are about HIV in the community, stigma, and if youth can consent to research. The team is interviewing 15 participants to learn how useful the deliberation was. Finally, the team is creating a guide to help researchers use public deliberation with vulnerable groups for sensitive health topics.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Goal |
|
| Approach | Mixed methods; community engagement; screening surveys; public deliberations; pre- and post-deliberation surveys; stakeholder interviews |