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
  1. Examine the use of public deliberation with vulnerable groups discussing a sensitive health topic.
  2. Describe the process by which public deliberation results in resolutions related to informed consent.
  3. Create a model briefing report for reporting on deliberation results and a guide on the use of public deliberation for engaging vulnerable groups in resolving barriers to clinical research on sensitive or stigmatizing health problems.
Approach Mixed methods; community engagement; screening surveys; public deliberations; pre- and post-deliberation surveys; stakeholder interviews

Project Information

Amelia S. Knopf, PhD, MPH, BSN
Trustees of Indiana University
Use of Public Deliberation in Diverse Communities to Improve Consent Processes for Clinical Research

Key Dates

August 2019
December 2024

Study Registration Information


Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: September 26, 2023