The Problem: The consent process offers patients the opportunity to learn about a research study, think about its risks and benefits, and decide whether to participate. To create a fair and acceptable consent process, it is important to have patients, families, communities, researchers, and scientists provide input.
Researchers have difficulty with consent processes when the patient population is vulnerable or the health problem is sensitive. When a vulnerable population needs to be involved in research on a sensitive topic, the difficulties with consent become even more complicated. For example, teenagers have higher than expected rates of HIV infection, which means it is important to include them in HIV prevention studies. But the teens at highest risk of HIV infection are members of a vulnerable population—sexual and gender minorities, sometimes called LGBTQ teens. These teens say they do not feel comfortable asking a parent or guardian for permission to join HIV studies, but scientists are rarely allowed to include them without parental permission.
Research indicates when parental permission is required, teens do not join studies on sensitive topics. When teens do not join studies, scientists are unable to say whether medicines and prevention tools are appropriate for them. This cycle contributes to HIV disparities. Researchers experience difficulties with complex ethical issues in other populations (e.g., those with cognitive impairments) and other sensitive health problems (e.g., substance use disorder). These issues are not easily resolved using traditional research methods, because solutions require careful consideration of facts and opinions, as well as the opportunity to compromise for the greater good.
A Solution: This project will test public deliberation to see if it is a useful method for gathering community input to improve consent processes for clinical research with vulnerable populations and sensitive health problems. Public deliberation involves gathering a group of community members for two weekends of in-depth education, presentations of conflicting perspectives from experts and key stakeholders, facilitated discussion, and development of resolutions about the best way forward.
Desired outcomes: We hope that public deliberation helps improve research consent processes by allowing people with different perspectives and concerns to come together to develop resolutions that are acceptable and fair to everyone. We chose minor consent to HIV research as our topic, which will allow us to use the deliberation results to inform current policy on minor consent. If the deliberation proves useful, we will develop a deliberation toolkit for other researchers to use with different communities and different health problems.
Importance to Patients and Meaningful Patient Engagement: Public deliberation is patient engagement. Patients and other stakeholders (ethicists, researchers, patient advocates) will be involved in every phase of this project. National and international research networks, scientists, and regulatory agencies (e.g., the US Food and Drug Administration) have called for resolution to consent-related problems in order to improve youth access to HIV research. This project has important implications for HIV prevention among a high-risk population, but is also broadly applicable to other sensitive health problems, including serious mental illness and substance use disorder.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.