Study Design
Guiding Principles for Returning Results to Participants in the Connect for Cancer Prevention Study Marie-Josephe Horner* Marie-Josephe Horner Horner Horner Horner Horner Horner Horner Horner Horner Horner Horner Horner Horner Horner Horner National Cancer Institute, NIH
Today’s study participants may ask or expect to receive timely research results, which embodies a shift from passive study involvement toward active engagement and partnership in the research process. However, implementing return of results in modern, general population cohorts is not straightforward. The what, when, and how of returning different types of results require careful consideration of ethical principles, and potential benefits and harms to participants and the study. On the one hand, return of a particular result can build trust and partnership with participants, enhance the participant experience, and improve retention and engagement. But it can also cause unforeseen negative impacts on the study and potential harms to participants, such as false positive results that lead to unnecessary clinical follow-up. Furthermore, analytic and clinical uncertainties surrounding a given result must be clearly conveyed to a lay audience, which can be challenging. During cohort study design, researchers need to find a balance between potential benefits, harms, and practical feasibility. Here, we will discuss our Guiding Principles for Returning Results in a new cohort, the Connect for Cancer Prevention Study (Connect). Early feedback in Connect shows that some participants desire full and timely access to results, captured by the sentiment, “we want it all, we want it now”, while others are less interested in receiving results, and cite altruism—rather than the desire for research results—as their primary motivation for participating in the study. In the context of these varied expectations, we outline six Guiding Principles: transparency of the research process, respect for participant autonomy, participant ownership of donated data, education, and privacy and confidentiality. We also share our framework to support thoughtful decision-making about how to return different types of results and explore trade-offs in modern cohort study design.