Ethical considerations for enrolling "invested parties" in large-scale clinical studies: Insights from the RECOVER Initiative
Owens, K; Anderson, EE; Esquenazi-Karonika, S; et al., Ethics & Human Research
Published
September 2024
Journal
Ethics & Human Research
Abstract
Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.
Authors
Kellie Owens, Emily E Anderson, Shari Esquenazi-Karonika, Keith Hanson, Maika Mitchell, Janelle Linton, Jasmine Briscoe, Leah Castro Baucom, Liza Fisher, Rebecca Letts, Kian Nguyen, Brendan Parent
Keywords
conflicts of interest; human subjects research; informed consent; privacy; research ethics; self‐experimentation; study recruitment
Short Summary
Many research centers have general formal guidelines about whether and how employees can participate in research studies. However, these guidelines don’t always discuss the risks and benefits of researchers, staff, and community partners enrolling in studies they are involved in, which can create ethical questions. It is very important to consider these ethical questions for studies that aim to enroll large numbers of diverse participants.
All authors of this article are part of the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large study enrolling participants at multiple locations across the country. They used what they learned from RECOVER to address what’s currently missing from existing policy and ethics papers by creating a set of guidelines for how research studies can enroll researchers, staff, and community partners. The authors conclude that people should not be excluded from participating in their own research studies if certain requirements are met and there are rules to ensure everyone’s safety.