R3 Seminar Recap: Ethical considerations for enrolling “invested parties” in large-scale clinical studies: Insights from the RECOVER Initiative
A RECOVER researcher and Representatives share that “invested parties” can ethically participate in clinical research they conduct or design with appropriate safeguards in place.
During the January 28th RECOVER Research Review (R3) Seminar, Dr. Kellie Owens, PhD (NYU Grossman School of Medicine) shared ethical guidance for enrolling individuals in clinical studies who have direct involvement with the research. Dr. Owens was joined by co-authors Leah Castro, MA (RECOVER Community and Caregiver Representative) and Rebecca Letts (RECOVER Patient and Caregiver Representative), who described Representatives’ important role in designing RECOVER clinical studies and developing peer-reviewed research publications.
Watch the R3 recording below or on YouTube
Dr. Owens summarized a recent RECOVER article highlighting ethical concerns and recommended safeguards to protect invested parties choosing to enroll in their own studies. Invested parties were described as individuals with “strong motivations to study the condition or intervention and to participate as study subjects.” These individuals may include investigators (researchers who are involved in running a clinical trial or research study), research staff, and patients, caregivers, and community members affected by the disease or intervention who have direct involvement with the study.
Previous study enrollment policies focused on preventing researchers from enrolling individuals who they have authority over (e.g., professors enrolling students), and preventing researchers from performing self-experimentation. However, there is not a universal policy that governs research staff enrolling themselves into studies, leaving the decision up to each research site’s institutional review board (a committee that reviews research studies to protect the rights, safety, and well-being of human participants).
The authors believe invested parties should be able to enroll as study participants so long as the clinical studies continue to meet the following ethical requirements:
Social or scientific value – The study should be able to improve health or well-being or increase knowledge about the issue being studied.
Scientific validity – The study uses accepted scientific methods and principles.
Fair subject selection – Vulnerable populations or communities should not be targeted to take part in studies where risks outweigh the benefits. People in positions of power should not be favored for beneficial research.
Favorable risk-benefit ratio – The risk from participating in a research study should be minimized and benefits should be maximized as much as possible.
Independent review – A review of the study design should be conducted by individuals not affiliated with the research to avoid conflicts of interest.
Informed consent – Study participants should understand the purpose of the research; how the research will be conducted; risks, benefits, and alternatives to taking part; and other relevant study information.
Respect for potential enrolled subjects – Participants should be able to withdraw (or quit) the study, if necessary, have their privacy and personal information protected, and be informed of new benefits or risks to taking part in the study.
Dr. Owens concluded her presentation by offering practical advice and guidelines for individuals who make decisions about clinical study enrollment.
RECOVER Representatives Leah Castro, MA and Rebecca Letts joined Dr. Owens for a Q&A session where they discussed the importance of including patients, advocates, and community members’ lived experiences in Long COVID research. Letts shared how her experience as both a RECOVER research participant and Representative helped improve study design for a RECOVER clinical trial. Additionally, Ms. Castro described the variety of ways Representatives can contribute to RECOVER research publications.
The Representatives also explained how people can get involved in research beyond being a study participant. They shared that interested individuals can find research representative roles by visiting clinical study websites. Additionally, patients can ask their primary care provider if they are aware of studies for people with symptoms or experiences common to theirs.
To find recordings and transcripts of more R3 seminars, visit the RECOVER YouTube channel and the R3 webpage.