The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)
As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.