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Demonstrating ‘respect for persons’ in clinical research: findings from qualitative interviews with diverse genomics research participants
  1. Stephanie A Kraft1,2,
  2. Erin Rothwell3,
  3. Seema K Shah4,5,
  4. Devan M Duenas1,
  5. Hannah Lewis1,
  6. Kristin Muessig6,
  7. Douglas J Opel1,2,
  8. Katrina A B Goddard6,
  9. Benjamin S Wilfond1,2
  1. 1Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington, USA
  2. 2Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA
  3. 3Obstetrics and Gynecology, The University of Utah School of Medicine, Salt Lake City, Utah, USA
  4. 4Stanley Manne Children's Research Institute, Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, USA
  5. 5Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
  6. 6Translational and Applied Genomics, Kaiser Permanente Center for Health Research Northwest Region, Portland, Oregon, USA
  1. Correspondence to Professor Stephanie A Kraft, Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA 98101, USA; stephanie.kraft{at}seattlechildrens.org

Abstract

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 (n=30) or Spanish (n=10) 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 (93%), identified as Hispanic/Latino(a) (43%) or non-Hispanic white (38%), reported annual household income under US$60 000 (70%) and did not have a Bachelor’s degree (65%); 30% had limited health literacy. We identified four key domains for demonstrating respect: (1) personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; (2) study communication processes, including following up and sharing results with participants; (3) inclusion, particularly ensuring materials are understandable and procedures are accessible; and (4) 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.

  • research ethics
  • informed consent
  • clinical trials
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Footnotes

  • Twitter @SeemaKShah

  • Contributors SAK obtained funding, designed the study, developed data collection tools, oversaw data collection and analysis, collected data, analysed data, and drafted and revised the manuscript. She is guarantor. ER and SS advised on study design, developed data collection tools, analysed data and revised the manuscript. DMD developed data collection tools, coordinated data collection, collected data, analysed data and revised the manuscript. HL developed data collection tools, collected data, analysed data and revised the manuscript. KM coordinated data collection and revised the manuscript. DO advised on study design, analysed data and revised the manuscript. KABG obtained funding, advised on study design, analysed data and revised the manuscript. BSW obtained funding, advised on study design, oversaw analysis, analysed data and revised the manuscript.

  • Funding This study was funded by NHGRI grant K01HG010361 (PI: SAK) and the Clinical Research Scholars Program at the Seattle Children’s Research Institute Center for Clinical and Translational Research (no award number, PI: SAK). Additional support was provided by the CHARM study (U01HG007292, MPIs: BSW, KABG) and the CSER Coordinating Center (U24HG007307) as part of the CSER consortium funded by NHGRI with cofunding from NIMHD and NCI. The contents of this paper are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. The CSER consortium thanks the staff and participants of all CSER studies for their important contributions. More information about CSER can be found at https://cser-consortium.org.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study was approved by the Kaiser Permanente Northwest Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon request.

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