Respect for Persons in the Genomics Research Enrollment Process: Incorporating Diverse Experiences and Attitudes
Institution: Seattle Children's Hospital
FOA Number: PA-18-363
Stephanie Kraft, JD, is an Acting Instructor in the Division of Bioethics, Department of Pediatrics, University of Washington School of Medicine. She has a background in law and economics and has completed postdoctoral fellowships in bioethics at the Stanford Center for Biomedical Ethics and the Treuman Katz Center for Pediatric Bioethics at Seattle Children?s Hospital and Research Institute. Her prior work includes mixed methods studies related to informed consent and the ethical, legal, and social implications (ELSI) of genetics and genomics. In this career development award, she will develop further expertise in qualitative research, including deliberative stakeholder engagement techniques, and strengthen her skills in intervention development and evaluation, including biostatistical analysis. She will also build subject matter expertise in research ethics and informed consent, particularly as they relate to increasing diversity in genomics research. Her long-term career goal is to be an independent investigator building practical tools to support the inclusion of diverse patient populations in research, in order to ultimately reduce health disparities. By the end of the award period, she plans to have successfully obtained R01 funding to continue this project?s line of work. Environment: Ms. Kraft has the institutional support of the Treuman Katz Center at Seattle Children?s, the University of Washington, and the Institute of Translational Health Sciences, all of which offer significant academic and research resources that will support her in her career development and research success. In addition, her strong mentorship and advisory teams include experts in research ethics and informed consent, as well as a range of methodological skills and perspectives that will support her at all stages of the planned research. Ms. Kraft?s primary mentor is Benjamin Wilfond, MD, who offers nationally recognized expertise in research ethics, informed consent, and mixed methods research. Her co-mentors are Erin Rothwell, PhD, an expert in ELSI genomics and qualitative research, and Seema Shah, JD, an expert in research ethics and informed consent theory. Project advisors Douglas Opel, MD, MPH, and Katrina Goddard, PhD, will provide additional expertise and guidance on intervention development and evaluation. Research: This proposed project will identify and evaluate ways of demonstrating respect to prospective research participants from diverse backgrounds.
Aim 1 will qualitatively examine the context and values that inform participants? perceptions of respect and decisions about enrollment.
Aim 2 will use deliberative techniques to identify specific ways to demonstrate respect to prospective participants.
Aim 3 will select an intervention and evaluate its effects on respect and trust in a feasibility study embedded in an ongoing clinical trial. This project?s outcomes will inform a subsequent R01 proposal to further test the intervention?s effects on respect in different populations of patients who are historically underrepresented in research, which will contribute to efforts to ensure that diversity in genomics research mirrors that of the general patient population.
Public Health Relevance: This project will identify ways to demonstrate respect to prospective research participants that incorporate the perspectives of diverse patient populations who have been historically underrepresented in research. Demonstrating respect in a way that is meaningful to patients from diverse backgrounds has the potential to contribute positively to trusting, collaborative investigator-participant partnerships and to increase recruitment and retention in both the short term and the long term. By building such partnerships, investigators can increase diversity in genomics research, ultimately producing more generalizable and impactful research findings and reducing health disparities.
NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Jan 14, 2019
Dec 31, 2023