There is no one path to become a bioethicist. The researchers in bioethics apply their diverse training on a range of topics within medicine and science to research projects within the center and in collaboration with investigators throughout Seattle Children’s. Below is a sampling of research projects going on within the center.
Eliciting Navajo Values and Concerns About Genetic Research Studies
Nanibaa’ Garrison, PhD, is a member of the Navajo Nation who is conducting interviews with Navajo individuals to learn about their perspectives and attitudes on genetic research. In 2002, the Navajo Nation placed a moratorium on genetic research studies within their boundaries after consultation with tribal leaders, traditional healers, and Navajo physicians and scientists, some of whom suggested there needed to be a genetic research policy in place.
Recently, the members of the Navajo Nation began to discuss possibly lifting the moratorium. One requirement before the moratorium can be lifted is developing a policy to provide guidance for what types of genetic research projects would be considered, under what conditions, and with what safeguards in place. Navajo people, and indigenous people more broadly, continue to be starkly underrepresented in research, remaining at around a 0.05% participation rate for genome-wide association studies; thus, their communities might be missing out on any benefit from participation in this type of research.
To date, no empirical studies have been done to ask about key concerns, needs and desires of Navajo community members, health professionals, policy experts and tribal leaders regarding this topic. Garrison, in collaboration with geneticist Katrina Claw, PhD, and environmental health scientist Clarita Lefthand-Begay, PhD, both Navajo and both at the University of Washington, hopes to learn:
- What would the Navajo community want to see included in a genetic research policy?
- What cultural principles should the policy have for the management of genetic study data, biospecimen storage, and results?
This work, funded by the CCTR Pediatric Pilot Funds, will influence policy of the Navajo Nation, and may inform the development of guidelines for other tribes and the National Congress of American Indians’ Policy Research Center.
Integrating Patient Values Into Precision Medicine Research
Stephanie Kraft, JD, in her Patient Values and Attitudes About a Library of Medical Information: Uses of EHRs and Samples in Research study, is asking how best to integrate patient values into institutional structures for precision medicine research. The practical application of this question has her exploring how research institutions can build trust with patients from diverse racial and ethnic backgrounds through recruitment, consent, oversight and other interactions. Specifically, she is looking at:
- How building trust and engaging with patients can contribute to goals of justice and equity across healthcare.
- What effect metaphors and multimedia can have on patient understanding of research.
Kraft SA, Cho MK, Gillespie K, Halley M, Varsava N, Ormond KE, Luft HS, Wilfond BS, Lee SS. Beyond consent: Building trusting relationships with diverse populations in precision medicine research. American Journal of Bioethics (in press).
Cho MK, Varsava N, Kraft SA, Ashwal G, Gillespie K, Magnus D, Ormond KE, Thomas A, Wilfond BS, Lee SS. Metaphors matter: From biobank to a library of medical information. Genetics in Medicine (in press).
Balancing Harm and Benefit in Human Challenge Trials: A Closer Look at Zika Virus
Recent outbreaks of Ebola and Zika viruses have exposed the dangers posed by emerging infectious diseases and the need for epidemic preparedness for potential future threats. Human challenge trials are studies where healthy volunteers are infected with a virus so that scientists can learn more about it. Seema Shah, JD, chaired the NIH Ethics Consult with a group of experts from various disciplines and federal agencies in the U.S. who debated if human challenge trials for Zika would be ethical—for instance, could they do more harm than good? Systematic ethical analysis of human challenge trials is a relatively recent endeavor, and has been limited in scope and application. Ethical questions that the committee considered included:
- How should we protect and respect participants given the limited time and capacity to conduct and review research?
- How should we engage communities?
- When can novel and controversial research designs be used ethically?
- When should experimental medications be made available?
The committee’s report, Ethical Considerations for Zika Virus Human Challenge Trials, stated that while Zika human challenge trials could be ethically justified, the committee felt it would be premature to proceed with these at present, given the many unknowns about the Zika virus, the relatively high mortality for people infected with Ebola virus disease, and the limited treatment and prevention options.
With funding from The Greenwall Foundation, Shah plans to address unresolved ethical questions such as do volunteers understand the risks and have good reasons to participate in challenge trials? She will work with stakeholders, researchers and ethicists in collaboration with WHO, NIH and PATH to develop a framework to determine when and how challenge trials in emerging infectious diseases are ethically acceptable. Some questions she hopes to answer include:
- Is it better to conduct a Zika virus challenge trial in a region that doesn’t face the threat of a Zika epidemic and the risks involved, or one that does?
- If there is a risk that a disease studied in a challenge trial might spread to some members of the community, what level of risk is acceptable, and how can that risk be ethically justified?
Additionally, Shah is collaborating with CCTR member and infectious disease researcher Janet Englund, MD, on a project to examine ethical issues in maternal respiratory syncytial virus (RSV) vaccination research, such as what should be offered to participants after trials are over.
Shah SK, Kimmelman J, Lyerly AD, et al. Ethical considerations for Zika virus human challenge trials: Report & recommendations. February 2017.
Developing a Conceptual Framework for Shared Decision Making in Pediatrics
Doug Opel, MD, MPH, is known for his work on provider-parent communication related to acceptance of recommended vaccines in children, especially for vaccine-hesitant parents. He has funding from The Greenwall Foundation to develop a conceptual framework for implementing shared decision making (SDM) in pediatrics. Though based on prior conceptual work on SDM in the adult setting, this framework accounts for salient differences in decision making between pediatric and adult medicine, such as the involvement of a competent adult patient versus a surrogate decision maker, as well as the limits of parental decision-making authority. It also incorporates several decisional characteristics, such as whether the proposed intervention is longitudinal (versus single event), provider- implemented (versus parent-) and high (versus low) urgency. This research will help to calibrate the type of SDM approach utilized.
The main objective of this work is to assess the validity and feasibility of this framework across pediatric disciplines through input from a geographically diverse panel of experts in pediatrics, communication and ethics. To this end, Opel is collaborating with a cross-disciplinary working group of CCTR members Carrie Heike in craniofacial, Elliott Weiss in neonatology, Abby Rosenberg in hematology-oncology, Seema Shah in bioethics and Jonna Clark in critical care.
Opel DJ. A push for progress with shared decision-making in pediatrics. Pediatrics. Feb 2017:139(2).
— Ellen Kuwana, MS