2014 Year in Review. Treuman Katz Center for Pediatric Bioethics

Transcription

1 2014 Year in Review Treuman Katz Center for Pediatric Bioethics

2 Benjamin Wilfond, Director, Treuman Katz Center for Pediatric Bioethics Our Mission To improve the lives of children and their families by enhancing ethical deliberation in pediatric healthcare and research. The Treuman Katz Center for Pediatric Bioethics had a busy year in Three major highlights are: Guild Association Award Creates Nursing Bioethics Program: With the Department of Nursing, we created a nursing bioethics program to train two nurse leaders in bioethics. These two nurses will in turn train unit-based nurse bioethics liaisons to enhance the bioethics culture on the front lines in the hospital. Ten-Year Anniversary of Our Bioethics Conference Sparks Philanthropy Campaign: We marked the 10-year anniversary of our annual bioethics conference, which draws 200 attendees each year. The focus of the 2014 conference was research ethics. In honor of the 10-year milestone, we kicked off a philanthropy campaign to seed funds for new bioethics research programs. This campaign raised close to $100,000. Center Undergoes External Review: Three distinguished bioethicists from outside institutions conducted a 2-day program review. The reviewers gave recommendations for faculty recruitment, further integration with clinical programs, collaboration with Seattle Children s Research Centers, expanding community outreach and opportunities for philanthropy. The information in the 2014 Year in Review provides updated information about the efforts of our faculty, fellows and staff to improve the lives of children and their families. 2 Treuman Katz Center for Pediatric Bioethics

3 10 faculty, 4 affiliate faculty, 5 staff members and 3 fellows continue to advance our understanding of ethical issues through a diverse collection of projects and studies. Faculty News Holly Tabor was promoted to Associate Professor. Doug Diekema was honored with the William G. Bartholome Award by the American Academy of Pediatrics and also received the Stanley Stamm Role Model in Medicine Award from the Seattle Children s Pediatric Residency Program. Paul Mann was elected to the Society for Pediatric Research. FACULTY Jonna Derbenwick Clark, MD, MA Douglas Diekema, MD, MPH Ross Hays, MD Maureen Kelley, PhD Mithya Lewis-Newby, MD, MPH AFFILIATE FACULTY Paul Mann, MD Denise Dudzinski, PhD, MTS Douglas Opel, MD, MPH Anna Mastroianni, JD, MPH Abby Rosenberg, MD, MS Helene Starks, PhD, MPH Holly Tabor, PhD David Woodrum, MD Benjamin Wilfond, MD seattlechildrens.org/bioethics 3

4 PRESENTATION HIGHLIGHTS Douglas Diekema Revisiting Assent in Pediatric Research and Clinical Care and Complementary and Alternative Medicine. American Academy of Pediatrics National Conference and Exhibition. San Diego, CA. October Maureen Kelley Assessing Public Attitudes about the Ethics of Research on Medical Practice. American Society for Bioethics and Humanities Annual Conference. San Diego, CA. October Mithya Lewis-Newby Managing Conscientious Objections in the ICU: American Thoracic Society Recommendations. American Society for Bioethics and Humanities Annual Conference. San Diego, CA. October Scholarship 52 presentations including 21 at national and international meetings 50 publications including 24 peer-reviewed papers and 9 editorials, commentaries and letters Selected Publications: - Clark J. Who decides who should benefit: Allocating critical care in the context of futile treatment. Critical Care Medicine 2014;42: Guon J, Wilfond BS, Farlow B, Brazg T, Janvier A. Our children are not a diagnosis: The experience of parents who continue their pregnancy after a prenatal diagnosis of trisomy 13 or 18. American Journal of Medical Genetics Part A 2014;164A: Johnson EM, Diekema DS, Lewis-Newby M, King MA. Pediatric triage and allocation of critical care resources during disaster: Northwest provider opinion. Prehospital and Disaster Medicine 2014;29: Kett JC, Woodrum DE, Diekema DS. A survey of fetal care centers in the United States. Journal of Neonatal-Perinatal Medicine 2014;7: Magnus DC, Wilfond BS, Caplan AL. Accepting brain death. New England Journal of Medicine 2014;370: Rosenberg AR, Orellana O, Dussel V, Kang T, Geyer JR, Feudtner C, Wolfe J. What s missing in missing data? Omissions in survey responses among parents of children with cancer. Journal of Palliative Medicine 2014;17: Taylor JA and Opel DJ. Using the placebo effect to treat cold symptoms in children. JAMA Pediatrics 2014;168: Wolf ER, Opel DJ, DeHart MP, Warren J, and Rowhani-Rahbar A. The impact of the pertussis epidemic on infant vaccination in Washington state. Pediatrics 2014;134: Yu JH, Harrell T, Jamal SM, Tabor HK, Bamshad MJ. Attitudes of genetics professionals toward return of incidental results from exome and whole genome sequencing. The American Journal of Human Genetics 2014;95: Treuman Katz Center for Pediatric Bioethics

5 PRESENTATION HIGHLIGHTS Douglas Opel Identifying, Understanding, and Talking with Vaccine- Hesitant Parents. International Symposium on Vaccine Hesitancy, Fondation Mérieux. Veyrier-du-Lac, France. September Holly Tabor My46 and Self-directed Results Management: Operationalizing Choice for Return of Results from Exome and Whole Genome Sequencing. National Leadership Selected Highlights: Jonna Clark, Ethics Committee, United Network for Organ Sharing Douglas Diekema, Ethics Committee, American Board of Pediatrics Mithya Lewis-Newby, Ethics Committee, American Thoracic Society Holly Tabor, Senior Editor, PLOS Genetics American Society of Bioethics and Humanities Annual Meeting. San Diego, CA. October Benjamin Wilfond Articulating the Goals and Assessing the Impact of Bioethics Projects. American Society of Bioethics and Humanities Annual Meeting. San Diego, CA. October Benjamin Wilfond, Chair, Clinical Research Ethics Consultation Collaborative, CTSA Consortium, National Center for Advancing Translational Sciences seattlechildrens.org/bioethicsh cs 5

6 Funded Research Projects 6 New Projects (11 submitted) Selected Highlights: Kate Gentry, Informed Consent in Pediatric Anesthesia (Pilot Award, Center for Clinical and Translational Research, Seattle Children s Research Institute) Abby Rosenberg, (KL2 Multidisciplinary Clinical Research Training Program, Institute of Translational Health Sciences, University of Washington) Abby Rosenberg, Promoting Resilience in Stress Management (PRISM): A Novel Intervention (CureSearch for Children s Cancer) Holly Tabor, Innovative Approaches to Communication and Dissemination of Genetic Testing Results: Characterizing Parent Perspectives on Patient-Centered Outcomes Research (Pilot Award, Center for Clinical and Translational Research, Seattle Children s Research Institute) Cathie Rea and Holly Tabor, Nursing Bioethics Liaison Program (Focus Program Award, Seattle Children s Guild Association) 6 Treuman Katz Center for Pediatric Bioethics

7 Consultation Our clinical ethics consultants completed 45 consults in Most common topics: treatment decisions (21), limitation of life-sustaining treatment (14), benefit/harm assessment (5), disclosure of results/information (2) - Most frequent requesting services: cardiology, general pediatrics, medically complex child service, NICU, PICU, palliative care, parent, psychiatry, pulmonary, social work, transplant Our research ethics consultants completed 11 consults in Most common topics: disclosure of results/information (3), legal/regulatory (2), data and safety monitoring (2) - Most frequent requesting services: biostatistics, biotechnological and pharmaceutical companies, epidemiology, parent, pulmonary, stem cell and regenerative medicine 10th Annual Conference In 2014, 204 clinicians and scholars from the U.S. and worldwide attended New Opportunities, New Challenges: Exploring the Ethical Boundaries of Pediatric Researchh. This conference marked the 10-year anniversary of this popular educational offering; the first conference also focused on research ethics. Questions discussed at the conference included: Should there be constraints on investigations using social media that allows researchers to eavesdrop on adolescent behavior? Is it ever acceptable to conduct research in developing countries that would be considered inappropriate in the United States? Is truly voluntary consent possible in situations where parents of seriously ill children are desperate for new therapies, even if in early phase trials? New Opportunities, New Challenges: Exploring the Ethical Boundaries of Pediatric Research L Tenth Annual Pediatric Bioethics Conference seattlechildrens.org/bioethics 7

8 Bioethics Fellows Jen Kett, MD is a neonatologist who completed her bioethics fellowship; her Master s thesis was The Prenatal Consultation for Extremely Preterm Neonates. Her research continues to focus on prenatal counseling with families facing the birth of a critically ill infant and the impact of multidisciplinary fetal diagnostic and treatment centers on these families. In 2014 she started a fellowship in palliative care at the University of Washington and Seattle Children s Hospital. My bioethics training has changed the way that I think about and practice medicine. I am more aware of difficult ethical issues that arise during patient care and am more skilled in navigating them. I am a more sensitive clinician who is better able to understand team dynamics and make certain that everyone s voice is heard. I am a more effective leader; I have learned how to enter situations where the stakes are high and emotions are strong, and help to develop an appropriate solution that all parties can embrace. I am also a better teacher; I have learned how to communicate difficult concepts in a way that can engage trainees across levels. I had expected to learn a great deal during my fellowship, but I learned much more than I expected and had a truly wonderful time along the way. Jen Kett Aaron Wightman, MD completed his bioethics fellowship in conjunction with a nephrology fellowship; his Master s thesis was Neurodevelopmental Status as Criteria for Pediatric Solid Organ Transplantation Eligibility. He s currently involved in projects examining decision making in infants with end-stage kidney disease; candidacy for solid organ transplant; and resource allocation in care for children with chronic conditions. He is currently Assistant Professor, Division of Nephology, Department of Pediatrics and Department of Medical History and Ethics, University of Wisconsin School of Medicine and Public Health. 8 Treuman Katz Center for Pediatric Bioethics

9 2013-present Tracy Brazg, MSW, MPH, MA is doing the fellowship in conjunction with pursuing her PhD in the UW School of Social Work. She is interested in strengthening the connections between social work and bioethics, in terms of scholarship, teaching and interprofessional practice. She completed the Bioethics Master s program in 2014; her thesis was Minimizing Disparities of Power in Clinical Ethics Consultation: A Place for Patient Advocacy present Kate Gentry, MD is doing the fellowship while being an attending anesthesiologist at Seattle Children s. Her research interests include the informed consent process for anesthesia and provider-parentchild communication in general. She is conducting an empirical study of how anesthesia providers communicate with families pre-operatively present Daniel Benedetti, MD started the bioethics fellowship this year following residency and prior to beginning a hematology/ oncology fellowship at Dana-Farber Cancer Institute. He is conducting an empirical research project examining communication at the time of a cancer diagnosis in pediatric patients in the context of family refusal of recommended treatment. seattlechildrens.org/bioethicstle c 9

10 Spotlight on Research Assessing Public Attitudes about Research on Medical Practices Most people think of clinical research as testing a new drug, but often medical research takes place in clinics and hospitals in the form of medical record review or randomized trials of already approved medications. There is not yet consensus about how to think about the risks and benefits of this type of research to participants and how to approach the informed consent process. In September 2013, the NIH funded four projects to better understand the public s views. These studies took place against the backdrop of concerns from the U.S. Office for Human Research Protections (OHRP) that the risks of this type of research and risks of usual medical care are equivalent. Bioethicists Exploring Stakeholders Viewpoints Dr. Wilfond has been conducting one of the four NIH-funded projects with Treuman Katz Center faculty and staff Maureen Kelley, Doug Diekema, Ellen Kuwana and Katie Porter. The project, Attitudes about the Ethics of Research on Medical Practices, called ROMP for short, is being conducted in collaboration with researchers at the University of Washington and Stanford University. What Patients Think: The ROMP team conducted an online survey of 1,095 adults located across the United States. Respondents were each presented with key features of research on medical practices via three narrative videos. These 3-minute videos explained in plain language the factors that influence variation in clinical practice, randomization and medical record review, and different approaches to notifying patients about research and obtaining consent to participate. The study findings, which were recently published in the Annals of Internal Medicine, provided additional clarity on potential participants preferences when it comes to securing consent to participate and the disclosure of risks associated with being in these studies. Patients want to be told about this research, whether it involves reviewing their medical records or randomizing them to different treatments, explains Dr. Wilfond. While patients prefer written permission for all research, most are comfortable with the simpler process of verbal permission or notification if doing so would make the research more feasible. 10 Treuman Katz Center for Pediatric Bioethics

11 What Institutional Review Board (IRB) Members Think: The ROMP team also conducted an online survey of 601 IRB members. This puts us in a position to see differences between IRB members and the public, Wilfond explains. What the team discovered is that fewer IRB members believed written consent was necessary for medical record review but more IRB members thought this was necessary for randomized ROMP studies. How do we reconcile these two discordant views? OHRP Draft Guidance Issued In October 2014, OHRP released draft guidance stating that when a study compares two already-approved treatments, being in that study constitutes a research risk (as distinguished from the potential risk to patients receiving the same treatment from their doctor outside of a research study) and should be disclosed to participants as such. Consent would not be necessary, however, for medical record review. The ROMP study does not support the position that OHRP took regarding risk and consent. We think that OHRP is mistaken and we presented our preliminary findings at an Institute of Medicine Workshop and to the NIH Collaboratory. We published an article in the February 2015 issue of Pediatrics criticizing the OHRP approach and proposed an alternative approach in the December 2014 The Hastings Center Bioethics Forum. We hope that the data we ve gathered informs this debate and influences policy, Wilfond concludes. This project is supported by the National Center for Advancing Translational Sciences (UL1 TR S1). For more information and to view short videos describing the main concepts of ROMP, visit the project website at Comic strip-style illustration from ROMP website explains the main concepts being explored to assess general public s attitudes about research on medical practices. Illustration by Booster Shot Media. seattlechildrens.org/bioethics 11

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