treuman katz center for pediatric bioethics 2019 year in ... · treuman katz center for pediatric...

Treuman Katz Center for Pediatric Bioethics

2019 Year in Review

Treuman Katz Center for Pediatric Bioethics

In 2019, the Treuman Katz Center for Pediatric Bioethics sponsored its 15th annual conference on Defining Moments in Pediatric Bioethics: Future Insights from Past Controversies. There were a record 272 participants from around the U.S. in attendance. Doug Diekema, Aaron Wightman and Hannah Lewis co-edited a supplement to Pediatrics in August 2020 which included papers written by the annual conference presenters.

Our clinical bioethics consultation service began a partnership with Seattle Children’s Center for Diversity and Health Equity to collaborate on responding to consultation requests for concerns about equitable care and how best to address these concerns within the organization. This partnership supplements our existing clinical ethics, nursing ethics, and research ethics consultation services, and is a model for how our Center collaborates with other important and ethically relevant initiatives at Seattle Children’s.

This Year in Review illustrates the publications, presentations, grants, and leadership of our faculty and staff. It also highlights the research of Stephanie Kraft, a faculty member who is deepening our understanding of a core concept in ethics: respect. In this report you will read about her interviews with research participants from diverse communities who describe what it means to be respected in a clinical study. The knowledge learned by Ms. Kraft and her research team can impact how researchers engage with participants in many contexts.

I hope that you enjoy reading about the efforts of the faculty, staff, and fellows to achieve our mission.

Benjamin S. Wilfond, Director Treuman Katz Center for Pediatric Bioethics

seattlechildrens.org/bioethics 3

GENERATING SCHOLARSHIP about emerging issues in pediatric bioethics

ENGAGING with professional organizations, government agencies and community groups to improve policies and practices related to critical bioethics issues

ADVISING families, clinicians, and leaders at Seattle Children’s who face challenging bioethics issues

EDUCATING our bioethics fellows, the Seattle Children’s community, and the broader professional and public communities about the unique issues in pediatric bioethics

MISSION: Improve the well-being of children, their families and communities by facilitating deliberation about ethical issues in pediatric healthcare and research

FACULTY

Emily Berkman, MD, MA

Jori Bogetz, MD

Jonna Clark, MD, MA

Douglas Diekema, MD, MPH

Nanibaa’ Garrison, PhD

Katherine Gentry, MD, MA

Ross Hays, MD

Stephanie Kraft, JD

Mithya Lewis-Newby, MD, MPH

Douglas Opel, MD, MPH

Amy Trowbridge, MD

Elliott Weiss, MD, MSME

Aaron Wightman, MD, MA

Benjamin Wilfond, MD

Joon-Ho Yu, PhD, MPH

AFFILIATES

Denise Dudzinski, PhD, MTS

Kristi Klee, DNP, MSN, MA

Leah Kroon, MN, MA

Jeff Sconyers, JD

STAFF

Devan Duenas, MA

Nicolas Dundas, MPH

Hannah Lewis, BA

Katie Porter, JD, MPH

Jennifer Scott, MHA, PMP

Kelly Shipman, MS

Sharee Smith, BA

Heather Spielvogle, PhD

Diana Wells, BA

4 Treuman Katz Center for Pediatric Bioethics

PRESENTATION HIGHLIGHTS

Stephanie Kraft: A crisis of trust: Rethinking respect and diversity in genomic research and medicine

American Society for Bioethics and Humanities Annual Meeting, Pittsburgh, PA; October 2019.

Douglas Opel: Religious Exemptions to Compulsory School Vaccinations: Legal and Ethical Issues

Pediatric Academic Societies Annual Meeting, Baltimore, MD; April 2019.

Kathryn Porter: When may physician- investigators permissibly invite their patients to participate in research?


Scholarship

39 presentations, including 11 at national and international meetings, plus others at Seattle Children’s, the University of Washington and in the community.

57 publications, including 43 peer-reviewed papers and professional organizational statements and 14 commentaries, editorials, and book chapters.

SELECTED PUBLICATIONS:

Berkman ER, Clark JD, Diekema DS, Lewis-Newby M. “We Can Do Anything but We Can’t Do Everything”: Exploring the Perceived Impact of International Pediatric Programs on U.S. PICUs. Frontiers in Pediatrics. 2019;7:470.

Bogetz JF, Marks A, Root MC, Purser L, Pantilat SZ. Development of the Pediatric Palliative Care Quality Network. Journal of Palliative Medicine. 2019;22(7):747-748.

Garrison NA, Barton KS, Porter KM, Mai T, Burke W, Carroll SR. Access and Management: Indigenous Perspectives on Genomic Data Sharing. Ethnicity & Disease. 2019;29(Suppl 3):659-668. eCollection 2019.

Kraft SA, Duenas DM, Kublin JG, Shipman KJ, Murphy SC, Shah SK. Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants’ Motivations and Attitudes. Journal of Empirical Research on Human Research Ethics. 2019;14(1):49-60.

Silverman RD, Opel DJ, Omer SB. Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines? New England Journal of Medicine. 2019;381(2):104-106.

Blumenthal-Barby J, Opel DJ, Dickert NW, Kramer DB, Tucker Edmonds B, Ladin K, Peek ME, Peppercorn J, Tilburt J. Potential Unintended Consequences Of Recent Shared Decision Making Policy Initiatives. Health Affairs (Millwood). 2019;38(11):1876-1881

Weiss EM, Clark JD, Heike CL, Rosenberg AR, Shah SK, Wilfond BS, Opel DJ. Gaps in the Implementation of Shared Decision-making: Illustrative Cases. Pediatrics. 2019;143(3). pii: e20183055.

Wightman A, Kett J, Campelia G, Wilfond BS. The Relational Potential Standard: Rethinking the Ethical Justification for Life-Sustaining Treatment for Children with Profound Cognitive Disabilities. The Hastings Center Report. 2019;49(3):18-25.


PRESENTATION HIGHLIGHTS

Elliott Weiss: Strategies to Improve Surrogate Decision-Making in Intensive Care


Aaron Wightman: Delivery of Care for the Disabled and Developmentally Delayed

American Society of Pediatric Nephrology Annual Meeting, Pediatric Academic Society, Baltimore, MD; April 2019

Benjamin Wilfond: The Value of Genetic Information: Patients Matter


National LeadershipSELECTED HIGHLIGHTS:

• Jori Bogetz, Co-Author/Course Designer, Talking About Serious Illness, EQIPP MOC Course, American Academy of Pediatrics

• Doug Diekema, Director at Large, American Society of Bioethics and Humanities

• Nanibaa Garrison, Advisory Committee to the Director’s Working Group on Diversity, National Institutes of Health

• Doug Opel, Committee on Bioethics, American Academy of Pediatrics

• Kathryn Porter, Chair, Clinical Research Ethics Consultation Affinity Group, American Society for Bioethics & Humanities

• Aaron Wightman, Ethics Committee, United Network for Organ Sharing

• Benjamin Wilfond, Planning Committee, An Examination of Emerging Issues in Biomedical Research Workshop, National Academy of Medicine

Publications 2015 - 2019

45

34

54

79

43

24

24

25

15

14

0

10

20

30

40

50

60

70

80

90

100

2015 2016 2017 2018 2019

Peer Reviewed Publications and Organizational Statements Commentaries, Editorials, Book Chapters, and Other

Publications 2015 – 2019


Funded Research Projects

7 new projects (16 submitted)

SELECTED HIGHLIGHTS:

• Jori Bogetz, Development of a Communication Tool for Relationship-Building Between Clinicians and Parents of Children with Severe Neurological Impairment

CRSP — Center for Clinical and Translational Research, Seattle Children’s Research Institute

• Nanibaa’ Garrison, Center on American Indian and Alaska Native Genomic Research

Supplement — National Human Genome Research Institute • Doug Opel, King County Child Health Improvement Partnership

Best Starts for Kids

• Benjamin Wilfond, ‘What it Means for our Family’ — Video Decision Supports for Parents Considering Pediatric Home Mechanical Ventilation’

National Palliative Care Research Center

Grant Applications 2015 - 2019

9

16

2120

16

6

8

12

15

7

0

5

10

15

20

25

2015 2016 2017 2018 2019

Submitted Awarded

Grant Applications 2015 – 2019


Consultation

Our clinical ethics consultants completed 51 consults in 2019.• Most common topics: treatment decisions (16), informed consent/parental permission (9), benefit/harm assessment (8),

limitation of life sustaining treatment (5), disclosure of results/information (3), other — moral distress (3), end of life care (2)

• Most frequent requesting services: inpatient medicine (22), outpatient medicine (11), intensive care (8), non-Children’s (4), surgery (3), hematology/oncology (2)

Our research ethics consultants completed 12 consults in 2019. • Most common topics:

benefit/harm assessment (4), conflict of interest (2), confidentiality/privacy (1), data & safety monitoring (1), informed consent/parental permission (1), legal/regulatory (1), other — deception (1), recruitment/incentives (1)

• Requesting services include:

Institutional Review Board, Rheumatology; Seattle Children’s Hospital and Research Institute.

Harborview Injury Prevention & Research Center, Epidemiology, Neurosurgery, Occupational Therapy, Pathology, Psychiatry & Behavioral Sciences; University of Washington.

Cystic Fibrosis Foundation, Bethesda, MD

Johns Hopkins University, Baltimore, MD

Pacific Northwest University of Health Sciences, Yakima, WA

PATH, Seattle, WA

St. Luke’s Health Systems, Boise, ID


15th Annual Conference

Seattle Children’s ICU 1982

Defining Moments in Pediatric Bioethics:Future Insights from Past Controversies

15th Annual Pediatric Bioethics Conference July 19–20, 2019

In 2019, 272 clinicians and scholars from the U.S. and worldwide attended Defining Moments in Pediatric Bioethics: Future Insights from Past Controversies

QUESTIONS DISCUSSED AT THE CONFERENCE INCLUDED:

• Are children with disabilities less deserving of life-saving treatments?

• Can a teen refuse life-sustaining interventions?

• How do we assess suffering in an infant?

• Should disability affect candidacy for a transplant?


Bioethics Fellows

2019 – present

Kate MacDuffie, PhD, is a licensed clinical psychologist in her first year of the bioethics fellowship program. Her research focuses on the ethical implications of emerging technologies in neuroscience.

2018 – present

Jenny Kingsley, MD, is a pediatric critical care medicine fellow who is concurrently in her second year of the bioethics fellowship program. Her research focuses on death and dying in the critical care setting.

2018 – present

Kim Sawyer, MD, is a pediatric palliative care physician in her second year of the bioethics fellowship program. Her research focuses on evaluating bioethics education and training.


Demonstrating ‘Respect for Persons’ in Clinical Research: Asking diverse voices to define respectful behaviors

Respect is critical in expanding research to underrepresented populationsRecognizing the importance of respect for research participants is a necessary first step for academic medical centers to become trust-worthy enterprises. Though foundational from an ethics perspective, researchers and academic medical centers have not always prioritized respecting participants in a meaningful way. Current research practices designed to protect the rights of research participants are a direct reaction to unethical activities in the past, many of which were directed at people of color and people from marginalized communities. Despite current regulatory protections, ongoing inequities and structural racism in healthcare and research systems contribute to a lack of diversity in clinical research, which contributes to inequities in the implementation and generalizability of research findings.

In order to expand research to include underrepresented groups, it is imperative that researchers think critically about how they respect participants. To date, efforts to demonstrate respect in research have predominantly focused on autonomy, each individual’s right to make their own informed decision about whether or not to participate in a study. Yet respect has broader though less well understood implications including participants’ needs, interests and values. Feeling respected is inherently subjective and likely to vary across individuals, communities and cultures. It is therefore necessary to understand what behaviors demonstrate respect from the perspective of a wide range of potential participants.

Listening to research participants: Respect in their own wordsTreuman Katz faculty member Stephanie Kraft, a lawyer and bioethicist, wants to shed light on what respect means from the research partici-pant’s point-of-view. Kraft explains that experiencing respect is critically important given the nature of the relationship between participant and researcher. “There is a heightened obligation to show respect in the clinical research setting because researchers are asking people to take on risks and burdens for the benefit of others,” says Kraft.

To address the gap in understanding what respect means to research participants, Kraft and her team conducted interviews with a diverse group of people who were participating in a research study imple-menting genomics testing-based services. Interviews focused on actions perceived as conveying respect, or a lack thereof, in research. Kraft’s team identified four key domains that researchers should attend to in order to demonstrate respect.

1. Personal study team interactions 2. Study communication processes 3. Inclusion 4. Consent and authorization

Stephanie Kraft studies the meaning of the core ethical concept respect for persons. Her research broadens the definition of respect in clinical research and provides a roadmap for researchers and academic medical centers to engage respectfully with participants.

Spotlight on Research


“ If we are asking patients and participants to place their trust in clinicians and researchers, we first and foremost must make sure we are holding up our end of the bargain and are deserving of the trust that we are asking people to place in us.”

Interactions with members of the study team were perceived as respectful, particularly when recruitment staff explained the study thoroughly, checked for understanding and provided the opportunity to answer questions. Kindness, patience, and interest in participant perspectives are also vital. Kraft’s earlier work has demonstrated that many individuals make decisions about participating in research before they even read the consent form, further highlighting the critical role played by research staff in recruitment and the importance of respectful interactions throughout the process.

Offering multiple ways for participants to get in touch with the study team, having a designated point of contact to answer questions, and sharing study results were ways that the study’s communication processes could demonstrate respect. Taking steps to ensure that language, disabilities, and location were not barriers to participation were seen as inclusive and respectful practices.

Finally, the consent process is important, and participants see thoroughness, neutral descriptions, privacy protections, time to make a decision, and choices about level of participation as respectful. Kraft’s newest project will augment these findings by using a survey-based consensus-building technique to identify approaches to demonstrating respect that are most important to patients who would potentially be eligible for, but are not currently enrolled in, genomics research.

Implications for the future Kraft says that the impact of the research teams’ interactions with participants illustrates the importance of building a culture of respect among members of the team and identifying opportunities to strengthen and support their innate abilities. To understand how to leverage this observation, Kraft, along with her co-PI Elliott Weiss and Research Scientist Katie Porter, are currently conducting interviews with research coordinators about how they seek to build relationships with patients and their families in the recruitment and consent processes.

With regard to the longer-term implications of her work, Kraft believes that strategies to effectively demonstrate respect must become a focus at the system and institutional levels with an eye toward ensuring equity, inclusivity, and positive health outcomes for all people.

treuman katz center for pediatric bioethics 2019 year in ... · treuman katz center for pediatric...

Documents