Establishing a Permanent Forum for Pediatric Bioethics

Children’s Hospitals Today, Winter 2006
By Doug Diekema, M.D., M.P.H.
Interim Director, Treuman Katz Center for Pediatric Bioethics
Children’s Hospital & Regional Medical Center
Seattle

Parents of a 10-year-old boy with Stage III lymphoma agree to allow their son to take a new cancer drug as part of a clinical trial. The parents assume that the drug will help their son since a physician asked for their consent; however, once the study is under way it is clear the parents do not understand that the drug may have serious side effects.  

A mother decides not to immunize her infant daughter. When the girl enters kindergarten at age 6, she places teachers and other children at risk of contracting any number of infectious diseases from her, including whooping cough and measles.

These are among the complex ethical issues that arise in pediatric health care institutions every day. Yet discussions around these controversial issues often remain within the walls of individual institutions due to patient privacy rights, legal sensitivities and the lack of a larger forum. However, a growing number of pediatricians and scholars scattered among children’s hospitals and universities are openly speaking and writing about ethical issues unique to children in medical and research settings.

Seeing the need to create a permanent forum for national debate on the ethical issues pediatric providers and researchers face each day, Children’s Hospital & Regional Medical Center in Seattle established the Treuman Katz Center for Pediatric Bioethics.

A Pediatric Podium

Launched in December 2004 as a resource for patients, parents, caregivers, physicians and researchers, the center’s purpose is twofold: to ensure the rights and protections of children who participate in research studies; and to give clinicians the resources they need to help patients and families think through the ethical aspects of complex care decisions.

While the idea for the center grew out of a national need to focus attention on the ethical issues of using children in research studies, the center’s purpose quickly broadened.

“We wanted to give medical leaders from around the world a podium to discuss all pediatric bioethics issues without sponsorship by commercial entities,” explains James Hendricks, Ph.D., Seattle Children’s vice president of research and the driving force behind the center. “We also felt strongly that Seattle Children’s ethical standards be carried beyond its own walls to promote [pediatric] bioethics policies and advocate best practices on a national and international level.”

The center is partially funded by a $3.5 million endowment from the Seattle Children’s Hospital board of trustees, which named the center for retired president and CEO Treuman Katz, who actively shared in the vision for the center’s creation.

The hospital’s Office of Research contributes approximately $200,000 per year toward center operating costs. This year, the center’s academic research costs, which include a yearly conference, are covered with a $340,000 federal appropriation through the U.S. Department of Health and Human Services. Located in a downtown Seattle office building, the center employs seven staff members, including physicians and personnel with advanced training in health policy, ethics and evaluation techniques.

Education and Advocacy

The center’s first conference in July 2005 attracted more than 200 attendees from the United States, Canada, South America and Africa who gathered to debate topics of interest in child research.

Conference topics included whether federal regulations governing child research are too restrictive; how conflicts of interest undermine the goals of research; the appropriate age of consent for children; the issues that arise when research involves genetic screening and treatment; what constitutes full disclosure to both the parent and child; and how to define the concept of minimal risk for child subjects. (View conference notes)

Entering its second year, the center is expanding beyond academic research to include education and advocacy.

The center is developing a pediatric bioethics curriculum for medical students and health care professionals with the eventual goal of designing Web-based education modules so that training can be done anywhere in the world.

In addition, two paid "research and family liaisons" are undergoing a two-month training that includes information about research rules and regulations, human subject participation in research, communicating with families, cultural sensitivity and ethics. These patient advocates will work with researchers and families at Seattle Children’s so the center can study whether this new role helps families better understand the concepts of informed consent, voluntary participation and right to withdraw. The center will make available to other children’s hospitals best practices gleaned from the experiences of the advocates, who will begin working with families in spring 2006.

Future Focus

A national search for a permanent director of the center is under way. The position will be funded through an endowed chair in pediatric bioethics. Once a permanent director is hired, the center will focus its efforts on recruiting faculty. Additional bioethics specialists will strengthen the current guidance being given to ethics committees and internal research boards at children’s hospitals and increase the center’s ability to respond to requests from physicians, media and speakers bureaus across the country.

Plans are also under way for the center’s second conference, which will explore the ethical controversies around childhood vaccinations. The conference, to be held July 14-15 in Seattle, will include discussions on topics such as: parents who refuse vaccinations for their children; how vaccines should be distributed in shortage situations; who should pay for vaccines; and the ethics of research on vaccines in foreign countries.

“As research continues to drive medical advances, we must be mindful of the ethical issues that affect the patients and families we serve,” says Tom Hansen, M.D., president and CEO of Seattle Children’s. Hansen recently joined the hospital from Children’s Hospital in Columbus, OH. “As the new leader of a growing pediatric research hospital, I strongly support our focus on bioethics, which is both timely and courageous.”

To receive Treuman Katz Center for Pediatric Bioethics conference information, register your e-mail address.

For more information about the Treuman Katz Center for Pediatric Bioethics, e-mail Doug Diekema.

Additional Bioethics Articles

Achieving Protection for Research Participants
Susan Kornetsky, M.P.H., director of clinical research compliance at the Office of Clinical Investigation at Children’s Hospital Boston – the nation’s first freestanding children’s hospital to achieve accreditation by the Association for the Accreditation of Human Research Protection Programs – explains why the hospital voluntarily opened its human protection program policies to scrutiny.

Surpassing Standards: Children Deserve Extra Research Protection
The Association for the Accreditation of Human Research Protection Programs explains how accreditation can help children’s hospitals ensure the safety of children in research studies and what the accreditation process entails.