SEATTLE — Apr. 30, 2002 — Fred Hutchinson Cancer Research Center officials have implemented a number of enhancements to their current practices and procedures involving the conduct of clinical trials. These enhancements are based on recommendations of the Patient Protection Oversight Committee (PPOC), a committee formed to assist Fred Hutchinson in evaluating and implementing the recommendations made in Sept. 2001 by the Committee for Patient Protection in Research Trials (CPPRT).
The 11-point course of action outlined by the PPOC includes changes to the center's conflict of interest policy as well as the hiring of a consultant with expertise in regulatory compliance issues and a physician's assistant to standardize and simplify the language of informed consent documents. Also provided is additional legal support for compliance matters. Many of these recommendations have already been implemented.
One of the recommendations of the PPOC is the amendment of the center's conflict of interest policy. The amended policy (PDF, 91K) now prohibits ownership of stock or receipt of royalty payments on patents by a researcher directly and significantly related to a clinical trial in which a researcher is involved. Scientists involved in the conduct of human subjects' trials will also be required to disclose to patients and in scientific publications any financial interest that they have in the for-profit company sponsoring the trial in which they are involved.
Bruce Pym, chair of the PPOC and a trustee since June 2000, said the enhancements make the center a national leader in human-subjects protections, a topic undergoing evaluation and discussion at major research institutions across the country.
"While Fred Hutchinson has always fully complied with government regulations, the PPOC is committed to continually improving the processes involving clinical trials," says Pym. "We believe that the terms of the enhanced conflict of interest policy, which are stricter than those mandated by the federal government and advocated by the Association of American Medical Colleges (AAMC), will ensure that Fred Hutchinson serves as a role model for the ethical conduct of human research."
In its study of conflict of interest policies, the PPOC compared policies of Fred Hutchinson with those of other research centers, U.S. Public Health Services regulations, as well as policies recently proposed by the AAMC. The stringency of the guidelines approved by the center's trustees exceeds the stringency of policies adopted by many leading research centers as well as recommendations by the AAMC, which issued its recommendations last December.
Dr. Lee Hartwell, Fred Hutchinson president and director, says he expects that the board-approved measures will foster increased confidence among patients that the center will let nothing stand in the way of providing the best care and the highest ethical standards in clinical trials.
"Those of us who conduct the medical research necessary to alleviate disease and suffering recognize the importance of ensuring that the clinical trials system meets strict safety and ethical standards," says Hartwell. "We all need clinical research and clinical trials to improve the outcomes and quality of life of the critically ill because any one of us might at some time be a patient with a life-threatening disease."
Hartwell notes that the revised conflict-of-interest policy has the full support of Fred Hutchinson faculty.
"They supported the proposed changes and firmly believe that the center should do everything possible to eliminate any appearance of conflict of interest."
The official report released by the PPOC provides details of enhancements implemented or for future implementation to Fred Hutchinson's current policies and practices. Below are highlights from the report.
- The center has allocated additional resources of $1 million per year to help support activities noted in the Committee for Patient Protection in Research Trials report and the action plans approved by the PPOC.
- Center staff will be further involved in national discussions regarding Institutional Review Board activities, protocol safety and data monitoring, and will increase participation in discussions on informed consent and the management of conflict of interest.
- The center has created a Research Trials Office that will track ongoing regulations that relate to trials involving human subjects and ensure that the center is in compliance.
- The center has hired additional staff and consultants to advise on Food and Drug Administration (FDA) regulatory compliance.
- The center will hire an additional trainer whose main role will be to address increased federal requirements for ongoing research integrity training.
- The center has improved the ethnic diversity of the Institutional Review Board membership that will serve to enhance sensitivity to cultural, racial, and language differences in the informed consent process.
- A physician assistant has been hired to help with standardization and simplification of language for the informed consent documents used for adults and children.
- An external consultant will be engaged to assist in evaluating the language and format of the informed consent documents for improvements.
- The center has recently updated its ongoing system for protocol data and safety monitoring.
- The center has hired an outside contract research organization to perform monitoring of protocol data.
- The center is creating a new research-ethics committee that will provide consultative services to researchers and staff designing or reviewing research studies and offer advice to Institutional Review Boards upon request.
- The center will engage independent reviewers for a follow-up review later in the year.
The PPOC was created by Fred Hutchinson's Board of Trustees in September 2001, following a review by the ad hoc community committee, the CPPRT, which was chaired by the Rev. William Sullivan, chancellor and former president of Seattle University and a center trustee. Community members and center trustees convened a panel of experts last year to review Fred Hutchinson's current practices and policies regarding clinical trials and clinical research.
The CPPRT reviewers found that Fred Hutchinson were in compliance with federal and state regulations and was comparable in its policies and practices to other institutions in each area that was evaluated. Although in compliance, both the expert reviewers and the CPPRT made recommendations to strengthen and enhance existing policies and practices.
The PPOC met from October 2001 through April 2002. Members reviewed current practices and policies and studied background material pertaining to Institutional Review Board activities, protocol safety and data monitoring, informed consent, management of conflict of interest and financial disclosure. The PPOC meetings included a session with former patients and a family member who described their experiences with the informed-consent process, a series of safeguards designed to ensure that patients are fully advised of the risks and benefits of a clinical trial. The PPOC is a standing committee and will continue to review and monitor work plans in progress and the suggestions for operational improvements made by the independent reviewers.
The eight-member Patient Protection Oversight Committee was comprised of members of Fred Hutchinson board of trustees. These included Bruce M. Pym, chair, a partner of the law firm of Heller Ehrman White & McAuliffe LLP, and former managing partner of its Northwest Offices; Carl G. Behnke chairman of Sur La Table and president of REB Enterprises Inc.; Philip K. Bussey, president of the Washington Roundtable, a public policy research and advocacy group comprised of 35 chief executive officers of major Washington state companies; Joan L. Enticknap, president of Homestreet Bank; Ed Fritzky, chief executive officer, Immunex Corporation; H. Jon Runstad, chairman and CEO of Wright Runstad & Company; Patricia Stanford, community activist, University of Washington board of regents and widow of former Seattle Schools Superintendent John Stanford; the Rev. William J. Sullivan, chancellor and past president of Seattle University; and Doug Walker, chief executive officer and founding member of WRQ.
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Fred Hutchinson Cancer Research Center
The Fred Hutchinson Cancer Research Center, home of two Nobel Prize laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Fred Hutchinson receives more funding from the National Institutes of Health than any other independent U.S. research center. Recognized internationally for its pioneering work in bone-marrow transplantation, the center's four scientific divisions collaborate to form a unique environment for conducting basic and applied science. Fred Hutchinson, in collaboration with its clinical and research partners, the University of Washington Academic Medical Center and Children's Hospital and Regional Medical Center, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest and is one of 38 nationwide. For more information, visit the center's Web site at www.fhcrc.org.