Photo by Clay Eals
An 11-point course of action to enhance the center's reputation for integrity in human- subjects research received the unanimous approval of the center's Board of Trustees last week.
The decision, reached Thursday, April 25, was based on the recommendations of the Patient Protection Oversight Committee, appointed by the trustees last September to oversee Fred Hutchinson's human-subjects research activities.
A critical portion of the action plan is an enhanced conflict-of-interest policy, which prohibits investigators from participating in human-subjects research trials in which they hold financial interests.
The action items also include 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 and the provision of added legal support for compliance matters. Many of these recommendations already have been implemented.
The amended conflict-of-interest policy prohibits ownership of stock, receipt of royalty payments on patents and receipt of payments in excess of $10,000 in a 12-month period by a researcher directly and significantly related to human-subjects research in which the researcher is participating. Previously, some stock and royalty interests were permitted.
Disclosure to patients
Scientists involved in the conduct of human subjects' trials also will be required to disclose to patients and in scientific publications any financial interests they have in the for-profit company sponsoring the trial in which they are involved.
Bruce Pym, committee chair and a trustee, said the revised policies will make the center a national leader in human-subjects protection, a topic undergoing evaluation and discussion at major research institutions across country.
"While Fred Hutchinson has always fully complied with government regulations, the Patient Protection Oversight Committee is committed to con tinually improving the processes involving clinical trials," he said.
"We believe that the terms of the enhanced conflict-of-interest policy, which are more restrictive than those mandated by the federal government and advocated by the Association of American Medical Colleges, will ensure that Fred Hutchinson serves as a role model for the ethical conduct of human research."
Dr. Lee Hartwell, center president and director, said he expects the trustees' course of action will foster patients' increased confidence 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 the strictest safety and ethical standards," he said.
"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 noted that the revised conflict-of-interest policy has the full support of center faculty.
"Before these recommendations were even formulated, faculty were polled for their sentiments regarding an enhanced conflict-of-interest policy," he said. "They supported the proposed changes and firmly believe that the center should do everything possible to eliminate even the appearance of conflict of interest."
Review began in September
The trustees created the Patient Protection Oversight Committee in September 2001 following a review by the community-based Committee on Patient Protection in Research Trials, chaired by the Rev. William Sullivan, chancellor and former president of Seattle University and a center trustee.
The Sullivan committee, composed of trustees, a former patient and community members, hired independent experts last year to review Fred Hutchinson's current practices and policies regarding clinical trials and clinical research.
The reviewers found Fred Hutchinson's policies and practices complied with federal and state regulations and was comparable to other institutions in each area that was evaluated.
In addition, both the experts and the Sullivan committee made recommendations to strengthen and enhance existing policies and practices, including formation of the Patient Protection Oversight Committee, charged with oversight of human-research studies and implementation of the Sullivan committee's recommendations.
Throughout meetings from October 2001 through last month, the Patient Protection Oversight Committee received updates on reviews of human-subjects research.
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 Patient Protection Oversight Committee meetings included a session with former patients and a family member who described their experiences with the informed-consent process, which consists of a series of safeguards designed to ensure that patients are fully advised of the risks and benefits of a clinical trial.
In its study of conflict-of-interest policies, the Patient Protection Oversight Committee compared policies of Fred Hutchinson with those of other research centers and U.S. Public Health Service regulations, as well as policies recently proposed by the Association of Academic Medical Colleges.
The stringency of the amended policy approved by center trustees exceeds the stringency of policies adopted by many leading research centers as well as recommendations by the association, which issued a statement on the topic last December.
'Prohibited financial interests'
Based on this review, the Patient Protection Oversight Committee proposed and center trustees approved amendments to Fred Hutchinson's existing conflict-of-interest policy that prohibit scientists from involvement in human-subjects trials if they hold certain "prohibited financial interests" in the for-profit sponsors of those trials.
Scientists with such prohibited financial interests in a for-profit company cannot act as principal investigator, recruit patients to protocols, seek consent from such patients or evaluate the response of patients on protocols sponsored by that company. Prohibited financial interests include shares of stock in any amount, royalty rights on patents or other intellectual property and payments in excess of $10,000 in a 12-month period. Payments of any sort based on or related to the outcome of trials will continue to be prohibited.
July 1 implementation
The targeted date to implement the revised policy is July 1. Scientists who hold financial interests disallowed by the new guidelines have until June 30, 2003, to divest themselves of those interests.
Scientific staff will continue to be allowed to receive honoraria for speeches, compensation for service on advisory boards and fees for general consultation services and travel expenses, not to exceed $10,000 per year from any single entity. This practice has been deemed acceptable by the U.S. Public Health Service and is common at research centers across the country.
Hartwell said such fees do not constitute financial rewards.
"The normal course of conducting clinical trials requires that investigators meet to discuss progress and give seminars to disseminate knowledge," he said.
"Our policy permits reimbursement for expenses incurred in the course of carrying out effective research and education. These costs are normally borne by the company supporting the trial."
What the trustees approved
- Scientists who own stock or other prohibited financial interests in a for-profit company may not participate in a human-subjects research trial that is sponsored by that company or could directly and significantly affect the scientists' financial interest.
- Scientists participating in a human-subjects research trial must disclose to participants in the trial any financial interest in a for-profit company that could be directly and significantly affected by that trial.
- The center will monitor and participate in national discussions on institutional conflict of interest as they unfold, and then adopt appropriate policies.
- The center has allocated an additional $1 million to help support activities noted in the Committee on Patient Protection in Research Trials (Sullivan committee) report and the action steps recommended by the Patient Protection Oversight Committee.
- Center staff will be further involved in national discussions regarding Institutional Review Board activities and protocol safety and data monitoring and will increase participation in discussions on informed consent and the management of conflict of interest.
- The center is creating a Research Trials Office that will track ongoing regulations that relate to trials involving human subjects.
- Regulatory compliance is a function of the general counsel's office. To provide increased support of this function, an associate general counsel has been added to the counsel's staff.
- The center has hired a consultant to advise on FDA regulatory compliance.
- The center will add a 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, to enhance sensitivity to cultural, racial, and language differences in the informed-consent process.
- A physician's 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 assist in evaluating the language and format of the informed-consent documents for improvements.
- The Patient Protection Oversight Committee will continue to evaluate ways to enhance the availability of patient advocacy in the informed-consent process.
- The center recently updated its system for protocol data and safety monitoring and hired an outside research organization to monitor protocol data.
- The center continues to recognize the importance of the contributions made by Institutional Review Board members in assuring the welfare of study participants and the integrity of research activities.
- The center is creating a research ethics committee that will provide consulting 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 in 2002.
- The Patient Protection Oversight Committee will continue to review and monitor work plans in progress and the suggestions for operational improvements made by the independent reviewers.
A look at who's who on the Patient Protection Oversight Committee
Bruce M. Pym, chair
A partner of the law firm of Heller Ehrman White & McAuliffe LLP, and former managing partner of its Northwest offices, Pym recently completed his first year as a Fred Hutchinson trustee. He served as a director for the center's Foundation Board for five years and as the co-president of the NorthWest Industry Partnership in 1997-98. He chairs the Fifth Avenue Theatre Association, chaired United Way of King County in 1990 and is a past president of the King County Bar Association. He has served on the boards of Seattle Repertory Theatre and the University of Washington Law School Foundation.
Carl G. Behnke
Chairman of Sur La Table and president of REB Enterprises, Inc., Behnke has served as a Fred Hutchinson trustee and on the Foundation Board for five years. He is also a trustee of the University of Puget Sound and serves on boards for the Pacific Northwest Ballet, PONCHO, the Northwestern Trust, YoCream International, the advisory board for the Northwest AIDS Foundation and the Commerce Bank of Washington. He has chaired the Seattle Rotary Service Foundation Board and the Sports Council of Seattle/King County.
Philip K. Bussey
President of the Washington Roundtable, a public-policy research and advocacy group composed of 35 chief executive officers of major state companies, Bussey has served as a Fred Hutchinson trustee for two years. He also serves on the boards of the Seattle Alliance for Education, the Washington Transportation Alliance and the Partnership for Learning.
Joan L. Enticknap
The president of Homestreet Bank and a retired executive of Bank of America/Seafirst Bank, Enticknap serves as a Fred Hutchinson trustee. She also serves on the boards of the state's Major League Baseball Stadium Public Facilities District and the Rainier Club. She has served as a board member of the Woodland Park Zoological Society, the Northwest Minority Supplier Development Council and the Washington State Convention & Trade Center Expansion Task Force.
The chair and CEO of the Immunex Corporation since January 1994, Fritzsky has been a Fred Hutchinson trustee for the past year. He serves on the board for the SonoSite and Geron corporations and chairs the Technology Alliance and the University of Washington Business School Advisory Board. He also is a trustee of United Way, the Pacific Science Center and the Medical Affairs Council of the UW.
H. Jon Runstad
The chair and CEO of Wright Runstad & Company, Runstad recently became a Fred Hutchinson trustee. He served on the University of Washington's Board of Regents in 1987-98 and is on the boards of the Washington Roundtable, the Downtown Seattle Association, the Greater Seattle Chamber of Commerce, the Seattle Symphony, the Institute for Systems Biology and the University of Washington Board of Rowing Stewards. He served as associate general chair of three United Way campaigns and in 1989 received the Greater Seattle Businessperson of the Year award in commercial real estate.
Besides serving as Fred Hutchinson trustee, Stanford belongs to boards for the Leukemia/Lymphoma Society, Higher Education Coordinating Board, Mothers Against Violence in America, University of Washington Medical Center, John Stanford Endowment Fund Committee Alliance for Education, Hillside Guild of Children's Hospital, United Negro College Fund Advisory Board, First Place Advisory Board and Leadership Council for the Childhaven capital campaign. The widow of former Seattle Schools Superintendent John Stanford formerly served on the boards for City Club, Make-A-Wish Foundation, Intiman Theatre, Childhaven and the Urban League.
The Rev. William J. Sullivan
The chancellor and past president of Seattle University, Sullivan has served as a Fred Hutchinson trustee for three years. He also serves on the boards for Seattle Preparatory School and Seattle University Regents. He has served as a board member of United Way of King County and chair of the Seattle Organizing Committee for the Goodwill Games.
The chief executive officer and founding member of WRQ, he recently became a Fred Hutchinson trustee. He is an active supporter of many charitable and community organizations. He serves on the Nature Conservancy board and received its highest individual award, the Oak Leaf, for his long-term volunteer commitment. He is also vice chair of REI's board, a member of the governing council of The Wilderness Society and a founding partner of Social Venture Partners.