Science Article
December 19, 2002

High marks for human-subjects research

Independent experts praise center conflict-of-interest policy, efforts to centralize and improve operations of clinical trials

By BARBARA BERG

Fred Hutchinson's policies to respect the rights and protect the interests of patients and study participants meet or exceed community standards, and its measures to prevent improper conflicts of interest rank among the strictest in the nation.

That's the gist of a recent evaluation commissioned by the committee that oversees such research at the center.

The Patient Protection Oversight Committee, a standing committee of the Board of Trustees, convened the panel of independent reviewers in October as part of a one-year follow-up to its previous assessment in the summer of 2001.

The earlier review found Fred Hutchinson to be fully compliant with federal regulations and comparable in its policies and practices to other institutions in each area that was evaluated. But the outside experts made recommendations to strengthen and enhance existing policies and practices, which led to an action plan that was approved by the full board in April.

Significant progress

In their report this fall, all reviewers found the center to have made significant progress in the implementation of the recommendations and offered suggestions for continued enhancement of center policies.

Following a review of the suggestions, the committee approved action plans for work over the next year, which will include:

• The center will continue to improve the process of informed consent.
• The committee will monitor the implementation of the center's newly revised conflict-of-interest policy.
• The committee will receive summaries of all external audits and reviews conducted at the center.
• The committee will study proposals on institutional conflict of interest and propose recommendations for a center policy.

Joan Enticknap, committee chair, acknowledged the hard work that contributed to the favorable review.

"We are very pleased with the reviewers' comments, particularly the finding that the center is one of the leaders in the country with respect to our conflict-of-interest policy," she said. "These achievements reflect the hard work of center staff, particularly members of the Clinical Research Division, who are committed to ensuring the highest standards for human-subjects protections. They can all be proud of these accomplishments."

Enticknap also reaffirmed the committee's commitment to its role in research oversight.

"We know that improvement is a continuous process," she said. "The committee will continue to work closely with center staff to further enhance research policies."

Shan Mullin, who chairs the center's Board of Trustees, echoed Enticknap's praise for center staff and the board's commitment to human-subjects protections.

"Enhancing the center's policies and procedures has been a top priority for the board over the last year," he said.

"It's clear, based on this review, that faculty and staff at the center have worked hard to successfully implement the committee's recommendations of last fall and are committed to ensuring that the integrity of Fred Hutchinson's human-subjects research remains at the highest level."

The Patient Protection Oversight Committee was created by the board in the fall of 2001 following a review by the Committee on Patient Protection in Research Trials, chaired by the Rev. William Sullivan, the chancellor of Seattle University and a center trustee.

That committee, composed of board members, former patients and community members, convened a panel of experts last year to review Fred Hutchinson's current practices and policies regarding clinical trials and clinical research.

Reviews conducted last year and this fall focused on three areas:

• The center's institutional review boards (IRBs), the committees made up of center researchers and community members that ensure ethical conduct of human-subjects research.
• Protocol Data and Safety Monitoring, a committee that reviews new studies and monitors ongoing trials for favorable and adverse outcomes of participants.
• The center's conflict-of-interest policy, created to ensure that investigators involved in human-subjects research do not maintain financial interests that might be perceived to compromise research integrity.

Documents, site visits

Reviewers examined documents pertinent to each area and conducted site visits to meet with center staff. Reports of the evaluations were submitted to the Patient Protection Oversight Committee.

Each area under review was found to meet or exceed community standards of practice, and the center was cited for its "impressive" or "significant" progress in the areas suggested for improvement last year.

Based on suggestions made by the reviewers, the Patient Protection Oversight Committee approved an action plan last month for continued enhancement of human-subjects research policies.

Among the goals are to continue to improve the process of informed consent and to provide the committee with semi-annual reviews of all external audits. In addition, the committee will begin discussions on institutional conflict of interest, a topic of interest at research institutions around the country.

The American Association of Medical Colleges (AAMC), a nonprofit group for reform of medical education, recently issued its report on this issue. The AAMC recommendations will inform discussions at the center.

Among the significant accomplishments during the last year noted by the independent reviewers:

Informed consent

• The Institutional Review Office, which oversees the IRBs, added several new staff positions that allow it to more effectively manage its workload.
• The IRBs increased the diversity of their membership to include representatives from the Native American, African American and Asian communities.
• Templates for informed-consent documents for study participants were revised for clarity and continue to undergo refinement.

Conflict of interest

• The center amended its conflict-of-interest policy to prohibit researchers’ ownership of stock or receipt of payments arising from their intellectual property interests that are directly and significantly related to a clinical trial if that researcher is participating in the trial. The reviewers found the policy to be among the strictest of cancer centers in the nation.
• The center established a conflict-of-interest committee to assist the center make decisions on these restrictions.

Protocol safety and data monitoring

• The center established the Research Trials Office to centralize functions relating to the conduct of clinical trials.
• The center hired a regulatory affairs and compliance officer.
• The Protocol Safety and Data Monitoring Committee revised its procedures to prioritize review of protocols based on risk. The revised procedures have been implemented for ongoing monitoring of center research studies.

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