Full disclosure at The Hutch

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Analytical skills that made The Fred Hutchinson Cancer Research Center a crown jewel of the Pacific Northwest need to be applied to three areas of surprising weakness:

• Providing patients with current, relevant, comprehensive and understandable information about the medical procedures and risks they face;

• Establishing financial-disclosure mechanisms as counterweights to the aggressive, entrepreneurial environment at The Hutch;

• Strengthening internal-review procedures that monitor medical research so they are not subordinate to, or ignored, by senior staff.

These conclusions can be drawn from a comprehensive investigative project printed in The Times last week. Reporters Duff Wilson and David Heath examined two clinical trials for their series, "Uninformed Consent."

The Hutch would be making a sad mistake if it assumed the detailed series leaves only a complicated public-relations problem.

This is a strong, respected institution that should be able to assess itself and make changes without feeling a loss of integrity or identity.

Too often, patients died who might have been expected to live, even those for whom The Hutch was the last measure of hope. Patients were enrolled in one experiment without knowing that staff experts had serious doubts about its merits. In another, patients were not advised of problems with the drug.

Needed is a better system of informed consent, so that anxious, frightened patients learn of the current status of experimental procedures in clear, jargon-free language.

Some may choose to proceed, assessing risk and weighing long- and short-term gains. Some may make selfless choices for future patients. Others deserve the opportunity to refuse to participate and know they do so without penalty. It is their choice.

• Make informed consent manageable, understandable and fully informative. Lurking in the background of a medical story was an aggressive, entrepreneurial atmosphere at The Hutch that became a tangle of financial relationships.

Clearly needed are mechanisms that put all business ties officially on the record for public scrutiny. The Hutch's peer institutions such as Harvard and Sloan-Kettering have tough rules that allow scant financial involvement. Public institutions such as the University of Washington also have broad, stringent rules. Those should be the benchmark for the industry.

• The Hutch should protect its reputation and mission by having current financial disclosure information available for review. No one can be against constructive, and, yes, profitable relationships. Just make them known, so the significance of any such interests on the study might be assessed.

Perhaps the most disturbing aspect of the series published in The Times was the ease with which The Hutch's own Institutional Review Board was held at bay by bluster, professional reputations and fear of career-damaging confrontations.

Federal law and sound practice requires research facilities to screen and monitor the assumptions, techniques and progress of medical research. Professionals assigned to ask those questions and make those judgments operated without institutional support.

The Hutch received $142 million in federal tax dollars last year to finance research; it is a terrific investment of the money. But receipt of the funds carries an obligation to have a credible system of oversight.

That was missing in what reporters Wilson and Heath described. The committee may exist, but not the administrative commitment to give it teeth. Reliance on outside agencies is futile. No level of government has the bureaucratic reflexes, talent or resources to make timely challenges. Periodic outside audits are no substitute for local control.

• Strengthen The Hutch's Institutional Review Board so it fosters a culture of accountability. The influence and credibility of senior staff must be engaged on behalf of the organization - to ask tough questions and say "no" and have it stick.

The Hutch is a great institution that remains first choice for anyone with a devastating cancer. But valid criticisms have been raised about how patients are informed, financial interests are disclosed and complex experiments on living patients are monitored.

Everyone in this community expects the best out of The Hutch. That should include informed consent, full disclosure and rigorous review.