Dismissing Informed Consent

Special thanks to Dr. Huan Vu, a researcher in surgical oncology at Virginia Commonwealth University, for bringing to my attention this interesting commentary by Michael Crichton in the Wall St Journal (link to full commentary requires subscription for access). If medical centers can trample clinical trial volunteer rights so easily, we can only expect the current crisis in low recruitment rates to get worse.

Body Snatchers, 2006
December 15, 2006; Page A20

… This week in St. Louis, the Eighth Circuit heard an appeal in the case of William Catalona, a famous prostate-cancer surgeon and the man who developed the PSA test to screen for prostate cancer. Over the years Dr. Catalona collected thousands of tissue samples from his patients to help him research this dreaded disease. The tissues were all from individuals who had family histories of prostate cancer, indicating a genetic cause. When Dr. Catalona left Washington University for Northwestern, he wanted to take these tissues with him. Six thousand patients notified the university that they wished their tissues to go with him.

Ignoring the requests of patients, Washington University claimed the tissue collection as its own, and sued Dr. Catalona. In March of this year the district court ruled the collection belonged to the university. Judge Stephen Limbaugh found that the patients had given their tissues to WU as a gift, and therefore the university owned the tissues outright. … In his view, the right to withdraw merely meant the right not to contribute more tissues. The right to have the tissues destroyed meant only that the samples would be used anonymously. The guarantee that tissues would only be used for prostate research could be ignored, and WU was free to use the tissues for any purpose whatever.

For universities, perhaps the most damaging outcome may be the loss of confidence that patients feel in major centers of research and healing.


1 Comment »

  1. […] Filed under Biomedical Research Ethics The 8th U.S. Circuit Court of Appeals unanimously upheld a lower court ruling that tissue and blood samples donated to Washington University School of Medicine in St. Louis for […]

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