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Talking Frankly

If you've ever experienced a terrible loss--the end of a marriage, the swift decline of an aging parent--you know how painful it can be to talk about. Last June 2, Johns Hopkins lost a member of the university's family: Ellen Roche, a healthy young technician at Hopkins's Asthma and Allergy Center. She died after participating in a Hopkins research study aimed at helping scientists better understand asthma. Around the university, a deep sadness settled in after news of Roche's death became public. As faculty, administrators, and students looked at newspaper photos of the sparkling-eyed 24-year-old, who had only recently bought her first house, they ached for her family and loved ones.

By now, you know the story didn't end there. Roche's death prompted a government regulatory agency to step in and temporarily halt nearly all federally funded clinical trials at Hopkins. And in the months since that July 2001 shutdown, researchers and administrators have worked marathon days to re-review thousands of protocols and, more fundamentally, to figure out what changes need to be made to better protect human research subjects at Johns Hopkins.

Painful stuff for a world-renowned academic medical center. Painful to undertake, painful to talk about publicly.

The easy route would have gone something like this: conduct countless closed-door sessions, refuse to say anything of substance to the press, and then emerge after several months by announcing an action plan guaranteed to set the new benchmark for patient safety. Problem solved. No questions, please.

But Johns Hopkins, to its credit, didn't take the easy route. From the outset, administrators have posted every important report--findings from internal and external committees, memos from government agencies--on the Web for all to see. They have spoken frequently, and candidly, with the local and national press. And they provided us with the access we needed to produce a special report in this issue that is both frank and comprehensive.

Spend some time with "Trials & Tribulation". I'm betting you'll wind up feeling reassured--as I did, after months of interviews with faculty and administrators--that out of this difficult period of loss and soul-searching will come positive advances for clinical research and patient safety at Johns Hopkins.

-Sue De Pasquale

Return to February 2002 Table of Contents

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