Winter 2001
 

 

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Our Legacy to Ellen Roche

By Edward D. Miller, M.D.

Edward D. Miller, M.D.We already have made substantive changes in the conduct of our research and more are coming.

When it comes to protecting human beings, medicine demands more of its practitioners than other professions. Reflected in both the Hippocratic ethic of "first, do no harm," and in the sometimes blistering self-criticism of the modern Mortality and Morbidity conference, keeping safe those entrusted to our care remains our chief responsibility.

In the aftermath of the tragic death of Ellen Roche, a healthy volunteer in a Johns Hopkins research study, no precept has ever been truer. For all of us at Hopkins, that truth must now be at the core of both our professional values and our corrective actions.

With respect to our values, Ellen’s death gives us all pause to remember why we are in medicine and why Hopkins is so important to us. Yes, we want to be the "best" physicians and scientists in the world in teaching, research and patient care. We want to work in an institution that encourages great clinical advances, brings in support for cutting-edge research and trains physicians to be leaders. But what defines leadership? For more than a century, Hopkins has been at the apex of the American health care system not because magazines proclaim us #1 or because we get more federal research grants than any other place, but because we have hundreds of faculty with a deep appreciation for the trust people place in them to ease their pain, cure their disease and treat them with dignity.

I, along with many of you, was stunned by the magnitude of the action by the Office for Human Research Protections, coming as it did on the heels of our internal review committee’s rigorous critique of some of our procedures, and our pledge to take substantial corrective actions. (These documents can be viewed at www.hopkinsmedicine.org.) We all worried about the impact of a broad shutdown of our research, no matter how temporary, on our most vulnerable patients. These were among the darkest days many of us have ever known.

But the bottom line is that a vibrant young woman died. Our values as professionals, an institution and human beings tell us that we must make sure that our procedures are as perfect as they can be, that human safety is assured in clinical studies and every aspect of care. If that means raising the bar higher, then that is what we will do.

Now, how do we do this? Words and pledges must be followed by action. I’m gratified that we have established collaborative relationships with the OHRP and the U.S. Food and Drug Administration to define and implement steps that not only meet government requirements, but go beyond them in some cases. Make no mistake: this is not an exercise in affixing Band-Aids. We already have made substantive changes in the conduct of our research and more are coming. I am pledged to make all necessary resources available.

Among the steps already taken are the creation of additional Institutional Review Boards and enhanced IRB training for faculty. We will audit more protocols more systematically. We will create policies that better define and communicate serious or unexpected adverse events. The University will require far wider prior academic review of human subject protocols, including an examination of each study’s scientific worth, design and safety. We will alter the way IRBs work, requiring full-group reviews of all proposals and better documentation of activities.

Additionally, we are developing standards for drug-related literature searches and adopting a policy that requires investigators who use any non-FDA-approved substance to file an application for an Investigational New Drug (IND). In cases in which no IND is required by the FDA, investigators will need to provide substantial evidence of safety for human use. A special committee has also been charged with creating a policy that requires involvement of an investigational drug service in all studies using drugs or substances in human subjects at both The Johns Hopkins Hospital and Bayview Medical Center.

Finally, we embrace the need for broad education throughout Hopkins to deepen our appreciation of our ethical obligations in conducting clinical research, and to build a human research protection system without peer.

Throughout these difficult days, two things have sustained us. One is the team of faculty and staff volunteers that has devoted countless hours, including nights and weekends, to the hard work of developing our corrective-action plan. These people have worked with the federal agencies re-reviewing hundreds of protocols. The other is the flood of letters, phone calls and e-mails we have received from colleagues, patients and friends offering support. I believe they recognize the qualities that have made Hopkins an honorable and great institution—a commitment to everyday excellence and the values that support it.

We will probably never know for certain why Ellen Roche was lost to us. But her loss can hold meaning for the whole Hopkins family if it reminds us of our obligation to protect the lives of those who seek our help.

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