JHMI Office of Communications and Public Affairs

September 7, 2001
MEDIA CONTACT: Joann Rodgers
PHONE: 410-955-6680
E-MAIL: jrodgers@jhmi.edu

HOPKINS RESPONSE TO FDA OBSERVATIONS

Johns Hopkins officials said today that receipt of the U.S. Food and Drug Administration (FDA) report on the agency’s observations of the events surrounding the death of a healthy research volunteer reinforces Hopkins’ commitment to improving its research protection system. "We appreciate the hard work FDA has done and the guidance it has given us to further improve our processes for conducting research involving human volunteers," according to Chi Dang, vice dean for research at The Johns Hopkins University School of Medicine.

The 483, received September 7, involves issues that Hopkins has been reviewing and addressing throughout the summer. Hopkins already has implemented corrective action for most of the observations cited in the 483 and plans to address the remainder are already underway. (See below.) In addition, the institution will continue to cooperate fully with FDA and other federal agencies in efforts to insure the safety of all research involving human volunteers.

ACTIONS TAKEN TO STRENGTHEN RESEARCH OVERSIGHT AT
JOHNS HOPKINS

Research conducted at Johns Hopkins produces life-saving and life-enhancing discoveries. To ensure the safety of those who participate in this research, Johns Hopkins is putting in place significant new safeguards that have been endorsed by the federal government and an external review committee. These safeguards include:

Beyond these specific actions, Johns Hopkins recognizes the need for a broad and long-term educational effort, at al levels of the institution, to ensure a full appreciation of he ethical obligations inherent in research involving humans. This broader effort will be pursued aggressively in the coming academic year.

In the wake of the tragedy of the death of a healthy volunteer in a Hopkins research study, we are fully engaged in improving our processes and strengthening our safeguards to reduce the chance of such an event occurring again. We are very proud of the Hopkins research that has done so much to improve health and extend life here in the United States and around the world. As we raise the bar on research safety, we believe these changes will enhance our research efforts.

 


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