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July 22, 2001

Hopkins Human Research Resumes

On July 22, 2001, the U.S. Office for Human Research Protections (OHRP) approved a corrective action plan formulated by Johns Hopkins to permit the resumption of human subject research at Johns Hopkins Medical Institutions. The plan is consistent with the approach Hopkins suggested as a result of its own internal investigation into the tragic death last month of a healthy subject enrolled in an NIH-funded research study. OHRP also imposed certain conditions on the resumption of research. The full details of the Johns Hopkins corrective plan and the reinstatement letter from the OHRP are available at www.hopkinsmedicine.org.

On July 19, the OHRP ordered the suspension of all federally funded human subject research at The Johns Hopkins University that had been approved under the Multiple Project Assurance M-1011. This decision did not apply to research approved by the Johns Hopkins Bloomberg School of Public Health, which has its own assurance with the OHRP and its own independent Institutional Review Boards (IRBs) to approve and oversee research studies. However, some faculty members at the Johns Hopkins Bloomberg School of Public Health have joint appointments and research activities with the affected Hopkins facilities. Researchers with human subject studies approved by the Joint Committee on Clinical Investigation (JCCI) at John Hopkins School of Medicine or the Bayview IRB were affected by the OHRP’s decision. Human subject research will resume as soon as possible under the conditions approved by the OHRP.

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For an explanation of an assurance with the federal government, please visit http://www.jhsph.edu/chr