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Rapid intravenous loading of levodopa for human research: clinical results.
These realities, she noted, have profound implications for human research.
The agency, the Office for Human Research Protections, eased the suspension this week after Hopkins officials agreed to change the way its internal panels assess proposals for human research.
Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research.
All contact with human subjects was conducted in conformance with established standards for human research.
The study was approved by the Australian Catholic University ethical review board for human research.
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The Office for Human Research Protections, in the Department of Health and Human Services, has jurisdiction only over research funded by the department.
Since this research uses publicly available de-identified data, it is considered exempt from the Committee for Human Research approval by the University of California, San Francisco.
The research study was approved by the Children's Hospital Boston Institutional Review Board for Human Research and also the Brigham and Women's Hospital Institutional Review Board for Human Research as an excess tissue protocol.
Experimental procedures with human thymic fragments have been approved by the Oswaldo Cruz Foundation Ethical Committee for Human Research.
Pat El-Hinnawy, a spokeswoman for the federal Office for Human Research Protections, said officials there were not aware of any problems arising from such experiments.
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