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New standards for Human Research Safety

Joint Commission on Accreditation of Health Care Organizations and the National Committee for Quality Assurance recently announced plans to set up a program to review the safety of clinical tests// in humans. This announcement came close on the heels of U.S. officials moving to suspend gene therapy studies pending an investigation of side effects in a French study, which found a cure for "bubble boy disease". Bubble boy disease - an immune disorder formally called severe combined immunodeficiency, or SCID - is the only disease ever to be cured with gene therapy.

The FDA and the U.S. Office for Human Research Protections currently oversee human research projects in the United States. The new program would review such things as staff and facilities, whether patients understand the risks of research, and what kinds of ethics education researchers receive. The program would include hospitals, academic medical centers and other facilities who would volunteer to have their research methods evaluated for accreditation by the health care groups. A fee would be charged for accreditation.


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