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비즈니스 · 2002. 3. 6.1 분 읽기
Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is considering whether to amend its institutional review board (IRB) regulations to require sponsors and investigators to inform IRBs about any prior IRB review decisions. These disclosures could help ensure that sponsors and clinical investigators who submit protocols to more than one IRB will not be able to ignore an unfavorable IRB review decision and that IRBs reviewing a protocol will be aware of what other IRBs reviewing similar protocols have concluded. FDA seeks information on IRB practices to determine whether it should draft a regulation and, if a regulation is to be drafted, to help determine the regulation's contents.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →