接上文21CFR PART 312 -§ 312.64 Investigator reports. 研究者报告（中英文）
§ 312.66 Assurance of IRB review. IRB审查保障
An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
研究者应确保符合第56部分规定的IRB将负责拟定临床研究的初始和持续审查和批准。研究者还应保证他或她将及时向伦理委员会报告研究活动中的所有变化和所有涉及受试者或其他人风险的未预料到的问题，并且在未经伦理委员会批准的情况下，他或她不会对研究进行任何更改，除非有必要消除对受试者的明显直接危害。
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