MSU HRPP手册部4-1

适用性

When a planned activity meets the definitions of “research” involving a “human subject,” the Common Rule regulations (45 CFR 46) and Subparts B, C, D, 和 E regarding 该 protection of human subjects apply, with limited exceptions specified in HRPP手册 4-11“修改后的通用规则(2018和要求)的适用性,”8-8“灵活举措,” 在一个特定HRPP或手动部分。请参阅手动HRPP 4-11“修改后的通用规则的适用性(2018和要求)” to determine whether the Pre-2018 Common Rule or the Revised Common Rule (2018 Requirements) apply. In instances when both the Pre-2018 Common Rule Requirements and the Revised Common Rule (2018 Requirements) both apply 和 conflict, 该 stricter regulatory requirement must be followed.

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看到HRPP手册 4-3“的决心人体试验的” 关于如何无论是确定的活动人体试验是由政策和程序。对考虑IRB审查范围的活动之外更多的指导,请参阅手册HRPP 4-3-A “的临床病例报告,” 09.06,“学生的课堂研究”12-1“质量保证,质量改进,或程序的评价。”

1-3“用制度授权协议” for requirements. Human subject research must be approved by an IRB or determined to be exempt from IRB review prior to any human research activity, including interacting or intervening with subjects 和 obtaining or analyzing identifiable private information about subjects or identifiable biospecimens.

生物医学和健康IRB(BIRB)和社会科学/行为/教育IRB(SIRB)复议申请的基础上,主要研究者主要的大学或单位的隶属关系。

一般BIRB评论人体试验的调查在生物医学和临床科室或单位的研究。 这些包括但高校局限于 高校 工程, 人的医学,护理学院,骨科医学学院,兽医学院。

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5-4“更多的专业知识。” 研究受FDA法规必须由BIRB进行审查。

其他注意事项

额外的联邦要求,请参阅HRPP手册的以下部分:

2-2-A美国国防部
2-2-B的美国环保局
2-2-C美国司法部
2-2-d美国教育部
2-2-E美国能源部

这个政策和程序取代了以前的那些起草。

由...批准: Vice President for Research and Graduate Studies, 4-21-2005; Revision 1 approved by the VP Research & Graduate Studies on 11-2-2005. Revision 2 approved by VP Research & Graduate Studies on 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 5-6-2008. Revision 4 approved by VP Research & Graduate Studies on 9-3-2009. Revision 5 approved by 该 VP Research & Graduate Studies on 7-21-2011. Revision 6 approved by Assistant VP Regulatory Affairs on 12-10-2015. Revision 7 approved by Senior VP for Research 和 Innovation on 1-18-2019.

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