Policies and Guides
Policies
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ºÚÁϳԹÏÍø IRB Policy and Procedures for Research Involving Human Subjects (Currently being updated to comply with Revised Common Rule)
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018 and June 19, 2018. The revised common rule takes effect January 19, 2019.
The Belmont Report was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
RESOURCES
- Revised Exempt Categories - Table Overview
- Revised Exempt Categories - Detailed Description
- Revised Exemption Decision Charts
- OHRP Revised Common Rule Q&As