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Human Subjects Protection

The Oak Ridge Institute for Science and Education (ORISE) performs technical assessments to assist U.S. Department of Energy (DOE) laboratories involved in human subjects research projects. Under DOE Order and Policy 443.1A, Protection of Human Subjects, and 10 CFR 745, DOE employees and contractors are expected to protect the rights and welfare of human research subjects.

In support of the DOE Office of Science and the Human Subjects Protection Program (HSPP), ORISE has most recently assisted with the development and distribution of tools to address classified research and to track potential human social cultural behavior systems (HSCB) research conducted by DOE laboratories.

Examples of products that ORISE has developed in support of the HSPP include:

DOE Human Subjects Protection Resource Book

This book is a joint project with DOE, the U.S. Department of Defense and the U.S. Department of Veteran Affairs. The book is a tool for new and long-term Institutional Review Board (IRB) members, principal investigators and DOE IRB administrators to help them understand the background, regulations and requirements for protecting human research subjects.

DOE Human Subjects Protection Web site

This Web site enhances communication among IRB members, administrators, researchers, institutional officers, management and potential human subjects within the DOE research community. The site is used to share information and provide resources that continually improve processes and practices in the most productive and ethical way.

HSCB SharePoint site

ORISE has developed a system using SharePoint to track potential human terrain systems projects. The SharePoint site gives the DOE Office of Science and National Nuclear Security Administration the ability to review and comment on potential HSCB projects.

Human Subjects Protection