DOE Human Subjects Resources

Guidelines

DOE Handbook
Access Handbook – Conducting Health Studies at Department of Energy Sites

Human Subjects Protection Resource Book
Synthesizes the information currently available on the protection of human subjects in research; the continuing application of such information to new areas of endeavor; and the ever-changing rules, regulations, and guidance involved.

From Paper to People: After IRB Approval of Research Studies (pdf)
Provides an overview of both novel and routine ways to assist Institutional Review Boards (IRB) in ensuring that human subject studies, once approved, are conducted properly and follow accepted ethical principles. It is intended as a supplement to human subject protection requirements and not in lieu of the regulations.

Protecting Workers Who Are Human Research Subjects brochure
Addresses the rights and concerns of DOE workers who participate as human research subjects.

Research on Human Subjects brochure
National Institutes of Health (NIH)-developed, user-friendly brochure to help investigators understand how human subjects regulations (45 CFR 46) apply to their research.

IRB Guidebook, HHS/OHRP
Second edition of the guidebook, developed to help researchers and IRB members understand the policies and principles that underlie the regulations governing research with human subjects, and identify the issues to which they should be sensitive in designing or reviewing research proposals.

Expedited Review
Details the procedure and categories of research that may be reviewed by an IRB through an Expedited Review. Located on the Health and Human Services/Office for Human Research Protections site.

Adverse Events and Unanticipated Problems
Offers guidance on the handling of adverse events or unanticipated problems in the course of a research project involving human subjects.

Content reviewed: November 12, 2013