DOE Resources

Creating an Ethical Framework for Studies That Involve the Worker Community

Ethical FrameworkStudies to assess the health effects that may be related to occupational environments and workplace exposures provide data essential to reducing or preventing illness, injury, or disease among current and future workers. For many years, DOE has had concerns, however, that unless their rights and welfare are fully protected, collecting these data may expose participating study subjects—the workers—to significant personal, professional, and economic risks.  DOE sees workers as vulnerable research subjects and has created tools to help IRBs and researchers ensure their protection.

Years ago, DOE also created a document entitled Creating an Ethical Framework for Studies that Involve the Worker Community.  While this guidebook now outdated, we have made available PDF files of the individual chapters.  Limited hard copies are also available upon request.

Post-IRB Approval Considerations

This guide, created years ago, provides an overview of 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.

DOE Resource Book

HSP Resource BookDOE's Human Subjects Protection Resource Book was first produced in 2006, with updates in 2007 and 2012, to help the DOE address changes in science, regulations, and practices. Additional updates will be made in 2020, to reflect the recent changes in both Federal and DOE-specific requirements.

The Book is an attempt to synthesize the information currently available on the protection of human subjects in research. It has been prepared for the convenience and reference of investigators, IRBs, research organizations, research subjects, government agencies, and others. Regulations are cited when appropriate, as is federal guidance.

While the 2012 updates were done by DOE, the original resource book was a collaborative project of multiple federal agencies and universities. We thank all who participated in its development.