DOE Resources

Creating an Ethical Framework for Studies That Involve the Worker Community

Ethical Framework Cover

Studies 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. We have 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.

The purpose of this guidebook is to raise the awareness of all stakeholders to the special needs and issues that apply to research using workers as study subjects. PDF files of the individual chapters and appendices are available on the Ethical Framework webpage.

Post-IRB Approval Considerations

This guide 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.

DOE Resource Book

2012 Human Subjects Protection Resource Book Cover

DOE'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 2016.

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.