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Human Subjects Research at the Environmental Protection Agency:
Ethical Standards and Regulatory Requirements

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This course was developed by the Program in Human Research Ethics at the U. S. Environmental Protection Agency (EPA). It provides training for investigators and others involved in human research supported by EPA and is free of charge.

The course is divided into an introduction and a series of modules, each of which can be taken separately. Module 1 covers the basic federal policy for the protection of human research subjects, also known as the Common Rule. This module was adapted from the course "Protecting Human Research Participants" developed by the Office of Extramural Research at the National Institutes of Health, and permission to use their materials is gratefully acknowledged.

Modules 2 and 3 were developed by the EPA Program in Human Research Ethics specifically for this course. Module 2 covers prohibitions and special protections for vulnerable subjects that are specific to EPA's regulations, and Module 3 covers community engagement.

A fourth module on distinguishing public health practice from public health research in an environmental context is currently under development.