Office of Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP)  is part of the U.S. Department of Health and Human Services (HHS). OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS  agencies, such as the National Institutes of  Health (NIH) and the Centers for Disease Control and Prevention (CDC). OHRP oversees and enforces the HHS regulations for protecting participants in research at 45 Code of Federal Regulations part 46 which includes subpart A, the Common Rule.

OHRP offers this five-lesson Human Research Protection Foundational Training as a comprehensive training on  the fundamentals of the framework of human research protections for HHS-funded research and the requirements of the Common Rule (or 2018 Requirements). Please complete the lessons in their current order. As a foundational training, references to the regulations may have been simplified to facilitate  understanding. Please refer to the regulatory text for accuracy. Completing this training is one way to fulfil NIH’s education requirement on human subjects protection for investigators and  key personnel (see NIH’s “Educational  Requirement” for additional information).

Please check with the U.S. federal department or agency at https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/common-rule-departments-agencies/index.html for any variations in application and interpretation of these requirements for the research they conduct or support.

For consistency, the course follows the regulations by referring to “human subjects” instead of “human participants.”

Human Research Protection Foundational Training

1. When HHS regulations Apply

2. What is Human Subjects Research

3. What are IRBs?

4. Independent Review of Research

5. Institutional Oversight of Human Research