- The Belmont Report
The document that summarizes the basic ethical principles of research.
- Electronic Research Administration (eRA) System
The electronic submission portal used to submit research submissions.
- HHS Regulations
Comprehensive information regarding the federal regulations.
- FDA Guidance
HHS agency that regulates clinical investigations products under its jurisdiction (drugs/biological products/medical devices).
- HHS Office for Human Research Protections (OHRP)
Information from the Department of Health and Human Services on protecting human subjects in research.
- HIPAA Privacy Rule
Conditions under which protected health information may be used or disclosed by covered entities for research purposes.
- OHRP's International Compilation of Human Subject Research Protections
A list of international agencies that oversee human subject research protections
- NIH Resources on Bioethics
An collection of informational resources pertaining to bioethics and biomedical research.
- Human Subject Regulations Decision Charts
A graphic aid to help you decide if your research must be reviewed by the IRB.