Regulatory Links

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.
eRA User Experience Survey
An anonymous survey about your use and interaction with the eRA submission system.

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