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Researcher Resource Library
Is It Human Subjects Research?
Does an Exemption Apply?
- Human Subject Regulations Decision Charts | HHS.gov
- Exempt and Expedited Categories
HIPAA
OHRP Educational Resources, Webinars, and Workshops
US Code of Federal Regulations
- 45 CFR 46 – Protection of Human Subjects
- Subpart B — Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research | HHS.gov
- Subpart C — Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects | HHS.gov
- Subpart D — Additional Protections for Children Involved as Subjects in Research | HHS.gov
OHRP Guidance
FDA Guidance
Data Safety and IT Security
- Protect Your Research: Information Technology - Northwestern University
- IT Policies, Standards, and Guidelines: Information Technology - Northwestern University
- Guidelines for Security and Confidentiality of Data Files: Information Technology - Northwestern University
- Data Security Plan Requirements for FSM Research: Feinberg Information Technology: Feinberg School of Medicine
Additional Training Resources
- Human Subjects Research | Grants & Funding| NIH
- Elements of a Successful Informed Consent Video - National Institute of Mental Health (NIMH)
- Webinars and Outreach | FDA
- SACHRP Committee (Secretary’s Advisory Committee on Human Research Protections) | HHS.gov
- Presidential Commission for the Study of Bioethical Issues
- Public Responsibility in Medicine and Research (PRIM&R)
- Good Clinical Practice Training: Northwestern University Clinical & Translational Sciences Institute: Feinberg School of Medicine