Regulatory and Resource Links
Regulations and Ethical Guidance
- 45 CFR 46 - The Common Rule
- The Belmont Report
- Search for Federalwide Assurances
- HHS Regulations and Policies Guidance
Food and Drug Administration (FDA)
- Adverse Event Reporting
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- FDA webpage: “What is a Serious Adverse Event?”
- Drug label changes per FDA-How to Receive Email Updates About FDA Drug Label Changes
- FDA Guidance: Expanded Access to Drugs for Treatment Use (updated 2017)
- How to submit an Expanded Access Request (FDA)
- Individual Expanded Access Applications: Form 3926 (2017)
- 21 CFR 50-Informed Consent and Children
- 21 CFR 56- Institutional Review Boards
- 21 CFR 312-INDs
- 21 CFR 812- IDEs
- Emergency IND FDA Information Sheet
NIH Resource Links
- Active Protocol Consents
- BTRIS
- Clinical Center
- Clinical Center Bioethics
- Genetic Information Nondiscrimination Act of 2008
- Genomic Data Sharing
- Human Subject Protection Unit Consult Service
- Inclusion Policies for Research Involving Human Subjects
- Institutional Biosafety Committee (IBC)
- Intramural Research Program (OIR)
- Intramural Research Sourcebook
- Medical Administrative Series Policies
- NEO Conflict of Interest Policy Page
- NIH Human Embryonic Stem Cell Registry
- NIH Guidelines for Human Stem Cell Research (NIH policy for research using hESCs and iPSCs)
- NIH Stem Cell Website
- NIH Manual - 1743-3000 Records Retention
- NIH Manual - 2300-308-4 - NIH On-Site Research Collaborator Policy
- NIH Manual- 2300-630-3: Employees participating in Research
- NIH Manual- 2809 Social Media Appendix A
- NIH Manual - 3014 HRPP
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Office of Clinical Research
- Office of Protocol Services
- Office of Technology Development
- OIR Policy Page: Human Embryonic Stem Cell Checklist and Induced Pluripotent Stem Cell Registration
- Paperwork Reduction Act Clearance System (PRACS)
- Privacy Act
- Privacy Coordinators by IC
- Radiation Safety Committee
- Stem Cell FAQs
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