Faculty Research Resources
U.S. Department of Health and Human Services (DHHS) – Research with Human Subjects
- Office of Human Research Protections (OHRP) – Limited sections in Spanish.
- 45 CFR 46 – Protection of Human Subjects
- OHRP IRB Guidebook by Topic
- OHRP Policy Guidance
- The Involvement of Prisoners in Research
- Informed Consent Checklist
- International Compilation of Human Subject Research Protections
Office of Human Subject Research
- Guidelines for Renumeration of Research Subjects
- HIPAA Privacy Rule and Research
- Issues Regarding Blinded, Randomized Studies in the NIH Intramural Research Program
- Procurement and Use of Biological Materials for Research
- NIH Requirements for the Research Use of Stored Specimens and Data
U.S. Food and Drug Administration (FDA)
- FDA Good Clinical Practice Program
- 21 CFR 50 – Protection of Human Subjects
- 21 CFR 54 – Financial Disclosure by Clinical Investigators
- 21 CFR 56 – Institutional Review Boards
- 21 CFR 312 – Investigational New Drug Application
- 21 CFR 600 – Biological Products
- 21 CFR 812 – Investigational Device Exemptions
- Information Sheets
- Waiver of IRB Requirements for Drug and Biologic Studies
- Frequently Asked Questions about IRB Review of Medical Devices
- Significant Risk and Nonsignificant Risk Medical Device Studies
- FDA Institutional Review Board Inspections
- FDA Inspections of Clinical Investigators
U.S. Department of Health & Human Services (DHHS) – Office for Civil Rights (OCR)
National Institutes of Health (NIH)
- Responsibilities of the Office of Human Subject Research
- Criteria for IRB Approval of Human Subjects Research
- Continuing Review of Human Subjects Research
- FAQs of NIH’s Office of Human Research
- Guidelines for Writing Research Protocols
- Guidelines for Writing Informed Consent Documents
- Guidelines on Women and Minorities
- Inclusion of Women and Minorities as participants in Research Involving Human Subjects
- Inclusion of Children Policy Implementation
- Research involving Cognitively Impared Subjects
- Research involving individuals with questionable capacity to consent
- Office of Biotechnology Activities/RAC
U.S. Department of Education (USDE)
- Protection of Human Subjects in Research
- General Guidance for Students FERPA
- Protection of Pupil Rights Amendment (PPRA)
Ethical Codes
Organizations & Educational Tutorials