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 

• 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

• 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

• HIPAA Privacy Rule
• OCR Guidance
• DHHS Guidance

• 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

• Protection of Human Subjects in Research
• General Guidance for Students FERPA
• Protection of Pupil Rights Amendment (PPRA)

• The Belmont Report
• World Medical Association Declaration of Helsinki

• PRIM&R
• Ethical and Legal Aspects of Human Subjects Research in Cyberspace
• Informed Consent – online tutorial