Federal and State Policies and Guideline Documents Regulations for the Conduct of Human Subjects Research Office for Human Research Protections (OHRP): 45 CFR 46 FDA Regulations Search (alternate link) FDA Regulations: Protection of Human Subjects (21 CFR 50) FDA Regulations: Institutional Review Board (21 CFR 56) FDA Regulations: Investigational New Drug Application (21 CFR 312) FDA Regulations: Investigational Device Exemptions (21 CFR 812) FDA Regulations: Premarket Approval of Medical Devices (21 CFR 814) FDA Regulations: Financial Disclosure by Clinical Investigators (21 CFR 54) The Privacy Rule (HIPAA): 45 CFR 164, Subpart E 14 CRR-NY 27.10 (mental health patients in NY) International Compilation of Human Research Standards NIAID's ClinRegs, an online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research. Additional Regulations that Impact the Conduct of Human Subjects Research NYS Civil Rights Law: Section 79-L (genetic research) Tissue Banks and Nontransplant Anatomic Banks (NYS Title 10, Part 52) (specimen storage/distribution) Protection of Pupil Rights Amendment (PPRA) (34 CFR 98) (student surveys) Family Educational Rights and Privacy Act (FERPA) (34 CFR 99) (student records) NJSA 18A:36-34 (student surveys in NJ) NYS Dept of Health: Patients Care and Consent for Minors Federal Guidance for the Conduct of Human Subjects Research OHRP Policy & Guidance Index FDA Guidance Documents Search Feature Selected FDA GCP/Clinical Trial Guidance Documents Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors ICH Guidance Documents GCP/Clinical Trial Notices State Guidance for the Conduct of Human Subjects Research New York State Task Force on the Life and Law's Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity