Education
|
Research
|
Health
Intranet
Overview
Getting Started
Forms and Templates
Education and Training
Policies and Procedures
Meetings and Deadlines
Resources
Federal Wide Assurance (FWA)
OHRA FAQ
Single IRB (sIRB)
ClinicalTrials.gov
Human Subjects Research Education
Good Clinical Practice (GCP) Education
Documentation of Human Subjects Education for NIH-funded Studies
iRIS Online Application System
Protocol Application & Tracking System (PATS)
Internal (Institutional) Resources
External Resources
Regulations and Guidance
Historical Background of Human Subject of Protection
Montefiore-Einstein Research Compliance
Home
>
Administration
>
Office of Human Research Affairs
>
Resources
>
Regulations and Guidance
Office of Human Research Affairs
Regulations and Guidance
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