Guidance

Office for Human Research Protections

IRB Guidebook

NIH Frequently Asked Questions

NIH Policy for Data and Safety

NIH guidance for Phase I and Phase II trials

Medical Device Advice

FDA Guidance to Investigators

Institutions with FWAs and Registered IRBs

Explanation of Federal Regulations for Human Subjects Research

Reading Questions for Federal Regulations for Human Subjects Research

Regulations

DHHS Common Rule (45 CFR 46)

Investigational New Drug (FDA IND, 21 DFR 312)

Investigational Device Exemption (FDA IDE, 21 CFR 812)

Biological Products (FDA, 21 CFR 600)

Family Educational Rights & Privacy Act (FERPA, 34 CFR 99)

Protection of Pupil rights Amendment (PPRA, 34 CFR 98)

Ethics

Belmont Report

Nuremberg Code

Declaration of Helsinki

American Psychological Association's Code of Ethics

Trainings

NIH Certification Training

OHRP Training

IUPUI Training

University of Michigan Training

Penn State Training

University of Wisconsin - Madison Training

University of California - Davis (log in as "guest")