Regulatory Links

Guidance from OHRP


Select OHRP Guidance


Codes of Ethics


Regulatory Essentials

  • 45CFR46 OHRP – Human Subjects (
  • 21CFR50 FDA – Human Subjects (FDA)
  • 21CFR56 FDA – IRBs


Additional Links

New York State Psychiatric Institute (NYSP) (

Research Foundation for Mental Hygiene (RFMH) ( (


Office for Human Research Protections (OHRP) ( )

Food and Drug Administration (FDA) (

National Institute of Mental Health (

Office of Research Integrity (

National Library of Medicine (

President’s Council of Bioethics (

Center for Bioethics at Columbia University (

Columbia University Medical Center IRB (

Center Watch – Clinical Trials Listing Service ( (

The Medical Letter for Drugs and Therapeutics (

The MEDLINEPlus Drug Link (

Medwatch (

RASCAL Website (

FDA: Center for Drug Evaluation and Research (CDER) Forms