Regulatory Links

Guidance from OHRP

 

Select OHRP Guidance

 

Codes of Ethics

 

Regulatory Essentials

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

 

Additional Links

New York State Psychiatric Institute (NYSP) (www.nyspi.org)

Research Foundation for Mental Hygiene (RFMH) ( (rfmh.nyspi.org)

RFMH IRB Manual

Office for Human Research Protections (OHRP) ( 222.hhs.gov )

Food and Drug Administration (FDA) (www.fda.gov)

National Institute of Mental Health (www.nimh.nih.gov)

Office of Research Integrity (ori.dhhs.gov)

National Library of Medicine (www.nlm.nig.gov)

President’s Council of Bioethics (www.bioethics.gov)

Center for Bioethics at Columbia University (www.bioethicscolumbia.org)

Columbia University Medical Center IRB (www.cpmcirb.hs.columbia.edu)

Center Watch – Clinical Trials Listing Service (www.centerwatch.com)

ClinicalTrials.gov (www.clinicaltrials.gov)

The Medical Letter for Drugs and Therapeutics (www.medicalletter.com)

The MEDLINEPlus Drug Link (www.nlm.nih.gov)

Medwatch (www.fda.gov)

Study Trax (…)

RASCAL Website (www.rascal.columbia.edu)

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