Links

Links

GENERAL LEGAL REFERENCES


FEDERAL OFFICES & AGENCIES

Office for Human Research Protections (OHRP)

 

 

IRB Registration
Assurances
Regulations (45 CFR 46)
Policy Guidance
Frequently Asked Questions (FAQ)
Compliance Oversight
Education
Conferences
Quality Improvement
SACHRP
OHRP News
Public Outreach
International


Food and Drug Administration (FDA)

21 CFR 50 (Subjects, 04/01/05)
21 CFR 56 (IRBs, 04/01/05)
21 CFR 312 (INDs, 04/01/05)
21 CFR 812 (IDEs, 04/01/05)
Food, Drug & Cosmetic (FD&C) Act
Public Health Service Act
Humanitarian Use Devices (HUDs) and
Humanitarian Device Exemptions (HDEs)

Guidance
Good Clinical Practice in FDA-Regulated Clinical Trials

National Institutes of Health (NIH)

NIH Research:
PHS 398
OER Human Subjects Web Site
Human Subjects Peer Review Criteria
Certificates of Confidentiality
Children and Clinical Studies
Institute-Specific Research:
NCI: Cancer
NHLBI: Heart, Lung, and Blood
NHGRI: Human Genome Research
NIA: Aging
NIAAA: Alcohol Abuse and Alcoholism
NIAID: Allergy and Infectious Diseases
NIAMS: Arthritis and Musculoskeletal and Skin Diseases
NIBIB: Biomedical Imaging and Bioengineering
NICHD: Child Health & Human Development
NIDCD: Deafness and Other Communication Disorders
NIDCR: Dental and Craniofacial Research
NIDDK: Diabetes and Digestive and Kidney Diseases
NIDA: Drug Abuse
NIEHS: Environmental Health Sciences
NIGMS: General Medical Sciences
NIMH: Mental Health
NINDS: Neurological Disorders and Stroke
NINR: Nursing Research
NLM: Library of Medicine

 PRIVATE ORGANIZATIONS

Association for the Accreditation of Human Research Protection Programs (AAHRPP)
IRB Forum
The National Academies
     Sciences, Engineering, Institute of Medicine [IOM], National Research Council [NRC]
Public Responsibility in Medicine and Research (PRIM&R)
Center for Practical Bioethics
NCCN Informed Consent Language (ICL) Database


HISTORICAL INFORMATION

Nuremberg Code (1949)
Declaration of Helsinki (1964-2002)
Belmont Report (1979)