GENERAL LEGAL REFERENCES

• 1975 Code of Alabama
• Electronic Code of Federal Regulations

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)