Links to Other Resources on Human Subjects Protection and Animal Welfare

Ethical Codes and Regulations for Human Subjects in Research

• Belmont Report
• The Nuremberg Code
• Declaration of Helsinki
• DHHS/NIH/OHRP Human Subject Regulations, 45 CFR Part 46
• **NEW**DHHS/NIH/OHRP Human Subject Regulations, 45 CFR Part 46 in Spanish
• FDA Regulations, 21 CFR Part 50, Protection of Human Subjects
• FDA Regulations, 21 CFR Part 56, Institutional Review Boards

Ethical Guidelines and Regulations for the Use of Animals in Research

• NIH Public Health Services Policy on Humane Care and Use of Laboratory Animals
• 1996 Guide for the Care and Use of Animals prepared by the National Academy of Sciences
• USDA Regulations, Animal Welfare Act, 9 CFR Parts 1-4. Copies available through the Institutional Review Office. [contact the IRO]
• OLAW brochure What Investigators Need to Know About the Use of Animals (PDF, 4MB)
• PHS Policy on Humane Care and Use of Laboratory Animals: Frequently Asked Questions

Guidelines for IACUC and IRB Committees

• OHRPs IRB Guidebook
• ARENA and OLAW IACUC Guidebook

Agencies and Organizations Involved with Human Subject Protections and Animal Welfare

• Office of Human Research Protections (OHRP)
• Office of Human Research Protections (OHRP) Resource page, last revised February 3, 2006 - This new webpage on OHRP provides links to reference documents, historical materials and Common Rule departments and agencies.
• OHRP's Spanish web page- The Office for Human Research Protections has recently launched its new Spanish web page.
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• Public Responsibility in Medicine and Research (PRIM&R)
• Food and Drug Administration (FDA)
• Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC)
• Net Vet, Veterinary Resources, prepared by Ken Boschert, DVM, Washington University, St. Louis, Missouri
• United States Departement of Agriculture (USDA)

Policy Development and Commissions

• NIH guidance on informed consent for gene transfer research
• FDA Information Sheets for IRBs and Clinical Investigators
• FDA Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators (pdf)
• FDA Guidance For Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies (pdf)
• FDA Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies (pdf)
• FDA Guidance For IRBs, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices (pdf)
• FDA Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Institutional Review Board Inspections (pdf)
• Final Report of the Task Force on Genetic Testing
• National Bioethics Advisory Commission (NBAC)
• Office for Human Research Protections (OHRP): Updated Human Subject Regulations Decision Charts, Oct 26, 2004. The revised decision charts provide graphic aids to assist institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

Other Institutions' IRB and IACUC Home Pages

• University of California, San Francisco (IRB Information)
• University of Minnesota Research Subject Protection Programs (IRB and IACUC Information)
• University of Washington (Human Subjects Division)
• Seattle Children's (IRB)