External Resources: Policies and Guidance

Office for Human Research Protections (Department of Health and Human Services)

The Office for Human Research Protections (OHRP) provides leadership in the protection of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP policies provide a model adopted by most other federal agencies funding research. OHRP provides Federalwide Assurances (FWAs) and a registration process for Institutional Review Boards.

OHRP Home Page
OHRP Policy & Guidance
OHRP Compliance Oversight Activities: Determinations of Noncompliance
IRB Guidebook
Code of Federal Regulations, Title 45, Part 46 (45 CFR 46). Protection of Human Subjects. Includes Subpart A, also known as "The Common Rule"

Guidance and Regulation for Other Federal Agencies

List of Agencies and Departments signed onto the Common Rule (OHRP)
U.S. Department of Education -- Protection of Human Subjects in Research
National Science Foundation (NSF) -- Human Subjects Policy
USDA National Institute of Food and Agriculture -- Assurances Regarding the Protection of Human Subjects
U.S. Department of Commerce -- Financial Assistance Standard Terms & Conditions See Section M.06 "Research Involving Human Subjects" (NOAA website)
U.S. Department of Energy -- Protecting Human Subjects

Research Exempt from IRB Review

See also the UAS IRB web page on Exemption Categories.
Code of Federal Regulations, Title 45, Section 46.101 (45 CFR 46.101) Exemption Categories defined (GPO)

Research Qualifying for Expedited IRB Review

Guidance on Expedited Review Procedures (OHRP)

Informed Consent

Informed Consent (OHRP)
Informed Consent Requirements in Emergency Research (OHRP)

Certificates of Confidentiality

Certificates of Confidentiality Kiosk (National Institutes of Health)
Certificates of Confidentiality (Informational page from USC)

Research with Alaska Natives

Alaska Federation of Natives, Guidelines for Research
NSF Principles for the Conduct of Research in the Arctic

Research with Children

Special Protections for Children as Research Subjects (OHRP)
Research with Children FAQs (OHRP)
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process (OHRP)
Family Educational Rights And Privacy Act (FERPA) (Dept. of Ed.) For research involving minors in school settings
Protection of Pupil Rights Amendment (PPRA) (Dept. of Ed.) For research involving surveys with minors in school settings
Family Policy Compliance Office (Dept. of Ed.)

Research with Other Vulnerable Populations

OHRP Guidance on Vulnerable Populations
Prisoner Research FAQ (OHRP)

International Research

Comparison of International Guidelines for Research Involving Humans Informational page from USC
International Conference on Harmonisation: Good Clinical Practice: Consolidated Guidance (FDA website)
Council for International Organizations of Medical Sciences (CIOMS) Home Page
International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS HTML version)
International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS PDF version)
Canadian Institutes of Health Research
National Council on Ethics in Human Research-Canada

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