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Federal Policies and Guidance


Office for Human Research Protections
Office for Human Research Protections (OHRP)
Office for Human Research Protection Policy Guidance by topic
OHRP Compliance Activities: Common Findings and Guidance
Guidance on Expedited Review Procedures
Exemption Categories 45 CFR 46.101, Categories (b)(1) thru (b)(6)
Federal Policy for the Protection of Human Rights (45 CFR 46), Subparts A, B, C, & D
Informed Consent
Informed Consent Requirements in Emergency Research
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
The Institutional Review Board Guidebook 
Special Protections for Children as Research Subjects
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process
Exempt Research and Research That May Undergo Expedited Review
U.S. Department of Education

U.S. Department of Education Protection of Human Subjects in Research Web site
Family Educational Rights And Privacy Act (FERPA) 34 C.F.R. Part 99
(Research involving minors in school settings)
Protection of Pupil Rights Amendment (PPRA) 34 CFR Part 98
(Research involving surveys with minors in school settings)
Family Policy Compliance Office

Other Federal Agencies and Guidance
OER Certificates of Confidentiality Code of Federal Regulations Index at the General Printing Office
Certificates of Confidentiality
Health Insurance Portability and Accountability Act (HIPAA) Regulations
National Bioethics Advisory Commission (NBAC)
National Bioethics Advisory Commission (NBAC) Reports 1997 - 2001
National Human Genome Research Institute - Ethical, Legal and Social Implications of Human Genetics Research
National Science Foundation (NSF) - Social, Behavioral & Economic Sciences
NSF - Frequently Asked Questions and Vignettes (Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research)
OER Research Involving Human Subjects - Grants Policy [NIH Office of Extramural Research (OER)]
Office of Research Integrity (ORI)
Office of Research Integrity Policies, Regulations and Statutes
U.S. Department of Energy - Protecting Human Subjects Homepage
U.S. Department of Health and Human Services Policies and Guidelines

International Research
Comparison of International Guidelines for Research Involving Humans
International Conference on Harmonisation: Good Clinical Practice
Council for International Organizations of Medical Sciences (CIOMS)
(International Ethical Guidelines for Biomedical Research Involving Human Subjects)
Canadian Institutes of Health Research
National Council on Ethics in Human Research-Canada

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