INSTITUTIONAL REVIEW BOARD

  

Federal Policies and Guidance

FDA

Food and Drug Administration (FDA) Homepage
Food and Drug Administration Regulations - Title 21 Searchable Database
Protection of Human Subjects (FDA Informed Consent) - 21 CFR 50
Financial Disclosure by Clinical Investigators - 21 CFR 54
Institutional Review Boards - 21 CFR 56
Investigational Device Exemptions (IDE) - 21 CFR 812
Clinical Trials and Investigational Device Exemption (application information)
Comprehensive List of Food & Drug Administration Guidance Documents
Exception from Informed Consent Requirements for Emergency Research. (Draft)
Information Sheets

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  (PDF)
Expedited Categories 45 CFR 46.110, Categories #1-9
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 Requirements in Emergency Research
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (PDF)
The Institutional Review Board Guidebook 
Research with Children

U.S. Department of Education

U.S. Department of Education Protection of Human Subjects in Research Website
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

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
National Human Genome Research Institute - Ethical, Legal and Social Implications of Human Genetics Research
National Institutes of Health (NIH)
NIH - Regulations, Policies & Guidance (Ethical Guidelines, Human Subjects Policies)
NIH - Recombinant DNA Advisory Committee (RAC) on Recombinant DNA and Gene Transfer
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 Human Subject Web Site: FAQs from Applicants (Office of Extramural Research)
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