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Federal Regulations

U.S. Department of Health and Human Services (DHHS)

45 CFR 46 Protection of Human Subjects

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

Subpart A:Basic HHS Policy for Protection of Human Research Subjects

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subparta

Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb

Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc

Subpart D: Additional Protections for Children Involved as Subjects in Research

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd

Exempt Research Categories: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101

Expedited Research Categories: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

U.S. Federal Drug Adminstration (FDA)

21 CFR 11 Electronic records; Electronic Signatures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

21 CFR 50 Protection of Human Subjects

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50

21 CFR 54 Financial Disclosures by Clinical Investigators

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

21 CFR 56 Institutional Review Boards

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

21 CFR 312 Investigational New Drug Application

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312

21 CFR 314 Applications for FDA Approval to Market a New Drug

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314

21 CFR 812 Investigational Device Exemptions

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812

21 CFR 814 Premarket Approval of Medical Devices

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814

21 CFR 820 Quality System Regualtion

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

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