Federal Regulations
Title 45 Code of Federal Regulations Part 46 (45 CFR 46) Protection of Human Subjects (Revised December 13, 2001)http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
Title 21 Food and Drugs (Regulations applied by the Food and Drug Administration relevant to human subjects research.)
Part 11 Electronic Records
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr11_01.htmlPart 50 Protection of Human Subjects
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.htmlPart 56 Institutional Review Boards
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr56_01.htmlPart 312 Investigational New Drug Application
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.htmlPart 600 Biologic Products
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr600_01.htmlPart 812 Investigational Devices
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr812_01.html
HIPAA Privacy Guidelines for Research [45 CFR §§ 164.501, 164.508(f), 164.512(i)]
Guidelines and Reference Materials
Belmont Reporthttp://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm
Centers
for Medicare and Medicaid Services (formerly known as Health Care Financing
Administration) Clinical Trials and Medicare Quick Reference Guide
http://www.hcfa.gov/medlearn/refctmed.htm
Decision
Tree for Inclusion of Women and Minorities in Clinical Research The Nuremberg Code
Declaration
of Helsinki
http://ohrp.osophs.dhhs.gov/irb/irb_appendices.htm#j6
Human Subjects Regulations Decision Charts
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm
Decision charts from the federal Office for Protection from Research Risks (OPRR)
regarding the definition of human research, exemption from full board
review, waiver of informed consent, and eligibility for expedited review.
Guidelines for the Study and Evaluation of Gender Differences in the
Clinical Evaluation of Drugs
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/58fr39406.htm
Fetal Tissue Transplantation –New Statutory Requirement OHRP Guidance
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/hsdc94-02.htm
OHRP IRB Guidebook
http://ohrp.osophs.dhhs.gov/irb/irb_appendices.htm
Federalwide Assurance (FWA)
http://ohrp.osophs.dhhs.gov/humansubjects/assurance/refinfo.htm#WHAT
An assurance of compliance, or simply "assurance", is an official document that confirms and defines particular relationships between federal agencies and individual institutions. UAMS and its affiliated institutions have a federal wide assurance that has been approved by the Office for Human Research Protections that formalizes the institution’s commitment to protect human subjects. All institutions "engaged" in federal funded research must have a federal wide assurance approved by OHRP.
Institutional Review Board Guidebook -- From the Office for Human Research Protectionshttp://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm/t_top
Provides a basic understanding of the background and purposes of the IRB review system. It should be particularly useful for new IRB members and investigators just beginning their clinical research. The "Guidebook" should not be confused with the HRAC Investigators Handbook for Human Research Studies.
National
Bioethics and Safety Commission Report
http://bioethics.georgetown.edu/nbac/human/overvol1.html
Volume 1 html
http://bioethics.georgetown.edu/nbac/human/overvol1.pdf
Volume 1 pdf
http://bioethics.georgetown.edu/nbac/human/overvol2.html
Volume 2 html
http://bioethics.georgetown.edu/nbac/human/overvol2.pdf
Volume 2 pdf
http://bioethics.georgetown.edu/nbac/human/oversumm.html
Summary html
http://bioethics.georgetown.edu/nbac/human/oversumm.pdf
Summary pdf
National Institutes of Health (NIH)
Office for Human Research Protections (OHRP)(formerly the Office for Protection from Research Risks, or OPRR)
Office of Research Compliance and Assurance (ORCA)
U. S. Food and Drug Administration (FDA)
ICH Tripartite Guideline for Good Clinical Practice 1996
U.S. FDA Good Clinical Practice Website