Food
and Drug Administration (FDA)
Information
Sheets for Clinical Investigators and IRBs
http://www.fda.gov/oc/oha/IRB/toc.html
These information sheets present the Food and Drug Administration's
(FDA) current guidance on protection of human subjects in
research. Topics include, among others: answers to FAQs,
informed consent guidance, list of various regulations and
their differences, and information on continuing review.
Good
Clinical Practice Articles (ICH)
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf
The International ethical and scientific quality standard
for designing, conducting, recording, and reporting trials
that involve the participation of human subjects.
FDA
Regulations
Title 21, Part 50: Protection of Human Subjects http://www.access.gpo.gov/nara/cfr/
waisidx_99/21cfr50_99.html
Title 21, Part 56: Institutional Review Boards
http://www.access.gpo.gov/nara/cfr/
waisidx_99/21cfr56_99.html.
Title 21, Part 312: Investigational New Drug Application
http://www.access.gpo.gov/nara/cfr/
waisidx_99/21cfr312_99.html
Title 21, Part 812: Investigational Device Exemption
http://www.access.gpo.gov/nara/cfr/
waisidx_02/21cfr812_02.html
Office of Human Research Protections (OHRP)
IRB
Guidebook, prepared by Robin
Levin Penslar, JD
http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
The
Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
This report outlines basic principles and guidelines for
human subjects research.
DHHS
Regulations
Title
45, Part 46: Protection of Human Subjects
http://www.access.gpo.gov/nara/cfr/
waisidx_99/45cfr46_99.html
Title
45, Parts 160 and 164: Standards for Privacy of Individually
Identifiable Health Information
http://www.hhs.gov/ocr/hipaa/
Title
45, Parts 160, 162 and 164: Health Insurance Reform: Security
Standards
http://aspe.hhs.gov/admnsimp/
