and Drug Administration (FDA)
Sheets for Clinical Investigators and IRBs
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.
Clinical Practice Articles (ICH)
The International ethical and scientific quality standard
for designing, conducting, recording, and reporting trials
that involve the participation of human subjects.
Title 21, Part 50: Protection of Human Subjects http://www.access.gpo.gov/nara/cfr/
Title 21, Part 56: Institutional Review Boards
Title 21, Part 312: Investigational New Drug Application
Title 21, Part 812: Investigational Device Exemption
Office of Human Research Protections (OHRP)
Guidebook, prepared by Robin
Levin Penslar, JD
This report outlines basic principles and guidelines for
human subjects research.
45, Part 46: Protection of Human Subjects
45, Parts 160 and 164: Standards for Privacy of Individually
Identifiable Health Information
45, Parts 160, 162 and 164: Health Insurance Reform: Security