Investigators are responsible for conducting clinical research in
accordance with the following:
The Belmont
Report
This report was issued in 1979 and outlines the basic ethical principles and
guidelines for research involving human subjects.
Good Clinical
Practice
Schulman Associates Institutional Review Board, Inc. is in compliance with the
International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
guidelines for IRBs.
Code
of Federal Regulations
Title 21 of the Code of Federal Regulations (CFR) addresses the requirements
for conducting clinical research involving human subjects. For more
information, please refer to the following sections of 21 CFR:
Food
and Drug Administration (FDA) Information Sheets
The FDA Information Sheets are designed to enhance the Code of Federal
Regulations by providing guidance on many topics including, but not limited to,
recruitment materials, subject compensation, and obtaining informed consent.
For federally funded studies, Title 45 CFR applies.