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 Regulations Part C Division 5
Part C, Division 5 of the Health Canada Food and Drug Regulations addresses the requirements
for conducting clinical research involving human subjects in Canada.
Tri-Council Policy Statement
Tri-Council Policy Statement was published in 1998 by the three major Canadian federal research funding agencies
to describe the obligations of institutions, researchers and REBs in the conduct of research involving human subjects.
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.
Personal Information Protection and Electronic Documents Act (PIPEDA)
PIPEDA describes Canadian regulations regarding personal information including
protected health information.
For federally funded studies, Title 45 CFR applies.