Regulatory Guidance

Center for Drug Evaluation and Research (CDER)
Contains important information concerning the conduct of FDA-regulated studies.

U.S. Food and Drug Administration (FDA)
Provides a wealth of information on all aspects of the drug and device approval processes, including the protection of human research participants.

National Institutes of Health (NIH)
Dedicated to the latest information regarding health issues and ongoing scientific research and special reports.

Office for Human Research Protections (OHRP)
Provides guidelines for human research participant protection.

International Conference on Harmonisation (ICH)
Provides access to all available guidance issued by the ICH organization.

The President’s Commission for the Study of Bioethical Issues
Offers current information on national meetings regarding research participant protection with use of biologic materials as well as other ethical dilemmas.

The Belmont Report
Important reading for every researcher and every person deciding whether or not to be a participant in a research study. This report was written in 1979 by a national commission investigating the conduct of clinical research with human participants.

Financial Conflict of Interest: HHS Guidance
OHRP published guidance for protecting research subjects from possible harm caused by financial conflicts of interest in research studies.

CenterWatch Clinical Trials Networking
Clincial trial information and listing of available research studies being conducted in the U.S. and abroad.

Clinical Trials Information
Provides patients, family members and members of the public with current information about clinical research studies for a wide range of diseases and conditions.

Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
FDA guidance documents on the protection human subjects in research.

Good Clinical Practice (GCP) Guidance in FDA-regulated Clinical Trials
This is the website for the FDA division that is responsible for overseeing Good Clinical Practice (GCP). GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting for clinical trials.

FDA Center for Devices and Radiological Health (CDRH)
Provides information regarding specific requirements for conducting research studies of medical devices.

Title 21 CFR (Code of Federal Regulations)
Federal regulations governing the proper conduct of clinical research and the makeup of IRBs. Elements of informed consent documents are also discussed.

Title 45 CFR Part 46 (Code of Federal Regulations)
Federal regulations governing the proper conduct of clinical research and the makeup of IRBs pertaining to federally funded research. Elements of informed consent documents are also discussed.

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