The Institutional Review Board (IRB) at GBMC is responsible for protecting the rights and welfare of human subjects participating in research at GBMC.

GBMC requires all proposed research that involves intervention with human subjects, identifiable private data in medical records and data collection/analysis be reviewed and approved by the IRB. The IRB monitors human subject research to determine that it is conducted ethically and in compliance with federal regulations, state laws and GBMC policies and procedures.

The function of the IRB is federally-mandated and is regulated by the Department of Health and Human Services (45 CFR 46) and the Food and Drug Administration (21 CFR 50 and 56).

GBMC maintains an assurance of compliance, called a Federalwide Assurance (FWA), with the Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (HHS).

FWA Number	Expiration Date
FWA00003849	July 25, 2022

All Institutional Review Boards designated in an FWA must be registered with the U.S. Department Health and Human Services (HHS). The IRB at GBMC is registered with the HHS.

Registration Number	Expiration Date
IRB00002961	August 8, 2020

The GBMC IRB is comprised of highly qualified members with varying backgrounds. The membership includes a chairperson, vice-chairperson and representatives from the medical staff, pharmacy, legal affairs, nursing, library services and the community.

The IRB meets every third Monday of the month at 5:00 p.m. in the GBMC Physicians Pavilion East Conference Center. View the Meeting Dates and Submission Deadlines.

GBMC uses IRBNet for the electronic administration and management of its IRB. All research projects submitted for review by the IRB must be sent electronically through IRBNet. Paper submissions are no longer accepted.

If you are a GBMC affiliated researcher interested in submitting a research project to the IRB, please refer to the “IRBNet” tab on the left of this screen for accessing and training information.

For further information, contact the IRB staff:

Cathy Demmitt
IRB Coordinator
Email: cdemmitt@gbmc.org
Phone: 443-849-2379


Martha McCracken
IRB Assistant
Email: mmccrack@gbmc.org
Phone: 443-849-3120

Office Fax Number: 443-849-4199

Helpful Web Links:

Code of Federal Regulations Title 21 Part 50 (Food and Drug Administration) Protection of Human Subjects

Code of Federal Regulations Title 21 Part 56 (Food and Drug Administration) Institutional Review Boards

Code of Federal Regulations Title 45 Part 46 (Department of Health and Human Services) Protection of Human Subjects

Code of Federal Regulations Title 21 Part 312 (Food and Drug Administration) Investigational New Drug Application

Code of Federal Regulations Title 21 Part 812 (Food and Drug Administration) Device Exemptions

Department of Health and Human Services Summary of the HIPAA Privacy Rule