Instructions

Institutional Review Board

Instructions and Information for Researchers

IRB Meetings are held the third Monday of the month at 5:00 pm in the Physicians Pavilion East Conference Center. The Principal Investigator or designee must present the new protocol for initial review. Refer to the IRB Meeting Schedule for dates to submit materials for full board review.

NEW PROTOCOL Checklist for IRB Review:

To schedule review of a new protocol, contact the IRB Coordinator at 443-849-2379.
Refer to the website www.gbmc.org/education/irb for updated IRB Bylaws.
Prepare an Application Form for New Protocols to attach to the protocol materials.
Sign Conflict of Interest Statement to submit with your application and protocol.
Complete the Clinical Trials Billing & Registration Plan to include with submission. Review the Billing and Registration Plan Communication Process for more information.
Review Fees are due at the time of submission. Make check payable to GBMC IRB.
For Informed Consent and HIPAA requirements, refer to the IRB Bylaws.
Submit 15 copies of complete research protocol and consent(s) and all required documents and the Review Fee to address below.
Include one extra unstapled Informed Consent to be stamped and returned to you.
Submit Investigator Brochure for a new protocol, if applicable.

OTHER MATERIALS submitted for IRB review:

Submit 15 copies of Status Report Form (renewal or closure), Adverse Event, Revision, Deviation
Submit one sponsor-generated Progress Report (including GBMC site-specific activities)
Submit one sponsor-generated Final Report (including GBMC site-specific results)
Submit 15 copies of Patient Materials (recruitment, instructions, media releases, advertisement)
Submit one Investigator Brochure (initial or revised)
Submit two copies of Expedited, Administrative, Cooperative or Exemption Reviews

REVIEW FEE SCHEDULE (due with submission, payable to GBMC IRB):

Full Board Review of New Protocol
Full Board Continuing Review for Renewal
Full Board Continuing Review for Closure
Expedited Review of Minimal Risk Protocol
Expedited Review of qualifying Status Report for Renewal
Cooperative/Facilitated Review (Central IRB Studies)

$500.00
$100.00
$100.00
$150.00
$100.00
$200.00

SUBMISSIONS and REVIEW FEES (Make checks payable to GBMC IRB)	Judy Disharoon, Coordinator Institutional Review Board 6701 North Charles Street Baltimore, Maryland 21204

For More IRB Information:	Phone: 443-849-2379 Voice Mail: 443-849-3120 Fax: 443-849-3776 Email: jdisharo@GBMC.org