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About Us

IRB Fee Schedule

These Fees Are Applicable to Industry Sponsored Studies Only

Initial Review: $2,000.00

This fee includes initial review of the following documents and subsequent submissions for the study for a one-year period following approval:

  • Application
  • Informed Consent
  • Protocol
  • Investigator Brochure
  • Recruitment Materials
  • Safety Issues (Safety Information, Serious Adverse Events, Safety Updates, etc)
  • Protocol Amendments
  • Informed Consent Amendments
  • Closure Notice
  • Correspondence from the Board for each of the above-listed actions.

Informed Consent Development-Initial Submission: $500.00

Continuing Review: $1,000.00

This fee includes annual renewal (unless the Board determines the study needs to be reviewed at different intervals due to the risk or nature of the study). The following documents are reviewed at that time:

  • Annual Renewal Report
  • Request for Renewal
  • Protocol Changes
  • Informed Consent Changes
  • Correspondence from the Board for each of the above-listed actions.

Research studies that are subject to IRB review fees may not begin until all IRB and applicable study start up fees are paid in full. Documentation of NHRMC IRB actions will not be provided for studies with outstanding balances. Please make your check payable to New Hanover Regional Medical Center IRB and remit to:

Amy Southerland, BS, CIP, IRB Coordinator
New Hanover Regional Medical Center
P.O. Box 9000 / 2131 S. 17th Street
Wilmington, NC 28402-9000

Administrative Fees

Contract Preparation: range $500-1,000

Contract review and negotiation for industry-sponsored clinical trials are some of the most important and time-consuming administrative activities. The Clinical Research Officer performs and/or coordinates the following services:

  • Reviews and revises sponsor agreement
  • Reviews and prepares PI/Co-PI agreement(s), if needed
  • With PI and study staff, delineates study-specific tasks from routine patient tests/procedures
  • Conducts a National coverage determination
  • Negotiates budgets
  • Coordinates internal reviews and approvals (contractual, financial, operational and compliance)
  • Presents documents for signatures and execution

Study Logistics Planning

Industry-sponsored studies typically require study-specific services provided by hospital departments outside routine activities. If significant work effort by a particular department is required (e.g. laboratory, pharmacy, etc.), a set-up fee based on the study requirements may be charged. The Clinical Research Officer performs and/or coordinates the following services:

  • Reviews protocol and application
  • Provides study information to departments to determine feasibility of providing study-specific services
  • Arranges meetings with department manager or designee to plan and establish study charges
  • Prepares communication to departments
  • Assists with departmental billing to the study and follow-up, as needed

Administrative Set-up: Simple (1-2 departments): $250

Administrative Set-up: Complex (>2 departments): $500

Department Set-up fees: range $250 - 1,000

Prior to the initiation of the study, all study agreements must be completed and payment of administrative fees must be received. Please make your check for admin start up fees payable to New Hanover Regional Medical Center and remit to:

Anne Patterson, Clinical Research Officer
New Hanover Regional Medical Center IRB
P.O. Box 9000 / 2131 S. 17th Street
Wilmington, NC 28402-9000
 
2131 S. 17th Street, Wilmington, NC 28401  |  910.343.7000