Institutional Review Board
An Institutional Review Board has been established (45 CFR 46; 21 CFR 56) to review the scientific merit, medical necessity, educational value, moral, ethical, legal and fiscal aspects of all clinical research as well as the rights and welfare of human subjects. All research studies are reviewed by the IRB before they begin and at least once annually to evaluate the risks to subjects and compliance with federal regulations and institutional policies.
The MCDH North Texas Institutional Review Board is registered with the Office for Human Research Protection (IRB00000852) and its Federal-Wide Assurance number is FWA00000220. This agreement is between MCDH North Texas IRB & DHHS stating that MCDH North Texas IRB is guided by the ethical principles of the Belmont Report and will comply with federal regulations for all research involving human subjects.
All research involving human subjects, regardless of funding source, conducted at or in affiliation with MCD shall be conducted in accordance with federal regulations. Applicable regulations include but are not limited to:
- 45 CFR 46, generally known as the Common Rule and subparts B, C & D
- 21 CFR 50 & 56, Human Subject Protection (Informed Consent) & IRBs
- 21 CFR 312, Investigational New Drug Application
- 21 CFR 812, Investigational Device Exemptions
The IRB has the authority to approve, require modifications of, or disapprove all human research that falls within its jurisdiction. The IRB monitors and conducts continuing review of approved research at intervals of at least once per year. The IRB has the authority to observe or have a third party observe the consent process. The IRB takes actions to comply with federal regulations or other applicable laws, including action to suspend or terminate approval of research. The IRB must report to appropriate MCDH institutional and federal government officials and any funding agency: any suspension or termination of research, any unanticipated problems involving risks to subjects and any serious continuing noncompliance with IRB requirements. Please view the full listing of the IRB policies and procedures.
All industry –sponsored applications submitted to the IRB for initial review will be assessed a fee for new applications in the amount of $2,000.00 for full board review. The fee for continuing review of such studies is $500.00. There is no fee for amendments to protocols. Applications supported by State, Federal, non-profit foundation, or internal funds are excluded from these charges.
IRB Contact Information
|Allan Naarden, MD