Quality Assurance

The MCD IRB follows all federal regulations (45 CFR 46; 21 CFR 56) when reviewing 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 MCD IRB is registered with the Office for Human Research Protection (IRB 00000852) and has a Federal-Wide Assurance Number (FWA 00000220). This agreement between MCD IRB and the Department of Health and Human Services states that MCD IRB is guided by the ethical principles of the Belmont Report and will comply with all federal regulations for all research involving human subjects. All human subject research, 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 and D
  • 21 CFR 50, Protection of Human Subjects, Informed Consent, and Additional Safeguards for Children in Clinical Investigations
  • 21 CFR 56, Institutional Review Boards
  • 21 CFR 312, Investigational New Drug application
  • 21 CFR 812, Investigational Device Exemptions