IRB

The IRB is a federally authorized administrative body established to protect the welfare, rights and privacy of human subjects’ involved in research activities. The IRB is charged with reviewing, prior to initiation, all research involving human participants. The MMC IRB Standard Operating Procedures Manual sets forth the IRB’s basic operational procedures. The IRB makes certain that research conducted at the College is in compliance with NIH’s Office of Human Research Protections (OHRP), Federal Drug Administration (FDA), Belmont Report and the Common Rule.

The IRB meets once a month (2nd Tuesday) to review studies qualifying for Full Board review. Exempt or Expedited reviews are considered on an ongoing basis.

The IRB, not the researcher, determines the review level. Correspondence with the IRB should be directed to IRB@mmc.edu. For IRB forms and documents, application information, study submission deadlines, administrative/noncompliance concerns, and general inquiries, see links provided.

External IRB reliance

When a single, external IRB is required for multi-site studies, Meharry contracts with Western Copernicus Group IRB. Contact IRB@mmc.edu for more information.

Meharry IRB Fees for industry sponsored trials:

  • Meharry Medical College charges the following fees for IRB reviews of industry-sponsored clinical trials:
    • Initial review, full board $2,000
    • Initial review, expedited $500
    • Continuing review, full board $700
    • Continuing review, expedited $300
    • Amendment, full board $500
    • Amendment, expedited $100
    • Administrative changes $0
  • Payment is required prior to IRB approval.
  • No fees are required for government-sponsored or investigator-initiated research.

CITI Training is required prior to eProtocol access.

eProtocol contains all forms, instructions and timelines.

Please read through all Human Subject Regulations Decision Charts.

Review the Code of Federal Regulations regarding the protection of human subjects: 45 CFR 46.

Please visit the Federal Office for Human Research Protections for all regulations, policies and guidelines.