Human Research Protection Program and 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 committee operates under institutional 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.
We use HealthStream.
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.
IRB Compliance Concerns/Whistle Blower Notification
The Office of Research and Innovation would like to hear from you.
If you would like to report a problem or raise questions or compliance concerns, please contact us at irb@mmc.edu or to report anonymously, click here. Reports will be treated as confidential to the extent possible and are subject to the University’s Whistleblower Protection Policy, which prevents retaliation.
Human Subject Regulations Decision Charts
Please read through all Human Subject Regulations Decision Charts.
Federal Regulations
Review the Code of Federal Regulations regarding the protection of human subjects: 45 CFR 46.
Federal Office for Human Research Protections
Please visit the Federal Office for Human Research Protections for all regulations, policies and guidelines.
IRB Chair and Vice-Chair
Rajbir Singh, MBBS
Associate Professor, Department of Internal Medicine
Co- Director, Center for Women’s Health Research
Executive Director, Center of Excellence for Clinical and Translational Research
Executive Director, Precision Medicine and Health Trials Design
Director, Regulatory Compliance Office, NIH AIM-AHEAD Consortium
Co-Director, Center for Women’s Health Research
Co-Investigator, NIH AIM-AHEAD Leadership Core Southeast Hub
Chair, Institutional Review Board (IRB), Meharry Medical College
