Regulatory Affairs Unit

MMC has multiple internal regulatory committees in place to ensure that all research conforms to the highest standards of ethics, compassion and professional responsibility. Researchers must comply with the latest federal/state/institutional guidelines for the protection of human and animal subjects, biohazardous materials research, scientific conduct and statements of conflict of interest. These committees also offer education and training for all MMC researchers (faculty, students and staff).

 

MMC’s policy regarding research states: All MMC research activities proposing to involve human, animal subjects and biohazardous materials MUST be reviewed and receive written, unconditional approval from the appropriate regulatory committee before commencing.

This policy applies to ALL research, including that in the School of Medicine, School of Dentistry and School of Graduate Studies, (behavioral and social sciences) regardless of whether it is funded or not.

The MMC IACUC and Animal Care Facility (ACF) oversees the institution’s animal program, facilities and procedures. The MMC IACUC membership includes practicing scientists experienced in research involving animals, the attending veterinarian, non‐scientists, and non‐affiliated members. The primary function of the IACUC is to review researchers’ applications for the use of animals in their experimental procedures following criteria set forth in the Guide for the Care and Use of Laboratory Animals, OLAW and UDSA. Additionally, the IACUC reviews any individual concerns reported to the Institutional Official, IACUC Chair, Attending Veterinarian, or any member of the IACUC.

 

The IACUC is scheduled to meet once a month (4th Tuesday) during the year and may have additional meetings to review studies qualifying for Full Board review, as needed. Studies qualifying for Expedited review are considered on an ongoing basis.

 

The IACUC, not the researcher, determines the review level. All applications for review and correspondence with the IACUC should be directed to the administrative office of the IACUC. For IACUC forms and documents, application information, study submission deadlines, administrative concerns, and general inquiries, see additional information below.

 

The Animal Care Facility (ACF) at Meharry is reviewed semiannually by the Institutional Animal Care and Use Committee (IACUC) and has been accredited by the Association for the Assessment and Accreditation for Laboratory Animal Care International (AAALAC) since 1972.  The ACF at Meharry operates in compliance with the Animal Welfare Act as Amended (7 USC, 2131-2156); Health Research Extension Act of 1985 (Public Law  99-158); follows the Public Health Service policy on Humane Care and Use of Laboratory Animals – revised 2015; and the Guide for the Care and Use of Laboratory Animals – revised 2011.

Contact Information

Aramandla Ramesh, PhD

IACUC Chair

Assoc. Professor

Biochemistry & Cancer Biology

Email: aramesh@mmc.edu

Anthony Archibong, PhD

IACUC Vice‐Chair

Assoc. Professor

Physiology

Email: aarchibong@mmc.edu

Regulatory Review Administrator

Phone: (615) 327‐6599

Email: mrobinson@mmc.edu or IACUC@mmc.edu

 

For more information, click here.

The MMC IBC has been charged by Federal law with the planning and implementation of the campus Biosafety Program with a purpose to ensure the health and safety of all personnel working with biohazardous agents. The IBC makes certain that research conducted at the College is in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules, Centers for Disease Control and Prevention (CDC) and the Select Agent Rule, drafts campus biosafety policies and procedures, and reviews individual research proposals for biosafety concerns.

 

The IBC is scheduled to meet quarterly or at least four times during a calendar year and may have additional meetings to review studies qualifying for Full Board review, as needed. Studies qualifying for Exempt or Expedited review are considered on an ongoing basis.

 

The IBC, not the researcher, determines the review level. All applications for review and correspondence with the IBC should be directed to the administrative office of the IBC. For IBC forms and documents, application information, study submission deadlines, administrative concerns, and general inquiries, see additional information below.

Contact Information

Bindong Liu, PhD

 IBC Chair

Assoc. Professor

Health Disparities and HIV

Email: bliu@mmc.edu

Regulatory Review Administrator

Phone: (615) 327‐6599

Email: mrobinson@mmc.edu or IBC@mmc.edu

For more information, click here.

The IRB is a standing administrative body established to protect the welfare, rights and privacy of human subjects’ involved in research activities. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research involving human participants. The MMC IRB Standard Operating Procedures (SOPs) 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 is scheduled to meet twice per month (1st and 3rd Tuesday) during the calendar year and may meet once a month to review studies qualifying for Full Board review, as needed. Studies qualifying for Exempt or Expedited review are considered on an ongoing basis.

 

The IRB, not the researcher, determines the review level. All applications for review and correspondence with the IRB should be directed to the administrative office of the IRB. For IRB forms and documents, application information, study submission deadlines, administrative/noncompliance concerns, and general inquiries, see additional information below.

Contact Information

Flora Ukoli, MD, MPH

IRB Chair

Professor

Dept. of Surgery

Email: fukoli@mmc.edu

Amosy M’Koma, MD, PhD

IRB Vice Chair

Assoc. Professor

Biochemistry & Cancer Biology

Email: amkoma@mmc.edu

Human Protections Administrator

Phone: (615) 327‐6735

Email: sroberson@mmc.edu or IRB@mmc.edu

 

For more information, click here

MMC’s regulatory committees maintains direct liaisons with other institutional offices to ensure research compliance is met and provide service/support to members of the campus who need access to regulatory information or involved in compliance issues.

 

Meharry’s institutional safety program offers, employee and occupational health services, educational training in a variety of subjects areas and performs campus‐wide evaluations and inspections related to environmental issues. For institutional safety program forms/documents, application information, office hours, administrative /noncompliance concerns, and general inquiries, see additional information below.

Employee & Occupational Health Services

Department of Family & Community Medicine

Old Hospital Building, 3rd floor, Suite 300

Phone: (615) 327‐5857

Twum Ansah, PhD

Chemical Biological Safety Officer

Dept. of Environmental Health & Safety

Phone: (615) 327‐6642

Email: tansah@mmc.edu

Julie Sejour, MA, RSO

Radiation Safety Officer

Dept. of Environmental Health & Safety

Phone: (615) 327‐6642

Email: jsejour@mmc.edu

Jeffrey Mitchell, CIH

Environmental Safety Officer

Dept. of Environmental Health & Safety

Phone: (615) 327‐ 6642

Email: jmitchell@mmc.edu