Institutional Review Board

The Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS) Institutional Review Board (IRB) operates under a Federalwide Assurance with the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS). The TDMHSAS IRB is responsible for reviewing and approving research proposals involving human subject research, records research, and specimen research, including grant proposals, submitted to the TDMHSAS IRB, in accordance with federal and state laws.

The TDMHSAS IRB is scheduled to meet on the 2nd Friday of each month for proposal review and/or to conduct other business. The chairperson, however, has the authority to convene meetings as needed. Research proposals submitted for review must be received within twenty (20) days of scheduled TDMHSAS-IRB meetings. Proposals received outside the window of scheduled meeting dates should allow at least thirty (30) days for review. Researchers/investigators submitting amendments or proposals for continuing review must submit before the oversight approval date expires to avoid suspension of research activities.

  1. IRB members will participate in valid human subjects’ protection training at minimum every three (3) years.
  2. Newly appointed TDMHSAS IRB members will obtain valid human subjects protection training within six (6) months of appointment to the Board.
  3. Teachable moments at IRB meetings may be used to provide additional training for membership.
  4. The IRB will conduct initial review of research activities involving appropriate studies.
  5. The IRB will conduct continuing review of research activities, as deemed necessary, involving appropriate studies.
  6. Limited IRB review will be conducted for exempted and/or expedited research as deemed necessary.
  7. The IRB will conduct review of amendments to previously approved research.
  8. The IRB will close-out a study when notified by the Principal Investigator (PI) or his or her designee that the only remaining activities are participant follow-up and/or data analyses.
  9. The IRB may take other actions such as suspending research activities when deemed warranted.
  1. IRB membership is approved by the TDMHSAS Commissioner and must consist of at least five (5) members.
  2. Every reasonable effort will be made to maintain at least nine (9) members on the IRB.
  3. The Chief Medical Officer is the appointed IRB Chairperson.
  4. In accordance with Federal regulations, the TDMHSAS IRB contains at least one member that is a nonscientist and at least one member that is not a departmental staff person.
  5. Per Board resolution, at least one member should be clinical staff from one of the department’s RMHIs or central office staff from the Division of Hospital Services.
  6. At least one community member who is representative of the behavioral health field will be recommended for membership.
  7. IRB members are approved by the Commissioner, and have complete review, discussion, and voting rights. (An IRB member may be appointed by the Chairperson to function as the Co-Chairperson. This individual will perform designated roles and responsibilities of the Chairperson in his or her absence.)
  8. Other individuals including student interns may be invited to participate in IRB meetings. They can provide information regarding specific proposals, review submitted material, answer questions from the membership, and engage in discussion. However, these individuals will not have voting privileges.

TDMHSAS IRB Members

Howard L. Burley, M.D.
IRB Chairperson and Chief Medical Officer, Division of Clinical Leadership (DCL), TDMHSAS

Wesley Geminn, Pharm.D.
IRB Co-Chairperson, Chief Pharmacist and State Opioid Treatment Authority (SOTA), Division of Clinical Leadership (DCL), TDMHSAS

Edwina Chappell, Ph.D.
IRB Administrator/Licensed Psychologist, Division of Clinical Leadership (DCL), TDMHSAS

Rebecca Hnilica, Ph.D.
Director, Office of Research, Division of Administrative & Regulatory Services (DARS), TDMHSAS

Brett George, M.D.
Clinical Director, Memphis Mental Health Institute (MMHI), TDMHSAS

Taryn Sloss, B.S.
Assistant Commissioner, Division of Substance Abuse Services (DSAS), TDMHSAS

Mary-Linden Salter, M.S.S.W.
Executive Director, Tennessee Association of Alcohol, Drug, and Other Addiction Substances (TAADAS)

Alysia Smith Knight, NPM
Executive Director, Tennessee Association of Mental Health Organizations (TAMHO)

Erica Hurst, Pharm.D.
Assistant Chief Pharmacist, Division of Clinical Leadership (DCL), TDMHSAS

Bev Fulkerson, M.A.
Deputy Assistant Commissioner, Division of Substance Abuse Services (DSAS), TDMHSAS

Elizabeth Setty Reeve, Esq.
Director, Juvenile Justice Programming, Division of Mental Health Services (DMHS), TDMHSAS

Alternate Members

James Don Walker, M.A., M.A.
Statistical Research Specialist, Office of Research, Division of Administrative & Regulatory Services (DARS), TDMHSAS

Current Pharmacy Resident, Pharm.D.
Pharmacy Resident, Division of Clinical Leadership (DCL), TDMHSAS

Legal Consultants

Cynthia Tyler, Esq.
Legal Consultant for IRB, Senior Associate Counsel, Division of General Counsel (DGC), TDMHSAS

Sam Boukli, J.D.
Alternate Legal Consultant for IRB,  Deputy General Counsel CO Legal Services & Investigations Counsel, Division of General Counsel (DGC), TDMHSAS

Questions or Concerns

If you have questions or concerns about the TDMHSAS IRB, please reach out to the IRB Administrator (IA).

Edwina Chappell, Ph.D.
Statistical Research Specialist/Licensed Psychologist
615-310-9598
Edwina.Chappell@tn.gov