Department of Mental Health and Substance Abuse Services
E. Douglas Varney, Commissioner

PURPOSE OF THE INSTITUTIONAL REVIEW BOARD

Our purpose is to support research activities designed to develop or contribute to scientific generalized knowledge while minimizing risk and protecting the confidentiality of all subjects by reviewing proposals involving human research, records research, and specimen research, including grant proposals, submitted to the Tennessee Department of Mental Health and Substance Abuse Services(TDMHSAS) Institutional Review Board (IRB).

This policy applies to all research undertaken by or for TDMHSAS. It further includes any request to utilize patients or their records or specimens for research purposes.

HOW TO SUBMIT A RESEARCH PROPOSAL

INSTRUCTIONS TO PROSPECTIVE RESEARCHERS

All researchers that plan to conduct research requiring data collection from service recipients or the use of patient records from any of the Regional Mental Health Institutes (RMHIs) or Central Office must submit a written request (proposal) to the Chairperson of the TDMHSAS IRB. The request should be as concise as possible, but include the following:

• Clearly defined objectives;
• Research questions or hypotheses;
• Research design;
• Detailed discussion of the population;
• Research methods; and
• Data analysis.

Study methods should incorporate how the researcher will obtain informed consent and protect the confidentiality of participants. A copy of all informed consent forms for study participants must be submitted at the time of the request.

Additionally, the request must be accompanied by written executive approval from the agency or institution where the research will be conducted. The executive approval letter must contain the following:

• A statement about previous IRB review, if conducted prior to submission to the TDMHSAS IRB. If no previous IRB review was conducted, this fact must be clearly indicated and an explanation provided.
• A statement concerning approval or exemption of the proposed research by the agency IRB, institution IRB, or other appropriate IRB. If exempted, include a statement that thoroughly explains the nature of the exemption.
• Evidence of support from the TDMHSAS Commissioner or designee or the Chief Operating Officer of the RMHI. The agency or institution where the study will be conducted will likely dictate the appropriate person to give evidence of support for the research.

Finally, delineate specific activities to be carried out by both TDMHSAS staff, if any, and the researcher(s) as part of the study.

As expected, include a cover letter with your request. Individuals to whom the cover letter should be addressed and the proposal materials should be sent are indicated below.

Decisions regarding proposals, including requests for additional information, will be provided within ten (10) days from the date that the proposal is reviewed. The TDMHSAS-IRB will meet in March, June, September, and December if proposals have been submitted for review. The Chair further has the authority to convene call meetings. Please include an email address in all requests to facilitate communications regarding additional information or decisions that have been made.

Information pertaining to nonapproval or continuing review will be communicated in appropriate decision letters following review as well.

TDMHSAS INSTITUTIONAL REVIEW BOARD (IRB) Membership

• Sandra Braber-Grove, Esq.
  Assistant General Counsel, Office of Legal Counsel
• Howard L. Burley, Jr., MD
  Chief Medical Director and IRB Chair, Division of Clinical Leadership
• Jason Carter, PharmD
  Chief Pharmacist, Division of Clinical Leadership
• Edwina Chappell, PhD
  Statistical Research Specialist and Licensed Psychologist, Division of Planning, Research & Forensics
• Karen Edwards, PhD
  Senior Policy Analyst and Research Coordinator, Division of Planning, Research & Forensics
• Terry Holmes, MD
  Medical Director, Moccasin Bend Mental Health Institute
• Russell Irvin, AA, RNC
  Nursing Coordinator, Forensic Services Program, Middle Tennessee Mental Health Institute
• Ellyn Wilbur, MPA
  Executive Director, Tennessee Association of Mental Health Organizations (TAMHO)