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 programs directly managed by Central Office must submit a written request (proposal) to Dr. Howard Burley, Chairman of the TDMHSAS IRB. The request should be as concise as possible, but include the following:

1. Study title
   
2. Study purpose
   
3. Research questions or hypotheses
   
4. Research design including information on the target population
   
5. Research method(s)* including instrumentation (commercial or locally developed)
   
6. Research ethics including informed consent procedures and forms, as well as how the data will be collected and protected
   
7. Data analysis

*Research methods should specifically incorporate how the researcher(s) will obtain informed consent and protect the confidentiality of participants throughout the study period. A copy of all informed-consent forms for study participants and any other pertinent forms and assessment tools 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 one or more of 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 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, the Chief Executive Officer of the RMHI, or their designee. The agency or institution where the study will be conducted will likely dictate the appropriate person to give evidence of support for the research.

The TDMHSAS IRB is an approved IRB under operational oversight by the U.S. Department of Health & Human Services (HHS), Office for Human Research Protections (OHRP). It is guided in its decision making by the three basic ethical principles outlined in The Belmont Report. Further, the IRB adheres to the specific protections of human study subjects as promulgated in the HHS Code of Federal Regulations (CFR) Title 45: Public Welfare, Part 46: Protection of Human Subjects.

Moreover, the IRB holds an OHRP-Federalwide Assurance (FWA), which makes it responsible for ensuring that investigators carrying out HHS-conducted or -supported human-subject research understand and act in accordance with the requirements of HHS regulations for the protection of human subjects. Therefore, principal investigators submitting requests for proposal must successfully complete and provide documentation of human subjects’ protection training as a condition of study approval in addition to the aforementioned required materials. Training may be obtained through the Collaborative Institutional Training Initiative (CITI) or the National Institutes of Health (NIH). Researchers affiliated with a fairly active research institution of higher education may have access to CITI training. The CITI Program provides research ethics education to all members of the research community but a subscription is required. NIH offers no-cost Human Subjects Protections’ training and can be accessed at http://phrp.nihtraining.com/users/login.php. Criteria for successful completion as delineated by CITI or NIH must be met as a condition of approval by the TDMHSAS IRB.

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

A cover letter should be included with the request.

If you have any questions, call Dr. Chappell at (615) 741-9476 or email Edwina.Chappell@tn.gov.

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.

SPECIFIC REQUIREMENTS FOR CONTINUING REVIEW SUBMISSION

Please provide, at minimum, the following materials with your request for continuing review:

• Cover letter to the TDMHSAS-IRB chairman requesting continuing review
  
• Summary of the current research
  
  • Brief overview of the project
    
  • Research question(s)
    
  • Preliminary data
    
    • Demographics
      
    • Successes/Challenges
      
    • Outcome data, if available
      
• Copies of forms, questionnaires, and/or other documents that are still being used, especially those that require an IRB stamp, such as informed consent forms, fidelity scales, adverse event form, etc. Make sure that any changes being proposed to the documents are listed. If so, submit the document(s) including proposed changes as well.
  
• Any adverse events and/or unanticipated problems
  
• Any documents relating to the research activities that have not been reviewed by the IRB since the last review/amendment
  
• Documentation of investigator training in human-subject protections, if necessary
  
  
  SUBMISSION SCHEDULE
  
  The TDMHSAS IRB is scheduled to meet in March, June, September, and December for proposal review and/or to conduct other business. However, the chairman has the authority to convene meetings. 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 submitting proposals for continuing review must submit before the end of the approval time period to avoid suspension of research activities.
  
  Decisions regarding proposals, including requests for additional information, will be provided within ten (10) days from the date that the proposal is reviewed. 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 IRB Members

• Howard L. Burley, Jr., M.D.
  IRB Chairman, Chief Medical Officer, Division of Clinical Leadership, TDMHSAS
  
• Jason Carter, Pharm.D.
  IRB Co-Chairman, Chief Pharmacist, Division of Clinical Leadership, TDMHSAS
  
• Edwina Chappell, Ph.D.
  Licensed Psychologist and IRB Administrator, Division of Clinical Leadership, TDMHSAS
  
• Sandra Braber-Grove, Esq.
  Director, Office of Contracts and Privacy/Assistant General Counsel, Division of General Counsel, TDMHSAS
  
• Karen Edwards, Ph.D.
  Director, Office of Research, Division of Planning, Research & Forensics, TDMHSAS
  
• Terry Holmes, M.D.
  Medical Director, Moccasin Bend Mental Health Institute (MBMHI), TDMHSAS
  
• Ellyn Wilbur, M.P.A.
  Executive Director, Tennessee Association of Mental Health Organizations (TAMHO)