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Data Governance

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What is Data Governance?

Data Governance is the strategic management of data throughout its lifecycle at Tennessee Department of Health.  It includes defined principles and practices that support data availability, usability, quality, security and privacy.  Key aims of our data governance program are to support the needs of data stewards and users, ensure transparency of data management roles and responsibilities throughout the department and establish standard, repeatable processes for effective data management.

Why is Data Governance Important?

Effective data governance enables better decision making, protects the needs of data stakeholders, ensures transparency of processes and reduces operational redundancies through coordination of data management efforts.  Each of these benefits improves our efforts to promote and protect health in Tennessee. 

We strive to ensure that data governance and stewardship policies, standards and processes about data definitions, data use and data protection will be transparent to all stakeholders

We strive to minimize risk and vulnerabilities through ongoing assessments of compliance with ethical, regulatory, standards, data privacy and best security practices

We will adopt and promote common set of process and instruments to granting and access and monitoring access to data and for defining data

We will work to define and align accountabilities for stewardship across stakeholder groups and leverage the collective knowledge of our stakeholders

We will serve as a resource to internal and external stakeholders who have questions, service needs, data access, while using obstacles and concerns about data use and sharing

Data Governance Core Services 


  • Centralized receipt and review of data requests through the Data Request System
  • Review of research protocol submissions by the TDH Institutional Review Board
  • Assistance with data sharing agreements
  • Review, clarification and updates of data release policies and practices

The Tennessee Department of Health Institutional Review Board (TDH IRB) serves to support research activities while ensuring to protect the rights and welfare of human subjects involved in research.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or  Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.​

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

 In order to start your application to TDH IRB please click on the link below to launch the iMedRIS application –

Institutional Review Board (IRB) FAQs 

If your project meets the definition of Human subject or Research then an IRB review is required.  These definitions may be reviewed at   https://www.hhs.gov/ohrp

No activities may be initiated prior to the IRB review and decision.  A decision letter will be available following the review.

When a complete IRB has been received and all initial questions have been answered, the submission will be referred to the appropriate IRB member(s) for review.  The convened IRB meets monthly; however, the length of time may vary based upon the number of times it is returned for corrections prior to being sent for a member review.

Once submitted the IRB staff reviews and returns for additional questions/clarifications or additional documents.  When these are received, the Data Stewards reviews the requested data and provides a recommendation or they do not recommend the data be used in the project.   The Data Steward may have additional clarifications or questions, if so; the submission will be returned for responses.   Once these steps are completed, the submission will either be sent to a member(s) for subcommittee review or placed on the agenda for full committee review.  Once a member receives the submission, they have two (2) weeks to complete their review.

IRB approval is for a 12-month period from the original approval.  You will be required to submit a continuing review at least 30 days prior to the expiration date.  If the continuation is approved another 12-month approval is granted.

To make changes to your study, including adding procedures, research personnel, or documentation, log into iMedRIS and submit the “Amendments” form. This form will give you an opportunity to modify your original application and submit new documentation to the IRB for review and approval.  These changes may not be implemented prior to the approval of the amendment.

All study staff are require to have CITI training.  A basic course in biomedical research, social/behavioral research, or research with records of lab specimens only must be completed with a score of 80% or above on each module.  A report identifying the completed modules must be submitted. https://about.citiprogram.org/en/homepage/

​To request data, documents, or analysis, please click button below:

Data Manager

Office of Informatics and Analytics (OIA)

Phone: 615-741-1954
Fax: 615-253-5187
Email: Data.Health@tn.gov

Tennessee Department of Health IRB Membership

Effective Jan 1st, 2020

Name

Credentials

Specialty

Ramona Lainhart

PhD

Research, Statistical Methods

Rachel Appelt

JD

Legal

John Benitez

MD

Emergency Preparedness, Medical Toxicology, Occupational/Environmental Medicine, Emergency Medicine

Zhi Chen

MD, PhD

Preventative Health

Chris Dorley

MSP, BS, MT

Newborn Screening, Genetics, Lab

Robin Gibson

PharmD

Pharmacology

Kate Goodin

MPH, MS

Biomedical Informatics, Biostatistics and Epidemiology

Elizabeth Harvey

PhD, MPH

Research Methodology

Angela Miller

DrPH

PRAMS; BRFSS

Aberlardo Moncayo

MD

Laboratory

Marco Robinson

M.A. Ed.

Regulatory Review

Rebecca Selove

PhD

Research, Behavioral Science Public Health Cancer Disparities

Martin Whiteside

DC, PhD, MSPH

Cancer Research

Xianglan Zhang

MD

Epidemiology

Consultants

Deborah Farringer                                                                                                     Bioethics; Health Law

If you have any questions or comments you would like to share, click on the link below to enter your information in the Office of Informatics and Analytics (OIA) Comments, Questions and Feedback form. You contact us directly at one the emails listed below. 

Data Governance – DataGovernance.Health@tn.gov  

                                                                        
Institutional Review Board (IRB) – TDH-IRB.Health@tn.gov  

                                                                       
Data Requests – Data.Health@tn.gov