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Research Involving Data Registries

No research involving non-public DOH data may proceed without DOH IRB approval. Programs may also require a data use agreement. If a program requires a data use agreement, the DOH IRB will not approve until the agreement is in place. Although a program may not approve research that has been approved by the DOH IRB, no research may proceed that has not been approved by the IRB. Researchers may also need to secure IRB review from their own institutions, if those institutions do not defer to the review of the Department's accredited IRB.

Publicly available data of the Department does not require IRB review. Publicly available data means data available through CHARTS, the Community Health Assessment Resource Toolkit. Determination of whether research involving the Department's data requires IRB review is the sole responsibility of the Department's IRB.

Data Source Authority Data use agreement required How to Apply
Birth Defects Registry 381.0032 F.S. authorizes the Department to conduct research into diseases of epidemiological significance, or to partner with universities in Florida to conduct epidemiological research The Data Use Agreement requires that data provided:
  • be used only for purpose for which it was requested and supplied
  • the researcher agrees to protect the confidentiality of data and reports involving data
  • the researcher does not link data to any other source
    the researcher does not attempt to contact any individuals or families referenced in the data
  • the researcher does not prepare or publish reports that identify individuals
  • the researcher designates a data custodian approved by the Department
 Apply simultaneously for DOH IRB review and for access to records from the Birth Defects Registry
Brain and Spinal Cord Injury Program 381.775 F. S. authorizes the Department to release records for research only if the records do not identify applicants or recipients, and when the research is approved by the Department. The Department may only release records that do not identify participants Registry is confidential; only records that do not identify applicants or recipients may be released for research
Florida Cancer Registry 385.202 F.S. provides for release of cancer registry data for research for medical or scientific research Researcher may not further disclose confidential information Apply simultaneously for DOH IRB review and access to records from the Florida Cancer Registry.
Medical Quality Assurance Physician Workforce Survey 458.3193 F.S. provides
for release of data to research entity, if
  • the entity seeks the records or data pursuant to a research protocol approved by the DOH IRB
  • maintains the records or data in accordance with the approved protocol
  • enters into a purchase and data-use agreement with the department
The Department may refuse a request if the protocol:
  • is not approved by the DOH IRB
  • provides for intrusive follow-back contacts
  • does not plan for the destruction of confidential records after the research is concluded
  • is administratively burdensome
  • does not have scientific merit
 The Data Use Agreement must:
  • restrict the release of information that would identify individuals
  • limit the use of records or data to the approved research protocol
  • prohibit any other use of the records or data
 Apply simultaneously for DOH IRB review and to Medical Quality Assurance for access to records from the Physician Workforce Survey
Child Abuse Death Review Established by statute in 1999 (F.S. Chapter 383.402 ) registry of child abuse and neglect deaths in which a verified report of abuse or neglect exists. The purpose of Child Death Reviews is to:
  • Develop a community based approach to address child abuse deaths and contributing factors.
  • Achieve a greater understanding of the causes and contributing factors of deaths resulting from child abuse or neglect.
  • Identify gaps, deficiencies or problems in service delivery to children and families by public and private agencies that may be related to child abuse deaths.
  • Develop and implement data-driven recommendations for reducing child abuse and neglect deaths.
 Data use agreement required. Apply simultaneously to the Child Abuse Death Review Committee and the DOH IRB.
Newborn Screening 383.14 F.S. authorizes release of data only to the newborn’s primary care physician. Statute does not authorize research release. 383.14 F.S. does not authorize research release to researchers who are not the newborn's primary care physician. 383.14 F.S. does not authorize research release to researchers who are not the newborn's primary care physician.
Office of Vital Statistics 382.025(3)(d) F. S. Florida Statues provides for release of Vital Statistics data if:
  • the research has scientific merit
  • research has approved by the DOH IRB
  • the protocol does not involve intrusive follow-back of contacts
  • a data use agreement has been approved by the Office of Vital Statistics
 The Data use agreement must:
  • restrict the release of any information which would permit the identification of persons found in Vital Statistics records
  • limit the use of the records or data to the approved research protocol
  • prohibit any other use of the records or data.
Apply simultaneously for DOH IRB review and for access to records from Vital Statistics