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Research involving data registries

Robert Hood

08/07/2008 09:24 pm

Researcher Help: Research involving data registries

Research involving data registries

Information

General Considerations
  • Research involving data registries falls under the regulatory definition of research involving a “human subject” when registry research involves records of a living individual about whom individually identifiable data was collected through intervention or interaction. The DOH IRB is responsible for determining when data registry research meets the regulatory definition of research involving human subjects. (Data refers to information, and does not include tissues used in research.)
  • Requirements of some of the more commonly used data registries at the Florida Department of Health are available. In general, research involving DOH non-public data requires approval from the program and a data-use agreement. No research may occur involving DOH non-public data without prior IRB review and approval.
  • Researchers must provide the IRB a list of variable names (a description of the data the researcher will be receiving) so the IRB can understand the project. Upload the codebook when available (See IRBWise Summary question M)
  • Researchers must indicate the number of records they are seeking. Reporting the number of records involved in a data research protocol is similar to reporting the number of participants to be recruited and enrolled in a survey or clinical trial. For example, if the researcher expects to request 20,000 records from the Florida Cancer Registry, then this would be the number of participants the researcher should list in the IRBWise application.
  • Research involving registry data requires the researcher upload in IRBWise a data use agreement and approval from the registry program, in addition to other materials that must be uploaded for all studies.
  • For research involving data registries, select "Indirect Interaction Only" in Question A, in Section III: Subject Information of the IRBWise application.
Required Determinations by the IRB The IRB must describe specific procedures to ensure the confidentiality of participants’ data and determine that the research makes adequate provisions to maintain the confidentiality of data. For more information about factors the IRB considers, see IRB Committee Member Help.
Accreditation Element Element III.1.E: The Investigator determines that the resources necessary to protect participants are present before conducting the research study.
Regulations 45 CFR §46.111(a)(7); 21 CFR §56.111(a)(7)
Guidance
References

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