GUIDANCE: Data Sets Not Requiring IRB Review

Purpose:

This document provides (1) a list of the data sets that the IRB has determined do not require IRB review or an exempt determination, and (2) guidance about the nature and use of these data sets.

Relevance:

Data sets on the list at the end of this document do not involve “human subjects” (as defined by federal regulations and guidance). Therefore, their use requires neither IRB review, an exempt determination, nor are users required to complete the NIH human subjects training.

Considerations:

Incomplete list. The list is provided as a service to researchers, by identifying data sets that have already been vetted by the IRB. It is not intended to be a complete list of all data sets that do not involve human subjects.

  • Researchers are welcome to consult with Kristen Kenny, Research Compliance Manager, about other data sets.

  • Other data sets may be nominated for inclusion on this list by following the procedures described in SOP for Data Sets Not Requiring IRB Review.

Exceptions. The following uses of the data sets listed below require prior IRB review or a determination of exempt/expedited status:

  • Merging data sets in such a way that individuals may be identified.

  • Enhancing a data set with identifiable or potentially identifiable data.

  • Research that consists of using one or more data sets on this list and also (1) the collection or use of private, identifiable data and/or (2) interactions or interventions with humans.

Data Use Agreements. The data set holder may require the researcher or the researcher’s institution to sign a Data Use Agreement (DUA) that explicitly requires IRB approval or an exempt/expedited determination. This condition of use must be honored, even for data sets on this list.

  • NIH dbGaP Controlled Access data sets are a common example. Federal regulators have advised NIH that the use of either public access or controlled access dbGaP data sets is not human subjects research because the data are coded and the identity of individuals from whom the data were obtained are not be readily ascertainable. However, in IRB’s experience, NIH frequently requires IRB approval as part of the use agreement.

  • The IRB will provide the documentation of IRB approval or exempt status. However, the IRB is not authorized to sign DUAs. DUAs that require an institutional signature should be signed by NBER’s Director of Research and Grants Management.

DATA SETS whose research use does not require IRB review or an exempt determination:

  • Healthcare Cost and Utilization Project (H-CUP) healthcare databases
    • The Nationwide Inpatient Sample (NIS)
    • The Kids’ Inpatient Database (KID)
    • The State Inpatient Databases (SID)
    • The State Ambulatory Surgery Databases (SASD)
    • The State Emergency Department Databases (SEDD)
    • Inter-University Consortium for Political and Social Research (ICPSR)
    • National Cancer Institute Surveillance Epidemiology and End Results Program(SEERS)
    • National Center for Health Statistics
      • NHANES: National Health and Nutrition Examination Survey
      • NHCS: National Health Care Survey
      • NHIS: National Health Interview Survey
      • NIS: National Immunization Survey
      • LSOAs: Longitudinal Studies of Aging
      • NSFG: National Survey of Family Growth
      • SLAITS: State & Local Area Integrated Telephone Survey
      • Vital Statistics: National Vital Statistics System
    • National Center for Education Statistics
    • National Hospital Ambulatory Medical Care Survey (NHAMCS)
    • National Longitudinal Survey (NLSY)
      • National Longitudinal Survey of Youth 1997 (NLSY97)
      • National Longitudinal Survey of Youth 1979 (NLSY79)
      • NLSY79 Children and Young Adults
      • National Longitudinal Survey of Young Women and Mature Women
      • National Longitudinal Survey of Young Men and Mature Men
      • Survey of Consumer Finances (SCF)
      • U.S. Bureau of the Census
      • U.S. Bureau of Labor Statistics


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      Requesting a Public Data Set be Added to the IRB Approved List:

      Additional data sets and archives may qualify for inclusion on this list. Investigators who wish to have a specific data set or data archive considered for inclusion on this list should follow the nomination instructions in SOP for Data Sets Not Requiring IRB Review.