Is IRB review required for use of public datasets?

Is IRB review required for use of public datasets?

Institutional Review Board (IRB) FAQs Is IRB review required for use of public datasets?

Is IRB review required for use of public datasets?

IRB approval is required for all research involving human subjects. The Common Rule defines "human subject" at 45 CFR 46.102(f) as follows:

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.

Generally, investigators should submit an "Application for Designation of Not Human Subjects Research (NHSR)" to the Office of the IRB (OIRB) for a formal NHSR determination if they want to use data about individuals when that data is (1) neither obtained through intervention or interaction with the individual, (2) nor private and individually identifiable.

However, the UAB OIRB has reviewed the datasets listed below and determined that research involving these datasets does not meet the regulatory criteria for human subjects research. It is not necessary to submit a NHSR application for use of the datasets specifically listed on this page.

Investigators can nominate additional datasets for inclusion on this list by submitting the "Public Dataset Nomination Form." Please provide in your submission as much information as possible to identify the dataset so that the OIRB can appropriately research the dataset and determine, in accordance with the regulations, whether the information in the data constitutes human subjects.

Existing Datasets that do not constitute Human Subjects Research

Many of the datasets listed below have a publically available component and a restricted use component. The use of data from the following list of UAB IRB approved public data sets is not considered human subject research as long as the following two criteria are met:

        Research will NOT involve merging any of the data sets in such a way that individuals might be identified

        Researcher will NOT enhance the public data set with identifiable, or potentially identifiable data

If the two criteria above are met and the research will involve data from a dataset listed below, no UAB IRB review or approval is needed.

NOTE: If restricted datasets will be used, contact the IRB.

Site of Data Data Set​​
1000 Genomes Project
Agency for Healthcare Research and Quality (AHRQ)
American College of Surgeons (ACS) National Trauma Data Bank (NTDB)

American College of Surgeons National Surgical Quality Improvement Program(ACS-NSQIP) Participant Use Data File

National Cancer Data Base Participant User File (NCDB PUF)​
Bureau of Labor Statistics  Public-Use Data Files Only - excludes restricted and geo-coded/zip code datasets
  • 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 (NLSW)
  • National Longitudinal Survey of Young Men and Older Men
American Time Use Survey (ATUS) 
Centers for Disease Control (CDC)

Behavioral Risk Factor Surveillance System (BRFSS)

Youth Risk Behavioral Survey Study (YRBSS)

National Ambulatory Medical Care Survey (NAMCS)National Hospital Ambulatory Medical Care Survey (NHAMCS) 

dbGAP: National Center for Biotechnology Information

All datasets except those which specifically require IRB approval. It is the PI's responsibility to ensure that proper documentation is procured prior to use of the data. 

Data Resource Center for Child & Adolescent Health National Survey of Children's Health (NSCH)
National Survey of Children with Special Health Care Needs (NS-CSHCN)
Survey of Pathways to Diagnosis and Services (Public Use File only)​
Economic and Social Data Service (ESDS) Longitudinal Public-Use Data Files Only - excludes restricted and geo-coded/zip code datasets 
  • 1970 British Cohort Study (BCS70)
  • British Household Panel Survey (BHPS)
  • English Longitudinal Study of Ageing (ELSA)
  • Families and Children Study (FACS)
  • Growing Up in Scotland (GUS)
  • Longitudinal Study of Young People in England (LSYPE)
  • Millennium Cohort Study (MCS)
  • National Child Development Study (NCDS)
International HapMap Project 
National Cancer Institute (NCI) The Cancer Genome Atlas (TCGA) Open Access data tier (Data Level 3 & 4) 
National Center for Education Statistics (NCES) Public-Use Data Files including, but not limited to:School Survey on Crime and Safety (SSOCS) 
National Center for Health Statistics Public-Use Data Files and Documentation
  • NHANES: National Health and Nutrition Examination Survey
  • NHCS: National Health Care Survey
  • NIS: National Immunization Survey
  • NHIS: National Health Interview 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 Data Archive on Child Abuse and Neglect National Survey of Child and Adolescent Well-Being (NSCAW - General Use Files Only)

National Study of the Incidence of Child Abuse and Neglect
National Neurosurgery Quality and Outcomes Database N2QOD Dataset
Roper Center for Public Opinion Research 
U.S. Bureau of Labor Statistics
U.S. Bureau of the Census
U.S. Department of Agriculture (USDA)

(Economic Research Service)

Food and Nutrition Assistance Research Database
​U.S. Department of Energy (DOE)​ ​​​​​​​​Comprehensive Epidemiologic Data Resource​​
​​​U.S. Food and Drug Administration (FDA) ​​CFSAN Adverse Event Reporting System (CAERS)​
University of Michigan Institute of Social Research Panel Study of Income Dynamics (public version only)

Health and Retirement Study (public version only)

Inter-University Consortium for Political and Social Research (ICPSR) (public version only)
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