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Differentiating Human Subjects Research from Public Health Practice and Quality Improvement Activities

The Ethics and Human Research Protection Program (HRPP) is responsible for differentiating research involving human participants from activities that are not research involving human participants, such as public health practice and quality improvement. When making determinations, the HRPP considers the regulations, laws, codes, and guidance that the Department of Health follows. Activities determined to be research require review and approval by the DOH IRB. Activities that are not research do not require IRB review or approval, but are required to follow DOH's ethical principles.

Criteria for making determinations are described in DOHP-400-1.4. Normally, HRPP Staff make the determination. However, if HRPP Staff have direct involvement in the activity being examined, the Director, Office of Public Health Research, makes the determination.

Officials use a worksheet to make determinations (click to view the worksheet in PDF format)

Guidance on activities that are normally not overseen by the HRPP

  • This is a partial list
  • Contact the HRPP for a determination
Case reports
  • Such activities are generally not systematic investigations
Disease outbreak investigations investigations into acute or chronic infectious diseases, conditions, or environmental hazards, and activities explicitly required by statute
  • When such activities are designed to identify and resolve a public health problem, and are not designed to contribute to generalizable knowledge, then review by the HRPP is not required
Surveillance required by statute
  • When required by statute, and when designed to identify and resolve a public health problem, then review by the HRPP is not required.
  • When the information is used in whole or in part for research (for example when information is used by University faculty or students for research), then review by the HRPP is required.
Quality assurance activities conducted as an ongoing part of program operations using a standard framework such as Sterling, Plan-Do-Check-Act, Six-Sigma
  • When such activities are designed to monitor and verify ongoing program operations, and are not designed to demonstrate or prove the effectiveness of programs, then review by the HRPP is not required
CHARTS data
  • Information does not contain private information, and it is not possible to readily ascertain the individual identities of participants

Resources:
Public Health Practice vs. Research: A Report for Public Health Practitioners Including Case Studies and Guidance. Council of State and Territorial Epidemiologists. http://www.cste.org/pdffiles/newpdffiles/CSTEPHResRptHodgeFinal.5.24.04.pdf

The Ethics Of Using QI Methods to Improve Healthcare Quality and Safety. Mary Ann Baily, Melissa Bottrell, Joanne Lynn and Bruce Jennings. Hastings Center (requires registration, but the report is available at no cost) http://www.thehastingscenter.org/publications/reports.asp

Additional Reading

  • Amoroso PJ, Middaugh JP (2003) Research vs. public health practice: when does a study require IRB review? Prev Med 36: 250-253.
  • Fairchild AL, Bayer R (2004) Public health. Ethics and the conduct of public health surveillance. Science 303: 631-632.
  • Middaugh JP, Hodge JG, Cartter ML (2004) The ethics of public health surveillance. Science 304: 681-4; author reply 681-4.