Distinguishing Research and Public Health Practice / Quality Improvement Activities

The Ethics and Human Research Protection Program is responsible for making determinations of whether an activity is research as defined in federal regulation and DOH policy, or public health practice, quality improvement or other activity not requiring IRB review.

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.