FAQ: Quality Improvement vs Research

  1. Do the regulations governing research involving human subjects apply to all QI activities within CHOP?

    Not all QI activities meet the definition of research as defined in "the regulations" (45 CFR 46).

    Examples of QI that are not research:

    • A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.

    • A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates, and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.

    • A clinic implements a widely accepted assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit medical charts to see if the assessments are performed for the appropriate patients, and will implement additional in-service training of clinic staff regarding the use of the assessment if it finds that the assessments are not being administered routinely to appropriate patients.

  2. Can I analyze data provided to me by the owner of a database, that are not individually identifiable, such as medication databases stripped of individual patient identifiers, for research purposes without having to apply the human research subjects protections regulations?

    Depending on how these data were stripped of individual patient identifiers, the resulting dataset would not meet the definition of human subject as found in the regulations. Thus if the research project includes the analysis of data for which the investigators cannot readily ascertain the identity of the subjects and the investigators did not obtain the data through an interaction or intervention with living individuals for the purposes of the research, this project does not meet the definition of human subjects research and does not require IRB review.

  3. Are there types of QI activities that are considered to be research that would require IRB review?

    If a project involves introducing an untested clinical intervention then this is considered research. When the purpose goes beyond simple QI and also involves collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, the project will likely meet the definition of human subjects research and will require IRB review. If even a small component of the QI activity is research, then the project must be reviewed by the IRB.

  4. I intend to publish the results of my QI activity; does this mean I am required to submit to the IRB for approval?

    The intent to publish is not a sufficient criterion for determining whether a QI activity involves research requiring IRB review. Planning to publish an account of a QI project does not necessarily mean that the project fits the definition of research. Download the worksheet on this page and if necessary, consult with one or more of the resources listed to determine if IRB review is necessary. Those intending to publish should consult the SQUIRE Website for checklists, explanations, resources and advice about publication standards for QI initiatives.