QI/QA and Informed Consent

Question

  • Is informed consent required if my graduate student project is quality improvement (QI) or quality assurance (QA)?

Answer

If all components of this project are consistent with standard care, routine practice, or existing operational activities for this QI/QA, no further consent-related action is required.

If any component of this project is specific to the purposes of this QI/QA project and not part of standard care or routine operations, unsigned/undocumented consent is the minimum requirement.

Examples

Example 1: All Components are Standard Practice → Informed Consent NOT Required

Fall Prevention Protocol Improvement

A nursing unit implements an evidence-based fall prevention bundle that includes:
  • Bed alarms

  • Hourly rounding

  • Standard fall risk assessments already used in care

  • Documentation in the existing EHR

The DNP student:
  • Tracks fall rates using existing clinical data

  • Reviews compliance with the protocol using routine documentation

  • Does not interact with patients beyond normal care

  • Does not introduce surveys or interviews

Why this fits your statement
  • All activities are already part of standard care

  • No new data collection or participant interaction is introduced

  • Data come from existing operational/clinical processes

Example 2: Project-Specific Activity (No or Minimal Risk) → Unsigned/Undocumented Informed Consent Required

Same Fall Prevention Project + Patient Survey

The project includes everything above plus:

  • A short survey given to patients asking:

    • Whether they felt safe during their stay

    • Their understanding of fall prevention education

  • The survey is not part of routine care

  • Patients can choose whether or not to complete it

Why this triggers consent consideration

  • The survey is new and project-specific

  • It introduces a voluntary interaction

  • It collects information outside routine care documentation

Example 3: Project-Specific Activity - More Than Minimal Risk → Signed/Documented Informed Consent Required

Same Fall Prevention Project + Identifiable Patient Interviews on Sensitive Topics

The project includes standard interventions plus:
  • One-on-one interviews with patients about:

    • Fear of falling

    • Past fall experiences and injuries

    • Confidence in mobility and independence

  • Interviews are:

    • Audio recorded

    • Linked to identifiable patient information

    • Potentially include sensitive personal or health-related disclosures

Why this elevates risk

  • Data are identifiable

  • Topics may be sensitive or emotionally impactful

  • Participation involves extended interaction beyond routine care

  • There may be privacy or reputational risks

Learn More

Need additional information or assistance? Search our Service Catalog, email grants@winona.edu, or call 507.457.5519.

WSU Grant & Research Services
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Email
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