Module Components

• Overview
• Assignments

Topics

• Quality Improvement vs Research
• DNP Project Proposal
• REDCap

NDNP 810 DNP Project Identification

Module 4: DNP Project Proposal

Quality Improvement vs Research

The following instrument used to assess the differences between Quality Improvement (QI) and research with human subjects was developed by Ogrinc et al. (2013). This checklist is intended to compare and contrast the general characteristics of quality improvement (QI) and clinical research activities and is for use by Institutional Review Boards (IRBs), administrative reviewers, investigators, and improvers. This checklist is also intended to guide discussion among these individuals and is not intended to supplant the judgment of IRBs or local QI ethics review committees. Please start by considering these overarching questions:

1. Will the activities of this project occur within the standard of care? If NO, then proceed to IRB review.
2. Is there risk? If YES, use charge below to determine whether this project requires QI review or IRB review.
3. Is this project primarily intended to generate generalizable knowledge? If YES, proceed to IRB review.
4. Does this project involve vulnerable populations? If YES, use chart below to determine whether this project requires QI review or IRB review.

Attribute	Quality Improvement	Clinical Research with Human Subjects
Intent and Background	Describes the nature and severity of a specific local performance gap Focus is to improve a specific aspect of health or health care delivery that is currently NOT consistently and appropriately being implemented at this time	Identifies a specific deficit in scientific knowledge from the literature Proposes to address or identify specific hypotheses in order to develop new knowledge or advance existing knowledge
Methods	Mechanisms of the intervention are expected to change over time (i.e., an iterative activity) in response to ongoing feedback. Plan for intervention and analysis includes an assessment of the system (I.e., process flow diagram, fishbone, etc.) Statistical methods evaluate system level processes and outcomes over time with statistical process control or other methods	Specific protocol defines the intervention, interaction, and use of collected data and tissues, plus project may rely on the randomization of individuals to enhance confidence in differences May use qualitative or quantitative methods to make observations, make comparisons between groups, or generate hypotheses Statistical methods primarily compare differences between groups or correlate observed differences with a known health condition
Intended Benefits	Intervention would be considered within the usual clinician-patient therapeutic relationship Direct benefit to participants is indicated (e.g., for the decrease in risk by receiving a vaccination or by creating a safer institutional system) Potential local institutional benefit is specified (e.g., increased efficiency or decreased cost)	Intervention, interaction, or use of identifiable private information occurs outside of the usual clinician-patient therapeutic relationship Direct benefit to each individual participant or for the institution is not typically the intent or is not certain Potential societal benefit in developing new or advancing existing generalizable knowledge
Risk	Risk is to privacy or the confidentiality of health information Risk may be described as higher for patients by not participating in this activity	Risk may be minimal, but may include physical, psychological, emotional, social or financial risks, as well as risk to privacy or the confidentiality of health information from participation in the project The informed consent process describes the risks to participants, who individually and voluntarily decide whether to participate or an IRB grants an alteration or waiver of the consent process
Applicability of Results	Implementation is immediate so that review of results occurs throughout the process and may be used for next QI activity Extrapolation of results to other settings is possible, but not the main intent of the activity	Results and analysis may be delayed or periodic throughout the duration of the project, except to protect patient safety. The results will primarily be used to inform further investigations, but may be implemented directly into clinical practice Results are intended to generalize beyond the study population
Sharing & Disseminating	System level outcomes, processes, refinement of the intervention, and the applicability of the intervention in specific settings/contexts may be shared through peer-reviewed publication and presentation outside the institution	It is expected that results will be published or presented to others through a peer-reviewed process

Interpretation

Any checkmarks (even one) in the “Clinical Research” column indicates that there are components of clinical research in the proposed activity.  The IRB or local QI ethics review committee should initiate a discussion with the improver/investigator to clarify the proposal.  If an activity such as public health practice, program evaluation, or quality improvement includes a research component, then IRB review should occur under current federal guidance and the policies of many institutions.