The IRB's Position on Quality Projects vs. Research

R. Peter Iafrate, Pharm.D.Chairman, Health Center IRB

University of Florida

Issues?

• Many requests from medical residents and fellows to satisfy a QA requirement– Want to include it as scholarly activity– Submit as original research– Written as a research protocol

• National “QA” Databases– Often has a research component– Who approves sending the data??

• Sometimes, hard to tell but not a “get out of IRB free card”

2

QI vs Research

• Does this project involve any of the following – Investigational Drug or Device– Randomizing patients – A fixed clinical protocol that may not be altered by

caregivers and staff– A non UF\Shands\VA site

• Is the project currently the standard of care?• Objectives other than producing an

improvement in safety or care.

Intent\Background

Quality• 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 site

Research• 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

Quality• 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)

Research• 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

Intended Benefit

Quality• Intervention would be

considered within the usual clinician-patient therapeutic relationship

• Potential local institutional benefit is specified (e.g., increased efficiency or decreased cost)

Research• Intervention, interaction, or

use of identifiable private information occurs outside of the usual clinician-patient therapeutic relationship

• Potential societal benefit in developing new or advancing existing generalizable knowledge

Risk

Quality• Risk is to privacy or the

confidentiality of health information

• Risk may be described as higher for patients by not participating in this activity

Research• Risks may or may not be

minimal, but may include physical, psychological, emotional, social, or financial risks,

• 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

Results

Quality• Implementation is

immediate so that review of results occurs throughout the process and may be used for next Ql activity

• Extrapolation of results to other settings is possible, but not the main intent of the activity

Research• 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

• Results are intended to generalize beyond the study population

Sharing Information

Quality• System level outcomes,

processes, refinement of the intervention, and the applicability of the intervention in specific settings/contexts might be shared through peer-reviewed publication and presentation outside the institution.

Research• It is expected that results

will be published or presented to others through a peer-reviewed process

Quality vs ResearchDetermination Process at UF

• Complete QA vs Research Form• Email to Peter Iafrate• If determined to be QA

– Requestor will receive an email, with an attached assessment letter and a stamped copy of their completed form as a PDF

– Emailed copied to Randy Harmatz and Debbie Lynn– If later determine that they wish to publish that data

• Submit a retrospective chart review study electronically• Upload PDF letter and stamped form

• If determined not to be QA, they will be instructed to submit to the IRB