Quality Activities and Regulatory Requirements
Steps To Determine If Your Project Requires IRB Review
The three steps outlined below are designed to assist researchers in discerning whether a proposed quality project—or one or more activities embedded in it—requires IRB review. FAQs (Frequently Asked Questions) about quality activities are found at the end of this webpage.
Step 1: Quality Activities And Research
Select and review a Reference Guide below, based on the type of project you are planning to perform. These Reference Guides will assist you to understand the various types of quality activities and learn what distinguishes them from research.
- Reference Guide: Quality Assurance [PDF]
- Reference Guide: Quality Improvement/Continuous Quality Improvement [PDF]
- Reference Guide: Program Evaluation [PDF]
- Reference Guide: Evidence-Based Practice [PDF]
- Reference Guide: Benchmarking [PDF]
- Definition: Human Subjects Research
Step 2: Determine If IRB Review Will Be Required For Your Project
The purpose of this worksheet is to provide support for Researchers making Quality Activity determinations when there is uncertainty regarding whether the quality activity contains Human Research which requires IRB Review.
- HRP-309 WORKSHEET: Quality Activity Determination [Link to WORD]
WORKSHEET: Quality Activity Determination | ||||
NUMBER: HRP-309
DATE: 9/1/2017
PAGE: 1 of 1
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Purpose: The purpose of this worksheet is to provide support for making Quality Activity determinations when there is uncertainty regarding whether the quality activity contains Human Research requiring IRB Review. It does not need to be completed or retained.
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Directions: For a proposed project to be classified as containing only quality activities—which do not require IRB review—the answers to all of the questions in the WORKSHEET must be ‘TRUE’ for each activity proposed in the project. If one or more answers is ‘FALSE or NOT SURE’, the project requires IRB review. | ||||
True
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False or Not Sure
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The intent of the proposed activity is to assess and/or improve the quality of a practice, product or program to ensure established educational, clinical or program service standards are met or best evidentiary practices attained.
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No activity proposed provides less than standard of care, services or instruction to participants.
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☐
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No practice, product or program changes proposed are experimental and no test interventions or research questions are added that go beyond established or evidentiary best practice.
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The proposed activity does not: (1) include a ‘control group’ in whom care, products, services or educational instruction are intentionally withheld to allow an assessment of its efficacy or (2) assign participants to receive different procedures, therapies or educational instruction based on a pre-determined plan such as randomization.
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☐
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The proposed activity does not involve the prospective evaluation of a drug, procedure or device that is not currently approved by the FDA for general use (including “off-label” indications).
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☐
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The proposed activity does not test an intervention or add research questions that go beyond established evidentiary best practice and/or are intended to generate generalizable knowledge.
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The proposed activity would not increase harm—physical, psychological, social or economic—than would normally be encountered by the individual if s/he was not participating in this activity.
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☐
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The lead person on the project has organizational responsibility and authority to recommend or impose a corrective action plan based on the outcome(s) of the activity, as applicable.
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Interpretation of the data or any feedback to those who would benefit from the findings will not be deliberately delayed.
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The proposed activity has merit and will likely be conducted regardless of any possibility of publication or presentation that may result from it.
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Visit [https://orra.rutgers.edu/qaguidance] to view the steps recommended for researchers to follow to assess whether their quality project includes activities requiring IRB review and approval.
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Step 3: Next Step
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If it is possible to separate the quality activities from the human subjects’ research activities submit only the activity or activities that reflect human subjects research to the IRB for review/approval. The quality activities embedded in the project need not undergo IRB review. If it makes sense, initiate the quality activities while you wait for the IRB to complete its review of the research component of the project.
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If it is not possible to separate the activities, submit a protocol outlining the whole project—both quality and human subjects research—activities to the IRB for review. In this scenario, you may not initiate any portion of the project until the IRB has completed its review and approved the project in its entirety.
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IMPORTANT NOTE: IRB approval cannot be backdated. If you begin your project without IRB approval and later assess that your project, or activities embedded in it, did require IRB approval, the human subjects’ research activities you conducted without IRB approval cannot be used to fulfill degree requirements or published in most peer-reviewed journals. Investigators may submit their studies for IRB review seeking a Not Human Subjects Research Determination/QI Activity to avoid the possibility of such problems later on. |
FAQs