Quality Activities and Regulatory Requirements

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Quality Assurance, Quality Improvement, Program Evaluation, Evidence-Based Practice and Benchmarking are quality activities used to evaluate and/or (continuously) improve the effectiveness of organizational processes and practices, products, programs or services, as well as, to develop the appropriate benchmarks. The purpose of quality activities, and their conclusions, are local and specific, aiming to improve organizational efficiencies and effectiveness and ensuring educational, clinical or program decisions rest on sound evidence.
 
Quality activities do not generally require IRB review or approval because they do not meet specific federal regulatory criteria of what constitutes Human Subjects Research. However, because quality activities are data-driven and often involve human participants, there can be overlap with methodologies common to human subjects’ research. In cases where overlap exists, the federal regulations that require IRB oversight may apply.

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.

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.

WORKSHEET: Quality Activity Determination
NUMBER: HRP-309
DATE: 9/1/2017
PAGE: 1 of 1
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.
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
False or Not Sure
                 
 ☐
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.
 ☐
No activity proposed provides less than standard of care, services or instruction to participants.
 ☐
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.
 ☐
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.
 ☐
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).
 ☐
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.
 ☐
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.
 ☐
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.
 ☐
Interpretation of the data or any feedback to those who would benefit from the findings will not be deliberately delayed.
 ☐
The proposed activity has merit and will likely be conducted regardless of any possibility of publication or presentation that may result from it.
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.

 

Step 3: Next Step

If You Know Your Project Does Not Include Human Subjects Research
There is no need to submit your project to the IRB for review. However, check with your Departmental and/or work location to secure any necessary approvals from them to conduct your Quality project.
***Read IMPORTANT NOTE below.
 
If You Know Your Project Includes Both A Quality Activity And Human Subjects Research
Submit the human subjects’ research portion of your project to the IRB for review and approval prior to its conduct. Consider the following practicalities:
  • 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.
  • 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.
***Read IMPORTANT NOTE below.
 
If You Are Not Sure Whether Your Project Requires IRB Review
Depending on the complexities of and nuances between activities, some projects may not be easily characterized. If questions or uncertainty remain, contact your IRB Office for further guidance (Contact Us) or submit your project to the IRB for a determination of whether it, or portions of it, constitute human subjects research (How To Submit Your Project For IRB Review).
 
 
 
 
 
 
 

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

Other Questions You May Have About Quality Activities and IRB Review
 
Q. If I started a quality project and now wish to expand it to add activities with human subjects that will generate generalizable knowledge, what should I do?
A. Submit an IRB application for the additional proposed activities. Wait for IRB approval before initiating them. The existing quality activities may continue while you await IRB approval for the proposed activities.
 
Q. If I started a quality project and realized during its conduct that it likely includes activities that qualify as human subjects’ research, what should I do?
A. Stop the research activities and submit an application to the IRB for review. Note: Data collected before IRB approval may not be used in the final analysis of the research.
 
Q. Can results of quality projects that do not include human subjects’ research be published even without IRB approval?
A. Yes. The insights learned may be worthy to share with others. To avoid confusion and delays, however, do not use the word ‘research’ in the article submitted. Out of an abundance of cause, Journal editors (and regulatory agencies) may request evidence of an IRB approval or determination of non-human subjects research for the project when the word ‘research’ appears in an article, particularly if the article reflects data gathering techniques that are also used in human subjects research.