NUMBER / DATE / PAGE
HRP-334 / 2/1/17 / 1 of 1
USED BY IRB FOR REVIEW OF QA/QI PROPOSALS
Quality Assurance (QA) and Quality Improvement (QI) consist of activities that are undertaken to measure the effectiveness of standard accepted processes, programs, or services, the results of which are intended to be shared only withindividuals associated with the process, program or service being evaluated. QA/QI projects cannot expose individuals to any additional risks.
In contrast, research consists of asystematic investigation that is designed to develop or contribute to generalizable knowledge, the resultsof which are to be shared with both individuals associated with and individuals unassociated with theinvestigation.
The IRB will review QA/QI projects to make a determination as to whether or not the project meets all the criteria for Non-Human Subject Determination.
Answer each question as it relates to your study:
CONDITIONS FOR DETERMINATION OF QA/QI STATUS /
Yes
/ No- The primary intent of the project is not peer reviewed publication and if publication of the results was prohibited, the project would still have merit as a QA/QI effort
- It is the purpose of this study to improve the quality of an existing program under investigation by assessing and encouraging standard medical care or educational goals.
- The chairperson has both clinical supervisory responsibility and the authority to impose a corrective plan based on the outcomes of the project.
- The project does not involve prospective assignment of patients to different procedures or therapies based on a predetermined plan such as randomization.
- The project does not involve a “control group” in whom therapeutic or study intervention is intentionally withheld to allow an assessment of its efficacy.
- The project 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).
- Human participants will not be exposed to additional physical, psychological, social or economic risks or burdens (beyond patient satisfaction surveys) in order to make the results of the project generalizable.
- Adequate protections are in place to maintain confidentiality of the data to be collected and there is a plan for who can access any data containing participant identifiers.
- If you wish to change any aspect of this project or add additional procedures that would impact answers to any of the above questions, you agree to submit changes for IRB review and approval prior to implementation of these changes.
In order for the study to be classified as a QA/QI effort, the answers to all of the above questions must be “Yes”. If one or more answer is “No” then the project requires review and approval by the Rutgers University IRB.