Completing the Not Research Page

How to complete the Not Research page

When is the Not Research page of the application completed?
The Not Research page appears when “Not Research” is selected on the Exemption page.  This page attempts to gather adequate information for the HS IRBs office to make a “Not Research” determination.

How should study teams answer question 19.1 (Describe the goals of the project and the procedures involved)?
This answer should describe the goals of the project (i.e. what is meant to be learned from the project or what aspect of a project is being evaluated).  It should also describe what procedures are involved, such as the following:
  • What is being evaluated
  • Who is being evaluated
  • How is it being evaluated
  • What type of analysis will be conducted on the data
How should the study teams answer question 19.2 (Select how the results of the project will be used)?
There are two options: Quality improvement/quality assurance within an organization/institution and Program Evaluation (e.g., required evaluation of a program).  If the intent of the project is to improve an area or aspect of the institution (e.g. UW-Madison, UWHC, UWMF, Madison VA), please select the first option.  If the intent of the project is to evaluate a certain program is going, or determine what needs to be changed within a program, please select the second option.  It is feasible to select both options for certain projects.

How should study teams answer questions 19.3/19.3.1 (Will the results of the project be published in a scholarly journal and/or presented at a peer conference or in any other manner contributing to generalizable knowledge through publication or dissemination?/ If yes, would the project be designed and conducted in the same manner as currently proposed if there was no potential for publication, presentation, and/or scholarly/scientific recognition?)?
If intent to publish or present is generally not presumed at the inception of the project, it is still possible to publish or present results at the conclusion.  However, the main purpose of the project cannot be a potential publication from its inception, as this indicates the primary goal is to obtain generalizable knowledge rather than improve quality or evaluate a program.  Acceptable answers are no to 19.3, or Yes/Yes to 19.3/19.3.1.  Usually, the combination of a Yes/No answer to 19.3/19.3.1 indicates the project is in fact research.

How should study teams answer question 19.4 (Provide justification for why this project does not fit the definition of research (e.g., explain how it is not a systematic investigation or it will not contribute to generalizable knowledge). NOTE: If justification cannot be provided, you will need to revise the type of application requested.)?
This answer should describe the following, specifically how the projects fits under Quality Improvement/ Program Evaluation within these topics and does not constitute Research as defined by the federal regulations:
  • Intent
  • Motivation for Project
  • Design
  • Mandate
  • Effect on Program or Practice Evaluated
  • Population
  • Benefits
  • Dissemination of results
It is suggested that the following chart be used to assist in the completion of this question:

Keywords:not research, qi, qa, program evaluation, quality improvement   Doc ID:29797
Owner:Faye L.Group:Health Sciences IRBs
Created:2013-04-22 16:26 CDTUpdated:2015-10-13 15:08 CDT
Sites:Health Sciences IRBs
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