VA PI - Delete All Italicized Text Before Submitting to VA Research Office
IRB Number:
Protocol Title:
Principal Investigator:
VA Investigator:
OMB Review Determination :
______
Signature of VA PI (Date) / VA PI - Please mark the appropriate boxes below:
Exempt from OMB Review: (check all that apply):
Clinical Trial
Clinical Examination
Direct Treatment
Prevention of Clinical Disorder
Interpretation of Biological Analyses
VA Research Administration Office OMB exemption concurrence:
______
Signature of AO/R&D (Date)
OR
______
Signature of ACOS/R&D (Date)
[VA PI - Delete all italicized text before submitting to VA Research Office]
Project Overview[Briefly describe the project goals and data sources.] This summary should provide a brief and focused overview of the study, and emphasize the importance of the research with regard to the applicable exemption criteria. The summary should also include a brief discussion of the data collection effort (e.g., phone survey of 100 veterans) and its importance to the overall research objectives.
(Sample Overview) This research study will examine the effects of ….. This study represents a unique opportunity to…. The study includes (number, brief description of subjects)…. (Describe exactly what will be done) The findings from this study will inform….
Justification for Exemption of this Study under 5 CFR Part 1320.3:
This project will provide clinical examination for patients by:
[Briefly describe the facts or opinions to be obtained from individuals under treatment or clinical examination, and how it is being used to inform innovations in improving clinical care.]
This project will contribute to prevention of clinical disorders by:
[ADD MAJOR PROJECT GOALS HERE RELATED TO PREVENTION OF CLINICAL DISORDERS, e.g.,]
- Identifying strategies that aim to prevent clinical conditions by optimizing care…
- Identifying successful clinical innovations…
- Identifying the care environment and practices to prevent missed care opportunities, thereby preventing clinical disorders.
An exemption can be based one or more criteria. The justification in the summary bullets must be succinct but sufficiently detailed to support the exemption criteria. It must be clear how the collection of information will support the exemption criterion. If “clinical examination” or “direct treatment” is the justification, there should be a brief description of the examination or treatment and its relationship to the collection of information.
(Sample Text) This research study…., and the survey/focus group of a cohort of male and female veterans…., is exempt from 5 CFR Part 1320.3 because the research will provide clinical examination and will prevent clinical disorders related to…….
This research will: [please use bullets]
- Provide clinical examination… [describe the clinical examination, if applicable]
- Prevent clinical disorders by[if applicable]:
- [Use bullets to list the various ways you expect this study to prevent clinical disorders and identify the disorder and means of prevention.]
Justification that the Survey is Not Duplicative:
[Explain how this project is unique and how the data collection methods (surveys, patient interviews and focus groups, etc.) are not duplicative of any other methods with this population.]
This section should be brief but focused regarding the uniqueness of the study and its data collection effort, as well as its importance.
(Sample Language for VA-funded studies)The Office of Research and Developmenthas fundedthis research study based on its originality in addressing the health care needs of veterans who have experienced….. This decision was based upon merit review and the portfolio manager’s examination of other research supported by VA and other organizations. This research is unique in its study of… The survey/focus group is not duplicative of any other survey with this population.