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Statement of Authority and Purpose

C. Responsibility

2. Failure to Submit a Project for IRB Review

The consequences of engaging in activities that qualify as research that is subject to IRB review without obtaining such review are significant.  Results from such studies may not be published unless IRB approval had been obtained prior to collecting the data.  To do so is in violation of Institutional policy.  It is also against Institutional policy to use those data to satisfy thesis or dissertation requirements.  If an investigator begins a project and later finds that the data gathered could contribute to the existing knowledge base or that he or she may wish to publish the results, the investigator should submit a proposal to the IRB for review as soon as possible.  If the IRB does not approve the research, data collected cannot be used as part of a thesis or dissertation, and/or the results of the research cannot be published.  Furthermore, the FDA may reject such data if it is submitted in support of a marketing application.

A. Governing Principles
B. Authority
C. Responsibility

1. IRB Review of Research
2. Failure to Submit a Project for IRB Review
3. Confidentiality