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institutional review board

 

Violations and Sanctions

The principal investigator(s) and faculty sponsor(s) both are responsible for Institutional Review Board policies.

Failure to apply for and receive permission for human participants research from the Institutional Review Board or altering the research process in a substantive manner after securing Institutional Review Board approval violates the St. Ambrose University Institutional Review Board policy and may result in any of the following sanctions:

1. The data may be rendered as unusable;
2. The Institutional Review Board may request the surrender of documents;
3. A citation of violation of academic integrity may be entered in the individual's professional file;
4. The collected data may be destroyed;
5. The principal investigator(s) and/or faculty sponsor(s) may be required to provide a letter of apology to research participants and representatives of external organizations including a plan of correction to address deficiencies in human participants protections;
6. The principal investigator(s) and/or faculty sponsor(s) may be required to provide a memorandum addressed to the Institutional Review Board explaining the actions of the investigator(s), acknowledging a violation of Institutional Review Board policies and procedures, and providing assurances that future violations will not occur;
7. The principal investigator(s) may be required to submit an acknowledgment in published work or work submitted for publication that the research did not conform to Institutional Review Board policies and procedures;
8. The Institutional Review Board may direct a formal memorandum of censure to the principal investigator(s) and, where appropriate, the principal investigator's faculty sponsor, department head, or dean (or any other recipient of the data); and/or
9. Other actions warranted by the specific circumstances surrounding the violation.

Members of the Institutional Review Board will address alleged violations of the St. Ambrose University Institutional Review Board policy. The Institutional Review Board will make a determination regarding the need for additional information or further investigation. The Dean and/or Department Head may be copied on all correspondence between the committee and the involved parties.

Upon determination that a violation of this policy has occurred, the Institutional Review Board may require that the activity in question be discontinued permanently or until such time corrective action is taken. Any suspension or termination of approval will include a statement of the reasons for the Institutional Review Board's suspension or termination action and the sanctions imposed. These will be sent promptly to the principal investigator and/or faculty sponsor and any other necessary university representative. Any appropriate agencies may also be notified of terminations and/or suspensions of the research.

The principal investigator(s) or faculty sponsor(s) who believe that there have been "errors in fact" in relation to decisions made by the Institutional Review Board may appeal those decisions to the St. Ambrose University Vice President for Academic and Student Affairs.