ST. AMBROSE UNIVERSITY
INSTITUTIONAL REVIEW BOARD POLICY
The Institutional Review Board is responsible for the review of all research using human participants conducted by people affiliated with St. Ambrose University. Specifically, the Institutional Review Board makes determinations in compliance with the United States Department of Health and Human services Office of Human Research Protection guidelines (http://www.hhs.gov/ohrp/) and all other federal human subjects’ regulations regarding:
1. Whether research proposals submitted for review are exempt or non-exempt;
2. Proposed modifications or amendments to research protocols previously reviewed and/or approved by the Institutional Review Board and;
3. Actions required due to adverse events or incidents as a result of approved research.
In regard to research activities affiliated with St. Ambrose University, the Institutional Review Board has the authority to approve, require modifications in, disapprove, suspend, or terminate research activities involving human participants that do not comply with the St. Ambrose University Institutional Review Board policy. The Institutional Review Board also has the authority to observe or monitor ongoing research, as necessary, to protect human participants. It is the responsibility of the principal investigator and/or faculty sponsor to adhere to the St. Ambrose University Institutional Review Board policies, to respond promptly to Institutional Review Board requests, and to notify the Institutional Review Board of any changes to the research protocol. Violations of the Institutional Review Board policy may include but are not limited to:
1. Breaches of Institutional Review Board policies and procedures by a principal investigator or faculty sponsor;
2. Adverse events that are not immediately suspended by the principal investigator(s) or faculty sponsor(s) after causing physical, psychological, social, or other harm to participants;
3. Changes in the risks and benefits of a study encountered during the course of the research; and/or
4. Other circumstances, which, in the judgment of the IRB, require action in order to protect human participants from harm.
All faculty, staff, or students who plan to use human participants in their primary research (for example, by utilizing surveys, focus groups, experiments, etc.) and/or are also planning to publish these findings (for example by, public presentation, journal article, book, Web site, Master’s thesis, doctoral dissertations, etc.) must first receive permission to do so from the St. Ambrose University Institutional Review Board and any other affiliated agencies before beginning the research.
Institutional Review Board Violations and Sanctions
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 principle investigator(s) may be required to submit an acknowledgement 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 in addition to the Associate Vice President for Assessment and Institutional Research 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.
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 Affairs.