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institutional review board

 

 

Policies

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Policy Declaration
It is the policy of the University that no research conducted under the jurisdiction of the University exposes persons who participate as participants or respondents to unreasonable risks to their health, general well-being, or privacy. Further, it is the policy of the University that no research conducted under its jurisdiction should be contrary to the mission of the institution.

Specifically, the University is concerned that in all research, development, and related activities involving the use of human participants:
• The rights and welfare of the individuals involved are adequately protected.
• The participation of participants is based on freely given informed consent; and the individual is free to withdraw consent and discontinue participation at any time without loss of benefits or other negative consequences.
• The risks to the participant are reasonable in relation to anticipated benefits to the participant and the importance of the knowledge to be gained as to warrant a decision to allow the participant to accept these risks.

Therefore all research activities involving the use of human participants are submitted for prior review by the University Institutional Review Board to (1) ensure that the above conditions are met, and (2) encourage and promote a high level of campus awareness and communication regarding University research projects.

Primary responsibility for assuring that the rights and welfare of the individuals involved are protected continues to rest with the principal investigators conducting research involving the use of human participants. This responsibility is shared by others engaged in the conduct of the research. Faculty or staff members who assign or supervise research conducted by students have an obligation to consider carefully whether those students are qualified to safeguard adequately the rights and welfare of participants.

Procedures
All members of the St. Ambrose University (faculty, staff, students) who wish to conduct research involving human participants are to complete an explanation of their intended research using the Research Proposal Form and submit it for review to the Institutional Review Board. The Board will then determine whether or not the research meets University policy guidelines.
• It is the researcher's responsibility to submit this information to the committee prior to conducting research, including pilot studies. You must adhere to these due dates and deadlines.
• Faculty members who intend to conduct research in their classrooms with their students should submit these forms prior to beginning that research.
• Projects are approved for a one (1) year period.
• Researchers are required to submit a status report either upon completion of a project, or within one year of approval, whichever comes first.
• Ongoing projects require annual submission of a status report.

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, 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.

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.