Fontbonne University affirms its policy to safeguard and respect the rights and welfare of human participants in research. In order to do this, the University is responsible for providing review and approval of all research that involves human participants.

All research conducted at or sponsored by Fontbonne University, whether subject to or exempt from prior review, must:

1. Adhere to the Belmont Principles;
2. Be in compliance with the Nuremberg Code or one of the ethical codes developed by a recognized professional association;
3. Adhere to codes developed in compliance with Federal guidelines; and
4. Adhere to the procedures set forth here in compliance with Fontbonne University policies.

This applies to all research, irrespective of funding, carried on at the University or under the University’s auspices.

The responsibility to protect human participants in research has been assigned to the Institutional Research Review Board Committee. The primary function of the Board is to assist the investigator in the protection of the rights and welfare of human participants. Investigators should not bear the sole responsibility for determining the standards of ethical conduct of research involving human participants. It is necessary for others, who are independent of this research, to share in this responsibility. The use of human participants is a privilege granted to the investigator rather than a right. The policies and procedures of this board are designed to meet the minimum criteria established by Federal law and regulations. See Title 45 CFR 46. The Office of the Vice President for Academic Affairs is the administrative office for the Institutional Research Review Board.

Depending on the nature of the research and the degree of risk, there are varying levels of review. Three levels of review have been established:

1. Exempt status
2. Expedited review
3. Full review

The Institutional Research Review Board approval of a research endeavor will be valid for a period of one year from the date of the approval. In cases where research instruments and/or methodology need to be changed for approved research already in progress, the principal investigator must submit a request to amend or extend the study. The Institutional Review Board Committee will determine if a major change has taken place. It is the responsibility of the Institutional Review Board Committee to determine what constitutes a major change in a proposal. Major changes in approved proposals require formal review and re-approval by the board.

Neither recruitment of participants nor research should be initiated until confirmation of either exemption or approval has been received.