Criteria for IRB Approval of Research

It is incumbent on any faculty, staff, administrators and students engaged in research involving human subjects to familiarize themselves with federal guidelines governing human subjects research. Any faculty, staff, administrator or student undertaking research involving human subjects is expected to submit the St. Norbert College Application for IRB Review prior to beginning their research. Failure to submit research for IRB approval constitutes a serious breach of professional standards. In the event of a legal challenge, the college will not defend research which has not been approved by the Institutional Review Board.
 
In order to approve research covered by federal regulations, the IRB shall determine that all of the following requirements are satisfied: 

1. Researchers possess appropriate knowledge of human subject protection.
2. Risks to participants are minimized.
3. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result.
4. Selection of participants is equitable.
5. Informed consent will be sought from each prospective participant or the participant’s legal representative and will be appropriately documented, in accordance with, and to the extent required by federal regulations.
6. Adequate safeguards are implemented to insure the safety of the participants during the data collection.
7. Participants’ right to privacy and confidentiality is protected.
8. Where some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economical or educationally disadvantaged persons, appropriate additional safeguards have been included in the study to protect the rights and welfare of these participants.
9. Projects that will be conducted in a cooperating institution or organization must include a letter of acceptance from the sponsoring individual or body of that institution or organization. 

The IRB shall have the authority to approve, require modification in (to secure approval) or disapprove all research activity covered by this policy. The institution may reverse an approval given by the IRB, but it cannot overrule a negative decision by the IRB.