Responsibilities of IRB
The IRB, as part of the execution of its responsibilities, shall:
- Establish and maintain procedures and documentation to accomplish the review of all research projects involving the use of human subjects.
- Establish and maintain guidelines and criteria for approval of research projects involving the use of human subjects.
- Require documentation of informed consent.
- Conduct a continuing review of all research projects at intervals appropriate to the degree of risk but not less than once per year.
- Notify the principal investigator, in writing, of the decision to approve or disapprove a research project. Provide to the principal investigator(s) any specific suggestions for enhancing the likelihood of approval for projects that do not receive initial approval from the IRB.
- Provide the principal investigator(s) with an opportunity to respond in writing or in person to the Chair of the IRB for reconsideration if the research project is not approved.
- Insure prompt reporting of any changes in the research protocol to the IRB once the research project has received IRB approval and of any unanticipated problems involving risks to subjects.
- Retain copies of all research protocols, copies of all correspondence between the IRB and principal investigator(s), records of continuing review, and statements of significant findings.
- Insure that records are maintained by principal investigator(s) for at least three years after completion of the research project.
- Provide to the appropriate persons and agencies adequate documentation that all research projects are in compliance with the policies and guidelines for the protection of human subjects at the University of Wisconsin-Eau Claire.
- Provide an annual report of the activities of the IRB to the Vice Chancellor for Academic Affairs.