Milestone #9 - Human Subjects Approval of Conduct of Research

Institutional Review Board Approval

Once the dissertation project has been approved at the proposal approval meeting, students should seek University approval to conduct research before going any further. Any research that employs the use of human subjects on or off campus must be approved by the University’s Human Subjects Committee prior to the gathering of data for the dissertation. The University of Minnesota and federal policies require that each project involving humans subjects be reviewed with respect to: (1) the rights and welfare of the individual(s) involved, (2) the appropriateness of the methods used to secure informed consent, and (3) the risks and potential benefits of the investigation.

Information and forms are available through the Institutional Review Board (IRB) Office. Questions concerning exemptions or other aspects of human subjects research review should be addressed to the IRB: Human Subjects Committee at 612-626-5654 or 612-626-6061 (fax). The website provides detailed information about the process and the conditions for each of the possible levels of review. There are three form/level options: a “full committee review,” an “expedited review,” and an “exempted review.” The “full review” requires a full review by the IRB and may take four to six weeks for review and notification of their decision. These forms are appropriate for research designs that may involve a potential threat to the human subjects or involves minors and thus may require more deliberation. The “expedited review” involves minimal risk to human subjects but has some potential risk nonetheless. The “exempted review” applies to those research projects that involve very minimal risk and thus is exempt from further IRB review. Many students’ dissertation projects qualify for the exempted review, but students should check with his/her advisor to find out whether the particular study is likely to fall into this category. Exemption waives only the need for further review and does not negate the need for the consent of subjects where applicable. The exempted review requests an exemption from the full review of the IRB and takes about two weeks for a review and decision.

Research may not be initiated until written notification of exemption is received. This includes recruitment of subjects, advertising, mailing or distributing consent forms, and data gathering. Any requirements indicated in the response of the Human Subjects Committee must be addressed before commencement of the research project.