F.36 The Institutional Review Board for the Protection of Human Subjects in Research

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The University’s IRB, or Institutional Review Board, is a federally mandated committee of faculty, administrators, and community representatives, which is charged to review and approve all research protocols involving humans as participants and created by anyone affiliated with the University of Southern Indiana (USI).

The mission of the USI IRB is to ensure protection of the rights of human subjects who participate in research activities conducted by the University community. The IRB is committed to the standards that ensure research is conducted in an ethical manner and complies with government regulations, ensuring the safety and wellbeing of human subjects at the highest level of excellence. USI complies with the ethical principles set forth in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In addition, USI complies with federal regulations (45 Code of Federal Regulations [CFR] Part 46) concerning research involving human subjects, regardless of the source of funding, as outlined in the Office of Human Research Protections (OHRP) by the United States Department of Health and Human Services (DHHS). USI is committed to standards of excellence for all research activities from the University community.

The IRB is considered a standing committee of USI. The IRB will be comprised of no fewer than nine (9) members who are committed to serving three-year renewable terms. A member may run for re-election an unlimited number of times. The composition of the membership of the IRB will be at least two representatives from each USI college unit, one community member, and at least three at large members.

USI has delegated authority to the IRB which will be empowered to:

  1. Review all funded and unfunded research proposals by faculty, students, or staff that involves the use of human subjects. This review must take place prior to the beginning of the research.
  2. Ensure that researchers have procedures in place to fully inform subjects about the nature, purposes, risks, and benefits of the research, and obtain informed consent as applicable.
  3. Educate the university community as to the responsibilities and duties of those conducting sound and ethical human subject research.
  4. Determine the type of review (exempt, expedited, or full board) the research requires.
  5. Disapprove, recommend modification, or approve research proposals based upon standards that ensure research is conducted in an ethical manner and complies with government regulations, ensuring the safety and wellbeing of human subjects at the highest level of excellence based upon the protection of human subjects.
  6. Suspend or terminate any human subject research that is not proposed or conducted within USI IRB and federal human subjects research guidelines.
  7. Require progress reports and/or monitoring as deemed necessary.

Under the terms of the university's current Federal-wide Assurance, the Director of the Office of Sponsored Projects and Research (OSPR) serves as the Human Protections Administrator. The Office of Sponsored Projects and Research is responsible for the administration of the IRB.

For more information on the IRB policies, visit OSPR’s website at www.usi.edu/ospra.