In compliance with NDUS Board Policy 611.8 ("Employee Responsibility and Activities: Research on Human Subjects") and out of concern for the welfare and protection of human subjects of research, it is the policy of Valley City State University that all research involving human subjects conducted under its auspices shall be in accordance with federal regulations including, but not limited to, the "Guidelines for Protection of Human Research Subjects" 45 Code of Federal Regulations (CFR) 46 established by the National Institutes of Health, and regulations to protect human subjects, 21 CFR 50, 312, 812 as established by the Food and Drug Administration. To this end, this document establishes rules for the creation and operation of an Institutional Review Board at Valley City State University.
The information found in this document is not a set of recommendations, but firm policies that will be enforced. These policies are not intended to infringe on the academic freedom of researchers. It is specifically intended to reaffirm that freedom while focusing on protection of human subjects and to comply with federal regulations. Safeguarding the rights and welfare of all those individuals involved as subjects in research, development, or related activities carried out or supervised by members of the faculty and staff of Valley City State University is not only the responsibility of the individual members of the faculty or staff involved, but is ultimately and directly the responsibility of the University.
To ensure adequate safeguards and to discharge the responsibility of the institution, no research (including grant applications), development, or related activity involving human subjects may be undertaken unless the University Committee appointed for the purpose has reviewed and approved such proposed activity.
The IRB shall maintain ongoing review of nonexempt human research with respect to subjects' rights. Monitoring procedures shall be arranged at the time of the review on a case-by-case basis.
Anyone who believes that the rights of any human subject involved in a VCSU related research project are being violated is encouraged to inform the IRB of their concern. The IRB will investigate the complaint to determine if, in the committee's majority opinion, it is valid. If so, the IRB shall require either (1) the problem be remedied or (2) the research be discontinued. Notification of such action will be forwarded to the investigators and any appropriate agencies and/or university personnel (e.g., president, VPAA, dean, department or division chair, etc.)
Sponsor: Vice President for Academic
Approved and Effective: February 2010