St. Cloud State University requires all research activities involving human subjects—whether or not they are supported by Federal funds—to comply with the Federal Policy for the Protection of Human Subjects (45 CFR 46). According to this policy, research activities that 1) intervene in people’s lives, observe human behavior, or 2) use data obtained directly or indirectly from living individuals must be reviewed and approved by an Institutional Review Board to ensure:
- risks to subjects will be minimized and reasonable in relation to anticipated benefits,
- informed consent will be obtained from subjects and appropriately documented, and
- the privacy and safety of subjects will be maintained.
St. Cloud State University is responsible for appointing qualified IRB members and meeting the minimum membership qualifications of at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects (45 CFR 46.107(a)).
The IRB at St. Cloud State University consists of the IRB chair, IRB administrator (currently a MSUAASF member), one faculty representative from psychology, one faculty representative from sociology, at least two other faculty representatives, and one community-at-large representative. Appointments to the IRB are made by the Institutional Official.
All IRB members remain an active member of the committee by fulfilling quorum requirements through meeting attendance or providing guidance/proxy voting information prior to scheduled meetings. Failure to remain active through attendance or proxy will result in resignation from the IRB.
To conduct official IRB business a meeting cannot proceed without a quorum, which is one more than half the total committee membership. At least one non-scientific member is needed for a quorum. Members may provide guidance and vote electronically or attend meetings via teleconferencing. Alternate members may substitute for IRB members who are unable to attend a meeting. Alternates may vote for an identified primary member in the primary member’s absence.
Exempt research may be reviewed by one IRB member, two IRB members or subject to full board review. The IRB shall approve expedited research with the review of two IRB members, with the option for all board members to review the application or subject to full board review. Applications brought to the full board require review by a quorum and approval by a majority of members present. Monthly meetings will be scheduled during each academic semester.
Research proposals requiring full review must be submitted to the IRB at least two weeks before a regularly scheduled meeting and will be distributed to the members prior to the meeting.
Current projects will be kept on file within the Office of Research and Sponsored Programs. Exempt projects may be securely stored electronically when deemed exempt. Closed projects may be securely stored in electronic archives when closed. Paper and electronic records remain accessible for inspection and copying by authorized representatives of the department or funding agency at reasonable times, in a reasonable manner, and retained for at least three years as required by 45 CFR 46.115(b).
Violations to the policies and procedures that are brought to the attention of the IRB will be handled on a case-by-case basis. As a general rule, the principal investigator of the alleged violation will be asked to meet with the IRB to discuss the situation.