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.
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.