St. Cloud State University Policies & Procedures

St. Cloud State University is committed to protecting the rights and privacy of human subjects in research. Establishing responsibilities, authority, regulations, and processes are measures to help protect the interests of the University and those involved in research associated with the University.

Research with human subjects at St. Cloud State University is governed by the Institutional Review Board (IRB) that holds a Federal-wide Assurance (FWA number 00002648) from the Office of Human Research Protection (OHRP) in the Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and St. Cloud State University. Any institution that receives federal funds is required to establish an IRB to review all research that directly or indirectly involves a human participant. St. Cloud State University requires that all research involving human subjects, whether conducted by a student, faculty, employee, or other party associated with the university, must be reviewed and approved by the Institutional Review Board (IRB) before initiation.(see Supporting URLs).

The St. Cloud State University president shall appoint an Institutional Official (IO) for the protection of human participants in research.

The IO has the following authority and responsibilities.

• The IO is responsible for assuring that the St. Cloud State University IRB complies with all applicable ethical principles, federal and state laws and institutional policies and procedures for the protection of human research participants, setting the "tone" for an institutional culture of respect for human research participants, and ensuring effective institution-wide communication and guidance on human research.
• The IO assures that the IRB functions independently and free from coercion and undue influence.
• The IO is kept informed of the activities of the IRB through consultation with IRB Chair(s) and staff from the Office of Research and Sponsored Programs (RSP) who attend IRB meetings.
• When necessary and appropriate, the IO communicates pertinent information about IRB activities to other St. Cloud State University officials and to federal regulatory agencies.
• The IO keeps up to date on federal, state and University requirements for the protection of human research participants, through consultation with university legal counsel, staff from the RSP, and the IRB Chair(s). When needed, the IO acts as arbiter and spokesperson for human participant’s protection issues in service to the St. Cloud State University research community.
• The IO approves IRB Authorization Agreements for collaborative research activities involving human participants.
• The IO has the authority to suspend an investigator’s privileges to conduct human participant research in cases of noncompliance.
• The IO reports IRB noncompliance, unanticipated problems, and suspensions and termination of research, to federal authorities.