St. Cloud State University Policies & Procedures

Research Involving Human Participants Link☍

Create PDF: Research Involving Human Participants

Current Status: Approved

Policy Type: Academic

Department/Division: Academic Affairs

Effective Date: 07/01/2013

Last Updated: 11/30/2021

Applies To: Students, Faculty, Staff, Visitors, Contractors, Vendors

Responsible University Officer: Interim Provost/Vice President for Academic Affairs

Policy Owner: Associate Provost for Research and Dean of Graduate Studies

Policy Contact: Director of Research Development


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.


Individuals conducting research involving human subjects must follow the processes and protocols established by the IRB as posted on the IRB webpages and in the IRB Procedures Handbook (see Supporting URLs).

Frequently Asked Questions

Q. Who is the Institutional Official at SCSU?

A. The 2021 IO is the Associate Provost for Research. It is unlikely, but possible, that the IO could change, The IRB and the Office of Research and Sponsored Programs will have a record of who has been assigned by the president to the IO role.

Q. What process should be followed if there is a concern of non-compliance with this policy?

A. Anyone with concerns related to research with human subjects should follow the guidance on the IRB website. 


IRB members, sponsored programs, vulnerable population, federal regulations, graduate research, human participants, institutional review,

Supporting URLs

Websites, Related External Documents, Statutes


Responsible University Officer
   Greer, Kimberly R.
   Interim Provost/Vice President for Academic Affairs
   Tomany, Maria-Claudia C.
   Associate Provost for Research and Dean of Graduate Studies
   Kuznia, Jodi L.
   Director of Research Development

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