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, Valley City State University has provided a formal assurance to the Office of Human Research Protections, in the Department of Health and Human Services (DHHS), that it will follow appropriate regulations, includinng the United States Codes of Federal Regulations (CFR), which will assure the protection of all human participants involved in federally-funded research projects. To ensure equivalent protections to all human research participants, the VCSU IRB procedures also apply to all such research conducted by faculty, students, staff, or other representatives of the University, whether or not the research is sponsored by agencies of the U.S. Government. 

To comply with this assurance and with federal provisions (Protection of Human Subjects (45 CFR 46, 21 CFR 50)), the University has established an Institutional Review Board (IRB) to review research projects that involve human participants. 

VCSU’s IRB safeguards the rights and welfare of all those individuals involved as human participants in research, development, or related activities. Sharing responsibility with the investigator, VCSU’s IRB determines and approves the standards for ethical conduct of research involving human participants. 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 Institutional Review Board (IRB) appointed for the purpose has reviewed and approved such proposed activity. The IRB’s Standard Operating Procedures are available on the VCSU IRB One Stop site.

Mission

The mission of the IRB at Valley City State University (VCSU) is to assist those engaged in human subject research in conducting research while conforming to ethical, professional, and community standards for the safety, rights, and protections of participants. Valley City State University is responsible for protecting the rights and welface of human research subjects, regardless of research funding sources.

Composition

The IRB is composed of five faculty members from academic program areas and one representative elected at large by the Faculty Association, ensuring diverse perceptives in the review process. The Director for Institutional Effectiveness and Planning serves as the IRB Chair. Additionally, the IRB shall include at least one unaffiliated representative from the community or surrounding area based on need for relevant composition and/or expertise on the Board, with preference for representatives of the medical and/or legal profession. This member will provide an unbiased perspective and contribute to the diversity of the IRB.

Conflict of Interest

To ensure the integrity and objectivity of the IRB review process, all IRB members and researchers must disclose any potential conflicts of interest. A conflict of interest may arise when an IRB member or researcher has a financial, personal, or professional interest that could affect their impartiality. The IRB Chair will review all disclosurs and determine appropriate actions to manage or eleminiate conflicts of interest. This may include recusal from the review process or other measures to ensure unbiased decision-making.

Documentation and Record-Keeping

The IRB will maintain detailed records of all activities, including minutes of IRB meetings, correspondence with researchers, and documentation of reviews and approvals. These records will be kept in accordance with federal regulations and institutional policies. The IRB Chair is responsible for ensuring that all records are accurate, complete, and securely stored.

Incident Reporting and Oversight

VCSU is committed to ensuring proper oversight and reporting of incidents related to nonexempt human research conducted by the institution or overseen by an IRB operated by te institution. The following procedures will be implemented:

1. Investigator Reporting: Investigators must report any incidents, including adverse events, protocol deviations, and noncompliance, to the reviewing IRB. This includes incidents occurring in research reviewed by an external IRB. Detailed operational procedures will be provided to investigators to ensure they understand their reporting obligations.
2. IRB Reporting: The IRB's written procedures will include sufficitent detail for IRB staff and members to understand which incidents need to be reported to the Office for Human Research Protections (OHRP). The IRB Chair will review all incident reports and determine the appropriate actions to address the incident and report to OHRP as needed.
3. Review and Action: The institution and the reviewing IRB willl review reports of incidents to ensure appropriate actions are taken to address the incident. This includes corrective actions, protocol modifications, and other measures to protect human subjects.
4. External IRB Agreements: Any agreement to document VCSU's reliance on an external IRB will outline the reporting responsibilities per 45 CFR 46.103(e). This includes specifying the roles and responsibilities of both the FWA-holding institution and external IRB in incident reporting and oversight.

Sponsor:  Vice President for Academic Affairs

Approved and Effective:  February 2010

Revised: December 2019

Revised: May 2021
Revised: April 2025