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360 Institutional Research Compliance

Authority: Approved by the Board of Trustees
Last Updated: June 18, 2021
360.1 Institutional Research Compliance

Indiana State University is committed to the responsible conduct of research in its pursuit of scientific inquiry. The responsible conduct of research fosters objective, safe, humane, and legally and ethically compliant practices and environments for scholarly activity. Faculty, students, and staff who conduct their work honestly, accurately, and objectively promote trust in the integrity of research and its value for the public good. Indiana State University acknowledges its responsibility to provide oversight in the responsible conduct of research and to comply with federal mandates.

The Chief Research Officer is the University official responsible for formal assurance and documentation of responsible research conduct and compliance in accordance with institutional and external guidelines. The areas of research oversight include: 1) avoidance of corruptive conflicts of interest, 2) protection of the confidentiality, well-being, and safety of human subjects and participants, 3) provision of humane treatment and environments for animal subjects, 4) adjudication of cases of research misconduct and 5) adjudication of data management and proprietary issues. The Chief Research Officer also serves as ISU’s Institutional Official for state and federal grants.

ISU faculty, staff, and students who engage in research are subject to institutional approval and oversight of research activities and are expected to comply with University policies and procedures. Violations of this policy will be managed by the Chief Research Officer, who will publish procedures for investigation and resolution of research misconduct.

To ensure expert review of compliance in the various domains of research oversight, the University has established compliance committees to review institutional research practice, advise the Chief Research Officer, and oversee the filing of assurances to governmental and regulatory entities.  The Chief Research Officer appoints the leadership of these compliance committees. The Chief Research Officer is responsible for responding to compliance inquiries by external agencies, in consultation with the relevant committee chair and the General Counsel.

  • 360.1.1 Committee Approval. Research projects requiring oversight from one or more of the compliance committees must receive approval through the review process before beginning to conduct the research.  If a research project involves multiple domains of oversight, the project must simultaneously be reviewed by each appropriate committee.
  • 360.1.2 Review Process. When oversight is required, the review of a research project is conducted according to guidelines, rules, processes, and timeline developed by the relevant compliance committee and in accordance with responsible practice and federal guidelines. The review typically involves submission and evaluation of a research proposal, followed by committee action to exempt, approve, propose modifications, or reject the project. Once the approval has been granted, it is non-compliant to deviate from the approved protocol without again obtaining approval.
360.2 Human Subjects Research

The committee empowered by federal regulations to review, approve and monitor research involving human subjects in order to assure their protection and welfare is the Institutional Review Board for the Protection of Human Subjects (IRB).  Prior to initiating research involving human subjects, project personnel must complete core training in Procedures for Human Subjects Protection. The IRB is responsible for the institutional record-keeping concerning human subjects projects, protocols, and committee business.

360.3 Research Involving Animal Care and Use

The committee empowered by federal regulations to review, approve, and monitor research, research training, experimentation, biological testing, educational or related activities, and facilities housing living, vertebrate animals (other than human beings) for research, is the Institutional Animal Care and Use Committee (IACUC). The IACUC provides oversight to ensure safety and humane treatment and conditions in vertebrate animal research. Prior to initiating research in the above areas, project personnel must complete core training in animal care and use. The IACUC is responsible for the institutional record-keeping concerning animal research projects, protocols, and committee business.

360.4 Research Involving Biohazards

The committee empowered by federal regulations to review, approve, and monitor research activities involving recombinant DNA, transgenic animals, human body fluids, human tissue or cells in culture, human pathogens, potential pathogen sources or other potentially infectious materials is the Institutional Biosafety Committee (IBC). The IBC provides oversight to ensure safety in biological and biomedical research. Prior to initiating research in the above areas, project personnel must complete core training in biosafety. The IBC is responsible for the institutional record-keeping concerning biosafety in projects, protocols, and committee business. Other compliance areas pertinent to the safety of research participants and environments, but not covered by the domains of these compliance committees, are overseen by the Office of Environmental Safety.

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