Assurances and Certifications

The Associate Vice President for Research, Grants, and Sponsored Programs is the official authorized to sign supporting assurances and certifications required by sponsoring agencies. However, certifications regarding fiscal matters are signed by the Vice President for Finance and Business.

Human Subjects in Research (IRB)

KSU adheres to a rigorous policy for the protection of human research subjects in accordance with the United States Department of Health and Human Services regulations, 45 CFR 46. All research projects involving human subjects that are conducted under the auspices of the University, regardless of the funding source, must be reviewed and approved by the Institutional Review Board (IRB). The Office of Research, Grants, and Sponsored Programs is the administrative unit responsible for coordinating the functions of the IRB. KSU’s Human Subjects Research Policy is included in the Appendix and located on the OSP web page in the Information section.

Proposals involving human subjects should be submitted to the IRPSP for assignment to the appropriate IRB, including the IRB Application for Approval of a Research Project Involving Human Subjects forms (KSU-IRB-001 for researchers, and KSU-IRB-002 for student researchers), the proposed research protocols and informed consent forms. The forms are located on the OSP Forms webpage and in the Appendix.  A model consent form necessary for documenting informed consent of human subjects is available from the OSP. Principal Investigators should allow at least 30 days for completion of IRB review. Following IRB review, the Principal Investigator will be advised of the outcome in writing of approval, disapproval, or suggestions for modifying the proposed protocol. Under no circumstances will a research project involving human subjects be allowed to proceed without prior IRB review and approval.

Use of Vertebrate Animals in Research (IACUC)

Federal regulations require that the university assure the humane care and use of animals as research subjects in accordance with the Animal Welfare Act (P.L. 99-158), located on the web at:   http://grants.nih.gov/grants/olaw/references/hrea1985.htm. The Public Health Service (PHS) Policy further requires that institutions must have on file in the Office for Protection from Research Risks (OPRR) of the National Institutes of Health (NIH) an approved Animal Welfare Assurance document before they can receive PHS research funds.

Environmental Health and Safety-Hazardous Materials and Biosafety

Principal Investigators are expected to exercise all appropriate precautions when working with potentially hazardous materials.

When appropriate the university safety office may assign a trained industrial hygienist or other technically qualified person to provide assistance. All incidents and potentially unsafe conditions must be reported immediately to the KSU Safety Officer, Mr. Grey Mandel at 502.597-6646 or grey.mandeel@kysu.edu.

Administrative Guidelines for BioHazard Materials 

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