Protection of Human Subjects
The Institutional Review Board (IRB) reviews all research conducted by students, staff and faculty, which involves human subjects.
Kutztown University’s policy is that no research done under its jurisdiction expose persons who participate as subjects or respondents to unreasonable risks to their health, general well-being, or privacy. Kutztown University follows the principles described in the Belmont Report for all research with human subjects. In addition, the IRB follows federally mandated regulations from the US Department of Health and Human Services as outlined in Title 45, Part 46 of the Code of Federal Regulations.
The approval of the IRB is a requirement for research projects involving human subjects. Approval must be obtained BEFORE the research is started. Please see links below for forms and procedures. The initial application and other forms, as applicable, must be submitted to the Office Of Grants and Sponsored Projects. If you have any questions please call 484-646-4167.
Required Training:
All investiagtors involved in human subjects research must complete training every three years. Training can be completed using NIH's training course "Protecting Human Research Participants." Once training is completed through NIH's training course, the investigator must print the certificate of completion and send it with their application to the IRB.Additional Information and Procedures:
- Definitions
- Composition of IRB
- Functions and Operations
- Review of Research
- Criteria for Approval of Research
- Suspension or Termination of Research
- Records
- Types of Review
- Reporting and Continuing Review
- Informed Consent and Assent
Forms: All forms are Word documents (.docx)
- Application for IRB Initial Review
- Waiver of Requirement to Obtain Signed Informed Consent Request Form
- Waiver or Alteration of Informed Consent Request Form
- Application for Revisions/Changes to IRB Approved Research
- Adverse Event/Unanticipated Problem Reporting Form
- IRB Yearly/Continuing Review Form
