5.3 Applications for Exempt Determination and IRB Review

Application Forms

Researchers seeking a determination of exempt status, an expedited initial review, an initial full review, or continuing review must complete the appropriate human research application form. The application form is intended to facilitate the review process by providing a complete and accurate representation of the project to reviewers and allowing researchers to reflect on and address directly questions about the protection of human subjects.

OSP staff will be responsible for developing, revising, and updating application forms and determining how applications should be completed and delivered to the OSP. This may include adoption of an online application system. In the development of application forms and submission procedures, staff will take into account suggestions from KSU researchers and IRB members, while also working to align application processes employed at other institutions of higher education. Applications will require signatures or endorsements by all researchers involved in the project. For students submitting an application, a signature by a faculty sponsor or advisor is required.

When completing human research application forms, researchers should thoroughly address all the questions and items on the applications. These will include questions regarding protecting the anonymity and confidentiality of human subjects and the security and retention of data.

Other Required Documents

All applicable supporting documents must be included with the application, which depending on the type of project, could include recruitment materials, such as flyers, the informed consent form, request for waiver of elements of informed consent, request for waiver of written informed consent, parental permission, any test or survey instruments to be used, child assent scripts, letters from school principals or district superintendents, and certificates of confidentiality. If the project is funded by an external grant, researchers may also be asked to provide a copy of the grant proposal. Application forms will have further instructions as to the additional documents that will be required for review.

Researchers seeking full or expedited review should complete training regarding the protection of human subjects through CITI. Documentation of completion of the CITI training must be submitted with the application. In those instances where a group of students are being used as research assistants for which human subjects are involved, a list of the students and the completion dates of their training must be included on the IRB application. CITI training is valid for three years after being completed.

5.4 Screenings of Protocols

The HRPP specialist or another OSP staff member with appropriate expertise or