APPLICATION FORMS (For new applications)
- Level I - Exemption applications (Examples include, but are not limited to: anonymous surveys, use of existing data, certain research performed in education settings or on typical educational processes).
- Level II and III research applications (Examples include, but are not limited to: research conducted on human subjects that involves the use of vulnerable populations, sensitive subjects, more risks for participants, suicidal thoughts, mental illness, substance abuse, deception, use of devices and/or drugs/supplements, invasive procedures)
- IRB Review Determination Form- Submit this completed form to the Office of Research Compliance form if you are unsure that your project requires IRB approval.
APPENDICES (To be used as applicable. Indications for when to use Appendices are included in application forms)
||Addition of Co-PI or Key Personnel|
||Addition of External Co-PI or Key Personnel|
||Drugs and Biologics|
||Biological Specimens Repository|
||Non-English Speaking Participants|
||Waiver of Alteration of Consent Process|
||Waiver of Consent Documentation|
||Collection of Family History Data|
||Blood, Injections, or Surgical Procedure|
||Adverse Event Involving Risks to Subjects or Others|
||Change in Principal Investigator
||Adults with Decisional Impairment|
|Appendix Y||Student Recruitment Online Pools|
||Conflict of Interest for Human Subjects Research|
Other Submission Forms
- Amendments or Changes to Study Procedures Form - All amendments and changes must be reviewed and approved by the IRB before they are implemented.
- Institution Authorization Agreement Request Form - use this form if you are requesting that the KSU IRB serve as the IRB of record for a multi-institution project, or if you are requesting that another Institution's IRB serve as the IRB of record for your project.
- Annual Review Form
- Closeout Form
- Adverse Event/Unanticipated Risks (Appendix R) - Use this form to report an adverse event, unanticipated risk, participant complaint, etc.
Information about HIPAA
- HIPAA Authorization Template
- Requirements for an Authorization Form for HIPAA Compliance
- Class Project Parameters and Forms
- Web-based study information
- Procedures for Compensating Research Participants
- Request for Information/Presentation
International Human Research Protections
- International compilation of Human Research Protections - a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations.