Modification Request Form

8. Changes Made To — check all that apply and attach appropriate documents

Form A: General Information Sheet

Form B: Research Description & Appendices

Anticipated Project End Date

□ Estimated # of Subjects

□ Objectives

Inclusion / Exclusion Criteria

☐ Subject Population

□ Vulnerable Subject Population

☐ Subject Recruitment

□ Procedures / Materials

Impaired Consent Capacity

Research Procedures

☐ Children age 17 or less ☐ Grant Application

Pregnant Women

□ Sponsor Protocol; Investigator Brochure

□ Prisoners

Waiver of Informed Consent

□ Other vulnerable population

□ Funding / Support

□ Study Personnel

□ Other – Describe:

Waiver of Documentation of Informed Consent

Research & Innovation (ORI) · IRB Guidelines · ORI@kysu.edu