Kentucky State University Office of Research and Innovation 400 E Main St, Frankfort KY, 40601 ORI@KYSU.EDU (502) 597-5997
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
a_end_date
□ Estimated # of Subjects
a_num_subjects
□ Objectives
b_objectives
Inclusion / Exclusion Criteria
b_incl_excl
☐ Subject Population
a_subject_pop
□ Vulnerable Subject Population
a_vuln_pop
☐ Subject Recruitment
b_recruitment
□ Procedures / Materials
b_procedures_mat
Impaired Consent Capacity
a_vuln_impaired
Research Procedures
b_research_proc
☐ Children age 17 or less ☐ Grant Application
a_vuln_children
b_grant
Pregnant Women
a_vuln_pregnant
□ Sponsor Protocol; Investigator Brochure
b_sponsor
□ Prisoners
a_vuln_prisoners
Waiver of Informed Consent
b_waiver_consent
□ Other vulnerable population
a_vuln_other
□ Funding / Support
a_funding
□ Study Personnel
a_personnel
□ Other – Describe:
a_other
Waiver of Documentation of Informed Consent
b_waiver_doc
Other - describe