Appendices (to be used as indicated in the application forms)
Appendix A/A1 — RETIRED! Amendment forms have been revised so that personnel will be accounted for directly in the form and not as an attached appendix) Addition of KSU Co-PI or Key Personnel
Appendix B — REVISED December 20, 2023 - Addition of Ancillary Personnel; See Cooperative/Multi-Institute Research (Section 8) in IRB Help.
Appendix C — Data Repositories
Appendix D — Deception
Appendix E — Devices
Appendix F — Drugs and Biologics
Appendix G — Genetic Testing
Appendix H — Biological Specimens Repository
Appendix I — Children
Appendix J — Non-English Speaking Participants
Appendix K — Pregnant Women, Fetuses, Neonates
Appendix L — Prisoners
Appendix M1 — Waiver of Alteration of Consent Process
Appendix M2 — Waiver of Consent Documentation
Appendix N — Use of HIPAA Regulated Data - NEW - all projects that require HIPAA Compliance review will be reviewed during a HIPAA team meeting on the the third Thursday of the month. This is due to the significantly increased number of requests that require HIPAA Compliance review. PIs will be invited to the meeting.
Appendix O — REVISED December 20, 2023 - Relying Site Local Context. See Cooperative/Multi-Institute Research (Section 8) in IRB Help.
Appendix P — Collection of Family History Data
Appendix Q — Blood, Injections, or Surgical Procedure
Appendix R — RETIRED! See Adverse Event Involving Risks to Subjects or Others. Event Reporting form under Other Submission.
Appendix S — REITRED! Change in Principal Investigator. Changes in PI can be noted in the body of the amendment form.
Appendix U — International Setting
Appendix V — Radiation
Appendix W — Adults With Decisional Impairment
Appendix Y — RETIRED! Student Recruitment Online Pools
Appendix Z — Conflict of Interest for Human Subjects Research