Appendices (to be used as indicated in the application forms)

Appendix E — Devices

Appendix F — Drugs and Biologics

Appendix G — Genetic Testing

Appendix H — Biological Specimens Repository

Appendix J — Non-English Speaking Participants

Appendix L — Prisoners

Appendix N — Use of HIPAA Regulated Data - 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 U — International Setting