№ files_lp_3_process_9_45117
Administrative compliance form outlining criteria, documentation requirements, and consent language provisions for human subjects research studies seeking reliance on an external Institutional Review Board.
Institution: Icahn School of Medicine at Mount Sinai
Form Number: HRP-232
Related Submission System: RUTH
Purpose: Documentation of reliance on an external IRB and waiver of IRB oversight
Document Type: Administrative research compliance form
Subject Area: Human subjects research oversight
Regulatory Framework: IRB review and HIPAA determinations
Applicable Agreements: SMART IRB Reliance Agreement; Institution-specific Reliance Agreement
External IRBs Referenced: BRANY; NCI CIRB; Sterling IRB; Advarra; WCG/WIRB; Alpha IRB
Funding Categories: Industry; Federal; Foundation; Other
Geographic References: NYC H+H/Queens; NYC H+H/Elmhurst
Required Attachments: Protocol; Investigator Brochure; Consent and Assent Forms; Reliance Forms; HIPAA Wizard Form; Ancillary Office Form; PRMC Approval Letter (for cancer studies)
Associated Offices: PPHS; FACTS/GCO
Scope: Multi-center clinical trials and federally funded research requiring single IRB review
HIPAA Considerations: Determination of HIPAA authorization or waiver by IRB of Record
Intended Users: Research personnel submitting studies for external IRB review
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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