Utilization of External Irbs

Utilization of External Irbs

/ Standard Operating Procedure (SOP)
Related Policy #: N/A
SOP #: 400.071 / Utilization of External IRBs /
Executive Owner: Vice President – Research Services / Effective Date:11/1/2016
Review Date: 11/1/2016
Scope / This standard operating procedure (SOP) applies to the investigators and Institutional Review Board (IRB) staff members, chair and committee members at Florida Hospital (FH).
Purpose / External regulatory and accrediting bodies such as the FDA and AAHRPP expect local IRBs to maintain a minimum amount of oversight for studies that rely upon external IRBs. The purpose of this SOP is to define responsibilities of the FH IRB and investigators requesting reliance upon external IRBs.
Qualified Personnel / IRB Chair, IRB Members, IRB Staff Members, Investigators and <Research Personnel>.
Training / Not applicable.
Supplies & Equipment / Not applicable.
Procedure/Process / NOTE: FH relies upon external IRBs for studies on a case-by-case basis.
Investigators wishing to utilize external IRBs must:
  1. Submit the following completed documents to the FH IRB via the IRB electronic submission platform:
  2. External IRB Review Application Form
  3. Research Personnel Log,
  4. Reviews Preparatory to Research forms, when applicable*
  5. Scientific Review Documents, when applicable
  6. Protocol
  7. Consent form for local use with required local boilerplate language incorporated*
  8. Refer to HRP-507 TEMPLATE: Consent language for studies that rely upon an external IRB
  9. Executed IRB Authorization Agreement, when applicable
  10. Other documents as required by the external IRB
  11. FH IRB will review the application in a timely manner not to exceed two business days and provide a letter either accepting or declining external IRB oversight of the study.
  12. If accepted, the investigator may proceed with review by external IRB.
  13. If declined, a reason will be provided and the investigator will be given an opportunity to provide additional or clarifying information. In the event that the decision to decline stands on re-review, the investigator may appeal the decision by contacting the IRB manager. Otherwise, the study will need to be reviewed by the FH IRB.
*External IRBs defer responsibility to local institutions to conduct any reviews necessary under HIPAA. External IRBs accept institutional boilerplate language for HIPAA authorizations if an institution incorporates authorization into the consent document. FH does incorporate authorization language into research consent forms. FH researchers will include HIPAA authorization language into each consent form for review by external IRB.
  1. Ongoing responsibilities of the FH investigator after study approval:
  2. Follow the external IRB’s written guidance for investigators.
  3. On an ongoing basis, submit the following to the FH IRB:
  4. Changes in local study personnel via a revised Research Personnel Log
  5. Reviews Preparatory to Research forms must be submitted on an annual basis, when adding personnel with this responsibility, and when adding this responsibility to existing personnel.
  6. Promptly Reportable Information in accordance with HRP-801 INVESTIGATOR GUIDANCE: Prompt Reporting Requirements.
  7. Inform OSP of any consent form changes related to subject injury, costs, or stipends prior to use of the form.
  1. Research open under an external IRB remains subject to FH policies and procedures related to the conduct of research including, but not limited to, FH IRB and FH OSP policies, procedures, and SOPs.

Definitions / AAHRPP: Association for the Accreditation of Human Research Protection Programs
FDA: US Food and Drug Administration
FH: Florida Hospital
HIPAA: Health Insurance Portability and Accountability Act
IRB: Institutional Review Board
OSP: Office of Sponsored Programs
Related Documents / Not applicable.
References / Electronic Code of Federal Regulations (e-CFR). (2012). Title 21: Food and Drugs. Subchapter A, Part 56: Institutional Review Boards. §56.101 to 56.124.Retrieved from: http://www.ecfr.gov/cgi-bin/text-idx?SID=1bcd2a8edeb3173c2eeb67de6e0d3d0a&c=ecfr&tpl=/ecfrbrowse/Title21/21cfrv1_02.tpl.
Electronic Code of Federal Regulations (e-CFR). (2012). Title 45: Public Welfare. Subchapter A, Part 46: Protection of Human Subjects. §46.101 to 46.505. Retrieved from: http://www.ecfr.gov/cgi-bin/text-idx?SID=1bcd2a8edeb3173c2eeb67de6e0d3d0a&c=ecfr&tpl=/ecfrbrowse/Title45/45cfrv1_02.tpl.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. April 18, 1979. Washington, D.C.: United States Government Printing Office. Retrieved from:
Approved By / Electronic Approval on File
[Signature – Executive Owner]
Electronic on File
[Print Name – Executive Owner]
Approval Date / Electronic on File – 03/05/2014
[MM/DD/YYYY]
Revision History / Original Date: 03/01/14 (400.071) New
Replaces: 03/01/14 (400.071) Annual review, edit 07/07/14. 09/27/2014 No change.
Keywords / IRB, institutional review board, IRB member
The printed copy is for temporary use only. Always refer to the FH intranet for the current official document. / Page 1 of 3
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