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. Promptly Reportable Information in accordance with HRP-801 INVESTIGATOR GUIDANCE: Prompt Reporting Requirements. Inform OSP of any consent form changes related to subject injury, costs, or stipends prior to use of the form. 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 US Food and Drug Administration FDA: Florida Hospital FH: Health Insurance Portability and Accountability Act HIPAA: Institutional Review Board IRB: OSP: Office of Sponsored Programs Related Documents Not applicable. References Electronic Code of Federal Regulations (e-CFR). (2012). Title 21: Food and Drugs. §56.101 to 56.124.Retrieved Subchapter A, Part 56: Institutional Review Boards. from: . 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: . National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the April 18, 1979. Washington, D.C.: protection of human subjects of research. 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] Original Date: 03/01/14 (400.071) Revision History 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
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. Promptly Reportable Information in accordance with HRP-801 INVESTIGATOR GUIDANCE: Prompt Reporting Requirements. Inform OSP of any consent form changes related to subject injury, costs, or stipends prior to use of the form. 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: . 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: . 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