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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| FDA Comment Number :
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| EC66
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| Submitter :
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| Miss. Shevon Scarafile
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| Date & Time:
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| 11/28/2006 08:11:14
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| Organization :
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| Villanova University School of Law -- Student
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| Category :
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| Other Organization
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| Issue Areas/Comments
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| A. Scientific Aspects of Emergency Research and Human Subject Protection
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| 1. Are the criteria for allowing studies conducted under 50.24 adequate to protect human subjects and to promote scientifically rigorous research
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| See Attached
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| 2. Are the following criteria easily understood and, if not, how can they be clarified?
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| See Attached
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| 3. Are there other criteria in the regulation, besides those identified in criteria
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| See Attached
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| 4. Are there challenges that have not been explicitly addressed in the regulation in designing scientifically rigorous and ethically sound emergency research protocols (e.g., pediatric protocols)?
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| See Attached
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| Additional Challenges
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| 20. Are there any additional challenges to the conduct of emergency research that have not been identified in the preceding questions?
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| See Attached
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| 21. If so, what are they and how should they be addressed?
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| See Attached
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| B. Additional Human Subject Protections
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| 5. What are the costs, benefits, and feasibility of community consultation as currently required under 50.24?
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| See Attached
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| 7. Are there elements of community consultation, both procedural and substantive, that should, at a minimum, be required (e.g., types of information presented, number and types of meetings or interactions, number of people reached)?
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| See Attached
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| 8. Would opt-out mechanism (e.g., advanced directives, jewelry similar to medical alert bracelet/necklace, and driver's license indicators to identify individuals who do not wish to be included as subjects in particular emergency research studies pr
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| See Attached
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| Public Disclosure Following Completion
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| 14. Is there information regarding study results that, at a minmum, should always be disclosed after the clinical investigation is completed?
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| See Attached
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| 16. When should a clinical investigation be considered "completed?"
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| See Attached
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| Public Disclousre Prior to Initiation
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| 12. Are there certain types of information (e.g., adverse event reports, study protocol, informed consent document) that should, at a minimum, be publicly disclosed to the communities in which the clinical investigation will be conducted and from w?
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| See Attached
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| 2006D-0331-EC66-Attach-1.DOC
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| 2006D-0331-EC66-Attach-1.DOC
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| 2006D-0331-EC66-Attach-1.DOC
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| 2006D-0331-EC66-Attach-1.DOC
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| 2006D-0331-EC66-Attach-1.DOC
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| 2006D-0331-EC66-Attach-1.DOC
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