Human Research Protections A Refresher - Yale University：人类研究保护复习-耶鲁大学.pptVIP

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Human Research Protections A Refresher - Yale University：人类研究保护复习-耶鲁大学.ppt

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Human Research Protections A Refresher - Yale University：人类研究保护复习-耶鲁大学

Be careful what you wish for: It might come true! December 13, 2012 Substantive changes proposed Good news scenario: improvements on several fronts that may lead to increased efficiency (such as not requiring continuing review for studies involving minimal risk) Bad news scenario: some proposals not thought through carefully and can have significant unplanned repercussions December 13, 2012 Broad categories of proposed changes Risk based protections: calibrate the type of review to the risk posed by the research, with resultant elimination of the need for annual review of minimal risk studies Revamp of informed consent, including requiring consent up front for all samples Mandate use of a single IRB for multisite studies December 13, 2012 Single IRB for multisite studies Great example of inadequate conceptualization of entire issue No universal model proposed/adapted Resultant myriad of models which all differ significantly and require new systems to be put in place Researchers will need to understand and comply with multiple systems Yale currently deals with 5 different models December 13, 2012 Strengthening data protection Streamlining adverse event reporting and cataloging via a website Extension of Federal Regulations to all human subjects research regardless of funding source Harmonization of guidance from myriad federal agencies December 13, 2012 December 13, 2012 Conclusions Conflicts of interest, and tissue banking, are evolving topics Lapses and clinical trials registration present challenges for compliance Evolving landscape in human subjects protections Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * Dr. Sandra L. Alfano * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * * Dr. Sandra L. Alfano * Dr. Sa