IRB PRESENTATION REGULATORY PATHWAYS HDE – PMA

IRB PRESENTATION REGULATORY PATHWAYS HDE – PMA . William Hellenbrand MD Director – Pediatric Cardiology Columbia University College of Physicians & Surgeons Morgan Stanley Children’s Hospital of New York-Presbyterian. DISCLOSURE. Medtronic Investigator Consultant Proctor.

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IRB Presentation

Institutional Review of Research Involving Human Participants. IRB Presentation . University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/irb.html. University of Central Florida Institutional Review Board Overview.

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IRB Review

IRB Review. Mechanics: Looking under the hood IRB Administrators 2012 PRIDE Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session Traveling to and fro (basic, beyond and in between) Exploring the IRB Meeting Agenda Quorum Approval Criteria Minutes

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IRB Workshops

IRB Workshops. Initially will be given in three parts 1. Human subject research ethics History of research ethics History of unethical research 2. Regulatory IRB responsibilities Investigator responsibilities Informed consent requirements 3. Logistics Office contacts

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IRB Insights

IRB Insights. UTHSC IRB irb@uthsc.edu 448-4824. Categories. Review Process Exempt Expedited Full Board Forms Initial Application Form 2 – Change Request & Amendment Form 3 – Continuation & Renewal Form 4 – Unanticipated & Adverse Events and Protocol Deviations

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IRB Review Process at IRB-HSBS

IRB Review Process at IRB-HSBS. IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010. Goals of this Audiocast. Describe possible IRB review paths Outline the general process of IRB review at IRB-HSBS Implications of timing of IRB submissions

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IRB Submission

UC DAVIS OFFICE OF RESEARCH. IRB Submission . Miles McFann IRB Administration Outreach, Training, and Education . Smallpox Vaccination . Objectives. Explain the history of Institutional Review Boards (IRBs) Define “Research” and “Minimal Risk”

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IRB

IRB. The purpose of IRB is to ensure the rights of research subjects are protected In accordance with the ethical standards of the U.S. Department of Health and Human Services, all research involving human subjects requires approval by the IRB prior to the start of the research project.

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IRB Training

IRB Training. What is irb ?. Work with a partner to answer these questions… 1. What does IRB stand for? 2. Why is the IRB important? 3. What are the steps to have your research project certified by the IRB?. What does irb stand for?. Institutional Review Board. Why is the IRB important?.

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IRB C Member Presentation

School Based Research: The Family Education Rights and Privacy Act (FERPA) & The Protection of Pupil Rights Amendment (PPRA). IRB C Member Presentation. The Family Education Rights and Privacy Act (FERPA). (20 U.S.C. § 1232g; 34 CFR Part 99). What is FERPA?.

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140

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IRB Workshop I: IRB Process

IRB Workshop I: IRB Process. Carolyn Murdaugh, PhD, RN, FAAN Alice Pasvogel, PhD, RN Office of Nursing Research. Keep in mind: Ongoing changes. IRB changes are constant Forms Guidelines Staff. How do I begin the process?. Defend research proposal or scholarly inquiry project

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IRB Accreditation and Local IRB Operations

IRB Accreditation and Local IRB Operations. Libbie Stephenson, UCLA Thomas Lindsay, UMN Jacob Carlson, Purdue IASSIST Conference, May 2009 Tampere, Finland. Privacy.

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+ 140. + 140.

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IRB Presentation

Institutional Review of Research Involving Human Participants. IRB Presentation. University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/irb.html. University of Central Florida Institutional Review Board Overview.

427 views • 32 slides

IRB Submission

UC DAVIS OFFICE OF RESEARCH. IRB Submission. Miles McFann IRB Administration Outreach, Training, and Education. Smallpox Vaccination. Objectives. Explain the history of Institutional Review Boards (IRBs) Define “Research” and “Minimal Risk”

461 views • 40 slides

IRB 7.2 IRB Member Training

IRB 7.2 IRB Member Training. Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office. Locating Checklists. Several worksheets and checklists are provided in the system to guide your review process and document your decisions.

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IRB C Member Presentation

School Based Research: The Family Education Rights and Privacy Act (FERPA) & The Protection of Pupil Rights Amendment (PPRA). IRB C Member Presentation. The Family Education Rights and Privacy Act (FERPA). (20 U.S.C. § 1232g; 34 CFR Part 99). What is FERPA?.

145 views • 14 slides

IRB Presentation

Institutional Review of Research Involving Human Participants. IRB Presentation. University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/irb.html. University of Central Florida Institutional Review Board Overview.

322 views • 32 slides