Institutional Review Board (IRB) Office of Sponsored Programs St. Cloud State University Agenda What is IRB? IRB at SCSU Project Examples Types of Reviews How IRB affects you and your projects? IRB Application Process IRB Application Consent Forms Student Research Funds Student Research Colloquium ...
–ProjectExamples–TypesofReviews •HowIRBaffectsyouandyourprojects?•IRBApplicationProcess –IRBApplication–ConsentForms •StudentResearchFunds•StudentResearchColloquium•Questions&Discussion WhatisIRB?•AnInstitutionalReviewBoard(IRB),accordingtofederallaw,mustevaluatethepotentialphysicalorpsychologicalriskof...
concerns, and, second, the IRB conducts periodic reviews of the study to monitor the research progress and address any ethical issues. The review process usually occurs annually. Although rarely used, the IRB can carry out additional reviews and actively conduct surprise inspections of research ...
MAIN OUTCOMES AND MEASURES: Calendar days from initial submission to final approval of research protocols. RESULTS: Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] a...
at a convened meeting or under an expedited review procedure during the preceding 12 months; and A description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in the protocols that the IRB reviews. ...
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In a reply to Trerotola’s letter, the authors explain that the study involved use of devices approved by the Food and Drug Administration and that they did not “routinely request IRB approval for retrospec- tive chart reviews or registry queries” (6). Richard notes that their division’s...
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