irb_workshop training presentation

irb_workshop training presentation - The Institutional...

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1 The Institutional Review Board An Introduction for SJSU Students and Faculty Prepared by What Is the IRB? A 10-15 member committee that reviews all research conducted by SJSU students, faculty, and staff that involves the use of human subjects to make sure that the research is being conducted in a manner compliant with SJSU and federal policy. SJSU Policy: http://www.sjsu.edu/senate/S08-7.htm Federal Guidelines: http://www.hhs.gov/ohrp/ When Is IRB Review Needed? Two Criteria 1. Is it research? A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge, including the dissemination, presentation, Publication, or use of research findings beyond the boundaries of a specific instructional setting. Examples: Independent student project, master’s thesis, activities intended to lead to publication.
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2 When Is IRB Review Needed? Two Criteria 2. Does the project involve human subjects? Yes if: ¾ People are asked to participate physically (physical procedures, manipulation of environment). ¾ People are asked to participate through interaction (communication, interpersonal contact, surveys, interviews, observation). ¾ Researcher seeks access to data that contains identifiable, private information through files, databases, or a third party. What Is Exemption? ± Research that involves minimal risk to participants, AND ± Does not involve a vulnerable population (minors, prisoners, institutionalized mentally disabled, pregnant women), AND ± Falls into one of the following categories…. . Examples of Exempt Research ¾ Educational assessment or evaluation of educational programs. ¾ Anonymous surveys or other data collected anonymously. ¾ Existing data – information that is not publicly available and that contains individually identifying information (pathological specimens and DNA also fall under this category).
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3 Exemption: What’s Required? ± Exempt status is determined by an IRB representative not the researcher. ± In order to confer this status, researcher must submit adequate information about the study to the IRB coordinator. ± All of the documents outlined in the checklist that follows are required except documentation of informed consent. ± But, Researcher must still provide participants with reasonable information so they may form their own decision to participate. Exemption: What’s the Difference?
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irb_workshop training presentation - The Institutional...

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