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Semelhante a Qi Irb Presentation
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Qi Irb Presentation
- 1. IRB Assessment and Management of QI Projects H. Edward Davidson, PharmD, MPH Assistant Professor, Clinical Internal Medicine Glennan Center for Geriatrics and Gerontology Eastern Virginia Medical School Partner, Insight Therapeutics, LLC
- 7. Research Vs. Quality Improvement Beyea SC. AORN J 1998. - Generally not required - Must be obtained if human subjects are involved (or justified to waive) Informed consent - Examines internal institution/process-specific issues - May be generalizable to other patients, situations, settings Scope - Examines internal processes and guides actions toward improvement - Generates new knowledge - Tests hypotheses Purpose QI Research Component
- 9. The Basics of IRB Review for a QI Project
- 10. Level of Risk Determines Level of IRB Review Minimal Risk Full IRB Committee Review Expedited Review Exempt from Review More than Minimal Risk
- 15. Human Subject Regulations Decision Charts
- 29. Case Study in QI Research
- 33. Controversies
- 34. Publication – ICMJE Requirements http://www.icmje.org/index.html#publish
Notas do Editor
- Other exemptions: Collection/study of existing data, documents, records, pathological/diagnostic specimens if these sources are publically available or if the information is recorded in such a way that subjects cannot be identified Federal department/agency research and demonstration projects evaluating public benefit programs Taste and food quality evaluation and consumer acceptance studies
- Waive consent: Research involves no more than minimal risk; Rights and welfare of subjects will not be adversely affected; Research could not be practicably carried out without waiver or alteration; and when appropriate, the subjects will be provided pertinent information after participation. Waive PHI: Minimal risk— The use or disclosure of PHI involves no more than minimal risk to the individuals, based on, at least, the presence of the following elements: – An adequate plan to protect the identifiers from improper use/disclosure – An adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research – Adequate written assurance that PHI will not be reused/disclosed to any other person or entity, except as required by law, for authorized oversight of the research project
- The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) requires that each institution "engaged" in Federally-supported human subject research file an "Assurance" of protection for human subjects. The Assurance formalizes the institution’s commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions.
- Eccles M et al. Qual Saf Health Care 2003;12:47-52 Speroff T et al. Qual Manag Health Care 2004;13:17-32.