Irb.ucsd.edu

What is and is not Protected Health Information (PHI) …

WebPHI is defined as a subset of individually identifiable health information (IIHI) that is maintained or transmitted in any form, including oral communications that is created or …

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URL: https://irb.ucsd.edu/_files/researchers/WhatIsandIsNotPHI1.pdf

NIH Definition of a Clinical Trial

Web3. Is the study designed to evaluate the effect of the intervention on the participants? 4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

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Guidance for Researchers

WebGuidance documents are for researchers and their teams to better understand OIA's thinking or expectations on matters for which there isn't an SOP or clear regulatory …

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De-identified Health Information

WebUNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTION PROGRAM FACT SHEET January, 2001 De-identified Health Information A common …

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University of California, San Diego Human Research …

WebCertificates of Confidentiality Persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, the use and effect of alcohol and other …

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Office of IRB Administration OIA

WebThe Office of IRB Administration (OIA) at UC San Diego

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HIPAA Authorization in Research

WebResearch Compliance Program. 200 West Arbor Drive, #8239 | San Diego, CA 92107‐8239 | T: 858.657.7487 | F: 858.657.7502 | [email protected]. HIPAA Authorization Form example. …

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EBP/QA/QI Projects

WebEBP/QA/QI Submissions & Forms EBP/QA/QI projects being conducted at UC San Diego Health. Please submit EBP/QA/QI projects for local improvements being conducted at …

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UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH …

WebNote: It is the treating physician’s responsibility to ensure the information included in the consent is accurate including the costs associated with the treatment such as the cost of …

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UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH …

Webpublic benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or. …

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University of California, San Diego Human Research …

WebResearch involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical …

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University of California, San Diego Human Research …

WebA majority of the IRB (exclusive of prisoner members) will have no association with the prison(s) involved, apart from their membership on the IRB. The research goals of the …

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UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH …

WebA device shipped solely for research on or with laboratory animals and labeled in accordance with Sec. 812.5(c). A custom device as defined in Sec. 812.3(b), unless the …

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ISSUES ON DNA AND INFORMED CONSENT

WebDNA samples may be subpoenaed by prosecutors under certain circumstances, unless the investigator has obtained “Certificate of Confidentiality” (call the Human Research …

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Returning Research and/or Incidental Findings

Weba) A finding that is collected or collated or interpreted after the study has ended and analysis of all participant data is complete. 3. Definition of an Incidental Finding. 1. A finding that …

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