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HIPAA Authorization Language

WebThis is the University of Utah's preferred HIPAA Authorization language for human subjects research. The following example combines both confidentiality and an …

Actived: 4 days ago

URL: https://irb.utah.edu/informed-consent/authorization-language.php

INSTITUTIONAL REVIEW BOARD Guidance Series THE …

WebINSTITUTIONAL REVIEW BOARD THE UNIVERSITY OF UTAH Investigator Guidance Series Please contact the IRB Office at (801) 581‐3655 or [email protected] for …

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Submission & Review Schedules

WebSubmission & Review Schedules. The IRB typically convenes at least once per week, and up to 12 times each month. All panels have representation from both Main …

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IRB FWA & Registration Information

WebIRB Assurance & Registration Information. On July 14, 2009, the new Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations …

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Consent Document Checklist

WebThe Common Rule sets forth general requirements for documentation of informed consent. An informed consent form approved by the IRB and signed by the participant or the …

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Forms & Templates

WebData / Biospecimen Repository Management Plan Template. 02.18.2022. Department of Defense (DoD) Supplement [PDF Form] 04.18.2024. Exclusion of …

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Investigator Guidance Series THE UNIVERSITY OF

Web**In order for a record (or research data set) to be considered de-identified, each of the above identifiers must be removed. This is applicable to identifiers of the individual, or of …

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INFORMED CONSENT DURING THE COVID-19 …

WebInformed consent is generally documented by use of a written consent document signed by the participant or Legally Authorized Representative (LAR).

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HIPAA PRIVACY RULE & AUTHORIZATION

Web•name and social security number; • street address, e-mail address, telephone and fax numbers; • certificate/license numbers; • vehicle identifiers and serial numbers; • URLs …

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RESEARCH INVOLVING RISK OF SUICIDE

WebResearch Involving Surveys Asking About Suicidal Thoughts and Behaviors . There are varying degrees of involvement by the researcher when including measures of …

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Adverse Device Effects

WebAdverse Device Effects. The investigational device exemption (IDE) regulations define an unanticipated adverse device effect (UADE) as “any serious …

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MANDATORY REPORTING

WebIn some cases, mandatory reporting of confidential information may be required. If researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse …

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INSURANCE BILLING AND CLINICAL TRIALS

WebCRCE Guidelines – Insurance Billing and Clinical Trials Compliance Services CRCE: 801.213.3601 August 2, 2018 Pulse: https://pulse.utah.edu/site/comser/Pages/Home.aspx

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INSTITUTIONAL REVIEW BOARD THE UNIVERSITY OF UTAH …

WebMinimal Risk: According to Subpart C, minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily …

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Investigator Guidance Series

WebDefinitions. Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research. Parent: A child’s biological or adoptive parent. Utah state law …

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Consent Verses Authorization

WebUniversity of Utah Institutional Review Board New Board Member Handbook Version D3008 Page 22 of 39

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Reviewer Checklist ­ Research Involving Prisoners

WebYes No N/A Clear 5. Information is presented in language which is understandable to the participant population. N/A if study is a retrospective record view.

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