Az.research.umich.edu

Protected Health Information (PHI) Research A to Z

WEBHealth information is considered to be individually identifiable health information if any of the following identifiers are included:. Name; Geographic …

Actived: 1 days ago

URL: https://az.research.umich.edu/medschool/guidance/protected-health-information-phi

Protected Health Information (PHI) Research A to Z

WEBIndividually identifiable health information is considered PHI protected under HIPAA when ALL of the following apply: Obtained from a covered entity (healthcare provider, plan, or …

Category: Health Go Health

Waiver or Alteration of HIPAA Authorization Research A to Z

WEBWaiver of HIPAA Authorization is often appropriate for:. identifying eligible potential participants for a clinical trial through medical record review (Part of the …

Category: Medical Go Health

Uses & Disclosures of Protected Health Information (PHI)

WEBA covered entity (CE) is a health care provider, health plan, or health care clearinghouse regulated by HIPAA.The University of Michigan is a "hybrid" covered entity because …

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HIPAA Research A to Z

WEBContact us at [email protected] or 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800. A list of IRBMED staff is …

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Federal Exemption Categories Research A to Z

WEBContact us at [email protected] or 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800. A list of IRBMED …

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De-identified Data Sets Research A to Z

WEBNOTE: This page provides HIPAA-related guidance on “de-identified data sets,” applicable only to data based on Protected Health Information (usually medical …

Category: Medical Go Health

Informed Consent Procedures Using Electronic Systems and …

WEBThe eIC must contain all elements of informed consent required by FDA regulations at 21 CFR 50.25 (the IRBMED standard informed consent template …

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Evaluating Risks to Participants Research A to Z

WEBIn human research studies, the IRBs are responsible for evaluating the risks, weighing the probability of each risk coming to pass, and assessing the magnitude of …

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Secondary Use research Research A to Z

WEBThe following two application types are available in Section 1-1.1 of eResearch application for research that will be using secondary use of private …

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Exempt Human Subjects Research Research A to Z

WEB“Exempt human subjects research” is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight, because the only …

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International Council for Harmonisation: Good Clinical Practice …

WEBThe ICH-GCP E6 Efficacy Guideline applies only to drug clinical trials, and does not represent a regulatory requirement in the United States; but may be required …

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Quality Assurance and Quality Improvement (QA/QI) Projects

WEBContact us at [email protected] or 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800. A list of …

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Blood Draw Guidance Research A to Z

WEBContact us at [email protected] or 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800. A list of …

Category: Health Go Health

Research Involving Genetic, Genomic, and/or DNA Collection or …

WEBGenetic analysis may be the main goal of the study, an optional sub-study, or otherwise a part of the study. For instance, analysis of genomic DNA as a comparator …

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Biosafety in Microbiological and Biomedical Laboratories (6th …

WEBPublished by the Centers for Disease Control and the National Institutes of Health, the Biosafety in Microbiological and Biomedical Laboratories (BMBL) is an advisory …

Category: Medical Go Health

End-Stage Illness Scoring System Research A to Z

WEBOct 20, 2023 12:00 am. To establish a guideline for an end-stage illness scoring system to be used for animals displaying severe signs of morbidity, or a moribund state. This …

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Policy on Investigating Noncompliance and Animal Welfare …

WEBThe University of Michigan’s Animal Care & Use Program (ACUP) adheres to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (), the …

Category: Health Go Health

Public Health Service Policy on Humane Care and Use of …

WEBThe Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), is a set of standards administered by the Office of Laboratory Animal Welfare …

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