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Research During a Public Health Emergency

WEBUse of a Product with an EUA in a Research Study. Congress created the Emergency Use Authorization (EUA) in the Project BioShield Act of 2004 to give the public health …

Actived: 2 days ago

URL: https://irb.upenn.edu/homepage/biomedical-homepage/guidance/research-during-a-public-health-emergency/

Penn IRB Guidance

WEBThis page is a central resource to guidance on conducting research with Penn patients. It includes guidance on HIPAA in research, the release of research information to the …

Category:  Health Go Health

Penn IRB Biomedical Research Homepage

WEBBiomedical Research Homepage. Biomedical research is a broad area of science seeking to prevent and treat diseases that cause illness and death. Biomedical …

Category:  Medical Go Health

Research During a Public Health Emergency

WEBWhat changes require IRB review and approval related to mitigating risk to participants during a pandemic or other health emergency? According to IRB policy, any changes in …

Category:  Health Go Health

Penn IRB Research with Penn Patients

WEBThe Penn IRB supports the use of remote consent and remote study procedures, when appropriate. However, the use of remote methods must be outlined for IRB review to …

Category:  Health Go Health

Penn IRB Release of Information to the EMR

WEBRelease of Research Information to the Electronic Medical Record. HIPAA provides patients with access to their medical records and more control over how their PHI is used and …

Category:  Medical Go Health

Penn IRB HIPAA in Research

WEBProtected health information is a combination of identifiers and health information generated and collected by a covered entity. The University of Pennsylvania has four …

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Penn IRB Health Literacy Guidance

WEBPenn IRB V.2018.4Institutional Review BoardHealth Literacy GuidanceAbout 30 million Americans have below-basic literacy, which can hamper the understanding of research. …

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Penn IRB Types of Biomedical Research

WEBA clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on …

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Requirements for Research Involving the Use of Protected Health

WEBRequirements for Research Involving the Use of Protected Health Information (PHI)

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Penn IRB Clinical Trials

WEBThe Department of Health and Human Services’ (HHS), Food and Drug Administration (FDA) and National Institutes of Health (NIH), and the International Committee of …

Category:  Food Go Health

Biomedical Submission Completion Guidance

WEBIRB & Penn Medicine Requirements regarding PHI Security and Storage. Submissions that involve the collection of HIPAA protected health information (PHI) are required to …

Category:  Medicine Go Health

Penn IRB Reportable Event Guidance

WEBClinical adverse events are often graded from 1 to 5 (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death). The IRB considers severity grades of 4 and 5 to be …

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Penn IRB About the IRB

WEBThe University of Pennsylvania is guided by the ethical principles set forth in Belmont Report.The minimum standards are set by the Department of Health and Human …

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Penn IRB Research Collecting Blood

WEBOther (i.e., non-healthy) adults and children considering the age, weight, and health of the subjects: the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg; Timing. …

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Penn IRB Informed Consent

WEBHealth Literacy Guidance Clinical Research Glossary. Remote Consent & Procedures. The Penn IRB supports the use of remote consent and remote study procedures, when …

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Quality or Performance Improvement Versus Research …

WEBVersion 2021.06 . Quality or Performance Improvement Versus Research Guidance . Applicability: This guidance applies to the following activities, which are defined below: …

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Penn IRB 2018 Common Rule

WEBThe 2018 Common Rule effective date was January 21, 2019. Guidance below contains detailed information about how each of these provisions was applied to new research …

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Suicidal Ideation and Behavior: Risk Mitigation Guidance

WEB• Patient Health Questionnaire (PHQ)-9 . Use of such scales in research indicates that the research team could receive information related to a participant’s suicidal ideation and …

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Guidance on Submitting Research Conducted at Princeton …

WEBPrinceton Health (PH) to the Penn IRB . The Penn IRB will serve as the IRB for Princeton Health as of April 2021. Please review the following information prior to …

Category:  Health Go Health

Penn IRB Protocol Template Retrospective Study

WEBProtocol Template Retrospective Review of Existing Data Specimens Guidance for using this template This protocol template is designed to facilitate the creation of a …

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Penn IRB Protected health information

WEBA combination of identifiers and health information generated and collected by a covered entity.

Category:  Health Go Health

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