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Penn IRB Human Research Participants

WEBThe purpose of the IRB is to ensure that the rights and welfare of people participating in research studies are protected. The Penn IRB is made up of Penn faculty and staff as …

Actived: 3 days ago

URL: https://irb.upenn.edu/homepage/about-the-irb/human-research-participants/

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 …

Category:  Health Go Health

Penn IRB Clinical Trials

WEBNIH defines a clinical trial as: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other …

Category:  Health Go Health

Research During a Public Health Emergency

WEBIRB Requirements for Research During a Public Health Emergency The IRB expects Penn research teams to follow any applicable and current guidelines and laws set forth by the …

Category:  Health 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 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 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 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

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 Research Collecting Blood

WEBBlood Collection. IRB Review procedures for research involving blood sampling require careful assessment of sample collection methods and volume of collection. This …

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Institutional Review Board

WEBPenn IRB V.2018.4 . Institutional Review Board . Health Literacy Guidance . About 30 million Americans have below-basic literacy, which can hamper the understanding of

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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 …

Category:  Health Go Health

Penn IRB Federalwide Assurance Info

WEBPenn operates under Federalwide Assurances (FWAs) in accordance Subpart A 46.103a which requires any institution engaged in non-exempt human subjects’ research, …

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Guidance on Submitting Research Conducted at Princeton

WEB2022.07.05 . Guidance on Submitting Research Conducted at . Princeton Health (PH) to the Penn IRB . The Penn IRB will serve as the IRB for Princeton Health as of April …

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Recruiting Human Research Subjects: Guidance and …

WEBVersion 2022.05.10 Page 5 of 8. information, HIV status, infertility, genetic information, substance abuse. • Consider using, whenever possible, more secure modes of contact …

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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 Recruitment and Consent

WEBPaying or otherwise incentivizing participants for their time contributing to a research study can be a useful tool to both recruit and retain participants. The Penn IRB is responsible …

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UNIVERSITY OF PENNSYLVANIA IRB

WEBUPenn IRB V.2018.4 . 2. What to include in the IRB application (in the Procedures section of HS-ERA): a. Please review the requirements for Interactive Recruitment noted above …

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New Jersey State Law: Research Guidance

WEB1. With a prospect of direct benefit • the risk is justified by the anticipated benefit to the subject; • the relation of the anticipated benefit to the risk is at least as favorable to the

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