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Investigational New Devices Human Subjects Stanford University Humansubjects Stanford Form
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People also ask
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Do you need IRB approval for cadavers?
Research involving cadavers, autopsy material, or biospecimens from now deceased individuals does not meet the regulatory definition of 'human subject research,' i.e., “a living individual…” However, if the research leads to information about living relatives, such as genetic studies, IRB review may be required. -
Which studies do not need IRB approval?
If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review. -
Do you need an IRB for Stanford University?
Do I have to submit an application to the IRB? Studies that meet the definition of Human Subject Research must be submitted to the IRB and must receive IRB approval before any study activities take place. -
What is required in human subjects research?
Information must be individually identifiable to constitute human subjects research. Research using human specimens or data. Human subjects research involving individually identifiable human specimens or data and subject to federal and state regulatory requirements. -
How do I contact the IRB at Stanford?
If You Have Questions. School of Medicine, please contact your Panel Manager, or email or call IRB Education at (650) 724-7141. Stanford University (outside the School of Medicine), please email or call (650) 723-2480. For Single IRB or Reliance questions, please email or call (650) 736-9024. -
What materials need IRB approval?
All materials aimed at recruiting participants into a research study (including the final copy of printed advertisements, scripts, audio or video tapes, or web sites) must be reviewed and approved by the IRB prior to use (HRP-315). -
Under what circumstances is IRB approval needed?
Research involving human subjects must receive IRB approval in ance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) (known as the “Common Rule”) and the U.S. Food and Drug Administration (FDA). -
What is exempt from IRB?
Exempt Review Categories Include: Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn or the assessment of educators.
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