Irb.northwestern.edu

Education : Institutional Review Board (IRB) Office

WEBNavigating Human Research Ethics & Regulatory Review with the Institutional Review Board Office is a comprehensive educational tool that can be accessed through MyHR …

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URL: https://irb.northwestern.edu/compliance-education/education/

SOPs: Institutional Review Board (IRB) Office

WEBHRP-072 – SOP Document Management and Record Retention of Institutional Review Board Records. HRP-080 – SOP IRB Formation. HRP-081 – SOP IRB Removal. HRP …

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Protocol Templates & Forms

WEBThe IRB Office has developed protocol templates for use by the Northwestern University research community to describe research/human research activities. Consult our …

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Considerations for Research that Involves Use of Mental …

WEBObjectives • Review the Illinois Mental Health & Developmental Disabilities Confidentiality Act (MHDDCA) – Terms most relevant to research -related purposes

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Expedited Review: Institutional Review Board (IRB) Office

WEBCategory 8. Continuing review of research previously approved by the convened IRB as follows: where (i) the research is permanently closed to the enrollment of new subjects; …

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Recruitment Materials & Guidelines

WEBAll 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 …

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HIPAA, PHI, & PII

WEBHIPAA applies whenever you use protected health information (PHI) for research purposes. For example: Recruitment: reviewing PHI, such as information from the medical record …

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U.S. Department of Health and Human Services (HHS) …

WEBU.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB) This form is used by institutions or organizations …

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Conduct of Clinical Trials of Medical Products During the …

WEBFDA recognizes that during the COVID-19 public health emergency, sponsors of clinical trials may need to modify protocol-specified procedures. As is …

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Guidance for Research Involving Mobile Apps or Mobile …

WEBVersion date: 5/16/2018 same risk-based approach the agency uses to assure safety and effectiveness for other medical devices. For more information about these types of apps, …

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How to Maintain Research Compliance During the Life of a …

WEBBest Practices. • Best practices are recommendations to maintain research compliance. – Often they overlap with regulations and policies that may not be …

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Research Recruitment Guidelines: Frequently Asked Questions

WEBApril 14, 2020 Page 4 of 20 Health information may be de-identified by one of two methods: A. All of the following identifiers of the individual or of relatives, employers, or

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Special populations in human research: Sexual and gender …

WEBGetting an X-ray to check your bones at the doctor's office Talking about sex with your friends *Having the inside of your mouth swabbed with a Q-tip to test your …

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Regulatory Agencies

WEBThe NIH is the primary agency of the U.S. government responsible for biomedical and public health research. National Science Foundation (NSF) The NSF is …

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