Irb.northwestern.edu

HIPAA, PHI, & PII

Personally Identifiable Information (PII) is defined as data used in research that is not considered PHI and is therefore not subject to the HIPAA Privacy and … See more

Actived: 7 days ago

URL: https://irb.northwestern.edu/resources-guidance/consent-templates-hipaa-requirements/consent-hipaa/hipaa-phi-pii.html

Research Recruitment Guidelines: Frequently Asked …

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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How to Maintain Research Compliance During the …

WebA standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. Essential documentation per GCP: − …

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Considerations for Research that Involves Use of …

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

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Informed Consent: All the Things You Need to Know!

WebAt minimum, it involves obtaining the signature of the participant as well as the person obtaining consent (if required by the IRB). The person obtaining consent …

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Suggested Consent Language

WebBone Marrow Biopsy. A small piece of bone with bone marrow (the soft, sponge-like tissue in the center of most bones) will be taken from the ___ (name the location of the …

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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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AAHRPP Accreditation

WebThe Association for the Accreditation of Human Research Protection Programs, Inc. is a independent, non-profit accrediting body, that uses a voluntary, peer-driven, educational …

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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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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 a …

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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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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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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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