Medical School Office of Research

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FAQ: Repository application (REP)

Policies

Jan 23, 2019

Statement of Practice: Flexibility Initiatives

The University of Michigan's federalwide assurance with the Department of Health and Human Services (HHS) allows the IRB flexibility in its application of federal regulations to studies not federally funded or FDA-regulated. Click here for PDF...

Guidance

Jan 18, 2019

Uses & Disclosures of Protected Health Information (PHI)

Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...

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Guidance

May 11, 2012

Recruitment Advertising

Advertisements for recruiting potential research subjects can take many shapes. Examples include: flyers in a hospital hallway or on a student union bulletin board; newspaper, radio or television ads; direct mailings; electronic mail announcements;...

Guidance

Jun 5, 2017

Telephonic Consent

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol , including its risks , benefits , and alternatives. The subject's voluntary and un-coerced choice to participate must usually be...

Guidance

Apr 17, 2012

Test Articles in Research

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...

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FAQ: Repository application (REP)

Statement of Practice: Flexibility Initiatives

Uses & Disclosures of Protected Health Information (PHI)

Most Viewed

Recruitment Advertising

Telephonic Consent

Test Articles in Research

Medical School Office of Research