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Emergency Research (Planned and Approved) with Exception from Informed Consent

Overview The Food and Drug Administration (FDA) regulation at 21 CFR 50.24 , and Office for Human Research Protections (OHRP) Secretary's Waiver , allows a narrow exception to the requirement to prospectively obtain and document informed consent...

Tags: Regulatory

Guidance

Aug 26, 2022

Radiation Exposure Guide

Ionizing radiation includes x-rays, beta-rays, gamma-rays, neutrons, and other high-speed particles. When subjects are exposed to ionizing radiation as part of their study activity, the risks incurred from radiation exposure must be assessed by the...

Tags: Regulatory Study Teams

Guidance

Aug 22, 2022

Emergency Use of a Test Article in Life-Threatening Circumstances

This guidance describes the circumstances regarding Emergency Use of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product. Emergency...

Tags: Regulatory MICHR Investigator Initiated

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Policies

Jun 15, 2017

Establishment of New Biospecimen Collections Policy

This policy operates subject to the University of Michigan Medical School ( UMMS ) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition Within All UMMS Research Biorepositories (“UMMS Tissue Ownership Policy”) and applies to...

Tags: Data Use Biorepository Use

Guidance

Feb 15, 2019

FAQ: Repository application (REP)

Guidance

May 22, 2018

UMMS Biorepository Registration Decision Tree

This decision tree represents UMMS policy for registration of biorepositories funded by a UMMS Department , and/or operating in UMMS space, and/or directed by faculty with an appointment in the Medical School. For more information, see Medical...

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Emergency Research (Planned and Approved) with Exception from Informed Consent

Radiation Exposure Guide

Emergency Use of a Test Article in Life-Threatening Circumstances

Most Viewed

Establishment of New Biospecimen Collections Policy

FAQ: Repository application (REP)

UMMS Biorepository Registration Decision Tree

Medical School Office of Research