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Humanitarian Use Device (HUD) Informed Consent Template

This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...

Guidance

May 11, 2020

Humanitarian Use Device Requirements for U-M Physicians & Investigators

The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals...

Guidance

Mar 27, 2020

Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents

Updated May 29, 2020 Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. This guidance is intended for...

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Policies

Jan 20, 2020

Policy on the Use of Expired Drugs and Medical Materials

This policy defines the expectations for the appropriate use and storage of expired drugs and medical materials.

Guidelines

Nov 1, 2018

Guidelines on Use of Streptozotocin in Rodents

To describe the appropriate use of streptozotocin for induction of diabetes mellitus (DM) in rats and mice and associated husbandry procedures. To describe the appropriate post-injection monitoring of rodents.

Forms

Mar 7, 2016

General Animal Diagnostic Laboratory Testing Submission Form

The In-Vivo Animal Core (IVAC) offers a wide-array of services and expertise in laboratory animal pathology, pathology preparations, and services. Services are offered on a fee-for-service basis . Requests should be submitted using the General...

Tags: IVAC