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Policies

Nov 21, 2019

University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...

Tags: MICHR

Guidance

May 7, 2018

FDA Expanded Access Program at the University of Michigan

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...

Templates

Mar 29, 2017

FDA Expanded Access Informed Consent Template

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...

Guidance

Apr 17, 2012

Federal Regulations

Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 -- Institutional Review Boards 21 CFR 11 -- Electronic Records; Electronic Signatures 21 CFR 312 -- Investigational New Drug (IND)...

Guidance

Dec 13, 2016

Emergency Use of a Test Article in Life-Threatening Circumstances

This guidance describes the circumstances regarding Expanded Access Emergency Use ( 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...

Guidance

Jul 14, 2016

Resources

The lists below provide direct links to resources both within the University of Michigan and outside the institution.

Guidance

Nov 2, 2020

FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations

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...

Guidance

Nov 14, 2011

Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g., DSMB, FDA)

The table below presents instructions and guidance on informing IRBMED of reports to or from oversight bodies.

Guidance

Dec 18, 2020

Investigational In Vitro Diagnostics (IVDs) utilized in Clinical Investigations of Therapeutic Products

Human subjects research applications received by IRBMED include clinical investigations of therapeutic products that propose to utilize in vitro diagnostic (IVD) tests or assays. PDF version

Policies

Aug 5, 2019

Statement of Practice: Ancillary Approval & Final IRBMED Approval

Click here for PDF version .

Templates

Jul 8, 2020

Specialty Informed Consent Templates

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks , discomforts, inconveniences, and potential benefits involved if...

Guidance

Dec 15, 2020

Reporting Time-Sensitive Modifications

PDF Version Revised 12/14/2020 NOTE: The following guidance does not apply to studies where IRBMED is relying on an external IRB for regulatory oversight ("ceding" IRB oversight). If your study is ceded, you must reach out to the IRB of Record for...