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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

Mar 19, 2021

Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity

Guidance

Mar 18, 2021

Assent of Children in Research

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. Links to additional information are...

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Policies

Dec 9, 2016

Recovering Full Indirect Costs: Industry Funded Research

This policy details the required process that should be used to negotiate the indirect cost rate with industry sponsors . The Medical School does not support indirect cost waivers on industry funded research. Please visit the Indirect Cost Waiver...

Templates

Mar 13, 2018

Data Office Access Request Form

Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at dataoffice@umich.edu .

Tags: Data Use

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...

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Emergency Use of a Test Article in Life-Threatening Circumstances

Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity

Assent of Children in Research

Most Viewed

Recovering Full Indirect Costs: Industry Funded Research

Data Office Access Request Form

Reporting Time-Sensitive Modifications

Medical School Office of Research