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Policies

Mar 19, 2018

Consent and HIPAA Privacy Rule Authorization Policy

This policy aims to ensure that donor preferences are given due respect in the conduct of research projects that are facilitated by the Central Biorepository (CBR). It operates subject to the UMMS Policy Governing Tissue Sample Collection, Ownership...

Tags: Data Use Biorepository Use

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...

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...

Policies

Feb 27, 2014

Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study Documents . Click here for PDF version of the current document . When watermarking consent documents and recruitment...

Templates

Jan 13, 2014

Assent Template

(Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.

Guidance

Apr 18, 2012

Who May Consent for Participation in Research Studies (Michigan)

Participant = Minor Participant = Incapacitated / Incompetent Adult Outpatient Psychotherapy Minor age 14 or over if seeking limited confidential outpatient psychotherapy services under M.C.L. §330.1707 Parent(s)* with legal custody or guardian† See...

Guidance

Feb 1, 1998

Radiation Exposure Guide

Templates

Apr 17, 2018

Biorepository Informed Consent Template

This biorepository informed consent template is designed to be accompanied by the illustrated biorepository informational sheet . Clinical teams engaging with the patients are provided with the Biorepository Consent and Authorization template to...

Guidance

Jul 10, 2020

eResearch Cross-Reference Table

These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...

Templates

Jul 8, 2020

Exempt Consent Template

The expectation for all human subject research—whether exempt or not—is for researchers to inform the subjects regarding the research and seek/secure the consent of subjects. Use this consent template for Exempt studies requiring Limited IRB review...

Tags: Study Teams

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