Home

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

Informational

Dec 17, 2020

CBR Guidance for Creating a Biospecimen Collection

This is not an exhaustive set of instructions on how you should complete your HUM application. This information only provides guidance on citing policies and practices related to CBR activities. You may have more information within each section...

Informational

Dec 17, 2020

CBR Guidance for Secondary Distribution

Most Viewed

Guidance

May 16, 2016

Children in Research

Guidance

Sep 5, 2005

Research and Non-English Speaking or Reading Subjects

Many patients at the University of Michigan Health System do not speak English or lack the fluency to understand medical and scientific information presented in English. In order for such a patient to participate in a research study, steps must be...

Guidance

Jan 16, 2019

Transition to 2018 Regulations

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...

Recently Updated

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

CBR Guidance for Creating a Biospecimen Collection

CBR Guidance for Secondary Distribution

Most Viewed

Children in Research

Research and Non-English Speaking or Reading Subjects

Transition to 2018 Regulations