A component of the University of Michigan's GENERAL SPOTLIGHT ANNOUNCEMENTS
Monitoring Requirements for NSR studies
On February 15, 2023, IRBMED posted new guidance on the monitoring requirements for non-significant risk (NSR) device studies. This guidance also provides instructions on completing the IRB application for the monitoring aspects. Click here to read the guidance.
Updating IRB applications when Researcher(s) Leave U-M
On November 28, 2022, IRBMED posted new guidance on updating IRB applications when study team members leave the University of Michigan. Click here to read the guidance.
Electronic Signatures for FDA regulated documents using SignNow
Updated March 16, 2022
The university’s E-signature Service, SignNow, has a version that is compliant with FDA regulations at 21 CFR Part 11. If you use SignNow to obtain signatures for FDA-regulated documents and don’t see this logo when logged into your SignNow account, please contact the ITS Service Center and let the E-Signature team know that your SignNow account needs to be updated. Research studies that are not FDA-regulated may use the standard version of SignNow to document consent or assent electronically.
More information is available here on the IRBMED website, including relevant FAQs.
HOW IRBMED SUPPORTS RESEARCH
Guidance documents represent the current thinking on the protection of human subjects in research. You can search and bookmark any guidance document in Research A-Z.
Informed Consent & Assent Templates
IRBMED offers numerous downloadable templates to assist researchers in creating informed consent and assent documents. In addition to standard consent and assent templates, several specialty templates, for use in specific types of research situations, are also offered. You can search and bookmark any template in Research A-Z.
Education & U-MICThe goal of IRBMED’s Education Program is to meet the ongoing educational needs of the research community. In addition to in-person classroom education on an assortment of relevant topics, IRBMED also offers multimedia presentations (U-MIC), which are short videos and voiceover slide shows that address topics relating both to ethics in human subjects research and to IRB procedures.
The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM). The IRBMED Standard Operating Procedures serve as a reference for investigators, IRBs, administrators, and others.
Information for Study Subjects
The IRBMED protects the rights and welfare of participants in clinical trials and other human subjects research studies by careful review and monitoring of research per applicable laws, regulations, and University policies.
Frequently Asked QuestionsA list of FAQs is available to answer commonly asked questions by the research community. If you cannot find an answer to your question here, please contact us at irbmed@umich.edu.
FREQUENTLY VIEWED DOCUMENTS
Standard Informed Consent Template
Exempt Human Subjects Research
Other Reportable Information or Occurrence (ORIO)