GENERAL SPOTLIGHT ANNOUNCEMENTS
Retention of data/biospecimens after study closure
On April 7, 2023, IRBMED posted new guidance on the proper completion of the eResearch application and the Informed Consent Document(s) with respect to the use of research data/biospecimens after the conclusion of the main study. Click here to read the guidance.
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.
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.
The 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.
A 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 firstname.lastname@example.org.
FREQUENTLY VIEWED DOCUMENTS
Standard Informed Consent Template
Exempt Human Subjects Research
Other Reportable Information or Occurrence (ORIO)