A component of the University of Michigan's GENERAL SPOTLIGHT ANNOUNCEMENTS
New and updated IRBMED guidance
IRBMED has recently posted new or revised guidance for the research community. Below are summaries of three new or revised pages, with a direct link to IRBMED guidance on Research A–Z.
Secondary Use Research
In August 2023, IRBMED posted a new guidance page for secondary use analysis of existing data and/or biospecimens, including tips for eResearch applications, explanations of regulatory pathways, and consideration of the necessity for (or waiver of) informed consent.
Reporting Time-Sensitive Modifications
In August 2023, IRBMED revised its guidance Reporting Time-Sensitive Modifications to clarify the ORIO process (Section II). Specifically, reminders were reinforced that
- Sponsors and/or coordinating centers, as applicable, must be involved in any proposed one-time change
- For FDA-regulated studies where the U-M investigator holds an IND/IDE, MIAP must be involved in the ORIO preparation and submission.
Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments
In August 2023, IRBMED revised its guidance on Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments. A new sub-heading under "Foreign Language Study Documents" clarifies the role of the witness to a consent process involving a non-English speaker
Retention of data/biospecimens
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.
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)