New & Revised IRBMED Guidance
IRBMED has recently posted new and revised guidance in Research A-Z for the research community.
Secondary Use Research (New)
In August 2023, IRBMED developed new guidance on IRB applications involving secondary use of existing data and/or biospecimens.
Reporting Time-Sensitive Modifications (Revised)
IRB approval is typically required before implementing changes to IRB approved research. In some instances, changes require urgent approval, which, depending on their nature, calls for different procedures. Most commonly, these include approval of an amendment application or, in case of immediate hazard to subjects, submission of an ORIO after the fact. Rarely, in some limited scenarios, the changes can be approved via the ORIO application route. In August 2023, IRBMED’s guidance on time-sensitive modifications (formerly titled “Urgent Amendment Procedures”) underwent revision to clarify the ORIO process.
In spring 2022, IRBMED posted extensive revisions to its guidance on Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments (formerly called “Research and Non-English Speaking or Reading Subjects”). This revision expanded the scope of the guidance to include potential participants with limited literacy as well as vision and hearing impairments. In August 2023, the guidance was again revised, this time to define more thoroughly the role of the witness in oral consent processes and the corresponding signature process.
Questions? Contact irbmed@umich.edu.