When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in...

Ionizing radiation includes x-rays, beta-rays, gamma-rays, neutrons, and other high-speed particles. When subjects are exposed to ionizing radiation as part of their study activity, the risks incurred from radiation exposure must be assessed by the...

According to U-M Human Research Protection Program (HRPP) and federal (OHRP) guidance, IRB review and approval is not required for activities that are limited to Quality Assurance and Quality Improvement (QA/QI) activities. However, IRB approval is...

This guidance document outlines IRB expectations for research involving genetic analysis which generates or uses human genetic information through analysis of human biospecimens and/or data. For this guidance, the relevant human genetic information...

Common Rule regulations and FDA guidance , and HIPAA regulations each allow for an IRB to approve research that departs from the usual requirements regarding the participant’s free and informed decision to participate in the study, or regarding the...

The study protocol should comprise all the key information about study conduct, including but not limited to rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study...

The IRBMED reviews the amount of payment, the proposed method, and timing of disbursement of payments investigators give to study participants to assure that they do not present undue influence [ 45 CFR 46 .116, 21 CFR 50 .20]. There is no set...

Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes...