May 10th, 2018
The University of Utah IRB continually strives to provide information and training to the research community. Additionally, we regularly review our guidance documents to make updates as necessary. This e-mail is intended to give a summary of updates that were made and posted during January-April of 2018. It may also be helpful to the research community to have a better understanding of research topics. Below, you will find a brief description of the updates. You can find the revised documents by clicking on the link or on the Investigator Guidance Series (IGS) page. You can also find tracked versions of updated documents.
Investigator Guidance Series: Compensation of Research Subjects (version 2/16/18)
This document describes the guidelines for participant compensation. A section was added to describe considerations for compensation to participants in FDA regulated clinical trials. Additionally, this guidance was updated to align with current VA policy regarding compensation to participants in VA research. Finally, additional description was added regarding Accounts Payable policy for research participant compensation.
This document describes follow-up guidelines for participant, pregnant partner, and newborn; monitoring pregnancy occurrences; and reporting guidelines should pregnancy occur during research participation. This document made minor updates to more clearly describe the process for investigators to outline the monitoring of pregnancy during research participation.
This IGS focuses on Subpart B and the additional protections for the inclusion of pregnant women and fetuses in research (approvable categories of research and additional considerations); a section about incidental partner pregnancy; research on dead fetuses or fetal material; and additional VA considerations for research on pregnant women. This document was updated to include a reference to the IGS: Pregnancy During Research Participation.
Board Member Guidance Series: Biopsies for Research Purposes (version 05/01/18)
This document is useful guidance for board members in making determinations. The document was updated to include clarifications such as research biopsies must only be obtained after clinical biopsies have been obtained.