Final Common Rule

May 8th, 2019

IRB Update: Changes to Investigator Guidance

 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 2019.  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 this page: https://irb.utah.edu/guidelines/investigator.php. You can also find tracked versions of updated documents.  

Investigator Guidance Series: Research Involving Neonates (version 1/21/19)

This document describes the additional protections required for studies involving neonates. The section describing VA research involving neonates was updated based on the new VHA Directive 1200.05 released in January, 2019. VA Medical Facility Director certification is required for neonatal research (rather than it not this research not being conducted unless a waiver is granted).

Investigator Guidance Series: Research Involving Children (version 1/21/19)

This document describes the additional protections required for studies involving children. Minor changes were made to ensure consistency with the new VHA Directive 1200.05 released in January, 2019.

Investigator Guidance Series: Research Involving Pregnant Women and Fetuses (version 1/21/19)

This document describes the additional protections required for research involving children. The section describing VA research was updated to state that the provision of in vitro fertilization services can be conducted by VA researchers (as was previously not allowed). There are other changes made to ensure consistency with the VHA Directive 1200.05 released in January, 2019. Finally, a change was made to clarify that while pregnant women are no longer named as a vulnerable population group in the revised Common Rule (also called the Final Rule), additional protections are still required and investigators should continue to identify pregnant women in applications.

Investigator Guidance Series: Exempt Research (version 1/21/19)

This document outlines the categories of research that are exempt from IRB review including the additional categories specific to the University of Utah. The categories of research were updated to reflect changes made with the Final Rule.

Investigator Guidance Series: Transitioning to the Final Rule (NEW)

This document was intended to assist investigators in understanding the University of Utah’s transition to adopting the Final Rule.

Investigator Guidance Series: Concise Summary (NEW)

This document was created to help investigators present a concise summary of information at the beginning of the consent process as required by the Final Rule.

Investigator Guidance Series: Genetic Research (version 1/21/19)

This document outlines requirements for genetic research. It was updated to include the requirement to inform participants whether whole genome sequencing will be conducted.

Investigator Guidance Series: Waiver or Alteration of Consent (version 1/21/19)

This document outlines the requirements for a Waiver or Alteration of Consent. This was updated to include the additional finding that the IRB must make as required by the Final Rule.