Updated Guidance for Genetic Research
September 30th, 2015
The IRB has updated the guidance on Genetic Research to add information on the topic
of disclosure of incidental findings. This update includes the new standard institutional
process for disclosure of incidental findings to research participants. The updated
guidance can be viewed online here: http://irb.utah.edu/_pdf/IGS%20-%20Genetic%20Research%20H2215.pdf.
As a complement to this guidance, the following new educational opportunity is offered through the Research Administration Training Series (RATS):
Managing the Return of Incidental Findings in Research
Instructors: Jeffrey Botkin, MD, MPH, Associate Vice President for Research & Professor of Pediatrics; Ann Johnson, IRB Associate Director
Date: Thursday, October 15, 2015
Location: HSEB 1750
To register, visit: https://education.research.utah.edu/class_details.jsp?offeringId=266.
Additionally, the IRB has made the following changes related to the updated guidance:
- New template language has been added to the Consent (and Authorization) Templates in the New Information section for informing participants about the possibility of incidental findings. The updated templates are available online at: http://irb.utah.edu/forms/health-sciences.php. Applicable studies will be required to include this language at initial submission of a new study application or at continuing review.
- The ERICA application will be updated to include new questions applicable to genetic research. This ERICA update is scheduled and more details will be made available at the time of release.
Please contact the IRB at 801-581-3655 or firstname.lastname@example.org if you have questions about this update.
Researchers conducting procedures at the Salt Lake City VA need to be aware of the additional administrative forms that may be required in addition to the IRB application.
The IRB has received several requests to allow the use of external research nurses who have contracted with a study sponsor to conduct research procedures with participants in their homes.
We are pleased to welcome a new Coordinator to the IRB.
Yan "Kiki" Wai, IRB Coordinator for Panel 2, has left the IRB. We are pleased to announce that Chantyl Staheli has been selected as the new IRB Coordinator for Panel 2.
The IRB is introducing Exemption Categories 8-11 as additional non-federal categories.