February 12th, 2020
Investigator Guidance Updates
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 September-December of 2019. It is also our hope
that the research community have materials that may enable a better understanding
of research topics. Below, you will find a brief description of the updates.
An index of all of our current guidance series documents can be found here: https://irb.utah.edu/guidelines/investigator.php.
You can also find tracked versions of updated documents, if applicable.
Gender Inclusive Language in Research
This guidance document is intended to assist researchers in using gender inclusive
language when collecting information about sex, gender identity, or sexual orientation.
Basic Physiological Research
This guidance document is intended to assist researchers in understanding basic physiological
research in relation to Investigational Device Exemption regulations.
Elements of a Safety Monitoring Plan (7/31/19)
Updated links.
Investigator Responsibilities for Drug Studies (version 8/1/19)
Updated links and contact information for investigational pharmacies.
Investigator Responsibilities for Device Studies (version 8/1/19)
Updated links.
Sponsor-Investigator Guidelines and Responsibilities (version 8/7/19)
Made changes to reconcile with updates in Good Clinical Practice and resources for
sponsor-investigators in preparation for study approval.
IND Exemption Criteria (version 8/14/19)
Updated links.
Research Involving Individuals with Decisional Impairment (version 8/30/19)
Removed references to Consent Template and replaced with directions for investigators
to use the Sample Signature Blocks.
UPDB Consent and Authorization Requirements (version 10/2/19)
Minor updates and clarifications.
Assent (version 10/14/19)
Minor grammatical edits were made and links were updated.
Multimedia Recordings (version 10/17/19)
Added a section for VA Research with reference to the requirements in the VA Handbook
1200.05. Added a Points to Consider section and a References section.
HIPAA Privacy Rule and Authorization (version 10/21/19)
Made updates to the description of procedures for obtaining the data use agreement
and updated links.
Investigator Qualifications (version 11/6/19)
Added clarifications regarding the Responsible Investigator and how this is used in
ERICA.
If you have questions, please Contact Us.