A number of revised templates and resources have been posted on the IRB web site.
Protocol Summary Template
New Protocol Summary. Instructions have been updated.
(NOTE: As of 1/16/2012, protocol summary now writes itself. Information pertaining to the link no longer applies.)
Study Procedures Section: Standard of care vs. research related procedures should be described if applicable.
Data safety and monitoring information must be provided for moderate risk studies. See Guidelines on the IRB web site for more detailed information.
Administrative Responsibility Section: Includes instructions to describe the resources available to conduct the research such as qualified personnel, time, space, data collection and management, etc.
Asks the investigator to provide the IRB with a plan as to how they will control investigational devices or drugs used in the research if applicable.
If applicable, investigators should provide communication plans for multi-center studies if the University of Utah is the lead site.
If applicable, investigators should provide additional information regarding participating sites for which the PI is responsible.
Research Summary Template (Main Campus)
New Research Summary. Instructions have been updated.
Administrative Responsibilities Section: Includes instructions to describe the resources available to conduct the research such as qualified personnel, time, space, data collection and management, etc.
If applicable, investigators should provide communication plans for multi-center studies if the University of Utah is the lead site.
If applicable, investigators should provide additional information regarding participating sites for which the PI is responsible.
Additional Resources Available
Sponsor-Investigator Responsibilities: This document is posted on the IRB web site under Guidelines (by topic) and provides investigators with information if they decide to become Sponsor-Investigator (e.g. investigators who conduct studies involving an FDA test article and for which they hold the IND or IDE).
Data and Safety Monitoring Board (DSMB) Guidelines: This document is posted on the IRB web site under Guidelines (by topic) and provides an outline of the information about the data and safety monitoring which should be provided to the IRB.
Other Updates: The procedure for verifying IND and IDE numbers has been modified. For verification of an IND the IRB will accept the FDA letter of receipt of IND or letter from sponsor identifying the IND or other sponsor-generated item with the IND.
For verification of an IDE the IRB will accept FDA letter granting an IDE for the proposed use or letter from sponsor stating that the study is a non-significant risk device study or letter explaining why the investigation is exempt from the IDE requirements under 21 CFR 812.2(ac) or otherwise exempt.