November 8, 2010
Internet Recruitment and Advertising
The IRB has revised the Recruitment Methods and Advertisements document in the Investigator Guidance Series to include guidance on internet advertising. This document may be accessed using the following link: (www.research.utah.edu/irb/guidelines/pdf/IGS/IGS-Advertisements.pdf)
The following information has been added to the guidance:
Advertisements posted on the internet must adhere to the advertising guidelines. All advertisements must be approved by the IRB prior to posting. The researcher may submit the advertisement text to the IRB as a document for approval. The intended internet sites where the advertisements will be posted must be described in the recruitment methods section of the IRB application or protocol.
Researchers may use the Internet as a forum for disseminating study information to participants. The use of websites, blogs, internet forums, and social networking sites for the dissemination of study information must be described in the recruitment methods section of the IRB application or protocol. The IRB requires the following statement to be posted on internet sites used for this purpose:
The information posted on this site is consistent with the research reviewed and approved by the University of Utah Institutional Review Board (IRB). However, the IRB has not reviewed all material posted on this site. Contact the IRB if you have questions regarding your rights as a research participant. Also contact the IRB if you have questions, complaint, or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at firstname.lastname@example.org.
October 26, 2010
National AWARE for ALL Program Event
This is an announcement for the National AWARE for All: Clinical Research Education Day for the Public.
Registration for this program is free and open to the public. We do ask however, that you register as soon as possible, so that we may plan for the right number of people.
Where: Salt Lake City Main Library Auditorium, 210 East 400 South
When: Saturday, November 6th from 9:15 AM - 12:30 PM MST
To view a copy of the promotional flyer.
To view a copy of the official U of U Press Release.
For more information or to register, please contact Sadie Quinn
Email: Sadie.Quinn@hsc.utah.edu or RSVP online at http://education.research.utah.edu/special_events.jsp.
October 8, 2010
The IRB has received record submissions in 2009 and 2010 due to the increase in human subject research being conducted at the University of Utah. As a result, the IRB has worked diligently to improve our processes to ensure that the review and approval of research is thorough as well as efficient. The following changes have been implemented to help address review for the increasing number of submissions.
Changes in Study Approval Periods
IRB policy has changed to allow an approval period up to two-years for some research studies, instead of the one-year approval period that is used today. Not all studies are eligible for two-year approval - the guidelines to issue up to a two year approval period are described in the attached document. Please read this document carefully in order to understand when a project is eligible for a two-year approval period.
All determinations regarding approval periods will be made by the IRB and will not be influenced by requests from investigators and study teams. Please do not request a two-year approval period as part of your submission. To ensure that your study receives an accurate review and the longest possible approval period, describe all procedures and funding sources in detail in the IRB application.
It is anticipated that this change will decrease the number of continuing review applications received each month and substantially reduce the workload for study teams, IRB members, and IRB staff.
Addition of IRB Panel Six
Due to the increase in submissions that require convened board review, a new IRB Panel Six has been created. Panel Six will convene at noon on the third Wednesday of each month beginning October 20, 2010.
The addition of Panel Six will decrease the length of time between initial submission and final approval of studies, and help to eliminate the need to “bump” studies from multiple meetings due to high volume.
The IRB appreciates the service of additional faculty as new members join us from departments across campus. These additional IRB members are essential to maintain expertise in all fields of research and conduct thorough and efficient reviews.
If you have any questions about these updates, please contact the IRB at 801-581-3655.
April 29, 2010
A new IRB assent template is available on the IRB website:
Assent form with HIPAA language
Assent form for Main Campus
This template was designed to better address assent needs for children and cognitively impaired adults.
A new section has also been added to the assent template. The section includes a set of options at the end of the document to be completed by the person obtaining assent. These options allow documentation of the participant’s ability to read the assent document. This may help some studies to document the assent process. This new section is not required and is optional.
The IRB will not be requesting changes to currently-approved assent documents at continuing review, as the required elements of the assent template have not changed; all currently-approved assent documents still meet assent requirements. If you would like to revise your current assent document to fit this template or to add the optional section mentioned above, you must submit an amendment application to the IRB.
Note: A tracked copy of the changes to the template has not been provided on the IRB website, as the formatting has changed substantially.
If you have any questions about these changes, please contact the IRB office at 801.581.3655.
February 8, 2010
IRB Report Form Changes
The report form has been reorganized, allowing the following features beginning 2.06.2010:
- All report form types (e.g. adverse events, deviations, breaches, information, etc.) can now be selected on the first page of the report form, instead of on multiple pages.
- The report form now includes a Documents and Attachments page for all types of reports, instead of allowing attachments on multiple pages.
The IRB has not changed any of the information that must be provided in the report form, nor have the IRB reporting requirements changed. For more information about IRB reporting requirements, please visit the IRB website at http://www.research.utah.edu/irb/adverse/index.html
Changing the PI on a Study
When an amendment is submitted to the IRB requesting to change the PI, the original PI is required to submit the amendment; beginning 2/6/2010, the new PI will also be required to sign off on the submission of the amendment. Once the new PI signs off, he/she will gain access to perform the PI role for the amendment application in ERICA and the old PI will no longer be required to respond to IRB requests for the amendment review. Previously, the new PI could not function as the PI in ERICA until the amendment was approved.
To ensure that the PI change is processed correctly, you MUST change the PI in the Update Study Application after completing the amendment application. This will allow the new PI to sign off on the submission after the original PI.
RGE Application - Amendments and Continuing Reviews
Beginning 2/6/2010, the Resource for Genetic Epidemiological Research (RGE) amendment and continuing review applications will be incorporated into the IRB amendment and continuing review applications. This means that all submissions to RGE will be made electronically through the ERICA system. When a PI submits an IRB amendment or continuing review, those studies also requiring review from RGE will be forwarded to the RGE committee. RGE review and approval will occur BEFORE IRB review; the IRB pre-review will not occur until RGE review is complete. PIs must account for this at the time of continuing review to ensure that their studies are submitted with enough time for re-approval prior to study expiration.
For questions regarding RGE submissions, please call 801.581.6351.
January 5, 2010
Please note that due to a greater than usual amount of applications submitted in recent weeks, and due to the holiday schedule, we are unable to guarantee that your submission will be reviewed at a particular meeting. Applications will generally be assigned to a meeting date based on date of expiration, expertise available on the panel, or based on the order in which completed applications are correctly submitted to the IRB. Any dates included in review letters or on the IRB website are estimates only. Please submit your completed revisions as early as possible, and log into ERICA frequently to check the current status and review date of your application, as it may change several times and notifications may not be automatically sent for each change. We apologize for any inconvenience.