2006 News Archive

December 20, 2006

The IRB will no longer electronically stamp the protocol/research summary or advertisements. These materials will still be 'approved' by the IRB but the electronic stamp will not be used. Consent forms and Questionnaire Cover Letters will still be stamped, although the look will be different. Please review the Frequently Asked Questions document regarding electronic stamps which will provide more information about this change and how the transition will be facilitated.

There is a new consent template for Main Campus researchers (there are also new parental permission and consent templates with authorization language). These templates have been updated in an effort to provide better instruction and to help researchers include required elements of informed consent. The templates were revised with input from main campus researchers.

October 27, 2006

The Clinical Cancer Investigations Committee (CCIC) November and December meeting dates and deadlines have changed:

New November Deadline: November 10th at noon

New December Deadline: December 15th at noon

October 20, 2006

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.

September 20, 2006

The Tissue/Specimen Banking guidelines and checkboxes have been revised to make it clear that participants who elect to de-identify their samples waive the right to withdraw consent for future research because the samples can longer be linked to them. Consent forms with tissue banking language must be updated at the time of continuing review / annual renewal.

The IRB will no longer accept hard copy Final Project Reports. Please submit these reports online via ERICA.

September 12, 2006

November and December IRB deadlines/meeting dates have changed. Please review the new deadlines and meeting dates. Laurel Hermanson, IRB Coordinator for Panel Two, has transitioned to a part-time role. Lisa Rigtrup, IRB Coordinator, will join the office September 14.

September 7, 2006

When submitting amendments (or applications for continuing review that include an amendment) that update the Investigator's Brochure (IB) to include new risks, please remember to update the Investigational Drug Data Form (IDDF). This can be done using the 'Update Study' ERICA process after completing the amendment application. The IDDF is an important tool used as the first resource when an adverse reaction question is raised.

August 31, 2006

Dr. Hurdle has stepped down as IRB Chair in order to prepare for his upcoming visiting scholar's fellowship at the NIH. If you have an IRB matter that requires the attention of the Chair, such as reporting a deviation or a study participant fatality, please contact Susan Howe, IRB Compliance Administrator. The IRB would like to take this opportunity to thank Dr. Hurdle for his work over the past 14 months, and we wish him well in his work in the Department of Biomedical Informative and at the NIH.

August 16, 2006

Due to the number of submissions that require full board review, some IRB applications will be bumped back one board meeting. This includes continuing reviews, amendments, and new studies. We apologize for any inconvenience and hope to be back on the regular review schedule by the end of August. Please contact the IRB to learn more.

May 20, 2006

For studies involving IND's, the IRB now requires the FDA 1572 Form and the FDA Letter of Receipt of the IND. These should be attached in the Other Documents section of the ERICA 'Documents and Attachments' page. The Department of Pharmacy Services Policies and Procedures has been posted under Guidelines. Please review these policies to make sure your investigational drug study complies with University policy.

May 17, 2006

We have changed the August 2006 submission deadlines and board meeting dates. Please refer to our Deadlines to avoid delays in the review process. The board will not meet August 2, 2006.

May 10, 2006

The Clinical Trials Facilitator now requires a Patient Care Classification Form be completed to clarify costs of standard-of-care procedures versus research-related procedures. If you are required to complete this form for the research project, it will be requested as an attachment in all IRB new study applications and continuing review applications. You will be reminded in section 6.3 of the IRB application to attach the document to the 'Documents and Attachments' page.

March 22, 2006

Lacy Clegg is our new IRB coordinator for Panel 3. Her first day is March 27 th . Please help us welcome her to our staff!

IRB Requirements: A reminder that for studies involving INDs the IRB now requires the FDA 1572 Form as well as the FDA Letter of Receipt of the IND. These should be attached in the Other Documents section of the "Documents and Attachments" page.

IRB Requirements: The Clinical Trials Facilitator now requires that a Patient Care Classification Form be completed to clarify costs of standard-of-care procedures versus research-related procedures. If you are required to complete this form for the research project, this form will also be requested as an attachment in all IRB new study applications. You will be reminded in section 6.3 of the application to attach the document to the "Documents and Attachments" page.

ERICA Updates: The Amendment Application will have some changes forthcoming in the next few weeks. Please watch for those and contact the IRB if you have any questions.

IRB Templates: The Parental Permission Form (HIPAA) has been revised. The signature page now defaults to two parental signatures along with a section to complete if one parent is not available to grant permission. Studies which are found to be greater than minimal risk will require this new signature block of two parents. The IRB may find that one parental permission is sufficient if the research is no more than minimal risk (45 CFR 46.408(b)). If the IRB finds one parental permission is sufficient, you will be notified via a revisions memo to revise the signature page.

January 19, 2006

The IRB is working to complete our response to the AAHRPP site visit recommendations. A number of documents, templates, and ERICA processes will be modified as part of this process. We will post all changes and additions on the News and Announcements page of our web site as they become available.