2007 News Archive

September 30, 2007

The ERICA renewal and amendment applications have been revised. Please read below for the updates:

Amendment Application
New questions have been added to this application and all amendments submitted after September 29th will be required to complete these questions. Amendments that are currently in process that have not been pre-reviewed by the IRB staff before September 29th will be required to complete the new questions in the application. If the amendment has been pre-reviewed by the IRB staff before this update, the new questions will not be required.

• Renewal Application
• Continuing Review Application FAQ
• How to Complete the Continuing Review Application

The renewal application is being re-named the Continuing Review Application and will now also include the Final Project Report. Studies will no longer have a “Renewals” tab or a “Final Report” tab – all continuing review applications (including all past renewal applications) and final project reports will be listed under the “Continuing Review” tab.

New questions have been added to the beginning of the application that will allow you to either submit a Continuing Review Application or a Final Project Report. Based on the answers you provide on the first page of the application, you will be directed to fill out the Final Project Report or the remaining pages of the Continuing Review Application. For more instructions about how to fill out this new combined application, please click here.

Other questions have been added or changed in the Continuing Review Application and all Continuing Reviews (Renewals) submitted after September 29th will be required to complete these questions.

Renewals that are currently in process that have not been pre-reviewed by the IRB staff before September 29th will be required to complete the new questions in the applications. If the Renewal has been pre-reviewed by the IRB staff before this update, the new questions will not be required.

June 12, 2007

Due to a large number of submissions and the July 4 holiday (Independence Day), there may be some delay in IRB review. We apologize for any inconvenience and hope to return to the regular review schedule as soon as possible.

April 13, 2007

The IRB review process is changing as of April 30, 2007.

• Pre-Review FAQ's
• Tips to Submit a Complete Application
• New Pre-Review Deadlines

New Study, Renewal, and Amendment applications will be assigned to the IRB staff for a pre-review. However, a board date will not be assigned to the study until any necessary pre-board revisions have been completed. This means a study will no longer automatically be assigned to a board date when the Principal Investigator clicks “Submit.”

Pre-board revisions must be completed and received by a designated deadline in order to be considered for a given board date. These deadlines are different from the deadlines used previously, but will still occur on a designated Monday at Noon.

This change has been made to help studies move faster through the board review, because many problems will be resolved before the board review process. This will also help prevent incomplete applications from being reviewed prematurely and subsequently tabled by the board. Additionally, it will be less likely that the study will have post-board revisions, allowing the study to be approved quickly after the board review date.

April 4, 2007

he University of Utah IRB has worked to improve the review process over the last 18-months in an effort to gain accreditation from the Association for Accreditation of Human Research Protection Programs (AAHRPP) and to address regulatory issues identified by the Office for Human Research Protection (OHRP). As the next step in this process, the IRB will formally implement a “pre-board” review workflow that is already in place for the most part.

The convened IRB must have sufficient information to approve human participant research, and many of you receive feedback from IRB staff prior to review by the board. This process substantially improves the quality of applications and leads to faster turn-around after the board meeting. It also significantly reduces the number of submissions that are tabled. In the coming weeks, board dates will not be automatically assigned according to a deadline. Applications will be assigned a board review date when IRB staff determine they are complete and ready for convened board review.

The IRB will post a new Pre-Board Review Schedule and Frequently Asked Questions (FAQ) web page for your review next week. Your input is welcome and encouraged. All suggestions for process improvement will be considered and implemented if possible.

Please note: This This change does not adversely affect and may improve turn-around for applications that are thorough and complete. As always, timely response to IRB revision requests is vital to quick turnaround.

March 26, 2007

The University of Utah IRB has worked very hard over the past 18 months to improve the review process. Many of you have received feedback from the staff prior to review by the board. Such a process has enabled more complete information to be presented to the board and resulted in a shorter turn-around after the board meeting and less tabling of studies. The IRB is planning to implement a more formal "pre-review" model. Board dates will not be automatically assigned. Rather, when the IRB staff determines an application is complete, it will be considered for a board date. More information will be provided in the coming weeks regarding the implementation of the pre-review model.

March 14, 2007

New HIPPA Consent and Authorization Templates

The IRB released new consent and authorization templates March 14, 2007. New study applications submitted after March 19, 2007, must follow the template requirements. For studies with approved consent documents, these updates should be made at the time of continuing review. Please review the updates as outlined below and make any necessary revisions prior to submission of an application for continuing review.

Many of the changes to the template reflect information which has been requested in practice by the IRB but was not outlined on the template (e.g. list acceptable methods of birth control). The IRB has made an effort to provide better instructions and a more understandable format. Example text is more clearly differentiated. Instructions now note when a section or portion of a section may be omitted.

If your current consent document already includes the following information, no change is necessary. The template is a tool for investigators to include required elements of informed consent. We encourage the use of the template to prevent omission of required information.

HIPPA Consent and Authorization, Parental Permission and VA Consent

1. Confidentiality section:
   1. If the research is subject to FDA regulation, a statement must be included that notes the possibility that the FDA may inspect the records.
   2. If applicable, a description of the Certificate of Confidentiality and any voluntary disclosure plans by the investigator(s) should be included.
   3. If applicable, additional information must be disclosed if HIV testing or testing for any reportable disease (by Utah State law) will be performed as a result of study participation.
2. Person to Contact Section:
   1. Contact information must be provided for whom participants should contact with a research-related injury, including name(s), telephone number(s), and when the person(s) listed may be contacted.
   2. If applicable, contact information should be provided about who to contact if the participant has questions about the billing of costs in the study.
3. The Institutional Review Board statement has been revised to a lower reading level and included the IRB's email address.
4. The University’s Liability Statement has been revised. The section is now entitled “Research-Related Injury” and provides flexibility for an explanation of who can provide care and who will be responsible for the cost of treatment.
5. For studies involving placebo or withheld treatment, instructions are included for providing the requisite information.
6. If applicable, information regarding reproductive risks, acceptable methods of birth control, and the action that will occur in the event of pregnancy is required.

Additional VA Consent Template Changes

• The Medical Treatment or Compensation for injury section has been revised. A statement is included regarding the VA’s authority to provide treatment. Also, if the study has a third party sponsor, an explanation of who will be responsible for the cost of treatment should be provided.
• The Costs and Compensation section provides better instruction regarding what information is required of VA studies.

February 9, 2007

Resume/CV: As you may know, the IRB requires the CV (or resume) of the principal investigator and faculty sponsor (if applicable) as part of the application. Instead of requiring this for each submission, ERICA will now keep the CV with the investigator’s profile.

For investigators who already attached a CV in the system, it will now populate automatically for any subsequent submissions. We attempted to select the CV from the latest project and attached it to the profile. If this is incorrect you may modify the CV.

For investigators who need to add or update a CV, it is still added or edited through the Documents and Attachments page of the application.

Conflict of Interest Disclosures: The administrative contacts will now receive an email when a conflict of interest disclosure is submitted.

ERICA Alert: With the Campus Conversion to Outlook, there are many email which are sent through the ERICA system that are not being delivered. This may impact you whether or not you have been converted to Outlook. Please be sure to check you study status in ERICA if you are waiting for email notifications e.g. revision notices, renewal reminders, etc.

ITS plans to complete the conversion during the President's Day holiday weekend, beginning Friday evening, February 16th. Hopefully it will be resolved by Tuesday morning, February 20th. If you have email problems, please contact the ITS Help Desk 587-6000.

January 5, 2007

Investigators, past or prospective participants or their designated representatives, and others who wish to obtain answers to questions, express concerns, and convey suggestions, or provide input regarding the Human Research Protection Program may contact the Research Integrity and Compliance Office by calling (801) 581-7170. This office is independent of the IRB and unaffiliated with any specific research protocol.