Erica Online

News and Announcements

The IRB sends out all announcements on the IRB listserv. If you would like to be added to this email list to begin receiving news and announcements from the IRB, please follow these instructions:

Send an email to sympa@lists.utah.edu. In the "subject" line, type "Subscribe irbalert <<yourname>>." <<yourname>> should be your first and last name.

November 4, 2008

Due to the increased number of study submissions and the Thanksgiving, Christmas, and New Year's holidays, please expect delays in the IRB review process during the months of November, December, and January. Some IRB applications will be bumped back one board meeting, including continuing reviews, amendments, and new studies.

Because of the holidays, changes have been made to the meeting dates in November and December. The most up-to-date IRB meeting schedule for these months is as follows:

If the IRB Staff determine a submitted study is ready for review by: Then it will be considered for board review on: Panel
October 27, 2008 November 5, 2008 Panel 1
November 3, 2008 November 12, 2008 Panel 2
November 10, 2008 November 21, 2008 (This is a Friday) Panel 3
November 17, 2008 November 26, 2008 Panel 4
November 24, 2008 December 3, 2008 Panel 1
December 1, 2008 December 10, 2008 Panel 2
December 8, 2008 December 17, 2008 Panel 3
December 12, 2008 December 19, 2008 (This is a Friday) Panel 4
December 29, 2008 January 7, 2009 Panel 1
January 5, 2009 January 14, 2009 Panel 2
January 12, 2009 January 21, 2009 Panel 3
January 19, 2009 January 28, 2009 Panel 4

Please Note: There will be a two week period between 12/19 and 1/7 when no IRB meetings are held.

All of these changes can be viewed on the deadlines page of the IRB website.

For studies that will expire around the Christmas and New Year holidays, please submit a continuing review application as soon as possible to ensure that the studies can be reviewed and approved before expiration. The IRB will work to have everything approved before the expiration, but this cannot be guaranteed if applications are not submitted on time.

If you have questions about these changes, please contact the IRB Office at 801.581.3655.

September 15, 2008

Changes have been made to the liability statement using the consent and parental permission forms for research conducted at Shriners Hospital for Children. The new statement is displayed below. Updated consent and parental permission templates are available on the IRB website.

This statement must be updated in consent and parental permission forms at the time of continuing review.

New Statement:
Also, in the event of injury or undesirable reaction from participation in research-related activities, Shriners Hospitals for Children can only provide those medical services available at the Shriners Salt Lake City Hospital. Shriners Hospitals for Children has no program to provide any financial compensation for a research-related injury or an undesirable reaction. If you believe that you have sustained an injury as a result of participating in this research program, please also contact the investigators and/or Chief of Staff, Shriners Hospitals for Children, Salt Lake City Hospital, at (801) 536-3600. By signing this document you are not giving up your right to pursue legal action against any and all parties involved with this research.

August 28, 2008

ERICA will be offline all day on Saturday, August 30th and Sunday, August 31st for maintenance and the following updates to the IRB Report Form:

  1. In the opinion of the local Principal Investigator, was the event unexpected?
  2. In the opinion of the local Principal Investigator, was the event related to research?
  3. In the opinion of the local Principal Investigator, does the event suggest that the research places subjects or others at greater risk of harm?

Please be advised that adverse events which do not meet the IRB's definition of an Unanticipated Problem (that is, an unexpected, related adverse event that places subjects at greater risk) should not be reported to the IRB. Please review the event reporting policy on the IRB website.

Beginning Monday, September 1st, adverse event reports will be automatically withdrawn if the Investigators' responses to these questions indicate that the adverse event is expected, not related, or does not involve greater risk of harm. These reports will not be reviewed by the IRB.

Investigators must maintain a record of all unreported adverse events. A summary of all adverse events should be submitted annually at continuing review.

All other types of events and problems will be reviewed by the IRB and do not apply to this automatic withdrawal process.

Please email Ann Johnson, IRB administrator, or call 801.587.9134 if you have questions regarding this change or the reporting policy.

April 22, 2008

As of July 1, 2008, the IRB will increase the fees charged to review for-profit sponsored research. This is the first increase since the fees were instituted in 2004 and is due in large part to the increase in F&A to 32.7%. IRB fees support a number of Research Administration operations including the ERICA system. Existing studies and studies that are submitted on or after July 1, 2008, will be subject to the new fee schedule. There will be no "grandfather clause" as this will only create confusion and additional administrative burden for researchers and the IRB. The current Fee Schedule will remain in effect until July 1, 2008. Please contact the institutional review board if you have questions or review the Frequently Asked Questions document on our web site.

July 1, 2008, new IRB Fee Schedule:

  • New Study
    $1600 paid by check
    $1206 paid with Campus Order
    $394 paid to F&A
  • Continuing Review
    $575 paid by check
    $434 paid with Campus Order
    $141 paid to F&A
  • Sponsor Initiated Amendment
    $575 paid by check
    $434 paid with Campus Order
    $141 paid to F&A
  • Continuing Review & Amendment
    $1150 paid by check
    $837 paid with Campus Order
    $283 paid to F&A

April 17, 2008

This announcement is in regards to the IRB policy regarding sponsor-investigators.

A sponsor-investigator is someone who both initiates and actually conducts a clinical investigation. According to IRB policy, sponsor-investigators must provide documentation of an audit performed by a CRO or an ad-hoc qualified auditor before the initiation of the study to verify the sponsor-investigator meets the sponsor function as described by the federal regulations.

The IRB has created Sponsor-Investigator Policies and Procedures templates for investigational drug/biologic and device studies. These templates will assist sponsor-investigators in providing documentation that they will fulfill all of the additional federal requirements to act as a sponsor. This will help to facilitate the required pre-approval audit.

These templates can be accessed on the IRB HIPAA Forms web page, or by clicking the links below:

If you would like more information about the IRB policy for sponsor-investigators, please see the document Sponsor-Investigator Guidelines and Responsibilities on the IRB website, or call the IRB office at 801-581-3655.

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.

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.

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.

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.

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 protocol 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.

September 14, 2005

The Principal Investigator's conflict of interest disclosure number (CoI number) for a project must be provided for IRB new study and renewal applications. If a CoI number is not provided, the application will not be accepted by the ERICA system. Please contact the Conflict of Interest Office - (801) 581-6351 - for more information.