News and Announcements

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Click here to see archived news items from 2007 and earlier.

November 5, 2009

The IRB recently lost an important member of the staff. Jeanette Cuthbert has left us. We would like to thank Jeanette for the many years of service she has provided, not only to us, but also to all of you. We hope the future holds many wonderful things for her.

In her place, the IRB is excited to welcome Josi Wood! Josi is very ambitious and eager to help resolve all of your IRB questions and issues.

September 17, 2009

HHS & FDA Institutional Review Board Registration Requirements

On July 14, 2009, the new Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations requiring registration of institutional review boards (IRBs) that were published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358) will go into effect. The Office for Human Research Protections' (OHRP's) IRB registration system will be compatible with the requirements of both the HHS and FDA regulations.

The University of Utah IRB registration information for HHS and FDA is as follows:

Assurance: FWA00003745 - U Utah

Expiration: November 6, 2011

Panel 1 ID: IRB00000104 - U of Utah IRB #1
Panel 2 ID: IRB00000105 - U of Utah IRB #2
Panel 3 ID: IRB00000106 - U of Utah IRB #3
Panel 4 ID: IRB00000107 - U of Utah IRB #4
Panel 5 ID: IRB00006644 - U of Utah IRB #5

May 1, 2009

The IRB has recently received an increased volume of submissions, with nearly double the amount of reviews for the meetings in May. Due to the number of submissions that require review, some IRB applications will be bumped back 1 - 2 board meetings.

The IRB is assigning studies according to the following guidelines and there is no guarantee of a specific meeting date at this time. Studies must complete and submit pre board revisions before they will be considered for meeting assignment.

New Studies and Amendments
Priority for review goes to:

Studies that have already been bumped from a prior meeting
Studies that have completed and submitted pre board revisions the earliest
Studies for which the IRB has specific reviewing expertise

Continuing Review Applications:

For For continuing review applications that do not expire within the month of May, we will be bumping a significant portion to meetings throughout June in order to accommodate studies with more urgent expiration dates. See assignment schedule below:

Expiration Date	Assign to Panel:
Any time in May	Panel 2 - May meeting Panel 3 - May meeting Panel 4 - May meeting
June 1-15, 2009	Panel 4 - May meeting
June 16-30, 2009	Panel 1 - June meeting
July 1-15, 2009	Panel 2 - June meeting
July 16-30, 2009	Panel 3 - June meeting
Aug 1-15, 2009	Panel 4 - June meeting

We hope to be back on schedule by the beginning of June and apologize for any inconvenience. If you have any questions or concerns, please contact the IRB at 801-581-3655 or IRB@hsc.utah.edu.

April 16, 2009

The IRB has updated the Tissue Banking Consent Language Template. The new version can be found on the IRB website.

This new template should be used by all investigators when writing consent documents that involve the collection of tissues for storage in a tissue repository, whether the repository is housed at the University of Utah or at an outside entity.

Please note that all tissue banking language used from the old template is still compliant with this new template and no changes need to be made at continuing review. However, an investigator can choose to follow the new format and an amendment would need to be submitted to revise the consent document.

The IRB has also created an online resource for investigators who are conducting studies that involve tissue collection, use, and repositories. The online resource has been posted on the our website and can be found on this page.

This resource provides information on the following topics:

Tissue Collection and Use

Review Process for Tissue Collection and Use
Consent and Authorization for Tissue Collection and Use
Samples Collected for Non-Research Purposes(Pathology Samples)
Autopsy Samples
Publicly Available Tissue Samples
Sharing Samples with Other Institutions
VA Policies for Tissue Collection and Use

Tissue Repositories

Why Create or Use a Research Tissue Repository?
Developing and Maintaining a Tissue Repository
Review Process for Tissue Repositories
Consent and Authorization for Tissue Repositories
VA Policies for Tissue Repositories
Using Samples from a Tissue Repository

Additional Resources and Guidance

Genetic Research
Human Tissue Transfer
Tissue Banking Template Consent Language

March 27, 2009

RGE Application in ERICA
Beginning Sunday, March 29th, users who are requesting permission to use the Utah Population Database (UPDB) will be required to submit an application to RGE via the ERICA system. The RGE application has been incorporated into the IRB New Study Application and users will be prompted to complete the RGE application when they indicate the use of UPDB in the IRB application (question 4.2c).

This feature will allow the RGE application to be submitted with the IRB application when the PI clicks "Submit to the IRB", eliminating the need to submit both application separately. Please note that these are still two different application that require two separate reviews. RGE will review the study and must approve it before it will move on to the IRB for review.

PCMC Privacy Board Review in ERICA
Beginning Sunday, March 29th, for studies that require review by the PCMC Privacy Board, the process will now be completed entirely in the ERICA system. This eliminates the need for a separate application to be submitted to the PCMC Privacy Board (via the Intermountain Healthcare IRB). The Privacy Board will use the current IRB application in addition to the PCMC Administrative Research Questions, which are already requested as part of the IRB application.

Please note that these are still two separate reviews. The Privacy Board will review the study and must approve it before it will move on to the IRB for review.

February 17, 2009

Protocol and Research Summary Template Changes

The IRB has posted new versions of the Protocol and Research Summary templates.

Change 1: The title page of the Protocol and Research Summary templates now requests that contact information for the sponsor and CRO of a study be included. This will need to be revised for all applicable protocol and re4search summaries at a study's next continuing review.

Change 2: Various sections throughout the Protocol and Research Summary templates now request information regarding the use of the Utah Population Database (UPDB). The RGE Committee will be using the IRB Protocol and Research Summary templates in their review for the use of UPDB. If this information is not provided in a current study's protocol or research summary, it will need to be revised at the study's next continuing review.

Change 3: The Administrative Responsibilities section now requests that contact information for participating sites be included with the IRB application for studies where the University of Utah is the lead site. This list does not need to be provided for multi-center studies where the University of Utah is not the lead site. This will need to be revised for all protocol and research summaries at a study's next continuing review.

New templates have been posted on the IRB website. Tracked copies of these templates are posted as well in order for you to easily view the changes.

If you have any questions about these changes, please feel free to contact the IRB.

February 2, 2009

Justification for Use of the Short Form
When an informed consent process is conducted with an individual who does not speak English, participants should be presented with the consent document written in a language understandable to them. The IRB strongly encourages the use of this procedure whenever possible. However, the Short Form is often used as a method to consent non-English speaking participants into research, using an oral consent process, without the full translation of the consent document. For full instructions on the purpose of the use of the Short Form, please refer to the IRB guidance.

Because using a full, translated consent is the preferred method, the IRB will now be requesting that justification for the use of the Short Form be provided in the New Study Application. A question has been added to the New Study Application to request this justification. Please click here for the New Study Application changes.

Please not that all studies previously approved to use the Short Form will not be reassessed for justification. All studies with a currently approved Short Form may continue with this consent process.

If you have any questions about these changes, please feel free to contact the IRB.

January 27, 2009

Witness Signature Page
The IRB has recently created a witness signature page. The witness signature page is intended to be used in unanticipated situations when a participant is able to give full consent for participation in a research study, however, a witness to the consent process is necessary. Such situations may include:

The participant is illiterate and must have the consent document read aloud.
The participant is blind and must have the consent document read aloud.
The participant is physically unable to write and cannot sign the consent document.

IRB approval for use of the witness signature page is not needed. This page may be printed for use at any time there is an unanticipated need for a witness to the consent process.

The witness signature page should not be used for studies that are required to have a witness present or for studies that anticipate a large portion of the participant population will require a witness to the consent process. For these studies, the witness signature lines should be included on the signature page of the full, IRB approve consent document.

The witness signature page must not be used for the following situations:

Consenting individuals who do not read or speak English as their primary language.
Consenting individuals who are cognitively impaired or mentally disabled.
Consenting minors without parental permission.

Any study found to be using the witness signature page for these purposes will be non-compliant with IRB policy.

You can find a copy of the witness signature page on the IRB website by clicking here.

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:

In the opinion of the local Principal Investigator, was the event unexpected?
In the opinion of the local Principal Investigator, was the event related to research?
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.