2008 News Archive

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:

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:

• Sponsor-Investigator Policies and Procedures Templates - Devices
• Sponsor-Investigator Policies and Procedures Template - Drugs and Biologics

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.