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 […]
Read MoreJustification 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 […]
Read MoreWitness 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 […]
Read MoreDue 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 […]
Read MoreChanges 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 […]
Read MoreERICA 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 […]
Read MoreAs 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. […]
Read MoreThis 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 […]
Read MoreThe 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 […]
Read MoreDue 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.
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