News and Announcements Archive

August 1, 2011

The Accounts Payable Office has revised the Payment to Human Research Participant Guideline. You can access the new July 2011 guideline via the Financial and Business Services website at the following link: http://fbs.admin.utah.edu/download/AP/ResearchPartPayments.pdf

Important items outlined in the new guideline are summarized below:

• Distinction is made between payment processes if the payment to participants is $100 or less, or more than $100 in a calendar year.
• Payments of $100 or less do not require the collection of participant tax information if payment is made via petty cash, gift card or certificate, or tangible personal property.
• All payments made with a Limited Purchase Check require the collection of participant tax information via the IRS W-9 form.
• Payment process exceptions are granted by the IRB and must be approved as part of the regular IRB review process.

The revised payment guideline might impact your payment methods and the information you provide to participants as part of the consent process and form. In some cases the revised guideline will allow study teams to maintain participant information for payment purposes on site. Please thoroughly review the guideline to ensure your participant payment methods are compliant. Any changes to currently approved studies as a result of this guideline must be submitted to the IRB via an amendment.

If you have any questions about this update, please contact the IRB at 801-581-3655 or irb@hsc.utah.edu.

April 19, 2011

Previously Approved Consent Documents

The IRB would like to clarify that we do not keep stamped versions of previously approved consent documents on file in the ERICA system. The ERICA system maintains a copy of all past consent documents, but only the currently approved cersion maintains the approval stamp in the footer.

To ensure complete documentation in the study record, you must save a copy of all IRB-approved consent documents at the time they are approved. If you have any questions, please contact the IRB at 801.581.3655 or by email at IRB@hsc.utah.edu.

February 22, 2011

IRB Updates

New guidance regarding the Conflict of Interest policy was recently released in a response to the University’s accreditation through AAHRPP (http://aahrpp.org). As a result of this new guidance, several changes have been made to the ERICA system related to Conflict of Interest disclosures and the IRB application. These changes will take effect on Monday, February 28, 2011.

Please read the information below to understand how these changes will affect the IRB application and review process.

Changes to the IRB Application

• On the Contacts page of the IRB application, you are now asked to list “Internal Staff and Sub-Investigators”, not just sub-investigators. Internal staff and sub-investigators are those persons who are responsible for the design, conduct or reporting of research. This definition is directly from the Conflict of Interest policy (www.regulations.utah.edu/general/1-006.html). For guidance about how to determine who meets the requirements of this definition, please refer to the Conflict of Interest Guidance for Investigators available at www.research.utah.edu/irb/news/newsArchive(PDF)/CoI_GuidanceForInvestigators-Feb2011.doc, or contact the Conflict of Interest Office at 801-581-6351.

• The Conflict of Interest section has been moved to the second page of the IRB application. The format of this page has been changed so that the PI’s existing disclosures are displayed in a searchable format. You are still required to select the relevant Conflict of Interest Disclosure(s) for the PI from this list. The PI’s most recent disclosures appear first in the list.

• If you select more than one relevant disclosure in the IRB application, you are asked to indicate which disclosure is the primary/main disclosure for the study. This is indicated on a new page in the IRB application, which appears when you click “Continue” after selecting the disclosures. If you have only selected one disclosure, this page does not appear.

Changes to the IRB Review Process

• When the PI submits a new study to the IRB, all persons listed as “Internal Staff and Sub-Investigators” are automatically sent an email notice to complete a Conflict of Interest Disclosure if they have not previously done so for this project. The notice includes a link to the Conflict of Interest Project Information Page in ERICA where a new disclosure can be created. These disclosures are linked to the PI’s disclosure, so they do not need to be linked to the IRB application independent from the PI’s disclosure.

• Review by ancillary committees in ERICA and pre-review for the IRB proceeds while the internal staff and sub-investigators complete and submit their disclosures. However, the IRB cannot assign a study for exemption, expedited, or full board review until all disclosures are submitted and finalized. Disclosures with potential conflicts of interest are not finalized until they are reviewed and resolved by the Conflict of Interest Committee. Studies will enter a “Pending COI” state after IRB pre-review if disclosures are not finalized for all internal staff and sub-investigators.

• Continuing Review for studies originally approved before February 1, 2011: Current internal staff and sub-investigators listed on the IRB application are required to submit their disclosures at Continuing Review. The IRB cannot assign a continuing review application for expedited or full board review until all disclosures are submitted and finalized. This means that studies will enter a “Pending COI” state after IRB pre-review if disclosures are not finalized for all internal staff and sub-investigators. No exceptions will be made for studies that are expired or will expire before IRB approval can be issued. Please submit continuing review applications with enough time for COI disclosure submission, COI review of potential conflicts, and IRB review.

• Amendments for studies originally approved before February 1, 2011: Current internal staff and sub-investigators listed on the IRB application are not required to submit their disclosures at the time of an amendment; however, they are notified via email that they will need to complete a disclosure prior to continuing review. If the amendment adds a new person, the new person being added will be required to submit a disclosure. The IRB cannot assign an amendment application for expedited or full board review until the disclosure for the new person is submitted and finalized. This means that studies will enter a “Pending COI” state after IRB pre-review if disclosures are not finalized.

For frequently asked questions, please view this document.

If you have any questions, about these changes and requirements, please contact

Conflict of Interest Office
Phone: 801.581.6351

Institutional Review Board
Phone: 801.581.3655
Email: IRB@hsc.utah.edu

February 16, 2011

Conflict of Interest Policy

Message from Jeffrrey R. Botkin, M.D., M.P.H - Associate Vice President for Research

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredits the University of Utah oversight of research involving human participants. During our recent re-accreditation evaluation, AAHRPP determined that the University of Utah is not adequately capturing conflict of interest disclosures from staff, students, post-docs and residents involved in human subjects research. Additionally, they determined that we are not adequately capturing conflict of interest disclosures from co-investigators who are added to a project after IRB approval.

Resolution of these determinations is necessary for our re-accreditation.

The University Conflict of Interest Policy requires that a conflict of interest disclosure be submitted by "the principal investigator and all faculty, staff, postdoctoral appointees, residents or students, whether paid by the University or not, who are responsible for the design, conduct or reporting of research or scholarly activities conducted in whole or in part at the University." (U Pol 1-006 http://www.regulations.utah.edu) To foster better compliance with our institutional policy, we have developed additional guidance to assist you in identifying who should be completing conflict of interest disclosures for research conducted under the auspices of the University. Principal Investigators and their staff are encouraged to consider this guidance when submitting applications to the IRB.

We are also implementing new safeguards in ERICA to ensure that all appropriate individuals complete conflict of interest disclosures before a study is approved by the IRB, or as individuals are added to an existing study through the IRB amendment process.

More details about how this will be implemented in ERICA will be provided in the near future. We appreciate your cooperation with our research integrity and compliance efforts. Please contact me if you have any questions about these changes.

February 7, 2011

IRB Updates

The new, revised VHA Handbook 1200.05, "Requirements for the Protection of Human Subjects in Research," has been released. The following changes to the conduct of research at the VA are now in effect:

• The PI must provide a signed statement at continuing review, certifying that all subjects entered onto the master list of subjects for the study signed an informed consent form prior to undergoing any study interactions or interventions, unless a waiver of consent is applicable. The SLC VA Research Review Committee (RRC) will be responsible for requesting and verifying this document upon continuing review; this form should NOT be attached to the IRB application. A template statement/form is available for PIs to use at:
  http://www.research.utah.edu/irb/forms/hipaa/pdf/VACertificationofInformedConsent-Jan11.pdf

• A witness signature and the PI signature are no longer required on VA consent documents. An updated VA Consent Template is available from the IRB at: http://www.research.utah.edu/irb/forms/hipaa/index.html. This change will be enforced for all new studies submitted on or after 2/5/2011, as well as at continuing review.

• The HIPAA Authorization section has been separated from the main consent. This means that participants must sign the document twice: once for consent and once for authorization. The VA Consent Template includes all sections and signature blocks for consent and authorization in one document, meaning that you do not need to upload two separate documents into ERICA; however the IRB will no longer use an approval stamp on the bottom of the HIPAA Authorization section. Because of the complexity of the template, be careful to follow the instructions included at the beginning and throughout the template. This change will be enforced for all new studies submitted on or after 2/5/2011, as well as at continuing review.

• The VA 10-1223 Form is no longer required. All new studies submitted to the IRB will not be required to submit a VA 10-1223 Form with the IRB application. Currently approved studies will not be required to remove the VA 10-1223 Form at continuing review.

For additional guidance regarding these new requirements, the following resources are available:

VHA 1200.05 Handbook: http://www.research.va.gov/pride/policy/default.cfm

VA HRPP Administrator
Phone: 801.582.1565 X4666

Institutional Review Board

February 4, 2011

IRB Updates

The IRB has made several changes to the IRB Consent Templates that are available online. IRB Consent Templates may be accessed by using the following links:

Main Campus Forms: http://www.research.utah.edu/irb/forms/campus/index.html
HIPAA Forms: http://www.research.utah.edu/irb/forms/hipaa/index.html

All changes below will be enforced for new studies submitted on or after Feb. 05, 2011. Changes marked as (*) will be enforced at continuing review.

HIPAA Consent/Parental Permission Templates Summary of Changes

• Verbatim language has been added to the Confidentiality section of the template for use by studies that are required to register on ClinicalTrials.gov.
• The University of Utah has revised the verbatim Research-Related Injury Statement.

Main Campus Consent/Parental Permission Templates Summary of Changes

• In the signature block, the "Name of Researcher or Staff" has been revised to "Person Obtaining Consent".

VA Consent Template

• Verbatim language has been added to the Confidentiality section of the template for use by studies that are required to register on ClinicalTrials.gov.
• The witness and PI signature block for the consent document has been deleted. The VA now only requires signatures from the participant/LAR and the personal obtaining consent.
• The HIPAA Authorization section has been separated from the main consent. This means that participants must sign the document twice: once for consent and once for authorization. The VA Consent Template includes all sections and signature blocks for consent and authorization in one document, meaning that you do not need to upload two separate documents into ERICA; however the IRB will no longer use an approval stamp on the bottom of the HIPAA Authorization section. Because of the complexity of the template, be careful to follow the instructions included at the beginning and throughout the template.

HUD VA Consent Template

• The witness and PI signature block for the consent document has been deleted. The VA now only requires signatures from the participant/LAR and the person obtaining consent.
• The HIPAA Authorization section has been separated from the main consent. This means that participants must sign the document twice: once for consent and once for authorization. The VA Consent Template includes all sections and signature blocks for consent and authorization in one document, meaning that you do not need to upload two separate documents into ERICA; however the IRB will no longer use an approval stamp on the bottom of the HIPAA Authorization section. Because of the complexity of the template, be careful to follow the instructions included at the beginning and throughout the template.

Please note that a separate listserv announcement will be sent providing additional detail for the changes affecting studies conducted at the VA. If you have any questions about these updates, please contact the IRB at 801.581.3655, or by email at IRB@hsc.utah.edu.

February 2, 2011

IRB Updates

The Utah Population Database was recently determined to be outside of the University of Utah Covered Entity. This means that for studies using the UPDB, new HIPAA requirements and privacy and confidentiality protections may be applicable, depending on (a) the location of the study (i.e. Inside or outside the covered entity), as well as (b) the nature of the data being shared by the study to the UPDB. These new requirements will affect the HIPAA Authorization section of consent document, as well as various sections of the IRB application (no new questions have been added to the IRB application at this time).

The IRB and the Resource for Genetic and Epidemiologic Research (RGE) have published guidance (attached) that is available online at: http://www.research.utah.edu/irb/forms/hipaa/pdf/UPDB-ConsentAndAuth-Feb11.pdf.

This guidance discusses

• The applicability of the new requirements to studies using the UPDB
• The new requirements that must be addressed in the IRB application and the consent document
• Template language regarding UPDB that may be used in the consent document

Beginning 2/2/2011, this policy will be enforced for all applicable new studies and at continuing review. For additional guidance regarding these new requirements, you may contact the following offices:

Resource for Genetic and Epidemiologic Research
Phone: 801.581.6351

Institutional Review Board

November 8, 2010

Internet Recruitment and Advertising

The IRB has revised the Recruitment Methods and Advertisements document in the Investigator Guidance Series to include guidance on internet advertising. This document may be accessed using the following link: (http://www.research.utah.edu/irb/guidelines/pdf/IGS-RecruitmentMethodsAdvertisements-J0810-1.pdf)

The following information has been added to the guidance:

Internet Advertising

Advertisements posted on the internet must adhere to the advertising guidelines. All advertisements must be approved by the IRB prior to posting. The researcher may submit the advertisement text to the IRB as a document for approval. The intended internet sites where the advertisements will be posted must be described in the recruitment methods section of the IRB application or protocol.

Researchers may use the Internet as a forum for disseminating study information to participants. The use of websites, blogs, internet forums, and social networking sites for the dissemination of study information must be described in the recruitment methods section of the IRB application or protocol. The IRB requires the following statement to be posted on internet sites used for this purpose:

The information posted on this site is consistent with the research reviewed and approved by the University of Utah Institutional Review Board (IRB). However, the IRB has not reviewed all material posted on this site. Contact the IRB if you have questions regarding your rights as a research participant. Also contact the IRB if you have questions, complaint, or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu.

October 26, 2010

National AWARE for ALL Program Event

This is an announcement for the National AWARE for All: Clinical Research Education Day for the Public.

Registration for this program is free and open to the public. We do ask however, that you register as soon as possible, so that we may plan for the right number of people.

Where: Salt Lake City Main Library Auditorium, 210 East 400 South
When: Saturday, November 6th from 9:15 AM - 12:30 PM MST

To view a copy of the promotional flyer, click here.
To view a copy of the official U of U Press Release, click here.

For more information or to register, please contact Sadie Quinn
Phone: (801)581.3803
Email: Sadie.Quinn@hsc.utah.edu or RSVP online at http://education.research.utah.edu/special_events.jsp.

October 8, 2010

IRB Updates

The IRB has received record submissions in 2009 and 2010 due to the increase in human subject research being conducted at the University of Utah. As a result, the IRB has worked diligently to improve our processes to ensure that the review and approval of research is thorough as well as efficient. The following changes have been implemented to help address review for the increasing number of submissions.

Changes in Study Approval Periods

IRB policy has changed to allow an approval period up to two-years for some research studies, instead of the one-year approval period that is used today. Not all studies are eligible for two-year approval - the guidelines to issue up to a two year approval period are described in the attached document. Please read this document carefully in order to understand when a project is eligible for a two-year approval period.

All determinations regarding approval periods will be made by the IRB and will not be influenced by requests from investigators and study teams. Please do not request a two-year approval period as part of your submission. To ensure that your study receives an accurate review and the longest possible approval period, describe all procedures and funding sources in detail in the IRB application.

It is anticipated that this change will decrease the number of continuing review applications received each month and substantially reduce the workload for study teams, IRB members, and IRB staff.

Addition of IRB Panel Six

Due to the increase in submissions that require convened board review, a new IRB Panel Six has been created. Panel Six will convene at noon on the third Wednesday of each month beginning October 20, 2010.

The addition of Panel Six will decrease the length of time between initial submission and final approval of studies, and help to eliminate the need to “bump” studies from multiple meetings due to high volume.

The IRB appreciates the service of additional faculty as new members join us from departments across campus. These additional IRB members are essential to maintain expertise in all fields of research and conduct thorough and efficient reviews.

If you have any questions about these updates, please contact the IRB at 801-581-3655.

April 29, 2010

A new IRB assent template is available on the IRB website:

Assent form with HIPAA language
Assent form for Main Campus

This template was designed to better address assent needs for children and cognitively impaired adults.

A new section has also been added to the assent template. The section includes a set of options at the end of the document to be completed by the person obtaining assent. These options allow documentation of the participant’s ability to read the assent document. This may help some studies to document the assent process. This new section is not required and is optional.

The IRB will not be requesting changes to currently-approved assent documents at continuing review, as the required elements of the assent template have not changed; all currently-approved assent documents still meet assent requirements. If you would like to revise your current assent document to fit this template or to add the optional section mentioned above, you must submit an amendment application to the IRB.

Note: A tracked copy of the changes to the template has not been provided on the IRB website, as the formatting has changed substantially.

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

February 8, 2010

IRB Report Form Changes
The report form has been reorganized, allowing the following features beginning 2.06.2010:

• All report form types (e.g. adverse events, deviations, breaches, information, etc.) can now be selected on the first page of the report form, instead of on multiple pages.
• The report form now includes a Documents and Attachments page for all types of reports, instead of allowing attachments on multiple pages.

The IRB has not changed any of the information that must be provided in the report form, nor have the IRB reporting requirements changed. For more information about IRB reporting requirements, please visit the IRB website at http://www.research.utah.edu/irb/adverse/index.html

Changing the PI on a Study
When an amendment is submitted to the IRB requesting to change the PI, the original PI is required to submit the amendment; beginning 2/6/2010, the new PI will also be required to sign off on the submission of the amendment. Once the new PI signs off, he/she will gain access to perform the PI role for the amendment application in ERICA and the old PI will no longer be required to respond to IRB requests for the amendment review. Previously, the new PI could not function as the PI in ERICA until the amendment was approved.

To ensure that the PI change is processed correctly, you MUST change the PI in the Update Study Application after completing the amendment application. This will allow the new PI to sign off on the submission after the original PI.

RGE Application - Amendments and Continuing Reviews
Beginning 2/6/2010, the Resource for Genetic Epidemiological Research (RGE) amendment and continuing review applications will be incorporated into the IRB amendment and continuing review applications. This means that all submissions to RGE will be made electronically through the ERICA system. When a PI submits an IRB amendment or continuing review, those studies also requiring review from RGE will be forwarded to the RGE committee. RGE review and approval will occur BEFORE IRB review; the IRB pre-review will not occur until RGE review is complete. PIs must account for this at the time of continuing review to ensure that their studies are submitted with enough time for re-approval prior to study expiration.

For questions regarding RGE submissions, please call 801.581.6351.

January 5, 2010

Please note that due to a greater than usual amount of applications submitted in recent weeks, and due to the holiday schedule, we are unable to guarantee that your submission will be reviewed at a particular meeting. Applications will generally be assigned to a meeting date based on date of expiration, expertise available on the panel, or based on the order in which completed applications are correctly submitted to the IRB. Any dates included in review letters or on the IRB website are estimates only. Please submit your completed revisions as early as possible, and log into ERICA frequently to check the current status and review date of your application, as it may change several times and notifications may not be automatically sent for each change. We apologize for any inconvenience.

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:

1. Studies that have already been bumped from a prior meeting
2. Studies that have completed and submitted pre board revisions the earliest
3. 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:

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

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:

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.

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.

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.