2011 News 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: www.research.utah.edu/irb/forms/mainCampusForms
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