Research Conducted at Veterans Affairs (VA)

The IRB follows our SOPs and guidance, as well as the VHA Directive 1200.05 for IRB composition, management, and review of new studies, continuing reviews, and amendments.  VA research must be submitted using the applications in ERICA.

There are additional requirements for VA research that must be addressed by investigators:

• By marking the VA as a research site, the ERICA new study application requires additional pages to address VA personnel and study information, VA-University collaboration, and VA information security. 
• By marking the VA as a research site, the ERICA continuing review application requires an additional page to address VA participant enrollment status.
• VA-specific consent elements are required. To ensure all elements are met, the IRB outlines requirements on the Consent Document Checklist, including additional elements required by the VA.
• If requesting a waiver of authorization in ERICA, the VA IRB Documentation of Waiver of HIPAA Authorization for Research (VA Form 10-0521) should be submitted. See the Forms and Templates page to download a copy. Complete the top half of this form and attach it under “Other Documents” in ERICA.  The IRB staff will complete all remaining sections of the form. 
• Additional paperwork is required outside of the ERICA system in order to secure VA R&D Committee review and approval.  This paperwork must be obtained from and submitted to the VA HRPP Office.  This paperwork includes the following:
  • Investigator and study information forms
  • VA conflict of interest disclosures
  • VA pharmacy forms

Review Process Considerations

When applications are submitted in ERICA, the VA administrative review process is conducted prior to being received and reviewed by the IRB. During the VA administrative review, investigators may receive revision requests relevant to VA information in the ERICA application.  After VA administrative review is completed, the application is forwarded to the IRB for review. 

The IRB makes determinations required by our SOPs and the VHA Directive 1200.05.  After IRB approval or exemption is secured, the investigator must receive approval from the VA R&D Committee.  This is required before initiating study procedures at the VA location.  For questions about R&D Committee review and approval, contact the VA HRPP Administrator.

VA participants must be enrolled using a consent form including VA consent requirements.  HIPAA Authorization for VA studies may be included within the consent document or a separate document (VA Authorization Form). If the study includes optional specimen/data banking or impaired decision making individuals (using LAR), the consent document should not include authorization language and the VA Form 10-4093, Authorization for Use & Release of Individually Identifiable Health Information for VHA Research should be used. The VA form is available on the Forms & Templates page.

Points to Consider for Consent

• The University of Utah IRB requires the following elements of consent for all studies, including VA studies:
  • For studies with a certificate of confidentiality, the informed consent document includes a description (see Consent Checklist - Basic Elements).
  • A description of payments the participant will receive for participation in the study (see Consent Document Checklist - Additional Elements).
  • A statement of any conflicts of interest by the researcher (see Consent Document Checklist - Supplemental Elements)
• The University of Utah IRB requires the following elements of consent for VA studies:
  • A statement that the VA will provide treatment for research related injury (see Consent Document Checklist - Additional Elements Required by the VA).
  •  When appropriate, a statement that informs VA subjects that insurance will not be charged for costs related to the research ( see Consent Document Checklist - Additional Elements Required by the VA).
  • A description of the use of photographs, video, and/or audio recordings to be taken for research purposes (see Consent Document Checklist - Additional Elements Required by the VA).

The IRB follows our SOPs as well as the VHA Directives 1200.05 and 1058.01 for review of problems, events, and deviations that occur in VA research.  Investigators must use the ERICA Report Form to submit this information to the IRB, with applicable instructions available through the Report Forms page.

There are key difference between University of Utah and VA reporting policies that investigators must take into account.

General Considerations

• Prompt reporting for VA research is 5 business days upon becoming aware of a reportable problem, event, or deviation.  For the other locations covered by the University of Utah IRB, prompt reporting is 10 business days. 
• There are differences in the timelines and procedures used by the IRB to conduct reviews of Report Forms for VA research. While the IRB follows the same process for review as described in SOP 901, the IRB uses the timelines described in VHA Directive 1058.01 for review.
• The are differences in the institutional reporting timelines use by the IRB for VA research.  While the IRB follows the same process for reporting as described in SOP 905, the IRB uses the timelines described in VHA Directive 1058.01 for institutional reporting.
• The investigator must notify the IRB same-day by email upon becoming aware of any local research-related deaths that are unanticipated.  Send notification, including the IRB number, to: irb@hsc.utah.edu.  The investigator must then submit a Report Form within 5 business days.  

• Investigators must take care in documenting appropriate evaluation of unanticipated problems.  Unfounded classification of problems as unrelated or anticipated must be reviewed by the IRB for possible serious non-compliance.

Deviations and Non-Compliance

• The VA uses the following definitions of serious and continuing non-compliance, as follows:
  
  Serious non-compliance is any failure to adhere to the requirements for conducting human research that may reasonably be regarded as (a) presenting a genuine risk of substantive harm to the safety, rights, or welfare of human research subjects, research personnel, or others, including their rights to privacy and confidentiality of identifiable information; or (b) substantively compromising a facility’s HRPP.
  
  Continuing non-compliancemeans repeated instances of noncompliance with applicable laws, regulations, policies, agreements, or determinations of a research review committee or the prolonged persistence of noncompliance occurring after its identification, awareness, or implementation of a corrective action intended.  
  
  These definitions do not differ substantially from the University of Utah IRB definitions, as all are very likely to yield the same determination outcome in the vast majority of cases.  Presently, there is no anecdotal evidence to suggest meaningful differences in the interpretations of VA and University definitions.  However, the University of Utah IRB will use the VA definitions when reviewing non-compliance in VA research.

Administrative Holds, Suspensions, and Terminations

• Administrative hold is a voluntary interruption of research enrollments and ongoing research activities by an appropriate VA facility official, investigator, or sponsor. An administrative hold cannot be placed for interruptions in research related to concerns regarding the safety, rights, and welfare of human research participants or others or to avoid reporting other deficiencies. 
  
  Suspension is a temporary interruption in enrollment or other research activities due to concerns regarding the safety, rights, and welfare of human research participants or others.  
  
  Termination is a permanent halt to enrollment or other research activities due to concerns regarding the safety, rights, and welfare of human research participants or others.
• A study is still considered open during administrative hold and suspension.  As such, continuing review applications must be submitted.  If a termination results in closure of the study by the IRB, continuing review applications are no longer required.  

The VA has more stringent requirements than DHHS and the FDA for protection of vulnerable populations.  Review the table below to determine the VA requirements and IRB guidance for each vulnerable population.  

Please note that A VA facility may NOT use Facebook as a method of advertising non-VA studies.

If you are the lead investigator/site for a multi-centered study, you have additional responsibilities for overseeing the activities at the SLC VA as well as the other sites participating in the study.  The following is a summarized list of responsibilities of the lead investigator; the full list of responsibilities is located in the VHA Directive 1200.05.  

• The lead VA investigator and University of Utah IRB will consider each site's activities to determine whether the site is engaged in research.  The lead VA investigator must provide these details in the new study application.  For sites engaged in research, IRB approval from that site must be provided.  Each site remains responsibility for its own local reviews and compliance and may not begin research activities until all local requirements are met.
• The lead VA investigator must provide a plan for communicating with all sites in the new study application.  This communication plan must address how amendments, problems and events, monitoring results, etc., will be communicated and considered. The University of Utah IRB will consider this plan as it applies to all participating sites.  

Research conducted at the University of Utah and the SLC VA is considered multi-center research, even if the principal investigator acts as the investigator for both sites.  Because the University of Utah IRB serves as the IRB of record for both sites, separate IRB approval and a communication plan are not needed.  VA patients may be recruited for non-VA research using advertisements posted at the VA, but there is a separate approval process involved.  Please contact the VA HRPP Administrator for assistance.  Physicians can refer potential participants to a study at the University provided they are not referring patients to themselves.  If an investigator at the University of Utah wants to enroll VA participants, the VA must be included as a research site and all VA requirements must be met. 

Research approved by the VA CIRB must also be submitted in the ERICA system for VA review and possibly University of Utah IRB review.  The VA CIRB will only make determinations for VA components of the research and will not accept review for University of Utah-only investigators and activities.  If there are University of Utah-only investigators or activities, University of Utah IRB review is also required.  

When designing projects for VA research tissue banks or non-VA research tissue banks that include VA participant tissue samples, you must follow the University of Utah policy on future use of biospecimens. This includes consent language for banking as well as banking management plans.

Investigators should review the VA Tissue Banking Guidance for more information.  

VA research involving stem cells shall be governed by the policy set by NIH.

A University of Utah employee who will be conducting research procedures at the VA must be designated with Working Without Compensation (WOC) status at the VA. To initiate this process, contact the VA HRPP Office.  

The IRB has the authority and obligation to monitor SLC VA research through routine or for-cause regulatory audits. VA studies will be audited annually by the VA Research Compliance Officer; however, the IRB may require the study to be audited more frequently if there is concern for ongoing research compliance and the safety or welfare of participants. Investigators may contact the VA Research Compliance Officer for more information about the annual audits.  The following information is available regarding IRB auditing policy and process:

• IRB Self-Assessments
• IRB SOP 908: Routine and For Cause Audits

All investigators and staff conducting research at the VA must complete the necessary VA training modules.  This includes investigators and staff who are University of Utah employees and those with WOC status.  The VA accepts either the U of U or the VA modules, but it's ideal if you affiliate with both institutions on your CITI login profile.  For instructions on completing the VA CITI training modules, visit Investigator & Research Staff Training. 

IRB staff and members are encouraged to complete the VA CITI training modules.  IRB staff and members receive VA-relevant training at annual training events.