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 informed consent and authorization templates and requirements are necessary.  VA consent and authorization templates may be found on the Forms & Templates page.
• The following forms must also be completed and attached in ERICA:
  • IRB Documentation of Waiver of HIPAA Authorization for Research – if you are requesting a waiver of authorization in ERICA, complete the top half of this form and attach it under “Other Documents.”  The IRB staff will complete all remaining sections of the form. 
  • PI Certification of Informed Consent at Continuing Review – if you obtain informed consent from participants, this form must be submitted under “Other Documents” with every continuing review application. 
• 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 initiated 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 the VA Consent Form and, if applicable, the VA Authorization Form.  Templates are available on the Forms & Templates page.  There are several differences between the VA and University templates, so it is important that the correct version is used.  These differences reflect requirements outlined in the VA Directive 1200.05.

Points to Consider for Consent

• If applicable, the VA Consent Form must include a statement that the participants will be re-contacted for future research whether within or outside the VA. 
• If applicable, the VA Consent Form must include a statement that the participant will receive a report of the aggregate results or any results specific to the study.
• If applicable, the VA Consent Form must include information about future use of specimens and data.  See the section below titled, “Research Tissue Banks,” for more details.

Points to Consider for Authorization

• The VA Authorization Form is a document separate from the VA Consent Form.  Participants must sign both in order to participate in research that involves the use of protected health information (PHI). The VA Consent and Authorization forms must be consistent.
• When using a participant’s legally authorized representative (LAR) for the consent process, there are different VA requirements for who may sign the VA Consent Form and who many sign the VA Authorization Form, as follows:
  • The standard LAR requirements used by the University of Utah apply to the VA Consent and Authorization Form.  This is according to Utah State Law, and an LAR may be the participant’s spouse, adult child, or legally documented representative (i.e., an individual with power of attorney or who is designated on a valid Advance Directive).

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.

Unanticipated Problems (including Adverse Events)

• The VA does not use the OHRP term of an unanticipated problem involving risks to participants or others.  However, the VA uses criteria for reporting problems and events that are nearly exact when compared to the criteria for an unanticipated problem involving risks to participants or others, which is used by the University of Utah IRB.  Thus, investigators conducting VA research should follow the standard Unanticipated Problem criteria for evaluating and reporting problems and events.
• 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 different 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-compliance is the persistent failure to adhere to the requirements governing human research.  
  
  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

• The VA uses different definitions for these terms, as follows:
  
  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 tissue banking guidelines which are consistent with VA requirements. This includes consent language for tissue banking as well as tissue banking management plans.

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

• VA participant samples cannot be stored at a for-profit institution.

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.