Research Conducted at Veterans Affairs (VA)
The University of Utah IRB acts as the IRB of record for the Salt Lake City VA. The Salt Lake City VA has its own human research protection program (HRPP), of which the University of Utah IRB is a part. The IRB adheres to the IRB responsibilities and requirements outlined in 38 CFR 16 and the VHA Handbooks when reviewing and making determinations for research conducted at the VA. Policies and procedures related to the Salt Lake City VA HRPP that do not address IRB responsibilities and requirements can be obtained by contacting the VA HRPP Office at 801-584-1271.
This webpage includes guidance and instruction for specific research topics as relevant to VA policies and handbooks; however, this webpage is not meant to act as a full representation of the information in 38 CFR 16 and the VHA Handbooks. Investigators should consult the appropriate regulations and handbooks for full information about the requirements.
Contact the VA Human Research Protection Program
|Caroline Phinney||VA HRPP Administrator||caroline.Phinney@va.gov||801.582.1565 x4866|
|Bryan Johnson||Information Security Officeremail@example.com||801.582.1565 x5443|
|Robert Janes||Privacy Officerfirstname.lastname@example.org||801.582.1565 x1636|
|Holly Cannon||Research Compliance Officeremail@example.com||801.582.1565 x1825|
|Ruben Hernandez||Research Compliance Officerfirstname.lastname@example.org||801.582.1565 x4857|
|Misti Seppi||AO/R&Demail@example.com||801.582.1565 x4860|
|John Hoidal||ACOS/R&Dfirstname.lastname@example.org||801.582.1565 x1238|
|Shella Stovall||Facility Directoremail@example.com||801.582.1565 x1211|
New Study, Continuing Review, and Amendment Submissions
The IRB follows our SOPs and guidance, as well as the VHA Handbook 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 IRB Health Sciences Forms 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 new studies 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 new study application is forwarded to the IRB for review.
Additionally, if an amendment is submitted to add the VA as a research site, VA administrative review is required; however, this review process is not yet built into the ERICA system. Investigators must obtain VA administrative review by emailing the VA HRPP Administrator.
The IRB makes determinations required by our SOPs and the VHA Handbook 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.
Informed Consent and Authorization
VA participants must be enrolled using the VA Consent Form (VA Form 10-1086) and, if applicable, the VA Authorization Form. Templates are available on the Health Sciences Forms Template 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 Handbook 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 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).
- Only a legally documented representative (i.e., an individual with power of attorney or who is designated on a valid Advance Directive) has authority to sign the VA Authorization Form.
Report Form Submissions
The IRB follows our SOPs as well as the VHA Handbooks 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.
- 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 Handbook 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 Handbook 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: firstname.lastname@example.org. 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.
Vulnerable Populations in VA Research
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.
|Population||VA Requirement||University of Utah IRB Guidance|
|Adults with Decisional Impairment||
May be enrolled in VA research.
|Go to: Research Involving Individuals with Decisional Impairment|
May be enrolled in VA research, i.e., pregnant women are the focus of the research (not fetuses or fetal tissue) when the VA Facility Director certifies that the VA facility has sufficient expertise in women's health to conduct the proposed research. Documentation from the VA Facility Director must be attached to the IRB application.
Follow standard requirements included in the IRB guidance document.
Additional items to consider:
|Go to: Research Involving Pregnant Women and Fetuses|
May be enrolled in minimal risk VA research only with approval from the VA Facility Director.
Follow the standard requirements included in the IRB guidance document.
|Go to: Children in Research|
May be enrolled in VA research only with an approved waiver from CRADO. Requirements for requesting a waiver may be obtained by contacting the VA Office for Research Development.
After obtaining a CRADO waiver, prisoners may be enrolled in VA studies. Follow the standard requirements included in the IRB guidance document.
International research on the prisoner population will not be approved.
|Go to: Research Involving Prisoners|
May be enrolled in VA research that only involves observational or retrospective record review of neonate participants. Requires approval from the VA Facility Director.
Follow the standard requirements included in the IRB guidance document.
Go to: Research Involving Neonates
|Fetuses||May not be enrolled in VA research, i.e., fetuses or fetal tissue are the focus of the research.||
May be enrolled at the University of Utah.
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 Handbook 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 not be recruited for non-VA research using advertisements posted at the VA or referrals made from physicians at the VA. 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.
Research Tissue Banks
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.
Working Without Compensation (WOC) Status
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:
Human Subject Research Training
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 does not accept the University of Utah version of the CITI training modules. For instructions on completing the VA CITI training modules, visit Investigator & Research Staff Training.
As applicable, investigators and staff are also required to complete training modules for the following:
- VA ORD Biosecurity Training (can be added as a module to the VA CITI training)
- VA Privacy and Information Security Training (contact the VA HRPP Office for instructions)
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.
Guidelines and Policies
Note: This is not a comprehensive list of guidelines and policies for VA research, but represents guidelines and policies commonly referenced for research reviewed by the University of Utah.
- VHA Handbook, 1058.01: Research Compliance Reporting Requirements
- VHA Handbook, 1058.05: VHA Operations Activities That May Constitute Research
- VHA Handbook, 1200.05: Requirements for the Protection of Human Subjects in Research
- VHA Handbook, 1200.12: Use of Data and Data Repositories in VHA Research
- VHA Handbook, 1605.1: Privacy and Release of Information
- VA Tissue Banking Guidance - VHA Research and Development
- VA Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy From VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring
- VA ORO HRPP FAQ [PDF]
- VA SLCHCS SOPs
- VHA Publications List
- VHA Guidance Documents