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2022 Traditional Pilot Awards RFA

CTSI Pilot Translational and Clinical Studies Program (PTCS)
2022 Request for Applications for Traditional Pilot Awards

The CTSI Translational and Clinical Studies Program Traditional Pilot Awards are supported by the Medical College of Wisconsin and the National Institutes of Health (NIH).

Up to 5 meritorious projects will be awarded at up to $50,000 each for the 2022 Traditional Pilot cycle.

Team Science: These awards are intended to stimulate inter-institutional and interdisciplinary / multidisciplinary clinical and translational research among the CTSI partner institutions. In supporting such collaboration, these Pilot awards promote and support best practices in team science research.1

For more information on team science, see: Collaboration and team science: From theory to practice; Making virtual teams work: Ten basic principles; Team science learning module from Northwestern University

Key Dates

  • Intent to Apply due: August 2, 2021, 5:00 p.m. CDT
  • Application deadline via REDCap: October 15, 2021, 5:00 p.m. CDT
  • Notification of recommendation for award: February 1, 2022
  • IRB Submission deadline: February 15, 2022*
  • Mandatory orientation for PIs whose project has been recommended for funding: February 2022
  • Project start date: April 1, 2022**
  • Project end date: March 31, 2023***


*CTSI is supported by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS). As such:

  •  “NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.” (https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm)
    Please reach out to your respective IRB Reliance office at the time of application if needed. Please note that if you request that the MCW IRB serve as single IRB for a project, and if your project requires IRB oversight for sites outside of the Milwaukee area CTSI partner institutions, there may be a fee associated with this service. Additionally, please be aware that IRB reliance is a process that can take some time as all sites must ensure that they understand the project, are willing to rely or accept IRB oversight, ensure their local requirements have been satisfied, and agree with the terms of the reliance. Each site may have their own unique reliance documentation system. MCW IRB Reliance can be reached at ude.wcm@ecnaileRBRIWCM.
  • CTSI is required to obtain documentation based on IRB/IACUC approval for each applicable pilot project that has been recommended for funding. IRB/IACUC must be submitted no later than February 15, 2022 or the recommendation for funding may be withdrawn. Verifiable proof of submission is required.

**Funding will not be released until all regulatory approvals are in place.
*** All funds must be EXPENDED within the 12-month award period. No extensions are permitted.

Overview & Purpose

About The CTSI Pilot Translational & Clinical Studies Program (PTCS)

This program is designed to advocate, facilitate, and foster the continuum of research from bench to bedside, and from bedside to community practice. In a sense, translational research focuses on discovery and the application of scientific findings into a real-world setting. It is the goal of the CTSI to diminish the barriers between institutions and disciplines while encouraging novel approaches to solving complex health related problems. Ultimately, we strive to improve health outcomes by creating new, bidirectional flows of information between our biomedical research enterprise and the community we serve.

Goals of this funding opportunity

The fundamental goal of this RFA is to stimulate clinical and translational research among the institutions that comprise the CTSI of Southeast Wisconsin through meaningful collaboration and high-quality team science. This award uses a multiple investigator model to encourage inter- institutional and interdisciplinary collaboration between clinical and basic biomedical scientists, social scientists, ethicists, engineers, biostatisticians, informatics specialists, and other members of the clinical health care delivery team with the appropriate training and expertise to make a substantive scientific contribution to the study.

Funds will be provided to:
  • Support new and promising clinical and translational projects across all disciplines, including special emphasis categories of community-related research and underserved and special populations;
  • Support projects across the translational continuum in Translational Research Track 1 (T1 to T2) and Translational Research Track 2 (T3 to T4)
    • Generate preliminary data for projects poised to be competitive for new extramural grant submissions;
  • Model best practices in team science research;
  • Maximize scientific interactions between junior and senior investigators;
  • Stimulate collaborative research between bench and clinical investigators from similar research areas;
  • Foster interdisciplinary and inter-institutional collaborations;
  • Support research in novel technologies and/or novel approaches and applications to clinical practice and community health

Definitions & Requirements

Clinical & Translational Research

This CTSI Pilot Translational and Clinical Studies Program (PTCS) funds clinical and translational research according to the NIH definitions described below:

Clinical Research

The NIH definition of clinical research1 has three parts:

  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
  2. Epidemiologic and behavioral studies
  3. Outcomes research

1 Glossary of NIH Terms

Translational Research

Applications will be reviewed and considered for funding based on NIH-identified translational areas.

Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes.

2 NCATS Factsheet PDF

Translation-levels (T-levels)

Applications must provide a T-level designation for the proposed research according to the CTSI translational continuum described below, based on NIH guidelines.

Proposals for T1-T2 studies will be grouped and reviewed together; likewise, proposals for T3-T4 studies will be grouped and reviewed together.

  • Proposals that are only T-0 are not eligible to apply. T-0 research can be described as:
    • Pre-clinical approaches designed to inform an investigator about a pathway, pathophysiology, or treatment approach. Examples include:
      • animal models of human disease, human blood or cell lines
      • development of questionnaires, computational models, and human physiological studies
    • “Bench” research which may or may not require approvals from human or animal use committees.
  • T-1 Translation to Humans
    • Studies with human participants that yield knowledge about human behavior, physiology, pathophysiology and the potential for intervention (i.e. diagnoses, therapies, etc.)
    • Findings from basic research are tested for clinical effect and/or applicability.3
  • T-2 Translation to Patients
    • Test new interventions under controlled environments to form the basis for clinical application and evidence-based guidelines.3
    • Yield knowledge about the efficacy of the interventions in optimal settings.3

NOTE: Pilot studies in T-3 and T-4 levels would provide preliminary evidence to bolster competitiveness for larger studies in the following areas:

  • T-3 Translation to Practice
    • Study health services and community-based participatory research (dissemination, communication, implementation)
    • Explore ways of applying recommendations or guidelines in general practice.3
    • Yield knowledge about how interventions work in real-world settings.3
  • T-4 Translation to Communities/Population Health
    • Study factors and interventions that influence the health of populations.3
    • Obtain results to benefit society & improve global health in areas such as improving disease prevention and reducing medical costs.
  • T-5 Policy-level Research
    Proposals that incorporate T5 in addition to one of T1 through T4 are eligible to apply.

3 T-levels of translational research

Special Emphasis Categories

Research in these areas is not a requirement for the award; however, additional review weight will be applied to these studies as being in alignment with a focus of the CTSI.

  • Community-Engaged Research, Underrepresented Minority Populations/Under-served Populations, or Special Populations Research.
    Examples include:
  • Community-Engaged Research4
    “…The process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people.” “Community engagement can take many forms, and partners can include organized groups, agencies, institutions, or individuals. Collaborators may be engaged in health promotion, research, or policy making.”
  • Underrepresented Minority Populations and Underserved Populations5, CTSI adheres to the definitions set forth by the NIH for these populations.
    • underserved minorities; socioeconomically disadvantaged populations (low-income communities); rural populations; health disparity populations including but not limited to disabled, aging population, mentally ill, pregnant women, prisoners, sexual and gender minorities, etc.
  • Special Populations6: includes but is not limited to – specific age groups (infants; children; geriatric); survivors of formerly lethal childhood diseases; adults with chronic health conditions that originated in childhood, other vulnerable populations, etc.

4 NIH Community-Engagement
5 NIH Underrepresented Populations
6 NIH-NIA Special Populations

Principal Investigator & Study Team Roles

Note that for the purposes of this award and in the language of this RFA, the roles of Principal Investigator (PI) and multiple-Principal Investigator (mPI) are equivalent. These are distinct and have different requirements from the roles of the Co-Investigator (Co-I).

For the Traditional Pilot Awards, only CTSI partner institution faculty meeting their institution’s requirements to serve as PI can be listed as PIs or mPIs. A PI can submit more than one application but only one project can be funded, with one exception. The CTSI allows for a multiple PI model such that the mPI can be from a partner institution. Therefore, a second award to an MCW PI will be considered if the following are clearly explicated and justified:

  1. the study proposed is part of the program of research of the mPI from the partner institution;
  2. the MCW PI has meaningful contribution to the science (cannot be an administrative PI only);
  3. the study protocols are distinctly different; and,
  4. the scientific research teams are substantially different.

For questions, please contact the CTSI Pilot Award Program Manager, Renee McCoy, at ude.wcm@yoccmr.

PI Requirements

  • All projects must have an MCW PI. This condition is a requirement of the funding source of these awards.
  • This award allows for, but does not mandate, a multiple PI model. In cases where a project has multiple PIs, the primary PI must be from MCW.
  • mPIs must be from a CTSI Partner Institution and must meet the PI eligibility requirements of their Primary Institution.
  • The role of PI must remain as originally submitted.
  • According to MCW corporate policy, the MCW PI has overall responsibility for the conduct of a research project, including all technical, programmatic, financial, compliance, and administrative aspects. The PI is responsible for controlling the technical direction and academic quality of the project and will ensure that the project is carried out in compliance with the terms, conditions, and policies of the institution and sponsor, when applicable.4
  • The MCW PI will have the additional expectation of managing the award through their department.
  • The lead MCW PI must have a minimum of 5% effort and be fully vested in the project in both spirit and practice and contribute actively on the project. All other mPIs must have a minimum of 1% effort. Note: Investigators will be required to attest to effort and cost-sharing intent on the application. Cost-sharing commitment forms/documentation is not required at the time of application and is only required for projects which have received recommendation for funding.
  • All PIs must have full-time or full professional effort status. Adjunct and part-time faculty are not eligible to apply as a PI.7
  • Primary PIs are responsible for fulfilling reporting requirements as a condition of receipt and continuation of funds. Non-compliance of benchmark, final, and/or annual reporting could result in the rescission of funds by CTSI.
  • All PIs must be CTSI Members. To become a member, please complete the CTSI Membership Form.

7 Principal Investigator Eligibility

Co-Investigator / Other Personnel

  • A co-investigator must have the requisite research training/credentials/expertise to make a substantive contribution to the science of the study and must have a minimum of 1% effort on the project. Note: Investigators will be required to attest to effort and cost-sharing intent. Cost-sharing commitment forms/documentation is not required at the time of application and is only required for projects which have received recommendation for funding.
  • Study personnel such as research assistant, study coordinator or other staff needed for the conduct of the study may not serve as a Co-Investigator
  • The role of Co-investigator must remain as originally submitted
  • All investigators must be CTSI Members. To become a member, please complete the CTSI Membership Form.

Inter-institutional Requirement

  • Proposals must be inter-institutional: the scientific team must include investigators from at least two different CTSI partner institutions: Versiti, Children’s Wisconsin, Froedtert, MCW, MSOE, MU, UWM, Milwaukee VA (Zablocki). Please note, this condition is based on the investigator’s institution of primary employment. Volunteer appointments do not qualify.
  • Community partners or investigators from other academic institutions would be welcome additions to projects as co-investigators, but alone do not meet the inter-institutional requirement. Please note, primary employment is used to determine institutional affiliation.
  • Faculty from the MU/MCW joint department of biomedical engineering should use their primary employment platform to determine institutional affiliation.
  • Investigators that are interested in forming new collaborative relationships are encouraged to contact the CTSI Pilot Award Program Manager, Renee McCoy at ude.wcm@yoccmr.

Regulatory Requirements

  • PIs must provide verifiable proof that all regulatory applications (IRB/IACUC, etc.) are in at least pre-submission. If applicable, proof of any exempt status must be provided.
  • Please note that all applicable projects that receive recommendation for funding must provide proof that the IRB application/amendment has been submitted by February 15, 2022; this is a firm deadline. This requirement is to accommodate necessary timelines for receiving notice of award and funding.
  • All individuals involved in the design, conduct or review of human subjects research are required to have current CITI training. If your project involves human subject research, all study team members must obtain CITI training or equivalent training in human research protections.
  • For research involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies, FDA regulated research or NIH-funded clinical trials, all study team members must also obtain training in Good Clinical Practice (GCP).
  • Clinical research and clinical trials that utilize any Froedtert Hospital (FH) resources – medical records, staff, facilities, equipment, etc. – must be reviewed via the Office of Clinical Research and Innovative Care Compliance (OCRICC) to ensure that FH has the staff, equipment, and other resources to successfully support the study. Visit the OCRICC website for a list of services that require OCRICC approval.
    To help expedite OCRICC approval:

    • Submit your project’s OCRICC application at a minimum at the same time as your IRB submission. Note: OCRICC application requires ALL project documents. This supports OCRICC’s timely and efficient operational and financial feasibility review. A project submitted without all required documents is placed On Hold.
    • Add “CTSI PILOT” in the title of your OCRICC application
    • Notify OCRICC when you receive IRB approval
  • Applicants are encouraged to contact CTSI IRB Navigator, Charlotte Klis for assistance with any IRB-related issues: ude.wcm@silkc
  • This program has an accelerated nature and only a 12-month funding period. If your project requires working with federal agencies such as NIDA, FDA (e.g., IND, IDE applications) or pharmacological agreements (e.g., clinical trial agreements, material transfer agreements), you must contact the CTSI Pilot Award Program Manager, Renee McCoy, at ude.wcm@yoccmr prior to applying.

Budget Requirements

  • Projects will be funded at a level of up to $50,000
  • Project duration will be 12 months (no extensions are permitted)
  • All funds must be EXPENDED within the 12-month period.
  • Funding under this RFA cannot be used as “bridge funding” for lapsed grants from any extramural source and is intended to be used for new projects.
    • funds are limited to MCW purchasing regulations. o funds cannot be used to supplant funds or resources that are available from other sources. However, matching funding and opportunities to leverage Traditional Pilot funds to obtain other sources of financial support are encouraged.
    • no “indirect costs” may be charged.
  • All salaries are subject to the FY21 Executive Level II salary cap of $199,300.
  • Effort must be specified for all investigators (and personnel), even when effort is fully cost-shared by the institution/department. Indicate any cost-sharing within the budget justification under each investigator’s name, under ‘Sharing’, and within a Letter of Support; cost-sharing commitment forms are not required at the time of application; however, these will need to be provided from MCW departments upon notification of recommendation for funding. Institutional base salary must be listed for any individual providing effort and/or receiving salary support from the project.
  • One budget form is required for each partner institution providing personnel effort on the study that is not considered consultative or fee-for-service. Consultant and/or service fees sourced from another institution or agency such as CW or Froedtert Hospital need not be paid via a subcontract. Use the appropriate budget template provided on the CTSI Traditional Pilot Award website.

Procedure

How to Apply

FIRST STEP: THE ONLINE INTENT TO APPLY FORM MUST BE COMPLETED AND SUBMITTED BY August 2, 2021, 5:00 P.M. CDT.

Required Application Materials

Once the Intent to Apply Form is reviewed and approved, applicants will be sent a link to an online application form which must be submitted along with the following documents (templates are available below).

  1. 2022 CTSI Traditional Pilot Award Proposal Form 52 KB2022 Proposal Form
  2. Budget and Budget Justification Forms, one form is required for each partner institution providing personnel effort on the project that is not considered consultative or fee-for-service. 36 KBBudget and Budget Justification Form
  3. NIH Biosketch in the most current NIH format is required for all PIs, Co-Investigators, and Other Significant Contributors. (limit 5 pages per individual) 28 KBNIH Biosketch – Exp 02-28-2023
  4. Letters of Support / Intent
    • a. From Co-Investigators to PI(s)
      • a.i. A Letter of Support is required from each co-Investigator to the mPI(s) explaining her/his intention and commitment to this project.
      • a.ii. Letters of Support should be addressed to all mPIs.
      • a.iii. A Letter of Support is not required from a mPI to the other PI(s).
    • b. From Department Chair(s) to the project PI(s).
      • b.i. To acknowledge awareness and support of the project (including cost-sharing).
    • c. From other institutions – Letters of Intent
      • c.i. A Letter of Intent/Support is required from any non-MCW institution indicating a willingness to negotiate a project-specific subaward and validation that the institution is on-board with the project and is aware of the effort commitments being made.

Applications for this award are not required to be submitted in eBridge. Instead of starting a funding proposal in eBridge, please simply submit the online REDCap application form to CTSI by 5:00 p.m. on October 15, 2021. If your application is selected for funding, a funding proposal in eBridge will be initiated at that time.

Additional Requirements By Institution

For Marquette University (MU) investigators involved in a grant application, please contact the Proposal Planning and Development team in the Office of Research and Sponsored Programs (ORSP) early in the proposal development process. You can reach ORSP through your normal contacts or at ude.etteuqram@dpppsro. Following contact with ORSP, next steps and the process for internal routing and approvals will be determined. ORSP can assist with forms, budget formulation, proofreading, securing sub-award letters of intent, etc. ORSP involvement is essential in making sure your application has received any necessary approvals prior to submission. If you are unaffiliated with MU and would like to collaborate with a Marquette investigator, please contact the Proposal Planning and Development team within ORSP at ude.etteuqram@dpppsro or if the collaborator has been identified, they can contact ORSP.

UW-Milwaukee investigators: applications will need to be routed using the WISPER system and approved by the Office of Sponsored Programs (OSP) prior to submission. Please contact an OSP staff member (https://uwm.edu/officeofresearch/contact/#pre-award) early in your application preparation process to ensure accurate compliance. Email: ude.mwu@eciton-tnarg

MSOE investigators, please contact Sheku Kamara, Dean of Applied Research (ude.eosm@aramak), and fill the Early Notification Form at https://www.msoe.edu/faculty-staff/grant-policies-procedures/early-notification-form/.

Review Process

Each Intent to Apply that has been received by deadline will be reviewed; for those that meet eligibility criteria and are approved, the submitting MCW PI will be notified and sent a personalized link to proceed with the full application.

To ensure that the results of scientific research will be used to directly benefit human health, proposals in all disciplines relevant to biomedical investigation will be considered for funding. Criteria that must be met for funding of any proposal include:

  • the clear potential to directly translate anticipated results into improved preventative health, diagnostics, therapeutics or health outcomes for our southeast Wisconsin community; and
  • the potential for proposed studies, when completed, to generate extramural funding.

Projects will be reviewed based on their selected Translational T-level according to specific review criteria for each T-level grouping: T-1 and T2 will be grouped and reviewed together and T-3 and T-4 will be grouped and reviewed together.

CTSI and the CTSI Pilot Award Committee (PAC) will initially review all applications for technical feasibility and compliance with above requirements. CTSI PAC is comprised of members from partner institutions Marquette University (MU), Medical College of Wisconsin (MCW), Milwaukee School of Engineering (MSOE), University of Wisconsin-Milwaukee (UWM), and Versiti Blood Research Institute (Versiti).

All applications will undergo peer-review. To assist you in developing a strong proposal, specific review criteria will be available within the online application form for your reference.

CTSI participates in a national CTSA External Reviewer Exchange Consortium (CEREC) to improve fairness in the scientific review process and better match applicants with feedback from experts in their respective fields. Applications for this cycle may be reviewed externally through our association with CEREC and we require that you acknowledge within the online application form that your proposal may undergo external review.

Maintaining confidentiality throughout the peer review process is essential to allow for the candid exchange of scientific opinions and evaluations; and to protect trade secrets, commercial or financial information, and information that is privileged or confidential. Similar to the NIH peer review process, the CTSI is committed to protect the integrity of and to maintain confidentiality in peer review. See NOT-OD-18-115.

Terms & Conditions

Although not directly funded with National Institutes of Health (NIH) dollars, CTSI follows NIH National Center for Advancing Translational Sciences (NCATS) and Medical College of Wisconsin (MCW) Terms and Conditions for all CTSI Pilot Award Projects.

Restriction Of Clinical Activity Beyond The End Of Phase IIB

In accordance with section 479(b) of the Public Health Service Act (as amended by the Consolidated Appropriations Act, 2012, Public Law 112-74 and by the 21st Century Cures Act, 2016, Public Law 114-255), NCATS is authorized to use fiscal year 2020 funds to provideinfrastructure and resources for all phases of clinical trials research, but can only support clinical trials through the end of Phase IIB (with the exception of certain clinical trial activities involvingtreatment of a rare disease or condition; consult NCATS program staff for additional information).

Therefore, unless specifically authorized via Revised Notice of Award, with attendant specificTerms of Award, no clinical trial activity beyond phase IIB using fiscal year 2020 funds may besupported by this grant through the pilot project, K or T programs. However, all phases of clinicaltrials may utilize infrastructure and resources provided through the CTSA.

Stem Cells

No funds in this award may be used for any research involving human embryonic stem cells (hESCs) until the grantee has submitted to NIH information on the specific, approved hESC line(s) that will be used from the NIH Human Embryonic Stem Cell Registry. While the Registry will include lines pending review; only those hESCs listed on the Registry as eligible for NIH funding may be used in this award. Information should be submitted from an Authorized Organizational Representative to the assigned Grants Management Specialist.

The grantee may use only those hESCs that appear on the NIH Human Embryonic Stem Cell Registry as eligible for NIH funding and in accord with any restrictions placed on the use of those lines. For more information, view the NIH Guidelines on Human Stem Cell Research.

Human/Animal Subjects Restriction

  • It is understood that no clinical research study member will be permitted to work on any project involving live vertebrate animals or human subjects that has not been approved by the IACUC and/or IRB, as appropriate.
  • No funds may be drawn down from the payment system and no obligations may be made against Federal funds for research involving human subjects by any site engaged in such research for any period not covered by both an OHRP-approved Assurance and an IRB approval consistent with 45 CFR Part 46. See “Human Subjects Protections” Part II, Chapter 4 (NIH Grants Policy Statement) for specific requirements and grantee responsibilities related to the protection of human subjects.

Human Subjects Education Certification Requirement

This award reflects the NCATS’ acceptance of the certification that all key personnel have completed education on the protection of human subjects, in accordance with NIH policy, Required Education in the Protection of Human Research Participants. Any individual involved in the design and conduct of the study that is not included in the certification must satisfy this requirement prior to participating in the project. Failure to comply can result in the suspension and/or termination of this award, withholding of support of the continuation award, audit disallowances, and/or other appropriate action.

Age Data Collection

NIH recipients/offerors must submit data on participant age at enrollment in progress reports. Investigators planning to conduct research involving human subjects should design their studies in such a way that de-identified individual-level participant data on sex/gender, race, ethnicity, and age at enrollment may be provided to NIH in progress reports. Age at enrollment may be reported to NIH in units ranging from hours to years. Recipients/offerors are responsible for ensuring informed consent documents allow submission of de-identified individual-level data on participant sex/gender, race, ethnicity, and age at enrollment to NIH.

Clinical & Translational Science Institute (CTSI) Resources For Applicants

CTSI provides access to numerous CTSI resources and services. These include but are not limited to the MCW Clinical Trials Office (CTO), Adult, Pediatric, Community/Mobile, and Zablocki VA/Geriatric Translational Research Units (TRU), REDCap Secure Data Collection & Storage, as well as research support services in Biomedical Informatics, and Biostatistics / Epidemiology Research Design (BERD). Please see our website for resources available to our investigators and applicants.

Reporting

As an NIH supported program, the CTSI is required to collect benchmark, annual progress, and long-term outcomes reports of all Pilot awarded projects. Timely progress and reporting of the funded research project is a requirement of the award.

The CTSI Traditional Pilot Awards are funded by the Medical College of Wisconsin (MCW). All applications and awarded projects must follow respective processes including but not limited to reporting requirements.

Funding Acknowledgment

Important Reminder – Please acknowledge the National Institutes of Health (NIH) CTSA award when publishing or presenting any outcomes resulting from your study by including the CTSI Funding Acknowledgement.

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

Children's Hospital of WisconsinMarquette UniversityMSOEUWMVersitiVA Medical Center