Research

The Research Service includes support of the Network of Dedicated Enrollment Sites (NODES), the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE), Lung Precision Oncology Program (LPOP), Stellate Ganglion Block (SGB) for post traumatic stress syndrome, Mental Illness Research, Education and Clinical Center (MIRECC), and Center for VA Women’s Health Practice-based research network (PbRN) . In addition, we provide support for many basic science, animal, and epidemiologic research projects.

The Research Office supports the research team, facilities, and committees that oversee the research activities in addition to managing the pre- and post-award activities for VA-grants.

As a Veteran, we thank you for your service to our country and for your interest in VA research. We value your input into how research is conducted at the VA Long Beach Healthcare System, and will respond to the concerns, opinions and suggestions of research participants.

Research Participants (current, prospective or past), or their designated representatives, may contact our team to discuss any of these topics about research studies at the VALBHS:

• General questions, concerns or complaints about research.
• Research related injury.
• Questions about your rights as a research participant.
• Questions, concerns or complaints about a specific study when study staff are not available or when you would rather talk to someone other than a study staff member.

We are committed to handling inquiries in a safe, courteous, confidential, and reliable way. We will try to answer questions and resolve problems or concerns as soon as possible. If an issue cannot be resolved satisfactorily, it will be forwarded to the Administrative Officer for Research and/ or the Associate Chief of Staff for Research. In addition, contact information for Research Subjects Rights is on the last page of all VA Consent Form.

The Network of Dedicated Enrollment Sites (NODES) is a consortium of VA medical centers that have teams (nodes) dedicated to conducting VA Cooperative Studies Program (CSP) clinical trials to enhance the overall performance, compliance, and management of CSP multi-site research. In addition, NODES share best practices and provide local insights to CSP Central Office and CSP Centers on trial design and related considerations that can help with study management and conduct. Further, each node helps to create a stronger local community of clinical research. For more information, visit the VA Cooperative Studies Program website. 

VA Long Beach Healthcare System (VALBHS) has been a site for NODES since the program was established in 2012. There are currently 21 NODES working together to share best practice and provide insights.

NODES Director

Timothy Morgan, MD, has been the VALB NODES Director since 2012. He is the Chief of Hepatology at the VALBHS. In addition to leading VALB NODES, he serves in multiple leadership positions at the VA as well as external to VA. He is the Director of the VA’s Liver Disease Program. For the past 35 years, Dr. Morgan has been a Principal Investigator (PI) on clinical research projects, including CSPs, multicenter NIH clinical trials, investigator-initiated, and industry-sponsored projects. He is the Site Investigator for the VA’s Million Veteran Program (MVP), and CSP #2023 (the PREMIUM Study), and was the Principal Proponent for CSP #275.

Dr. Morgan is the chair of the VALB Research and Department (R&D) Committee. 

NODES Associate Director of Operations (ADO)

Aliya Asghar has been with VALB NODES since 2012. She is a foreign medical graduate with extensive knowledge in clinical trials. Ms. Asghar joined NODES after serving as a research coordinator for 8 years with Dr. Morgan on NIH, and Industry- sponsored trials. Ms. Asghar is a scientific voting member of the local Institutional Review Board (IRB).

NODES Support Staff

Enrollment Manager: Romena Helal, MS 
Quality Assurance Specialist: Karyn Isip, BA
NODES Assistant: Diana Pham, BS 

For research study volunteer opportunities at the VA Long Beach Healthcare System, visit the National Library of Medicine Clinical Trials. You can also download the Volunteering in Research brochure for more information.

CSP Studies

Project # & Title  

• CSP #577 - Colonoscopy vs. Fecal Immunochemical Testing in Reducing Mortality from Colorectal Cancer  (Active, Not Recruiting)
• CSP #2001 - Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA Intrepid) – (Recruiting)
• CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT) – (Recruiting)
• CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy trial (VALOR) – (Recruiting)
• CSP #2008 - Pentoxifylline in Diabetic Kidney Diseases – (Recruiting)
• CSP #2009 - Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response: The SCEPTER Trial – (Recruiting)
• CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE) – (Recruiting)
• CSP #2016 - National Adaptive Trial for PTSD related Insomnia – (Recruiting)
• CSP #2019 - Basal Cell Carcinoma Chemoprevention Trial (B3C) (Not yet recruiting)
• CSP #2023 - Preventing Liver Cancer Mortality through Imaging with Ultrasound vs. MRI (The PREMIUM Study) – (Recruiting)
• CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in heart failure: Veterans Affairs (GOURMET-VA) – (Not yet recruiting)

The meeting was called to order at 1:03 p.m.

NIH Guidelines for Continuing Review Process

Research approved by the VA Long Beach Health Care System (VALBHCS) IBC may continue only for the time frame established by the IBC. In accordance to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), investigators are required to submit a continuation application for review by the IBC on a yearly basis from the date of approval for recombinant DNA (rDNA) or synthetic nucleic acid molecule experiments that involve Human Gene Therapy or experiments conducted under Biosafety Level Three (3) or Biosafety Level Four (4).

Investigators that conduct experiments at Biosafety Level One (1) or Biosafety Level Two (2) are required to submit a continuation application for review by the IBC every three years from the date of approval. The expiration date will be determined by the IBC based on the biological safety level. Due to the nature of some experiments, the IBC may request a shorter duration between continuing review between continuing review periods to ensure safe conduct of research covered by the NIH Guidelines.

1. [1803545-10] (SHASTA-4 Study) Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia
   PI: Vo, Anthony, MD
   Project Status: Continuing Review
   
   The IBC met to conduct the annual oversight of this IBC Exempt project.  The purpose of this research study is to look at how safe and effective the study drug, Plozasarin, is at lowering triglycerides in people with severe hypertriglyceridemia. The goal is to demonstrate the efficacy of Plozasarin on reducing fasting serum triglyceride levels. 
   
   This project received initial IBC approval with annual oversight per NIH guidelines Section III-C-1-BSL-1.  No work will be conducted in a BSL-2 or higher laboratory. The project does not involve experiments in a laboratory. The project involves recombinant or synthetic nucleic acid molecules (rDNA). The project does not involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally. No manipulations are planned, there will be no sequencing, and no vectors will be used.
   
   MOTION: To approve this IBC project. For = 6; Opposed = 0
    
2. [1808509-10] (MUIR-3 Study) Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate The Efficacy and Safety of Plozasarin in Adults with Hypertriglyceridemia 
   PI: Vo, Anthony, MD
   Project Status: Continuing Review
   
   The IBC met to conduct the annual oversight of this IBC Exempt project. The purpose of this study is to look at how safe and effective the study drug, AROAPOC3, is at lowering triglycerides in people with hypertriglyceridemia. The primary objective is to demonstrate the efficacy of Plozasiran on reducing fasting serum triglyceride levels. 
   
   This project received initial IBC approval with annual oversight per NIH guidelines Section III-C-1-BSL-1.  No work will be conducted in a BSL-2 or higher laboratory. The project does not involve experiments in a laboratory. The project involves recombinant or synthetic nucleic acid molecules (rDNA). The project does not involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally. No manipulations are planned, there will be no sequencing, and no vectors will be used.
   
   MOTION: To approve this IBC project. For = 6; Opposed = 0

Meeting was Adjourned at 1:45 p.m.

Meeting was called to order at 1:00 p.m.

Note: The approved meeting minutes will be posted publicly per the National Institutes of Health (NIH), Office of Science Policy (OSP) requirement NOT-OD-25-082. All information on matters not covered by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules will be redacted as allowed in NOT-OD-25-082.

Minutes: Review of IBC Minutes from the July 9th Meeting
MOTION: To approve the minutes as written. For = 6; Opposed = 0

NIH guidelines for continuing review process

Research approved by the VA Long Beach Health Care System (VALBHCS) IBC may continue only for the time frame established by the IBC. In accordance to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), investigators are required to submit a continuation application for review by the IBC on a yearly basis from the date of approval for recombinant DNA (rDNA) or synthetic nucleic acid molecule experiments that involve Human Gene Therapy or experiments conducted under Biosafety Level Three (3) or Biosafety Level Four (4).

Investigators that conduct experiments at Biosafety Level One (1) or Biosafety Level Two (2) are required to submit a continuation application for review by the IBC every three years from the date of approval. The expiration date will be determined by the IBC based on the biological safety level. Due to the nature of some experiments, the IBC may request a shorter duration between continuing review between continuing review periods to ensure safe conduct of research covered by the NIH Guidelines.

1. [1888203-1] Cellular and molecular . . . 
   PI: Zhao, Haibo, MD, PhD
   Project Status: New Project
   
   Summary and Discussion: The aim of this project is to explore the cellular and molecular mechanisms of the gene that causes osteoporosis. The biochemical assays will be conducted to figure out how the genes regulate activation and function. 
   
   The IBC members determined that this project shall receive initial IBC approval with oversight per NIH guidelines Section III-F-1. The project meets the criteria for IBC exemption. The plan for the use and containment of biological agents is adequate.
   
   The project involves recombinant or synthetic nucleic acid molecules (rDNA). The project does not involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally. No manipulations are planned, there will be no sequencing, and no vectors will be used.
   
   Investigational study Agent(s)/Toxin(s): N/A
   Biosafety Level Assignment: BSL-2
   NIH Guidelines Section: III-F-1, meets criteria for IBC exemption
   Next Periodic Review: Three Years, August 2028
   Enhanced Work Practices: None
   Training Requirements: None
   
   MOTION: To approve this IBC BSL-2 project for three years.
   For = 6; Opposed = 0

Meeting was adjourned at 1:47 p.m.

The meeting was called to order at 1:02 p.m.

Note: The approved meeting minutes will be posted publicly per the National Institutes of Health (NIH), Office of Science Policy (OSP) requirement NOT-OD-25-082. All information on matters not covered by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules will be redacted as allowed in NOT-OD-25-082.

Minutes: Review of IBC Minutes from the August 13th Meeting
MOTION: To approve the minutes as written. For = 7; Opposed = 0

NIH guidelines for continuing review process

Research approved by the VA Long Beach Health Care System (VALBHCS) IBC may continue only for the time frame established by the IBC. In accordance to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), investigators are required to submit a continuation application for review by the IBC on a yearly basis from the date of approval for recombinant DNA (rDNA) or synthetic nucleic acid molecule experiments that involve Human Gene Therapy or experiments conducted under Biosafety Level Three (3) or Biosafety Level Four (4).

Investigators that conduct experiments at Biosafety Level One (1) or Biosafety Level Two (2) are required to submit a continuation application for review by the IBC every three years from the date of approval. The expiration date will be determined by the IBC based on the biological safety level. Due to the nature of some experiments, the IBC may request a shorter duration between continuing review between continuing review periods to ensure safe conduct of research covered by the NIH Guidelines.

1. [1866285-1] V940-009 A Phase 3 Randomized Double-blind Study of Adjuvant . . .
   PI: Gupta, Pankaj, MD
   Project Status: New project
   Containment Level: BSL-2
   NIH Guidelines Section: III-C
   
   Project Overview: The IBC met to conduct the initial oversight of this IBC project.  
   
   The purpose of this research study is to evaluate the addition of V940 to adjuvant pembrolizumab in patients with resectable stages who did not achieve a pCR after neoadjuvant pembrolizumab with platinum-doublet chemotherapy followed by surgery.
   
   The Drug is an investigational product: V940 (mRNA-4157).  The study drug does not require compounding by research pharmacy. Research activities may be performed using BSL-1 containment/safety procedures.  No work will be conducted in a BSL-2 or higher laboratory. 
   
   This project falls under Human gene transfer: The current study involves clinical trials of the Investigational product and therefore falls under Section III-C-1: Experiments Involving the Deliberate Transfer of Recombinant or Synthetic Nucleic Acid Molecules, or DNA or RNA Derived from Recombinant or Synthetic Nucleic Acid Molecules, into One or More Human Research Participants.
   
   This project received initial IBC approval with annual oversight.  The project does not involve experiments in a laboratory. 
   
   Investigational study Agent(s)/Toxin(s): None
   Risk Group:
   Biosafety Level Assignment: BSL-1
   Next Periodic Review: Annually at continuing review
   Training Requirements: None
   MOTION: To approve this IBC project. For = 7; Opposed = 0

Meeting was Adjourned at 1:50 p.m.