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CSRD Newsletter

Vol. 6, No. 1, 2024.1.25

ORD Releases Special RFA for Psychedelic Research

From the desk of Vetisha L. McClair, PhD:

First, I want to wish everyone a very Happy New Year!  2024 will be a very exciting year for the Office of Research and Development.  We have new initiatives and opportunities that will be released in the upcoming months.  I am very pleased to announce the release of our special Request for Applications (RFA) for the Psychedelic Parent Merit Review Award.  In recent years, a number of investigators have contacted CSRD about the possibility for funding of psychedelic research projects.  Until very recently, there was little Federal funding available for research into these compounds.  Previously, most of the funding available was through private foundation and philanthropic sources.  VA researchers have been conducting smaller studies with private funding in a limited number of VA facilities across the country. This new RFA will permit the important next step of directly assessing effectiveness and safety of using MDMA and psilocybin-augmented psychotherapy in Veterans.

In response to our publication of the RFA, Secretary of Veterans Affairs Denis McDonough said: “Our nation’s Veterans deserve the very best care, and VA is constantly supporting innovations to deliver that.” He also added: “This is an important step to explore the efficacy of a potential new set of promising treatments that could improve the health and quality of life for Veterans.”

There is rapidly expanding public awareness of, and interest in, the use of psychedelic treatments for mental health conditions prevalent in the Veteran population, such as depression, PTSD, and substance abuse. Due to growing evidence from preclinical studies and clinical trials, several psychedelic treatments are in the pipeline and have high potential for U.S. Food and Drug Administration approval within the next 1-5 years, including MDMA-assisted psychotherapy for PTSD and psilocybin therapy for depression.

ORD and the Office of Mental Health and Suicide Prevention (OMHSP) co-hosted a “State of the Art (SOTA) Conference: Psychedelic Treatments for Mental Health Conditions” in September 2023 to help address two major objectives. The first objective was to better understand the current state of scientific evidence and to identify a strategic framework to conduct future psychedelic treatment research for select mental health conditions. The second objective was to determine the necessary next steps for potential VA system-wide clinical implementation for agents where FDA-approval may be anticipated. The 70-plus participants included key internal VA stakeholders, clinicians, and psychedelic researchers along with representatives from key partner Federal agencies (such as National Institutes of Health, FDA, U.S. Department of Defense, Substance Abuse and Mental Health Services Administration, and the Office of the Assistant Secretary for Health). One of the key gaps in research identified at the SOTA was the need to conduct more trials with Veteran subjects - specifically the unique and diverse population of Veterans who receive care through VHA.

You can review the RFA here: https://vaww.research.va.gov/funding/docs/ORD_RFA_BXCXHXRX-24-038_Psychedelic.pdf (VA intranet access required). This RFA is specifically focused on projects testing MDMA (3,4-Methyl enedioxymethamphetamine) and Psilocybin for the treatment of mental health conditions (including PTSD and Depression).  Investigators can submit a proposal to any of the four Services (BLRD, CSRD, HSRD, or RRD). Pre-applications will be required for submission to this RFA. Please see https://vaww.research.va.gov/funding/docs/ORD_RFA_BXCXHXRX-24-201_Psychedelic-Pre-application.pdf. Pre-applications will be accepted two times this year (April 1 and October 1).  If you are invited to submit a full application, it will be reviewed in the relevant Service’s review panels.   If you have any questions, feel free to reach out to the Mental Health SPM of the Service you are interested in applying to and/or me (Vetisha.mcclair@va.gov).

JIT for January What is JIT? Just-in-Time (JIT), and precisely eRA Commons JIT, allows for the electronic submission of additional grant application information requested by the Office of Research and Development (ORD) while the application is still in the pre-award phase. Applications in JIT are still under consideration for funding and intent-to-fund email is not a notice of award. Changes to an application in JIT, such as change in budget, etc., does not require a Project Modification Opportunity (PMO) form to be completed as applications are not projects until after completing the JIT process and receiving funding. In such cases, please contact the Scientific Program Manager for the application or contact the JIT Manager at vhacoblcsrdjit@va.gov.

Applications due February 1:

John B. Barnwell Award

The 2024 Barnwell Award Applications are due by February 1, 2024. The John B. Barnwell Award (Barnwell Award) is the Clinical Science Research and Development Service’s highest honor for outstanding achievement in clinical research that advances the diagnosis, prevention and/or treatment of diseases and disorders in the Veteran population.

Nominations for this award must come from the VA Medical Center through the local R&D Office. To be eligible for the Barnwell Award, nominees must meet specific qualifications. For further details, please review the program guide and instructions by searching Barnwell Award at the ORD website:

John Blair Barnwell Award (va.gov)

Questions may be directed to Dr. Mark Roltsch (Mark.Roltsch@va.gov).

William S. Middleton Award

Nominations for the Middleton Award are due by February 1, 2024.  The William S. Middleton Award is the highest honor awarded by Biomedical Laboratory Research and Development Service (BLRD) for outstanding scientific contributions and achievements in the areas of biomedical research. More information and submission instructions for the Middleton Award can be found at:  https://www.research.va.gov/services/blrd/middleton.cfm, or you can contact Carol.fowler@va.gov.

Intent-to-Fund Notices Have Been Sent

The CSRD margin meeting for the Fall 2023 funding cycle was held on January 11 and “Intent-to-Fund” notices have been sent to stations.

Letters of Intent Numbers Released

The following show results of recent review of Letters of Intent (LOIs) received November 1, 2023, for the Spring 2024 funding cycle for Clinical Trials (CT) and Career Development Awards (CDA) The graphs depict trends over the last six cycles.

CSRD Merit Review Clinical Trial LOIs

Submitted: 27

Referred to another Service: 1

Disapproved: 6

Withdrawn: 1

Approved:  19

CSRD Career Development Award LOIs

Submitted: 16

Disapproved 1

Withdrawn: 2

Approved: 13

Applications for DEI Training and Leadership Development due April 3

Please distribute widely to interested parties.  Application instructions may be found at:  https://www.research.va.gov/funding/diversity.cfm.

The Office of Research and Development, Diversity, Equity and Inclusion committee announces two funding opportunities:

1. SUPPORT FOR DIVERSITY, EQUITY, AND INCLUSION TRAINING FOR VETERANS AFFAIRS FIELD RESEARCH EMPLOYEES

Applicants can request up to $5,000 to support training or education in topics related to diversity, equity, and inclusion. The education or training should be focused on raising awareness of perpetual, institutional, and other barriers that may influence workplace culture, recruitment, and retention. Funds must be expended by September 30, 2024. Training must be completed within a year of the award. 

Applications must be submitted to the mailbox VHACOORDDEIWG@va.gov with the subject line “DEI Training” by April 3, 2024. Please include applicant and station name in the subject line

2. LEADERSHIP DEVELOPMENT FOR VA EMPLOYEES AFFILIATED WITH AN ORD PROGRAM/SERVICE

Applicants can request up to $8,000 to support participation in a leadership development course or program (excludes attendance to meetings and conferences). The professional development training must be organized by an accredited institution or federal agency and focus on leadership skill development (e.g., Graduate Health Administrative Training Program, Partnership for Public Service leadership development programs). Funds must be expended by September 30, 2024. Training must be completed within a year of the award. 

Applications must be submitted to the mailbox VHACOORDDEIWG@va.gov with the subject line “Professional Development Training” by April 3, 2024. Please include applicant name and station name in the subject line.

Please direct any questions to VHACOORDDEIWG@va.gov.

Interested in Increasing Service to VA?

The CSRD Data Monitoring Committee (DMC), that provides data and safety monitoring for CSRD-funded projects, is seeking biostatisticians (especially), neurologists, and other new members. For more information, please contact DMC Manager Dr. Tamara Paine.at Tamara.Paine@va.gov.

Contact Information for CSRD

Career Development: VHACADEReview@va.gov

Clinical Trials: clin-review@va.gov

General Mailbox: VHABLRD-CSRD@va.gov  (Please note this is a shared mailbox that should be used for general questions that will be triaged by staff to the appropriate individual.)

Just-in-Time Mailbox: VHACOBLCSRDJIT@va.gov

Scientific Portfolio/Program Managers: BLR&D and CSR&D Contact Information (va.gov)

Newsletter:  Lucindia.Shouse@va.gov