U.S. GOVERNMENT PUBLISHING OFFICE

35–488 WASHINGTON : 2019

VA RESEARCH: FOCUSING ON FUNDING, FINDINGS, 

AND PARTNERSHIPS 

JOINT HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

JOINT WITH

SUBCOMMITTEE ON OVERSIGHT & INVESTIGATIONS 

OF THE

COMMITTEE ON VETERANS’ AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

THURSDAY, MAY 17, 2018 

Serial No. 115–60 

Printed for the use of the Committee on Veterans’ Affairs 

( 

Available via the World Wide Web: http://www.govinfo.gov 

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COMMITTEE ON VETERANS’ AFFAIRS 

DAVID P. ROE, Tennessee, Chairman 

GUS M. BILIRAKIS, Florida, Vice-Chairman 

MIKE COFFMAN, Colorado 

BRAD R. WENSTRUP, Ohio 

AMATA COLEMAN RADEWAGEN, American 

Samoa 

MIKE BOST, Illinois 

BRUCE POLIQUIN, Maine 

NEAL DUNN, Florida 

JODEY ARRINGTON, Texas 

JOHN RUTHERFORD, Florida 

CLAY HIGGINS, Louisiana 

JACK BERGMAN, Michigan 

JIM BANKS, Indiana 

JENNIFFER GONZALEZ-COLON, Puerto 

Rico 

TIM WALZ, Minnesota, Ranking Member 

MARK TAKANO, California 

JULIA BROWNLEY, California 

ANN M. KUSTER, New Hampshire 

BETO O’ROURKE, Texas 

KATHLEEN RICE, New York 

J. LUIS CORREA, California 

CONOR LAMB, Pennsylvania 

ELIZABETH ESTY, Connecticut 

SCOTT PETERS, California 

JON TOWERS, Staff Director 

RAY KELLEY, Democratic Staff Director 

SUBCOMMITTEE ON HEALTH 

BRAD WENSTRUP, Ohio, Chairman 

GUS BILIRAKIS, Florida 

AMATA RADEWAGEN, American Samoa 

NEAL DUNN, Florida 

JOHN RUTHERFORD, Florida 

CLAY HIGGINS, Louisiana 

JENNIFER GONZALEZ-COLON, Puerto Rico 

JULIA BROWNLEY, California, Ranking 

Member 

MARK TAKANO, California 

ANN MCLANE KUSTER, New Hampshire 

BETO O’ROURKE, Texas 

LUIS CORREA, California 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

JACK BERGMAN, Michigan, Chairman 

MIKE BOST, Illinois 

BRUCE POLIQUIN, Maine 

NEAL DUNN, Florida 

JODEY ARRINGTON, Texas 

JENNIFER GONZALEZ-COLON, Puerto Rico 

ANN MCLANE KUSTER, New Hampshire, 

Ranking Member 

KATHLEEN RICE, New York 

SCOTT PETERS, California 

KILILI SABLAN, Northern Mariana Islands 

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public hearing records 

of the Committee on Veterans’ Affairs are also published in electronic form. The printed 

hearing record remains the official version. Because electronic submissions are used to 

prepare both printed and electronic versions of the hearing record, the process of converting 

between various electronic formats may introduce unintentional errors or omissions. Such occurrences are inherent in the current publication process and should diminish as the process 

is further refined. 

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C O N T E N T S 

Thursday, May 17, 2018 

Page 

VA Research: Focusing On Funding, Findings, And Partnerships ..................... 1 

OPENING STATEMENTS 

Honorable Neal Dunn, Acting Chairman .............................................................. 1 

Honorable Julia Brownley, Ranking Member, Subcommittee on Health ........... 2 

WITNESSES 

Robin L. Rusconi J.D., Chair, Board of Directors, National Association of 

Veterans’ Research & Education Foundations .................................................. 4 

Paul Klotman M.D., President, Chief Executive Officer, and Executive Dean, 

Baylor College of Medicine, On behalf of Association of American Medical 

Colleges ................................................................................................................. 5 

Carolyn Clancy M.D., Executive in Charge, Veterans Health Administration, 

U.S. Department of Veterans Affairs ................................................................. 7 

Accompanied by: 

Rachel B. Ramoni D.M.D., Sc.D., Chief Research and Development Officer, Veterans Health Administration, U.S. Department of Veterans 

Affairs 

STATEMENTS FOR THE RECORD 

Roger Murray Executive Director, the Coalition to Heal Invisible Wounds ....... 37 

Rick Weidman, Executive Director for Policy & Government Affairs, Vietnam 

Veterans of America (VVA) ................................................................................. 41 

Ms. Jacqueline Garrick, LCSW-C, Whistleblowers of America ........................... 43 

National Association of Veterans’ Research and Education Foundations 

(NAVREF) ............................................................................................................. 48 

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VA RESEARCH: FOCUSING ON FUNDING, 

FINDINGS, AND PARTNERSHIPS 

Thursday, May 17, 2018 

U.S. HOUSE OF REPRESENTATIVES, COMMITTEE ON VETERANS’ AFFAIRS, SUBCOMMITTEE ON HEALTH

Washington, D.C. 

The Subcommittees met, pursuant to notice, at 10:03 a.m., in 

Room 334, Cannon House Office Building, Hon. Neal Dunn presiding. 

Present: Representatives Bergman, Dunn, Bost, Poliquin, 

Arrington, Higgins, Coffman, Brownley, Kuster, Rice, O’Rourke, 

Correa, and Lamb. 

OPENING STATEMENT OF NEAL DUNN, ACTING CHAIRMAN 

Mr. DUNN. This meeting has come to order. Good morning, I 

thank all of you for joining us today to discuss the Department of 

Veterans Affairs medical and prosthetic research program. Before 

I begin, I would like to ask unanimous consent for our friend and 

fellow Committee Member Congressman Coffman from Colorado to 

join us on the dais for today’s proceeding, when he comes in we will 

seat him. 

Without objection, that is ordered. 

All right. Well, current law requires VA to conduct research in 

order to carry out more effectively the primary function of veteran’s 

health administration in order to contribute to the Nation’s knowledge about disease and disability. The VA research program has attracted high quality clinician researchers to VA medical centers 

and led to many important partnerships. This has resulted in discoveries that have benefitted everybody in this room. You will hear 

the VA tout some of these most notable discoveries this morning. 

They range from the pacemaker in 1959 to the shingles vaccine in 

2006. 

Despite these successes, the Committee has become increasingly 

concerned that the VA’s research program is in need of refocusing 

in several important areas. First, it is not clear that the majority 

of the research that the VA conducts displays a concentrated focus 

on veteran specific conditions and concerns. 

There are many valuable research topics such as obesity and 

heart disease that are very deserving of research dollars and attention. But the VA’s research program is meant to support research 

on issues that are unique to or particularly prevalent among veterans, and may not be receiving the funding and attention they deserve by other research entities. And these issues are such as toxic 

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exposures, traumatic brain injuries, and post-traumatic stress disorder. 

Secondly, there are concerns that VA medical facilities are not 

complying with the VA policy by administering grants from outside 

entities through VA non-profit research and education corporations 

to the extent that is possible. The vast majority of VA researchers 

are duly appointed at both a VA medical facility and a nearby academic affiliate, which can create conflicts of interest when it comes 

time to determine where our given grant is administered. 

There are significant financial considerations inherent in that determination, and the VA has to make sure that the department is 

given due consideration and not leaving a cent of potential research 

funding on the table and out of the veterans reach. Finally, there 

are concerns that the VA’s not getting a significant return on its 

investment in research overall. 

A statement from the record from the Vietnam Veterans of 

America said it perhaps most succinctly. ‘‘How much of what VA 

research produced recently is of significant benefit to veterans?’’ 

And I have no doubt that the VA’s researchers are leaders in their 

field, making great progress on a regular basis, but we are not sure 

that enough of what VA researchers are discovering is being translated efficiently and effectively into the VA medical centers and 

clinics to benefit veterans across the country. 

I am grateful today for our witnesses for their attendance here 

this morning to discuss these issues with us. One thing I will note 

before yielding is that the Subcommittee on health will be holding 

another hearing on June 8th that will focus specifically on burn pit 

research. I am looking forward to that and diving deeper into that 

specific research efforts at that hearing and not today. 

I will yield to Ranking Member Brownley for any opening statement that she may at this time. Thank you. 

OPENING STATEMENT OF JULIA BROWNLEY, RANKING 

MEMBER, SUBCOMMITTEE ON HEALTH 

Ms. BROWNLEY. Thank you, Mr. Chairman. This morning this 

Subcommittee will delve into issues involving VA’s mission to discover knowledge, develop researchers and health care leaders, and 

create innovations to advance health care for veterans and the Nation. 

The successful advancement of this mission has positioned VA as 

the largest single provider of medical training in the United States. 

Today, over 70 percent of health care providers have received training through the VA. The partnerships VA has established with academic institutions and VA non-profit corporation have proven integral to VA’s advancement of veteran-centric research. 

VA’s relationship to its academic affiliates is essential if VA is 

to provide the level of health care that we all expect for our veterans. This is why Congress, the VA, and it academic affiliates 

must work together to address areas that need improvement. 

While our overall health care system reaps the benefits of VA inventions, VA also benefits by being able to rely on the high-quality 

providers and specialists that this type of research attracts. VA 

physicians are often on the leading edge of medical knowledge and 

leaders in their field of practice. 

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For instance, earlier this year the Minneapolis VA published a 

study that found that opioid pain killer are no more effective than 

safer alternatives in long-term treatment of patients with chronic 

pain. Not only is this information timely but it will likely shape 

Federal policies surrounding the prescribing of opioids in the future 

and save thousands of Americans from falling victim to opioid addiction. 

Because of the important work VA’s Office of Research and Development has accomplished, I wish to examine how we can better 

support VA research and research conducted by our academic affiliates in VA non-profit research corporations. I am concerned that 

VA’s current research budget is not keeping pace with inflation. 

And if NIH awards significantly fewer research grants, this will 

have a negative effect on VA’s ability to develop treatments for our 

veterans. 

If funding for VA research continues to be lacking, I want to 

know about how VA can continue to leverage private investment in 

non-profit funding through our non-profit research corporations 

and through our academic affiliates to make up for Federal research funding shortfalls. 

Finally, I want to continue to work with Ranking Member Kuster 

and our colleagues across the aisle to ensure VA is properly overseeing its research programs and the administration of NIH funded 

research through the VA’s non-profits research corporations and its 

academic affiliates. 

I would also like to better understand when it is appropriate for 

VA non-profit corporations and academic affiliates to administer 

NIH grants, and ensure VA is following its current policy directives. We need to come together to figure out the best way to ensure vital research to advance veterans health care needs is funded, and that it is administered properly so that this funding results 

in treatments that improve, and in some cases, save veterans lives. 

Educating our Nation’s health care providers and developing medical breakthroughs to provide treatment to our veterans are part of 

VA’s core mission. It is vital that we, as Members of Congress, support this mission. 

So thank you, Mr. Chairman, Dr. Dunn. And I yield back the balance of my time. 

Mr. DUNN. Thank you very much Representative Brownley. 

I will make note that Chairman Bergman and Ranking Member 

Kuster will be making closing statements at the end of our hearing. 

And so I welcome our panel, and I will introduce you now. 

First, we have Robin Rusconi, Chair of the Board of Directors for 

the National Association of Veterans’ Research & Education Foundations. Next, we have Dr. Paul Klotman who is a nephrologist by 

training, the President and Chief Executive Officer, and Dean of 

Baylor College of Medicine, and here on behalf of the Association 

of American Medical Colleges. And I will make note that they are 

also the very first VA hospital ever. 

Also, Dr. Carolyn Clancy, Executive in Charge of the Veterans 

Health Administration for the U.S. Department of Veteran Affairs, 

and who is accompanied also by Dr. Rachel Ramoni, VA’s Chief Research and Development Officer. Welcome panel, we thank you all 

for being here with us this afternoon. 

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And, Mrs. Rusconi, I believe we will start with you. And you are 

now recognized for five minutes. 

STATEMENT OF ROBIN RUSCONI 

Ms. RUSCONI. Chairman Bergman and Dunn, Ranking Members 

Kuster and Brownley, distinguished Members of the Subcommittees, thank you for holding this important hearing. 

VA research is an essential but under-publicized element of the 

VA health care system. It has a distinguished history of discovery 

and innovation that has benefitted veterans and the Nation for 

over 90 years. The Congressionally authorized VA affiliated nonprofit corporations are proud to support and augment VA research. 

My name is Robin Rusconi. Since 2014, I have been the executive 

director of the VA affiliated non-profit corporation located in Kansas City, Missouri. I am currently the chair of the Board of Directors for the National Association of Veterans’ Research and Education Foundations, known as NAVREF. 

As a child of two World War II veterans, I am proud to be supporting the VA research program and helping improve the lives of 

veterans. NAVREF’s mission is simple, we exist to advance the success of the VA affiliated non-profit corporations. I am here today 

to tell you about the great work of our non-profits, our potential for 

greater contributions, and the progress made since last year’s hearing. 

We are pleased that the House Veterans Affairs Committee recognizes the importance of the non-profit corporations in the VA research enterprise. Over the last four years alone, the NPC’s have 

administered over $1 billion in support of the research and education activities at VA medical centers. 

NAVREF and its members are excited too to support Dr. 

Ramoni’s three strategic priorities for VA research; to provide 

greater access to clinical trials for veterans, to make VA data a national resource, and to achieve substantial real-world impact. 

While NAV—excuse me—while NAVREF is proud of all the 

NPCs have accomplished, we feel they have the potential to make 

even greater contributions. In June 2017 the House Veterans Affairs Oversight and Investigations Subcommittee held a hearing 

about VA research that included testimony from NAVREF. During 

that testimony, NAVREF made several recommendations. I would 

like to update you on the progress made on two of those recommendations. 

First of all, we were heartened to hear that the Office of Research and Development would engage an outside consultant to assess the need for VA to establish and enforce clear guidelines for 

administering Federal awards. Unfortunately, we are frustrated 

that the process has moved slowly, and we are concerned that the 

perspective of the non-profit corporation is not being fully investigated and appreciated. 

We believe the VA should enforce clear guidelines for the administration of extramural research activities that offer the NPC right 

of first refusal for all research efforts when the majority of this 

work occurs physically within the VA. 

Second, the VA’s non-profit oversight board took several positive 

steps last October regarding the oversight reviews being conducted 

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by the non-profit program office. Specifically, the NPOB created a 

clear appeals process, established an anonymous survey tool to receive feedback, and ensured oversight review out briefs include the 

full board of directors and the executive director of the non-profit 

corporation. 

Each of these changes have been in place for a short time, so it 

is too early to determine if they have been effectively communicated to local VA leadership and if they will have their intended 

impact. Additionally, we would like to see greater clarity on the 

scope of these reviews. Our members are all independent 501(c)3 

corporations remain confused about what is subject to VA review 

and what may be out of scope. 

Thank you again for your attention to these matters. We greatly 

appreciate your continuing support of the VA research program 

and your support of the VA affiliated non-profit corporations. We 

look forward to working with you to achieve our vision of a Nation 

in which veterans receive the finest care based on innovated research and education. 

Mr. DUNN. Thank you very much, Ms. Rusconi. 

Dr. Klotman, you are now recognized for five minutes. 

STATEMENT OF PAUL KLOTMAN 

Dr. KLOTMAN. Thank you, Dr. Dunn. I really appreciate the opportunity to testify in front of you today. In addition to the Baylor 

College of Medicine, I also represent the Association of American 

Medical Colleges, which is a non-profit organization comprised of 

all the U.S. medical schools and major teaching hospitals including 

many of the VA hospitals. 

And I would like to thank the Full VA Committee for preserving 

the VA’s clinical relationship with academic medicine in the VA 

mission act to ensure our Nation’s veterans have access to clinical 

services at our institutions and receive the highest quality of 

health care. 

For this hearing I will share information on the research enterprise and the VA academic relationship through my experience as 

a clinician and researcher. For you—you may not know this, but 

I began my career as a trainee clinician physician scientist at the 

VA, and I was also supported by the NIH. I was a staff physician 

at the Durham VA for 13 years while at the faculty at Duke Medical School. And both my wife and I are partially supported by 

Duke to work at the Durham VA. I have spent 17 years in civil 

service between my time at the VA and the NIH. And, by the way, 

I am the Dean, my wife is also the Dean at the Duke Medical 

School, we all started our careers at the VA. 

The Michael DeBakey VA Medical Center in Houston was the 

first to affiliated with an academic partner, and has been affiliated 

with Baylor since 1949. Today, it is one of the VA’s largest hospitals serving Harris County, Texas, in 27 surrounding counties. 

Baylor physicians provide virtually 100 percent of the medical 

care at the DeBakey VA. The veterans from around the country are 

referred there, and Baylor physicians provide the clinical services 

often not available by other providers, same physicians at Baylor 

hospitals and the VA hospital. 

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Medical schools fully integrate research and education with patient care, and these are very interdependent, as many of you physicians know, and to split those apart would really jeopardize the 

quality of care. Interestingly, the VA medical centers share the 

same tripartite mission of education, research, and clinical care. 

And by working together, we enhance the care for veterans—research that provides new treatments and train the next generation 

of health care providers, many of whom are then attracted to have 

a career in the VA. 

Our clinical research partnership has led to tremendous care for 

our Nation’s veterans at the DeBakey VA. We have one of the ten 

VA trans-aortic valve replacements programs, it is only one of two 

in the country with expertise in bronchial stenting for patients 

with lung cancer and fibrosis, and is one of the few that has a designated stroke center. 

The DeBakey VA is the hub of our VISN, but it also gets national referrals with complex cases, second opinions, we have people sent from all over the country to our VA. And we have launch 

centers of excellence in cancer and Parkinson’s Disease, post-traumatic stress disorder, liver transplant, epilepsy, substance abuse, 

and rehabilitation for mild to traumatic brain injury. 

Our faculty are absolutely passionate about improving quality of 

care for the veterans, as well as our other affiliated hospitals. As 

national leaders, they can rapidly implement new guidelines and 

best practice initiatives for medical conditions in the care of our 

veterans. This partnership has played an important role in the 

DeBakey VA achieving a four-star rating in just a six-month period 

of time. 

Research leads to medical advances, and Baylor and DeBakey VA 

have supported collaborations leading to innovation in mental 

health and cancer treatment, and prevention of antibiotic resistant 

infections, and chronic obstruction lung disease and emphysema, as 

well as cardiac care. 

Nationally, most VA researchers have joint appointments at the 

VA and the affiliated medical school, which to physician scientists 

views it as a huge advantage, and it is a real important recruiting 

tool. At DeBakey, VA researchers have faculty appointment at 

Baylor giving them access to all the resources at Baylor including 

core laboratory facilities, oversight committees, dedicated IRB to 

the VA clinical trials, accreditation for human and animal research, 

and pre-award management for all non-VA grants. And these resources can be prohibitively expensive for VA medical centers and 

their not-for-profit corporations to support if they were independent 

of the affiliate. Sharing with academic affiliates reduces unnecessary redundances and maximizes the use of Federal dollars. 

Each VA academic partnership is unique. For example, about 20 

years ago Baylor and the DeBakey VA consulted with the VA, our 

non-for-profit organization, and HHS, and agreed that we should be 

reimbursed by NIH grants for the on-campus facility FNA. Baylor 

provides complete research oversight support and provides annual 

contributions to the non-for-profit corporation to support VA research. So money is flowing to the VA from us. 

All other medical schools—at other medical schools, NIH grants 

are administered via VA researchers vary based on the amount of 

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infrastructure provided by the VA. Due to this variation in support 

that various VAs have for the research enterprise, the AAMC believes that administration of NIH grants should be determined at 

the local level by each VA medical center. A one-size fits all approach could hurt VA research programs as well as the collaborations with affiliates. 

The DeBakey VA relationship with Baylor and the joint appointment of researchers also is an important tool for recruiting physicians and scientists to the VA and retaining high quality researchers. The VA affiliation also enhances the training quality of our 

programs, the Baylor programs. Our students and residents have 

the opportunity to work with veterans and learn about military 

health, which makes them better doctors. 

There are additional recommendations in the written testimony, 

but if I leave you with one message today, it is without the synergistic 70-year partnership with academic medicine, the VA’s ability 

to fulfil its mission of patient care, education, research would be 

limited. 

I appreciate this opportunity again, and I look forward to answering any questions that you have. 

Mr. DUNN. Thank you very much, Dr. Klotman. 

Dr. Clancy, you are now recognized for five minutes. 

STATEMENT OF CAROLYN CLANCY 

Dr. CLANCY. Good morning, Chairman Dunn, Chairman 

Bergman, Ranking Members Brownley and Kuster, Members of the 

Subcommittee. I appreciate the opportunity to discuss VA’s medical 

and prosthetic research program, and I am accompanied by Dr. Rachel Ramoni our chief research and development officer. 

VA’s Office of Research and Development has been improving the 

lives of veterans through health care innovation and discovery for 

more than 90 years. And in so doing, civilians have also benefitted 

from groundbreaking advances including the first successful liver 

transplant, and, as mentioned by the Chairman, the pacemaker, 

and the first shingles vaccine. 

We continue to conduct cutting-edge research such as the development of a bionic ankle that helps propel users forward, the creation of the Million Veteran Precision Medicine Initiative, and 

groundbreaking work to repair severed spinal cords. In addition to 

the scientific merit of VA research, VA is also recognized for its 

ability to translate research findings into real-world benefits for 

our veterans. 

I want to thank the Committee for the additional resources you 

provided in the omnibus. And, in fact, we have created a one-page 

summary of how we will prioritize that unexpected but very welcome investment of resources, which I would like to ask be entered 

into the record. 

Mr. DUNN. Without objection, it is entered. 

Dr. CLANCY. The non-profit research and education corporations, 

or NPCs, are an important part of the VA research partnership 

ecosystem, established in 1988 to serve as a flexible vehicle to receive the external funds that help drive VA innovation. For example, a recently announced multi-million-dollar interagency agreeleonard.horne on VACREP0180 with DISTILLER

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ment with the National Cancer Institute will be administered by 

the not-for-profit corporations. 

VA’s affiliations with our Nation’s medical schools go back to 

1946 when General Omar Bradley forged this pioneering partnership. Seventy-two years later, we are affiliated with well over 90 

percent of medical and osteopathic schools, so these partnerships 

give us access to cutting-edge technology, expertise, and national 

research networks that would be difficult, costly, and wasteful to 

duplicate within VA. For example, the spinal cord repair program 

previously mentioned is the product of a very strong collaboration 

with the University of California system. 

VA research is committed to supporting activities that improve 

the health and well-being of our veterans. Our office of research 

and development evaluates proposed research projects by conducting rigorous scientific peer review. Projects that are not veteran focused do not receive funding. 

In addition, our research portfolio is continually rebalanced over 

time to meet our veterans most pressing needs. So, today, our five 

clinical priorities are post-traumatic stress disorder, traumatic 

brain injury, suicide prevention, opioids, and Gulf War illness. 

While VA’s medical and prosthetic research program focuses on 

benefitting current and future veterans, the output of our research 

ultimately benefits the Nation. For example, in 2017 VA launched 

a nationwide study of the health benefits of a robotic exoskeleton 

for veterans with spinal cord injury. VA research also has an impressive track record of transforming VA health care by bringing 

new evidence-based treatments and technologies into everyday clinical care. 

Two key examples recently. First is the implementation of a new 

suicide prevention clinical initiative, this has been defused across 

our system. Based on predictive modeling and existing medical 

record data to identify veterans at the very highest risk of suicide 

so we can provide them with more intensive services and follow-up. 

Veterans are now using the bionic LUKE arm as the result of 

our Office of Research’s partnerships. The approval and delivery to 

veterans of the most advanced prosthetic arm ever created. This is 

an area upper limb prosthesis that has not seen advances in about 

50 years. 

VA’s medical and prosthetic and research program has significantly improved the care and well-being of our veterans. These 

gains have been possible because of consistent congressional commitment in both the form of attention and financial resources. And 

we believe it is critical to continue to move forward with the current momentum and preserve the gains made thus far. 

This concludes my testimony. My colleague and I are prepared 

to answer any questions. 

Mr. DUNN. Thank you very much, Dr. Clancy. 

We are going to take—go around the dais and have everybody 

five minutes to ask you questions. I am going to ask the panel to 

try to answer concisely. I know that it is hard sometimes, we ask 

vague questions. But since we each only have five minutes, it is a 

plus if we can be concise. 

So I am going to yield myself five minutes now. And start with 

Dr. Clancy a question. Given the prevalence of the PTSD and TBI 

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among veterans, I would like to know a little bit more about this. 

These are prioritized treatments you have and technologies, what 

do we—what can we offer our veterans that we hadn’t been offering? 

Dr. CLANCY. To some extent we are looking at different and can 

offer now new medical treatments, and we are also looking at ways 

of how to delivery those treatments. For example, I am going to 

guess that you are aware that one-third of the veterans we serve 

live in rural areas, so they have got a pretty substantial distance 

to travel to get care. And we have recently tested and developed 

a telehealth approach so that veterans can get this care virtually. 

And as nearly as we can tell from published studies, this is just 

as effective as traveling that distance and coming in person. 

Mr. DUNN. So you have got metrics on that? 

Dr. CLANCY. Yes. 

Mr. DUNN. We would love to have you share that with us. 

Dr. CLANCY. Sure. 

Mr. DUNN. Not right this minute, but that is something that 

would be of keen interest, I think, to everybody in this Committee. 

Dr. Klotman, you mentioned not one size fits all, and one of the 

areas that we have had some interactive with, which IRB do we 

use? 

Dr. KLOTMAN. So it depends on what institution. In our case, we 

have seven independent IRBs, but one of them is dedicated to the 

VA. So we can get very quick IRB approval for any clinical protocol. 

Mr. DUNN. Is the VA IRB quick for you? Is it easy to use? 

Dr. KLOTMAN. It is because it is run by Baylor. 

Mr. DUNN. Oh, okay. 

Dr. KLOTMAN. So we man—it is sort of outsourced to us, so we 

do it for— 

Mr. DUNN. Do you think that that translates across the country 

to all the researchers, because we get the sense that maybe it isn’t? 

Dr. KLOTMAN. I would say one of the big problems, when talking 

to academic institutions, with their VA affiliate is getting clinical 

trials approved. And I think it would—it is worth exploring how to 

improve the IRBs to facilitate clinical research for veterans. Absolutely important. 

Mr. DUNN. Okay. While I have got you there, Dr. Klotman, I am 

going to ask you about translation of VA research to the vet side. 

So that if a clinical translation, do you think that that is happening 

well? Do you think it is happening rapidly, or enough? 

Dr. KLOTMAN. I think it is happening terrifically well. We respond, you know, scientists respond to funding opportunities. When 

you list five priorities, our scientists are focused on mental health, 

on opioid addiction, on PTSD, traumatic brain injury. We are trying to do AI, run facial recognition to pick up depression by telemedicine. So we are very focused on trying to translate our work 

directly to patient care. But that is a mission, you know, of the— 

you look at the top 30 or 40 medical schools that are into research, 

it is—we do translation research, that is what we are trying to do, 

and the VA does it very well. 

Mr. DUNN. So if I am a medical student—I am not going to go 

back to medical school—if I was a medical student— 

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Dr. KLOTMAN. I would feel sorry for you. 

Mr. DUNN [continued]. —you could have a—you have a syllabus 

for —and I think these three would fit—or four, top four priorities, 

or five, would fit together very neatly; PTSD, TBI, suicide, and 

opioids. I mean, that sounds like one chapter, get this, and read it 

twice. Is that—we have a syllabus for that? 

Dr. KLOTMAN. Well, we don’t have a syllabus per se, but we do 

encourage our students to do research with these investigators. 

One of the—we have a specialized center called iQuest, which is 

really around health and human services research, it is one of the 

biggest in the country. And we have 25 faculty and probably 40 

trainees in that group all doing research appropriate for veterans. 

It is actually funded by the VA and the NIH, and it is a tremendous center. So we have direct access for our trainees and learners 

to get into issues related to veterans. 

Mr. DUNN. Great. 

Dr. Clancy, so the same question on translation. Can you address 

that from your point of view, or maybe Dr. Ramoni? You choose. 

Dr. CLANCY. Well, research that we publish, and support is highly publicized within our own system. The next step is obviously to 

make sure that that is tightly linked with clinical operations. And 

I have to say that under Dr. Ramoni’s leadership, there has been 

a much, much stronger partnership there between the research enterprise and the people who have got to worry every day about how 

to get this done. 

We literally had all of our network leaders in town this week, 

and to say—and Dr. Ramoni was not actually there for the conversation—but to say they were excited about research, and to hear 

where they have taken money out of their own budgets to make 

sure that their veterans have access to the findings so that they 

can put them into practice was quite— 

Mr. DUNN. I am running short on time— 

Dr. CLANCY [continued]. —wonderful. 

Mr. DUNN. —here, so I—and I want to be—I want to observe the 

limits so that I will be a good role model here. The ORIEN, Dr. 

Ramoni, are you using ORIEN for the total cancer care? Is that 

something that is? 

Dr. RAMONI. We are not—sorry—we are not yet participating in 

ORIEN, and that is in part because ORIEN and APOLLO in which 

we are participating, both are seeking the same types of samples. 

Mr. DUNN. Okay. You and I are going to talk offline. And I recognize my time has run out. I will yield to Ms. Brownley. Representative Brownley. 

Dr. RAMONI. I look forward to that. Thank you. 

Ms. BROWNLEY. Thank you very much. I have just sort of a general overall question as it relates to the research that VA is undertaking. So where does one go to find out where all of the research, 

you know, what are all of the research projects, you know, across 

the country, and where is that happening? You know, what are sort 

of the subject areas? Dr. Dunn just mentioned a couple in terms 

of opioid abuse or brain injuries, post-traumatic stress, et cetera. 

But where—I don’t know kind of what is happening on a global 

sense in terms of the research. 

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11 

Dr. CLANCY. It is a great, great question, and I am so glad you 

asked. We put out a lot of information in the form of quarterly updates and newsletters. And I will tell you if you run an organization, as I did for a number of years outside VA that funds a lot of 

research, it is a bit challenging to figure how do you put these into 

buckets together in a way that is very, very accessible. 

I think we could do a better job. I think that in many ways some 

of the phenomenal research we are funding has become one of the 

world’s best kept secrets, and we are working very hard to try to 

overcome that. Do you want to add to that? 

We also have an external research advisory committee that 

meets four times a year. So they become a very important source 

of spreading our research. But we have a lot more to do. 

Ms. BROWNLEY. Are they like an overseer, or? 

Dr. CLANCY. They are an advisory group. I think it is fair to say 

that they do give a lot of advice. And one person’s advice might feel 

like someone else’s oversight. But four times a year I think is a 

pretty good rhythm, and they are pretty current on what is going 

on. 

Dr. RAMONI. Hi. Thank you for your question. I would just like 

to add that all of the research we fund is available through ERA 

Commons, which is NIH reporter. So if you go to the NIH reporter 

Web site and you select VA, you can get a list of all the projects 

we fund. 

Now, as Dr. Clancy said, I think we can do a better job of summarizing that because I doubt with your busy schedules that you 

have time to scroll through our 2,000 funded projects. But what we 

are—what our national research advisory committee has advised 

us is that we ought to, at least on a yearly basis, summarize the 

research impact so that we can share more broadly with others. 

And we do have a breakdown of where our funding is going in 

terms of types of research that we can certainly make available to 

you. 

Ms. BROWNLEY. And is that found on a Web site somewhere as 

well in terms of the priorities and the amount of resources funding 

as priorities? 

Dr. RAMONI. We can certainly direct you to those. I am not certain if they are listed on the Web site because as Dr. Clancy said, 

it can sometimes be a challenge to clearly convey the distinct categories. For instance, if you were looking at suicide risk amongst 

people with opioid substance use disorder, they would be classified 

under two sections. And so that is sometimes a challenge for us to 

present. But we would be happy to walk you through that orally 

as well in a briefing. 

Ms. BROWNLEY. Yeah. And just as a, you know, a layperson looking into this, it seems—it just seems very complicated and complex 

in trying to, you know, pull the layers apart to kind of see what 

is there. And once you start doing that, it tends to get more confusing—to me, anyway—and more complicated as opposed to sort 

of understanding, you know, what are the broad strokes, and are 

we all in agreement in terms of where—what our priorities are in 

the areas in which we want to continue to explore. And so, anyway, 

it just is a general statement. I think for a layperson and for people 

to understand that we are actually doing research and pursuing inleonard.horne on VACREP0180 with DISTILLER

12 

novations when we really can’t translate to the public and to the 

communities so that people know that their tax dollars are going 

to a good purpose, and that we do want to resolve and solve some 

of these issues that particularly veterans are experiencing when 

they come home from the battlefield, so. 

Dr. CLANCY. So I am going to take that as a charge that we need 

a greatest hits. To use an old analogy. No, but I mean, I am saying 

that with the upmost respect. It takes some thought and so forth 

to do that. But we should. 

Ms. BROWNLEY. Very good. I see my time is out, so I will yield 

back. 

Mr. DUNN. Thank you, Representative Brownley. And since you 

yield back ten seconds, I am going to say we would all like to see 

that list of, you know, sort of—not the all 2,000 but how you are 

prioritizing, where the resources are going, and sort of by subject 

matter what they are. So thank you very much for that. 

We will now recognize Mr. Poliquin for five minutes. 

Mr. POLIQUIN. Thank you, Mr. Chairman, I appreciate it. Thank 

you all very much. It is so important to make sure that our research goes on with our affiliates, our academic affiliates, in concert with VA to make sure that we do the best we can for our veterans. We owe them that responsibility to do that. 

Dr. Klotman, I want to ask you a question. You mentioned a 

minute ago some of your research dealt with diabetes, and what 

have you. Why wouldn’t the VA—why wouldn’t all the research on 

behalf of our veterans focus on ailments and maladies that are specific to veterans like PTSD, and traumatic brain injury, and exposure to toxins, and so forth, so on? If you have all these other institutions around the country doing great work on cancer and diabetes, why would we spend tax payer dollars to do that when we can 

get that already? 

Dr. KLOTMAN. So I think you have to look at the broad health 

of veterans throughout their entire life span. Yet there are things 

that are very specific to veterans, but there are also things that impact veterans’ lives. If you look at, you know, the vast number of 

veterans that we are taking care of, their day-to-day problems are 

often common illnesses. 

Mr. POLIQUIN. Yeah. We have research on most of those common 

ailments. 

Dr. KLOTMAN. But breakthroughs come from all different places. 

It is really hard to, you know, to say, well, we are going to have 

a cure for diabetes that is NIH focused. 

Mr. POLIQUIN. So we might be doing— 

Dr. KLOTMAN. Another big breakthrough might come from— 

Mr. POLIQUIN [continued]. —we might be spending tax payer— 

Dr. KLOTMAN [continued]. —VA— 

Mr. POLIQUIN [continued]. —we might be spending tax payer dollars working on diabetes for veterans where we are doing it at 

other research facilities around the country, and you don’t think 

that is duplicative and wasteful? 

Dr. KLOTMAN. No, I actually don’t. I will tell you the vast majority of research that we do at the VA is very specific to veterans’ 

problems. But— 

Mr. POLIQUIN. The veterans—thank you, sir. Dr. Clancy— 

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13 

Dr. KLOTMAN. Let me just say one thing, though. If you are taking care of a veterans for their entire life span and you are trying 

to have them have a, you know, good outcomes, you have to take 

care of all of their illnesses. 

Mr. POLIQUIN. No, of course not. I am not talking about specific 

to a veteran, I am saying a malady that is specific to the veteran 

population, that is what I am referring to. 

Dr. Clancy, the VBA, the Veterans Benefit Administration, collects mountains of data on the 7 million veterans we take care of 

now. Do we aggregate this data, and whiteout, of course, who the 

individuals are, but aggregate this data such that we can use it to 

determine where the research should go? 

Dr. CLANCY. We have some people who are beginning to take a 

very hard look at that. I guess— 

Mr. POLIQUIN. Do we aggregate the data, and do we use it to 

make decisions on where the research dollars should go for our veterans? Because anybody that collects that amount of data on the 

veterans certainly know what their problems are. 

Dr. CLANCY. Yes, and we are certainly aware of where the greatest opportunities are in terms of— 

Mr. POLIQUIN. Okay. So who is aggregating— 

Dr. CLANCY [continued]. —how many people apply for benefits. 

Mr. POLIQUIN. So who is aggregating that data? 

Dr. CLANCY. We can take that for the record, and I will followup. It is not a routine function that feeds right into research priorities, but I—which is what I think you are suggesting. 

Mr. POLIQUIN. If we are looking for research on veterans who 

have problems, and we have mountains of data on what their ailments are, it would make sense to me that we use that information. So our office will get back to you to see what a more complete 

answer would be, if that is okay. 

Dr. CLANCY. Yes, that would be fine. 

Mr. POLIQUIN. Great. Thanks. Today, Mr. Chairman, there is about $600 million in the VA budget that is specifically earmarked 

for medical research that is conducted either at the VA medical facilities around the country, about 160 of them, but there is an additional $1.2 billion each year, roughly, for veterans—for research for 

veteran health, and it comes mostly from the NIH and the Department of Defense, and they are issued by grants. 

This research is either conducted at the VA or at medical institutions, affiliates, academic institutions, universities like Baylor, 

great universities like Baylor, across the country. Now there are, 

if I understand this correctly—and, Ms. Rusconi, you are going to 

correct me if I am wrong, I am sure—there are roughly 150 individuals across the country that make decisions where the administration of those research projects go. 

Either through you folks, through the NPCs, or they are administered actually through the research organization themselves. I 

think they are called investigators. And I think, Ms. Ramoni, you 

came to us several months ago, and you used to be an investigator. 

And, Mr. Klotman, you might be one now, I don’t know. 

But my point being this. If an investigator is an employee of the 

VA, and also an employee of say Harvard—my alma mater, so I am 

not picking on Baylor—and they all of a sudden are an individual, 

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14 

he or she, whose career is dependent upon how much tax payer dollars they can come to that institution, whether you are Baylor or 

Harvard, or Yale or Stanford, whatever it might be, but they are 

also in a position to determine who gets the administration dollars 

for that project. Now, up in Maine, where I come from, that is a 

conflict of interest. And here is why that matters. Let’s say you have a $10 million grant from the NIH. The administration cost is an add-on to that grant. Now if I am not mistaken, 

over at the NPCs that were formed 30 years ago specifically for 

this reason, your add-on cost is roughly 25, 26 percent. So that is 

$2-and-a-half million on a $10 million grant to develop whatever it 

might be, a new prosthetic. However, now places like Harvard, my 

understanding— 

Mr. DUNN. Mr. Poliquin. 

Mr. POLIQUIN [continued]. —is that the add-on cost— 

Mr. DUNN. Mr. Poliquin. 

Mr. POLIQUIN [continued]. —is roughly 70 percent. 

Mr. DUNN. Mr. Poliquin? 

Mr. POLIQUIN. Yes, sir. 

Mr. DUNN. Your time is expired, but I like your line of questioning. I encourage you to pursue that. 

Mr. POLIQUIN. Great. Would you like to, or anybody else like to 

give their time to me? Mr. Chairman. 

Mr. DUNN. I will give them their opportunity when your time 

comes. All right. So that will be the next. 

Mr. POLIQUIN. Thank you, sir. 

Mr. DUNN. Representative Kuster, you are recognized for five 

minutes. 

Ms. KUSTER. Thank you very much, Mr. Chairman, I appreciate 

it. And thank you to all of our witnesses for being with us. I want 

to also thank you for mentioning the LUKE arm in your testimony, 

Dr. Clancy. We are very proud in New Hampshire of the development of the LUKE arm, and I have had a chance to see it in action, 

and it is really very impressive. 

I wanted to hone in on the conversation about, our Chair today 

has mentioned PTSD, traumatic brain injury, opioid addiction. I 

am the Chair of a bipartisan task force in Congress, we now have 

105 Members working together, Republicans and Democrats, on 

legislation to combat the opioid epidemic, and I know that there is 

research being conducted, Congressman Brownley referenced a 

study out of Minnesota. It would be very helpful for us, and I 

would even like to ask our Chairs of the Health Committee, and 

the Subcommittee, and the Oversight Subcommittee, if we could 

put together a session that I would be happy to organization with 

members from the task force to talk about lessons that can be 

learned to reduce the use of opioid medication. 

But in that regard, can you talk a little bit more about how this 

research is getting from the lab to use across the VA? And then 

what we would like to do, I am working on legislation about a center of excellence, so that we can then take those lessons learned 

into the civilian population. 

Dr. CLANCY. So it is a great question, and, frankly, we use any 

vehicle that we can. So, for example, in terms of treating chronic 

pain and the use opioids, we have an evidence-base guideline that 

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we develop in collaboration with the Department of Defense because it speaks to the unique injuries and experiences of active 

duty members as well as veterans. 

So that becomes one—because those guidelines are updated almost continuously to make sure that they have all the current evidence, that becomes one great vehicle to incorporate our latest research. I think that your idea of having such a session would be 

phenomenal because there is a lot going on in three areas. 

One is, what other alternatives do we have to opioids? A second 

is, what nonpharmacologic in terms of chronic pain management, 

which the whole country is struggling for, and a bigger problem for 

our veterans. And the third is, how do we help people who are addicted actually begin to return to a functional life? 

Ms. KUSTER. And if I could just add to the list, a fourth would 

be the CDC has recognized that four out of five heroin users have 

co-occurring mental health issues— 

Dr. CLANCY. Yes. 

Ms. KUSTER [continued]. —and I think that veteran population, 

with the anxiety, depression, traumatic brain injury, we are finding 

in the civilian population trauma. For example, sexual assault, domestic violence trauma. So I think there is a lot to be learned, and 

you can tell from 105 Members of Congress coming and working together right now, this is very rare, and you can tell the urgency 

and the breadth of this problem across the country. So love to work 

with you on that. 

I guess my other question, I am very familiar, Dartmouth Medical School is my district, I work a lot with them, and they are the 

academic affiliate for White River Junction VA and hope—we are 

working on an affiliation, hopefully, with our Manchester VA that 

has had some troubles. I am familiar in the private sector in the 

civilian world that we have, for example, the New England Journal 

of Medicine, that physicians can stay current on research that is 

published. Is there a corollary from VA research where physicians 

can stay current based upon research results that are published? 

Dr. CLANCY. So we have a terrific dissemination center that is 

part of the Office of Research and Development, and they will routinely put out surveys of research, which is—not surveys, I am 

sorry, summaries of research that has just been published and so 

forth which is extremely helpful, they will usually give you the 

electronic link. So if the journal makes a free access, right then you 

have got it. And I was literally looking at one on the way over here. 

Some of our work is also going to get into something at NIH 

called Medline Plus, which actually translates into something closer to plain language English, I don’t want to over-state this, sort 

of abstracts of published studies and so forth. Whether we can and 

should do more, we share a lot of cutting-edge findings with our 

veteran’s service organizations and so forth. But I am sure that 

there is more that we could do. 

Ms. KUSTER. So my time is, but I think I would join my colleagues in saying that we would be very interested in accessing 

those preferably plain English versions to understand so that we 

can share with the tax payers the incredible advances that are 

coming out of the VA. And I yield back. 

Mr. DUNN. I thank you very much, Ms. Kuster. 

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Representative Higgins, we recognize you for five minutes. 

Mr. HIGGINS. Thank you, Mr. Chairman. I would like to yield a 

minute of my time to my colleague Mr. Poliquin. 

Mr. DUNN. You are recognized. 

Mr. POLIQUIN. Thank you, Mr. Higgins, very much, I appreciate 

it. 

We have already determined that at NPCs the add-on cost for 

administration is roughly 25, 26 percent. Mr. Klotman, what is the 

add-on cost of Baylor? 

Dr. KLOTMAN. 56.5 cents. 

Mr. POLIQUIN. Say it again, sir. 

Dr. KLOTMAN. 56.5 cents. 

Mr. POLIQUIN. 56.5. Ms. Rusconi, what is the difference between 

the administrative functions you provide for research down at the 

VA and the administrative that the folks at Baylor do, or at Harvard, or Yale, or anybody else? Is the service essentially the same? 

Does it include doing the paperwork, and paying the bills, and ordering supplies? Do I have that right? 

Ms. RUSCONI. For the most part I would agree. At our VA, our 

VA actually has—takes care of all of the RIB and all of the services 

that were described. 

Mr. POLIQUIN. Thank you. Mr. Klotman, who determines whether it is 56 percent or 70 percent? 

Dr. KLOTMAN. The NIH. The NIH comes—the HSS comes and 

does a very complete audit, which it is like everything— 

Mr. POLIQUIN. So it is NIH? 

Dr. KLOTMAN. Yes, it does. 

Mr. POLIQUIN. Whoever awards the grant, they determine what 

you are going to get paid? 

Dr. KLOTMAN. We negotiate with them every three years, and we 

show our costs. I mean, it is very rigorously reviewed, the costs of 

oversight and research. The differences are often what services you 

are providing. So we, you know, we provide IACUC, IRB, all those 

real—those are real costs that— 

Mr. POLIQUIN. Ms. Rusconi, do you provide the same services 

they do at the academic affiliates? 

Ms. RUSCONI. Actually, at the Kansas City VA we provide the 

IACUC, the IRB, and the R&D for our facility as well as the facility in Wichita, Kansas, and we provide— 

Mr. POLIQUIN. Okay. 

Ms. RUSCONI [continued]. —the IRB— 

Mr. POLIQUIN. Okay. 

Ms. RUSCONI [continued]. —and for— 

Mr. POLIQUIN. Thank you. We are stewards of the tax payer dollars, we are $21 trillion in debt, the interest payments on that debt 

are about $240 billion a year, that exceeds our entire budget by the 

VA by about 40 percent. Every dollar counts. 

Mr. DUNN. Mr. Poliquin. 

Mr. POLIQUIN. What I am trying to determine is, we have got two 

folks— 

Mr. DUNN. Mr. Higgins— 

Mr. POLIQUIN [continued]. —providing the same service— 

Mr. DUNN [continued]. —will you yield another minute— 

Mr. POLIQUIN [continued]. —but one is— 

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Mr. DUNN [continued]. —to Mr. Poliquin? 

Mr. POLIQUIN [continued]. —twice the cost of the other, and I am 

trying to figure out why. 

Mr. HIGGINS. I already have. 

Mr. POLIQUIN. Sorry, Clay. Thank you, Clay. 

Mr. DUNN. One more minute. 

Dr. KLOTMAN. I would just say, you should look at the services 

provided. I mean, this is a real menu of costs, these are not fictitious costs, they are real overhead. Just in the same way you come 

to this building— 

Mr. POLIQUIN. And whoever issues the grant, NIH DoD, they determine what your costs will be in negotiate with you, correct? 

Dr. KLOTMAN. Correct. 

Mr. POLIQUIN. Okay. 

Dr. KLOTMAN. And the grants—a point you made before about, 

it is the individual and the conflict of interest. The grants are administered to the institution not to the individual. 

Mr. POLIQUIN. No, but the individual— 

Dr. KLOTMAN. It is in the name of the institution. 

Mr. POLIQUIN [continued]. —who’s the investigator at the institution can also award the administration to you. 

Dr. KLOTMAN. The— 

Mr. POLIQUIN. Is that correct? 

Dr. KLOTMAN. Well, that is not really accurate. For NIH it is the 

grant is awarded to the institution on behalf of the individual. The 

expectation is that the institution supervises and oversees the research, and that the spending is responsible within— 

Mr. POLIQUIN. And who determines where that administration— 

administrative dollars go? Does the NIH or does the investigator? 

Dr. KLOTMAN. The NIH determines where it goes, it is not the 

individual investigator. With an individual— 

Mr. POLIQUIN. That is not what Dr. Clancy and Dr. Ramoni told 

me. 

Dr. KLOTMAN. No, if there is an individual who has shared time, 

every two weeks they have to fill out their activities report, and 

if—the amount of time that is covered at the VA is covered by the 

VA, and the amount of time that is covered by the NIH is covered 

by the NIH. There is no overlap of the two. 

Mr. POLIQUIN. Okay. So you don’t think it is a— 

Mr. DUNN. One moment, Mr. Poliquin. Representative Higgins, 

you have three minutes remaining. Do you— 

Mr. HIGGINS. (Inaudible). 

Mr. DUNN. Then you are recognized for three minutes, Representative Higgins. 

Mr. HIGGINS. Thank you, Mr. Chairman. And God bless you my 

colleague, Bruce. 

Dr. Clancy, you may recall, madam, we met in my office, and we 

briefly discussed inclusion of urgent care facilities as a means by 

which veterans could access care in their community. The VA mission act passed the House of Representatives yesterday. If signed 

into law, will this provision and the precedence set by the recent 

launch of urgent care access for veterans in Southern California, 

will that provide the VA adequate authority to expand access to 

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these walk-in urgent care facilities in other regions? I have been 

advised that it would. Thank you for that answer. 

Dr. CLANCY. Yes. 

Mr. HIGGINS. My larger question to you, Dr. Klotman, you mentioned some of the research being tele-medicine using facial recognition for depression. I have an overall concern about a culture 

of over prescription, of pharmaceuticals, for our veterans; opioids, 

anti-depressants. And when investing money that has been harvested from the people to pay for research, and I am a big supporter of tele-medicine, I think it is wonderful, I have large rural 

communities in my district, but facial recognition for depression, 

how would that determine the difference between temporary depression or normal moments of sadness, or reflection, a contemplative somber moment, how would that differentiate from the diagnosis of clinical depression which could lead to further over prescription of pharmaceuticals into our veterans population? I am 

very concerned— 

Dr. KLOTMAN. No, I understand. 

Mr. HIGGINS [continued]. —about the culture we have created 

within our veteran populations that our goal should be to get them 

back into a state of productive— 

Dr. KLOTMAN. I agree. 

Mr. HIGGINS [continued]. —participation in society, and yet we 

are building barriers for them to return to work, and return to society, as a productive citizen because of the pharmaceuticals that we 

prescribe. 

Dr. KLOTMAN. Well, I think you have hit upon a national problem, you are absolutely right. The study that is currently ongoing 

is to do exactly what you said, can you sort out a situational— 

Mr. HIGGINS. Are we working on non-medicinal treatment— 

Dr. KLOTMAN. Oh, yeah. 

Mr. HIGGINS [continued]. —research for PTSD, for instance? 

Dr. KLOTMAN. Absolutely. Absolutely, yeah. 

Mr. HIGGINS. Service dogs— 

Dr. KLOTMAN. And the other thing— 

Mr. HIGGINS [continued]. —exercise, group therapy, et cetera? 

Dr. KLOTMAN. And it is hard for veterans sometimes to come to 

the VA. The whole purpose of this is getting more continuous follow-up so you can detect problems sooner. I mean, the idea is to 

improve their lives in ways that are not drug dependent. Absolutely. 

Mr. HIGGINS. Thank you for your answer. And I would also like 

response, perhaps in writing, from my colleague brought up, Mr. 

Chairman, regarding where exactly can we observe what research 

is taking place across the country and what the nature of that research is. I yield back. 

Mr. DUNN. Your question is noted, Representative Higgins. 

Representative Lamb, you are recognized for five minutes. 

Mr. LAMB. Thank you, Mr. Chairman. 

Dr. Clancy, by way of greatest hits, I just wanted to note back 

in Pittsburgh in a VA that is not actually in my district, but it is 

near it, and it takes care of many of veterans from our district, we 

had the development of a pneumatic wheelchair powered by an air 

motor, Dr. Rory Cooper, we are very proud of that. 

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The chair only weighs 80 pounds, and it can be used—it is waterproof basically. So one of the things they have used it for is kids 

with disabilities go to water parks and they use it, veterans as 

well. So that was a great achievement by our VA research in Pittsburgh at the human engineering research lab. So I think that is 

a good one to highlight. It has made a big difference in people’s 

lives. It is easier for family members to carry it around because it 

is so light. 

One concern that I have heard expressed from folks back in 

Pittsburgh is that in the Office of Research and Development, there 

tends to be a lot of resources behind the research side of it and less 

behind the development side of it. So I will just throw it open, 

maybe either Dr. Clancy or Dr. Ramoni, have you heard that concern before from people within the system? 

Dr. RAMONI. Thank you, Congressman Lamb. That is, as you 

heard, one of my three priorities is to increase the real-world impact of VA research. And, in fact, in collaboration with Dr. Rory 

Cooper’s lab in Pittsburgh, and I had the pleasure of visiting it and 

using that pneumatic wheelchair which is really a remarkable invention, we are establishing a development pipeline with him. 

Often the first step is producing enough of a thing such that you 

can get buy in to produce it more broadly. For instance, to have 

enough versions of that pneumatic wheelchair such that a company 

might want to pick it up and produce it and distribute it. So we 

are entering currently into a partnership with Dr. Cooper’s lab in 

order to do that. 

In addition, we are taking a number of other steps to ensure that 

we move from bench or lab to bedside more quickly. We are, in the 

basic science space, funding actual development dollars to conduct 

toxicology studies which are the gap between the bench research 

and moving into clinical trials. So we have a broad-based effort to 

take more of our in-lab developed innovations and move them out 

where veterans can benefit from them. 

Mr. LAMB. What is kind of the number one thing that we can do 

to support that to make it easier? 

Dr. RAMONI. Well, it is certainly companies—I would say one of 

our great challenges is that sometimes veterans have very specialized needs. And so, for instance, an upper limb prosthesis, some 

companies might not find it financially attractive to proceed in 

those spaces. And so any help that, frankly, and party can provide 

to us in helping to overcome that barrier would be wonderful. 

As an alternative, we are looking at, in those cases, could we as 

a department, and obviously this would be outside of research and 

development, could we actually produce those items for our veterans if no for-profit company is willing to step into that space. 

Mr. LAMB. In addition to just overall more funding for research, 

are there specific programs that could use a shot in the arm to improve that transition that you are talking about? 

Dr. RAMONI. So in technology transfer, and, of course, people 

know a GAO report came out recently, and that is an area of intense focus for us, we are doing a fantastic job on getting invention 

disclosures. The machinery to then actually market those inventions to producers is something that we are building. And so that 

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area in particular will help us go from invention to actual realworld use by veterans. 

Mr. LAMB. Great. And I yield back the remainder of my time, Mr. 

Chairman. Thank you. 

Mr. DUNN. Thank you very much, Mr. Lamb. 

Mr. Arrington, you are recognized for five minutes. 

Mr. ARRINGTON. Thank you, Mr. Chairman. 

I want to follow along the line of my colleague Mr. Lamb. I was 

former vice chancellor for research and technology commercialization at Texas Tech, believe it or not. It is complicated, and it is 

challenging to get an early-stage technology to market. It takes a 

lot of time, it takes a lot of capital, it takes an entrepreneurial 

team. Not many universities are culturally aligned with sort of this 

sort of entrepreneurial dynamics that exist in the marketplace. So 

you got to really wire it well. There are some sophisticated ecosystems at Stanford, and Boston, and some other places, but it is 

very, very difficult. 

Personally, my take on this is get it out, get it out of the VA, 

for God’s sake. And I am just saying that because it is a big bureaucracy, and it is not entrepreneurial or innovative, but there 

could be some great discovers. I think relatively speaking, it is just 

universities don’t have that very well. The best way to commercialize it is get it to a start-up company, get it to an established 

industry partner and let them run with it, and make sure that we 

take a piece of the action to evergreen the research. 

Speaking of that, what are the deals that we made? How many— 

you said disclosures have increase, so what about revenue from— 

what about license agreements? Are they going up or down? Sorry, 

you, Ms. Ramoni. 

Dr. RAMONI. Rachel. Yes. So thank you for your question. It is 

an area that is a very high interest to me not only for the revenues 

but also because this means that these products are out there 

where veterans can benefit— 

Mr. ARRINGTON. Exactly. 

Dr. RAMONI [continued]. —from them. 

Mr. ARRINGTON. But if there is no financial motive they won’t do 

it. Just let’s be clear. 

Dr. RAMONI. Absolutely. 

Mr. ARRINGTON. So how many license agreements? Are they 

going up or down, or are they flat? 

Dr. RAMONI. They are going up. And I have the facts and figures 

in here. But I can tell you, in terms of royalties, and if you read 

the GAO report, it is a pretty stark description of where we are 

now, or where we were. Back in 2016, we just had $300,000 in royalties. And I have to say, historically that— 

Mr. ARRINGTON. 300, how much? 

Dr. RAMONI. Thousand dollars in royalties. 

Mr. ARRINGTON. That is it? 

Dr. RAMONI. Yes. And that is what I am saying. It is a pretty 

stark— 

Mr. ARRINGTON. How many annual disclosures do you get of potential IP— 

Dr. RAMONI. We get hundreds— 

Mr. ARRINGTON [continued]. —potential marketable product? 

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Dr. RAMONI. Over 500 disclosures. 

Mr. ARRINGTON. Over 500? 

Dr. RAMONI. That is right. 

Mr. ARRINGTON. So I would say that is— 

Dr. RAMONI. Yes. And I do want to add that— 

Mr. ARRINGTON. How long have you been in this space of technology transfer within the VA? 

Dr. RAMONI. Well, I have just been— 

Mr. ARRINGTON. Not you personally, the VA in general. 

Dr. RAMONI. So the VA, I think the—certainly the attention that 

the VA receive from the House Veterans Affairs Committee surrounding the Shanaze hepatitis C treatment brought greater attention, and we are grateful for Mr. Bergman having written to the 

Secretary to increase our number of staff in tech transfer. So it has 

been a relatively recent growth in our tech transfer team, and we 

got a new head of tech transfer— 

Mr. ARRINGTON. I would outsource it. 

Ms. RAMONI [continued]. —tech transfer team. 

Mr. ARRINGTON. I would give it to a group that does that, that 

that is their core competency. They do that for a living. They have 

the connections with the money guys. They have the connections 

with the industry. They move at the speed of business. I just would 

do it. 

I mean, I must say, 500 disclosures— 

Ms. RAMONI. Yes. 

Mr. ARRINGTON [continued]. —and $300,000 in revenue— 

Ms. RAMONI. Yeah, I know. 

Mr. ARRINGTON [continued]. —is paltry. 

Ms. RAMONI. I— 

Mr. ARRINGTON. And it is—I am not blaming you. I just don’t 

think it is aligned with the core mission. 

Ms. RAMONI. Well— 

Mr. ARRINGTON. We have got to have incentives to get these— 

this IP to—into the right hands, where they can raise the capital, 

take it to market, and make a difference. They will never make a 

difference, in my opinion, inside the VA culture. It is not wired for 

that. And it is— 

Ms. RAMONI. Right. 

Mr. ARRINGTON [continued]. —not an indictment on your skills 

and competency. It is just a culture reality. 

Ms. RAMONI. I agree with you— 

Mr. ARRINGTON. What is the— 

Ms. RAMONI [continued]. —entirely. 

Mr. ARRINGTON [continued]. —let me just jump to Clancy—for 

Dr. Clancy. What do you—how do you measure success? And I 

am not trying to be rude. I just—it is time. We don’t have a lot of 

time. So what—how do you measure success among your—the researchers that you give taxpayer money to, to discover? 

Dr. CLANCY. Sure. So broadly, that would be publications, of 

course. It would be who else or what other entities have picked up 

those publications. So for example, if work published becomes part 

of a Medicare quality measure, that is going to have a big impact— 

Mr. ARRINGTON. Does— 

Dr. CLANCY [continued]. —and get out and so forth. 

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Mr. ARRINGTON [continued]. —transferring the technology, to 

commercializing the technology, is that a metric? 

Dr. CLANCY. That has to be a metric. 

Mr. ARRINGTON. Is it a metric of success? Do you— 

Dr. CLANCY. Yes, yes. 

Mr. ARRINGTON [continued]. —hold people accountable for that? 

Dr. CLANCY. Do we hold them accountable? Not yet. I want to be 

clear. Under Rachel’s leadership, just in the past two years, we are 

on an upward curved for sure. I would love to have the opportunity 

to follow up with you, your staff, about what might be some options 

for who else we could partner with to make this happen. Some 

parts of the government have small business innovation research, 

and a variety of mechanisms that we actually do not have. 

But that is just one that occurs to the top of my brain. I am sure 

there is a variety of other mechanisms, and given your experience, 

I think it would be a great— 

Mr. ARRINGTON. I would love to— 

Dr. CLANCY [continued]. —opportunity to follow up on. 

Mr. ARRINGTON [continued]. —sit down with you. I want it to be 

successful, and I am over my time. 

If you have a second round, I am going to stick around. 

Mr. DUNN. And to that point, we will have time for a second 

round. I encourage you to stick around and take advantage of that. 

Mr. ARRINGTON. Thank you, Mr. Chairman. 

Mr. DUNN. These are great questions. 

Mr. ARRINGTON. Sorry to abuse my— 

Mr. DUNN. But I will recognize now, for five minutes, Representative Rice. 

Ms. RICE. Thank you, Mr. Chairman. The Vietnam Veterans of 

America’s statement for the record raised an issue about limited 

VA funded research for certain health conditions that are of immediate consequence to veterans, citing the long-term effects of Agent 

Orange exposure as an example. That remains significant for Vietnam war veterans. And conditions stemming from military exposure, such as toxic substances from burn pits for Iraq and Afghanistan veterans. 

This point relates to an issue that has been raised by veterans 

in my district, in New York, on Long Island, regarding exposure to 

liver fluke in Vietnam which is a parasite prevalent in Southeast 

Asia known to cause a certain type of cancer that can take, literally, decades for—I mean, I am telling you. You guys know this— 

for symptoms to appear. 

The VAMC in Northport, which is further out on Long Island, 

conducted the first ever pilot study on liver fluke in Vietnam vets 

through a partnership with an academic medical center in South 

Korea, which was privately funded after the VA declined to fund 

the study. For veterans who are just starting to show the long-term 

effects of something that they were exposed to in Vietnam, this 

type of health condition, obviously, is of immediate concern. 

So to any of the panel Members, this concern that the VA is not 

funding research for certain health issues that are of immediate 

consequence to veterans—and now, while I may admit that this— 

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23 

erans, they still served this country, and are suffering this condition because of their service. 

So if anyone can answer that question as to why the VA is not 

funding research for certain health issues that are, right now—and 

for that matter, the Iraq and Afghanistan veterans, that are of immediate consequence to veterans? 

Dr. CLANCY. Well, thanks to your support—that is of the Congress, right? We are funding a burn pits registry, and I have been 

really seriously impressed by the enthusiastic response from veterans in terms of their enrolling in this. And one of Dr. Ramoni’s 

five priority areas for the additional support we got through the 

omnibus is actually to focus on exposure to Agent Organ and the 

impacts among Blue Water Navy veterans. 

The liver fluke issue is quite interesting. I would say it is fair 

to say that one can find lots of examples, not just at VA but elsewhere, where somebody turned down a very novel, kind of, research product at one point in time or in—what was something 

that in—overtime turned out to be very, very consequential. 

The word is out among veterans. One of the challenges we have 

is that we do not, at this moment in time, as I understand it, have 

a commercially available test to be able to test for that. So many 

veterans are coming in to see their docs, saying ‘‘I want this test 

because I read about this research.’’ So we need to find out more 

about that, and we would be happy to follow up with you. 

Ms. RICE. Well, thank you. I would ask— 

Dr. CLANCY. And I know that Rick is very interested. 

Ms. RICE. Yes, thank you. Final question, then I will give whatever time I have to Mr. Poliquin, if he wants it. 

What steps can the VA take to standardize and eliminate delays 

associated with the ISO reviews, to advance clinical trials, and support successful research partnerships? 

Dr. CLANCY. ISO with you. 

Ms. RAMONI. Thank you for your question. As you might have 

heard, we held a summit on April 12th with a broad variety of 

stake holders to look at all the barriers that prevent us from starting up clinical trials, especially industry trials, efficiently. 

One of those was the information security officer review, and I 

am very happy and proud to say that we now have three research 

specific information security offers—officers in place, and I have 

been receiving e-mails from the field that say that this transforms 

everything, and this, when we announced it at the summit, received a standing ovation. So 

Ms. RICE. Well, that is great. 

Ms. RAMONI. —we are pleased to have addressed that. 

Ms. RICE. Great, great. That is great news. And I have 51 seconds for my friend Mr. Poliquin— 

Mr. POLIQUIN. Thank you. 

Ms. RICE [continued]. —with the Chairman’s approval. 

Mr. DUNN. You are recognized for 46 seconds. 

Mr. POLIQUIN. Thank you very much, Congressman. I have in 

front of me the May report of the Inspector General at HHS. Let 

me read this to you, if I may. 

‘‘The Department of Health and Human Services, which is the 

parent organization for the National Institute of Health, and under 

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that is the Division of Financial Advisory Service, DFAS, is the 

Federal agency responsible for negotiating and establishing indirect 

cost rates, i.e. administrative rates, for non-profit organizations, 

our affiliates, academic affiliates, that receive the majority of the 

Federal awards from HHS.’’ And their conclusion in part, ‘‘DFAS 

did not always comply with Federal requirements for establishing 

indirect cost rates.’’ 

So I am very suspect that the process that is used to determine 

the rates between our affiliates in the Federal government is up to 

snuff. But with that, thank you very much Congressman Rice. I 

know we are going to have a second round, if I am not mistaken, 

Mr. Chairman. 

Mr. DUNN. There will be a second round. 

Mr. POLIQUIN. Thank you. 

Mr. DUNN. I now recognize General Bergman for five minutes. 

Mr. BERGMAN. Thank you, Mr. Chairman. You know, we are 

overloaded with acronyms around here. We would like to give you 

a new one; RTR, Research to Results. 

So having said that, as you look at where you are, because we 

see—I see a lot of familiar faces at the testimony table, and you 

see at the front end of the food chain with those doing the research, 

we see you all the time. Why don’t we see them? That is okay. It 

is a rhetorical question. I can tell, stunned. 

No, the point is the—we have all played the game where you 

start the message around the room and by the time it gets back— 

and this Committee, you know, bipartisan, we want to get to the 

bottom line very quickly. Not that they have to come here and testify, but I would suggest to you that most of the Committee Members here would be more than willing to devote some time to walk 

right into a research lab because of the fact that we get to talk 

with the people right then, right there. 

So when front end, those literally in the labs doing the research, 

to this end where we are doing, you know, the testimony if you 

will, as far as the results—again, I will just speak for myself. I like 

to see the amount of layers that this goes through, and where it 

gets scrubbed, where it gets, you know, redirected. So the point is, 

we can do better. 

Dr. Clancy, do you think the VA, NIH, and possibly DoD are duplicating research? 

Dr. CLANCY. Having run a research agency for a number of 

years, for HHS, I can assure that a very key part of all applications 

submissions is saying where else that you are funded, and if you 

are untruthful about that, that is fraud and a reason to withdraw 

support. So by and large—and we have people that check that all 

the time. So I don’t think that they are duplicating research. 

What I worry about more is gaps, and that is where we have 

been reaching recently far more to the NIH, to Defense, and so 

forth, to figure out ‘‘Okay. Here is all this great stuff’’— 

Mr. BERGMAN. So the point is— 

Dr. CLANCY. Yes. 

Mr. BERGMAN [continued]. —if we were to say, ‘‘Okay. Can you 

give us an example over the last four or five years of where a— 

this review board or whoever the folks were, you could produce a 

list of said, ‘‘Okay? You know, Houston and New York are doing 

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this overlap, and we said no to one of them.’’ I mean, is there some 

kind of data that we could get? 

Dr. CLANCY. In general, that is almost always going to be handled before it even gets to peer review by a scientific committee. 

If it doesn’t get handled then, it is going to get handled before— 

Mr. BERGMAN. Are there records? I mean, of the peer—I mean, 

the bottom line is, when someone is sitting at a desk, is asked to 

look at a couple different proposals and says, ‘‘No, we are already 

doing it here,’’ is there data that we can pull up that says that? 

Dr. CLANCY. If it looks—I can’t speak for NIH, but could find out 

for you, and I don’t know if we have that kind of record. I know 

that in general, we feel like the opportunities greatly exceed available resources, which is not intended to sound ungrateful. But it 

also means that— 

Mr. BERGMAN. Well, that—but that is more of a reason— 

Dr. CLANCY. Exactly. 

Mr. BERGMAN [continued]. —because if you have more opportunities than you do have resources, we have to ensure everything— 

Dr. CLANCY. Yes. 

Mr. BERGMAN [continued]. —we do does not accidently overlap 

something that is already being done, because we are dealing with 

finite resources here that we have to focus on that research that 

is going to directly benefit our veterans in the long term. 

I would like to, just for a second here, to expand on Mr. 

Poliquin’s line of questioning. You know, Dr. Clancy, in many instances, a researcher who decides which entity, the VA or the affiliate, will administer the NIH or DoD grants. Do you think allowing 

the researcher to make the decision creates a conflict of interest? 

And if so, what can the VA do to eliminate that? 

Dr. CLANCY. I think that it may be perceived as a conflict of interest, which the distinction between those two, I think, is negligible. At— 

Mr. BERGMAN. A lot of cases, they have dual appointments. Do 

you think there is any pressure being put on, in some cases, because you have a dual appointment? You are basically working 

very hard, but you can only serve one master, but you might be 

serving two. 

Dr. CLANCY. Whether people perceive that there is implicit pressure, for example in the form of promotions and tenure and things 

like that, I can’t say. I think the study we are doing now will shed 

some light on that in terms of how those decisions are made. 

Mr. BERGMAN. When do you think that study will be done? 

Dr. CLANCY. Rachel? When will the WESTAT study be done? 

Ms. RAMONI. The WESTAT study will be complete by the end of 

September, sir. 

Mr. BERGMAN. Great. I look forward to that. And I am going to 

give you back ten seconds, Mr. Chairman. 

Mr. DUNN. Thank you very much, General Bergman. So we have 

finished the first round of questions. We are blessed to have some 

time left on the clock. We would like to go about around and allow 

additional questions. So in—clearly, there are passionate and interested people here on the dais. Representative Brownley, I recognize 

you for five minutes. 

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Ms. BROWNLEY. Thank you. Dr. Clancy, I wanted to ask you a 

question. Congress authorized two major medical leases at Heinz 

and Albuquerque focused on research activities. To date, neither 

lease appears to have been executed by the department, and in 

fact, VA has told stake holders that it is engaged in procuring a 

contract to re-examine the requirements for the Heinz location. 

This is concerning because Heinz researchers are located, my understanding, in a century-old building. Additionally, in this year’s 

President’s Budget Submission, VA removed a request for a lease 

for a research facility in San Francisco. I am concerned that VA is 

not taking action to ensure that VA researchers and partners have 

access to modern facilities to conduct research which we know is 

a major plus in VA for recruiting clinicians. 

Can you tell me what the status of the three leases, and what 

assistance you might need from Congress to move forward on these 

leases for which you clearly identified a need as recently as a year 

ago? 

Dr. CLANCY. I will take that for the record and get back to you 

promptly. I don’t know the status of the current leases. I do know 

that the San Francisco VA is now engaged in a partnership to 

move major chunks of their facility. So I can imagine that might 

have led to a delay or pause in the additional research space, but 

for Heinz and Albuquerque, I do not know. 

I do note to Mr. Poliquin and the Chairman Bergman’s questions 

that some of the issues around space and available research space 

have something to do, I believe, with where the indirect costs are 

actually administered on occasion. But we will get— 

Ms. BROWNLEY. If you could get back— 

Dr. CLANCY. Of course. 

Ms. BROWNLEY [continued]. —to me on that, I would appreciate 

it very much. 

And Dr. Klotman, in your testimony, you said ‘‘To duplicate services such as numerous oversight and review services, if NIH grants 

were to instead be managed by the NPC, would produce no additional value and be a wasteful use of tax dollars.’’ Can you expound 

on that? 

Mr. KLOTMAN. Well, I think it depends and, again, each institution is a little bit different. We do—and in part because we were— 

we have this long relationship with the VA dating back to the, you 

know, mid-40s. A lot of the research infrastructure was generated 

on the Baylor College of Medicine side. 

If, for some reason now, it was, ‘‘Well, let’s have it all administered by the not-for-profit entity,’’ they would have to duplicate a 

lot of things that we are doing. They would have to—the Oversight 

Committees, the IRB, everything, including bringing on and recruiting faculty, and educating them as to, you know, ethical conduct of research. There is just a lot infrastructure that would have 

to be duplicated to do that, and that is why I think it is duplicative 

in our case, but not in all cases. 

Ms. BROWNLEY. Yeah. 

Mr. KLOTMAN. But in our case. 

Ms. BROWNLEY. Ms. Rusconi, do you—would you like to comment? 

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Ms. RUSCONI. Yes, I would really like to respond to that. I applaud what they have going on down at Baylor. We absolutely 

would not ever want to upset a system that from all appearances 

is working very, very well, both for the VA, the non-profit, and for 

the affiliate. There is no reason to change that, but there are many, 

many other situations throughout the country where that is not 

happening, and that is part of our concern. 

There are also other models besides what is happening at Baylor, 

like in California, where some of those services are split between 

the VA and the affiliate, and also where there is a different format 

for the submission of grants. If the predominance of the work is occurring at the VA, then the non-profit takes the lead. If the predominance of the work is taking place at the affiliate, then the affiliate takes the lead. 

And that has worked out very well, and honestly, the most profitable—for the most part, the most profitable NPCs are actually on 

the West Coast and they benefit greatly from that, and their VAs 

benefit greatly from that. For instance, they get infrastructure and 

many other things, like buildings and all those other pieces that 

the non-profit can contribute to that VA. 

Ms. BROWNLEY. Thank you for that, and I yield back. 

Mr. DUNN. Thank you, Representative Brownley. Representative 

Poliquin, you are recognized for five minutes. 

Mr. POLIQUIN. Thank you very much, Mr. Chairman. Ms. 

Rusconi, if the NPC in your case is awarded the administrative 

work for research done at the VA, if you don’t use all those dollars 

in the administration of that project, does that go back to the VA? 

Ms. RUSCONI. I don’t think I understand the question. 

Mr. POLIQUIN. If in the administration of the project or the 

project itself, the research project itself, if all the funds are not consumed for that project, where does the money go? 

Ms. RUSCONI. If it is a Federal project, the way that it is done 

is we—the administrative body, whoever it is, whether— 

Mr. POLIQUIN. Yeah. 

Ms. RUSCONI [continued]. —it would be the affiliate or the NPC, 

they have to expend those costs first before they get reimbursed. 

And so we would not be able to draw down those funds. So that 

is— 

Mr. POLIQUIN. So it stays in the VA? 

Ms. RUSCONI. Well, it doesn’t go to the VA. It would never leave 

the NIH. So if we had a researcher that had $50,000 grant— 

Mr. POLIQUIN. Okay. Thank you. 

Ms. RUSCONI [continued]. —that is what would happen, but if— 

Mr. POLIQUIN. Thank you. Dr. Clancy—and I don’t want to be 

rude, Ms. Rusoni. We just have a limited amount of time. 

Dr. Clancy, if Harvard—to pick on Harvard a little bit, my Alma 

Mater. They are a great school. If they win a—they apply for and 

receive a $10 million grant from the NIH, they receive the money, 

they are doing the research, and they don’t—and also, the investigator is working for the VA and for Harvard. So the investigator 

says, ‘‘No, we are going to do the administration also,’’ which I 

think is an inherent conflict of interest. We have already discussed. 

Is that if—and that is—and their markup, I guess, is 70 percent. 

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So you are talking about $10 million for the research, $7 million 

for the add-on, administrative add-on. 

If that money in either case is not used, does Harvard keep it? If the research project ends without spending the $10 million, do 

they keep it, or do they return it to the VA, or to the NIH? 

Dr. CLANCY. They do not keep it. I— 

Mr. POLIQUIN. Where does it go? 

Dr. CLANCY [continued]. —don’t believe they return it. 

Mr. POLIQUIN. They just don’t draw it down; is that correct? 

Ms. RAMONI. They do not draw it down— 

Mr. POLIQUIN. Got it. 

Ms. RAMONI [continued]. —Mr. Poliquin. 

Mr. POLIQUIN. Thank you very much. 

Ms. RAMONI. Also, I would like to point out that the off-site 

rate—so if the work were being done at the VA but run through 

Harvard, the off-site rate for that typically is around 20 percent, 

25 percent. So pretty close to that of the NPC. 

Mr. POLIQUIN. Ms. Rusconi? 

Ms. RUSCONI. My question, when they are talking about the offsite rate for the affiliate, is if that work is happening at the VA, 

why would they be getting an indirect rate at that point? Because 

honestly, at that point, if the work is happening at the VA, there 

should be a subaward to the NPC. 

Mr. POLIQUIN. You know what I would like to see? And I am 

going—we have subpoena power here, don’t we? 

Mr. Chairman? We have subpoena power here, don’t we? Yeah, 

great. Okay. Here is what I would like to see. 

It is going to be very simple, and I think I asked for it last time 

Dr. Clancy and Dr. Ramoni were here. It is very simply. What I 

would like to see is going back—take five years. We could probably 

go back 50, but let’s take five years. 

What I would like to see is every grant that was awarded by the 

VA, by the NIH, by the DoD, and any other large organizations 

that do that outside the VA. I think it is the NIH and DoD. Every 

grant, what it was used for, who it went to, what the amount was 

for, who did the administrative work, and what that amounted to? 

That would be really tell-tale. So we can see—and what—so we can 

determine what the rate is. So we can see where the taxpayer dollars are going. 

This is supposed to be used for care of veterans. I am all for research. I love it. I want to make sure the taxpayers aren’t getting 

ripped off, and I want to make sure that our veterans get maximum bang for their buck. And when you have a delta between 25 

percent and 56 percent, or 70 percent, which was what was told 

last time, last July, if I understand this correctly, then something 

is wrong. I am missing something. 

And so I want to get that data. So Dr. Clancy, how do we get 

that data? 

Dr. CLANCY. We will take a first crack at assembling it for you. 

Mr. POLIQUIN. No, we already have a study that we went—we 

started back in July or September, whatever it was, we are six- or 

nine-months in. It will be a year before we get the study. Is it going 

to have this data? 

Dr. CLANCY. Rachel? 

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Ms. RAMONI. Mr. Poliquin, thank you for your question. As we 

discussed, both when you were kind enough to visit us, as well as 

with your staff— 

Mr. POLIQUIN. No, not to visit you. I paid an unannounced house 

call because you folks weren’t responsive to our staff in getting the 

data. So it wasn’t a scheduled visit. I just showed up. 

Ms. RAMONI. We appreciate that. 

Mr. POLIQUIN. Well, I appreciate getting— 

Ms. RAMONI. And— 

Mr. POLIQUIN [continued]. —us this data. How do we get this 

data? 

Ms. RAMONI. We explained to you at that point that that data 

currently is not in the VA’s hands, that we had made efforts to— 

Mr. POLIQUIN. So how do we get this data? 

Ms. RAMONI. The NIH would have to cooperate with us in releasing those data which would require a Congressional request. 

Mr. POLIQUIN. Okay. Good. And that data can be released directly, I think, Mr. Bergman, can’t it to this Committee? Thank you 

very much. I yield back my time. I don’t have any. 

Mr. DUNN. Thank you Representative Poliquin. Representative 

Kuster. 

Ms. KUSTER. Just a quick— 

Mr. DUNN. You have five minutes. 

Ms. KUSTER [continued]. —question, if I could. This is for 

Dr. Ramoni. We have been talking about bridging the gap between basic research and clinical research, and my particular interest is brain health diagnostics. 

The Director of National Institute of Mental Health, in 2013, 

stated ‘‘We must set our sights higher than a 19th century approach for mental health diagnosis.’’ So physicians need more than 

the current symptom-based categories. Symptoms alone rarely indicate the best choice of treatment. My question to you is can the VA 

support bio-marker discovery and validation, and pursue the deployment of at least two additional brain health diagnostic measurements before 2023? 

And if anyone else has any comment on that, I am happy to 

hear. 

Ms. RAMONI. Thank you for that question. As you heard, several 

of my priorities touch on mental health, with PTSD, suicide prevention, TBI, opioid use disorder, and it is a high priority of ours 

to move from symptom-based diagnostics to bio-marker based 

diagnostics. Even our work in Gulf War illness, we are moving towards bio-marker based diagnostics. 

To that end, we are developing road maps for a set of projects 

that are intended to lead to objective bio-marker diagnostics for 

both PTSD and TBI, and we are not doing this alone. We are working in collaboration with NIH, with DoD, and with co-inveterate 

bioscience and industry partners in order—that this should move 

forward as quickly as possible. 

Ms. KUSTER. Great. Thank you very much, and I yield back. 

Mr. DUNN. Thank you very much, Representative Kuster. Representative Arrington— 

Mr. ARRINGTON. Thank you. 

Mr. DUNN [continued]. —you are recognized for five minutes. 

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Mr. ARRINGTON. Thank you, Mr. Chairman. I, too, believe in research and the investment we make as a Federal government to 

discover, to solve problems, and I think that no place on planet 

Earth do we do that better than in the United States of America, 

and I think a part of that is the investment the Federal government makes. 

But we have got to do it in a smart way, in a strategic way, in 

a cost-effective way. We have to know what our core competencies 

are and what we are not as competent in, where there is greater 

expertise in the marketplace. So I think my colleague, Mr. Poliquin 

is—I appreciate his passion for making sure this is working the 

way it is supposed to, and we have an oversight roll, obviously in 

that. 

And I guess my first question is, what is the process by which 

we engage in the research agenda? When you set that agenda, and 

there have been questions about how do we prevent mission creep? 

How do we focus on our area of interest and impact, which is those 

things that affect the unique community of our veterans, as opposed to cancer and other areas of research that are important, but 

they affect everybody? But we are trying to get at those specific 

issues that plaque the veteran community. 

What is the process? Do you all bring that to the VA Committee 

or some Subcommittee prior to the concrete drying on that agenda 

so that we can provide some input and challenge you on why you 

are focused on area X, Y, or Z? 

Dr. Clancy? 

Dr. CLANCY. In terms of setting priorities for the research overall, we have some broad frameworks, right, that this is important 

to veteran’s health. We are not going to fund it unless it is a veteran focused project. 

I think the trickiest part is the one that you and a couple of your 

colleagues have keyed in on. The distinction between conditions 

that we know to be unique to veterans and what they are suffering 

right now, and conditions that are common, very prevalent— 

Mr. ARRINGTON. Right. 

Dr. CLANCY [continued]. —among veterans but also among other 

Americans as well. Creating that bright line is sometimes harder 

than you might think. For example, when Mr. Poliquin was asking 

about learning from VBA claims, which I think is a great idea, 

there are some exposures that have a very long latency and we 

might not know without having done research. 

In general, we are looking to our advisory committee, to researchers themselves, to lots and lots of stakeholders, veterans 

service organizations, and so forth. To the best of knowledge, we 

have not come to the Congress. We certainly give you reports on 

the other side. We could certainly make that part of a budget submission so that you would have a better sense, I think. 

I am not sure how close you want to get to that. Some people 

might think that was politicizing things too much, as opposed to 

substantive interest, which has been very much the theme of today’s conversation. 

Mr. ARRINGTON. I think it is part of our oversight role. I mean, 

I don’t—I think it is too late after we see the work that you are 

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doing to suggest that it is inside or outside the purview of the mission for research at the VA. 

But nevertheless, I think I am interested in how we can improve 

that process, so we are better engaged on the front end. How 

much—what percentage of the research at the VA is translational 

versus fundamental? Is it 50/50, Dr. Ramoni? 

Ms. RAMONI. So that is an area that I am, as you know, keenly 

focused on. Currently, the majority of our research is basic research, and some of that basic research, of course, is in veteran focused areas. For instance, a non-opioid pain medication is being researched in basic science, or traumatic brain injury— 

Mr. ARRINGTON. Just in the interest of time— 

Ms. RAMONI. Yes. 

Mr. ARRINGTON [continued]. —and I know I keep cutting you off, 

and I do apologize, but— 

Ms. RAMONI. But— 

Mr. ARRINGTON [continued]. —I think it is an opportunity. 

Ms. RAMONI. Yes. 

Mr. ARRINGTON. If I were there with you, I would say what— 

where can we have a strategic— 

Ms. RAMONI. I agree. 

Mr. ARRINGTON [continued]. —advantage and focus given our 

strengths, et cetera, sort of SWAT analysis. I would say— 

Ms. RAMONI. Right. 

Mr. ARRINGTON [continued]. —we should be more translational, 

less basic. NIH can do basic, all these other institutes. Let’s focus 

more on how we get at solving the problem, and a quicker way, and 

I would also say, ‘‘Can we use the inside of the Veteran Hospital 

System, Health System?’’ 

Ms. RAMONI. Yes. 

Mr. ARRINGTON. It is the largest in the country. 

Ms. RAMONI. Okay. 

Mr. ARRINGTON. How do we tap into that, like you did with telemedicine. That is why you are leading in tele-medicine. That is a 

leadership role for the VA. How to use the patient material and all 

that you have, but with some flexibility that you don’t have on the 

outside, that my friend from Baylor College of Medicine doesn’t 

have because of restrictions, how do you tap into that, so we can 

translate therapies and devices, so we can save lives? 

That is a question I have. I am out of time, but let’s talk about 

that. Let—you all come over to the office. I will come see you, and 

let’s see if we can’t share some thoughts and ideas on how to— 

Ms. RAMONI. I would welcome that. 

Mr. ARRINGTON [continued]. —have a— 

Dr. CLANCY. Mr. Chairman, could I make one quick point? One 

area where we do take great advantage of our system, and this is 

just getting started but very, very exciting. You may be aware that 

clinical trials are unbelievably expensive because effectively every 

study creates a separate infrastructure which is then disbanded. 

Because of our integrated system and an electronic record, we 

are actually now funding some point-of-care studies where patients 

are randomized when they are being seen for care. We are collecting data from the electronic record which takes the cost of a 

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clinical trial and reduces it by orders of magnitude. So we are with 

you, and we would love some follow-up. 

Mr. ARRINGTON. Thank you for that. Mr. Chairman, I yield back. 

Mr. BERGMAN. [Presiding.] Thank you. I am going to yield myself 

five minutes. That will complete the second round. I think—Representatives Brownley and Kuster, you have no more questions. 

Mr. Poliquin, you would like one more round? 

Mr. Arrington, would you like any more time? 

Mr. ARRINGTON. I am going to reserve mine for a meeting— 

Mr. BERGMAN. Okay. 

Mr. ARRINGTON [continued]. —but then, I appreciate their comments. 

Mr. BERGMAN. All right. 

Dr. Clancy, just—if you could take for the record, I would really 

like to know how many dual appointment researchers we have 

across the spectrum. Okay? And if you can give me a number, I assume you can give us a name. Okay? 

So a by name, which then would therefore assume a by location 

list, because I sense across the Committee that there is keen interest in the how things are getting done, and not that all of you don’t 

have—you know all your data, you know, because you do. But it 

is important for us to hear it from boots on the ground as well. So 

I think that is going to be an important step going forward. 

Dr. Ramoni, Mr. Poliquin brought up problems with data sharing 

between VHA and VBA. What are some of the impediments to 

working with VBA? 

Ms. RAMONI. Thank you for your question. So I think the first 

impediment is simply an historical inertia. We simply haven’t 

worked that much with VBA in the past, although some of our researcher now are beginning to use VBA data, for instance in our 

suicide prevention work and also in our evidence-based policy 

group. 

What would need to happen is to have a data use agreement 

with VBA, and to have that prioritized in both on the ORD side, 

which it certainly would be, and also on the VBA side so that we 

can establish those relationships and also have that work properly 

staffed because sharing data takes curation. It takes explanations 

of the data. It takes having some understanding from the VBA 

side. 

Mr. BERGMAN. Is there any ongoing institutional resistance 

based on the, you know, old ‘‘if not invented here’’ syndrome type 

of thing? I mean, is there—do we have any cultural barriers that 

we need to break down between VHA and VBA? 

Dr. CLANCY. I don’t think so. 

Ms. RAMONI. I don’t think there are cultural barriers. Again, it 

has been a sort of inertia that we both need—we need to work on 

both sides to break down, and I certainly am committed to do so. 

And as we proceed, we will, of course, keep this Subcommittee informed and should we encounter any of the barriers you mentioned, we are grateful for your support. 

Mr. BERGMAN. Oh, we know that human behavior is such that 

everyone in a, if you will, in a chain of command or a food chain, 

they look up to see the behavior above them. And if the leadership 

at all levels is not having cross-talks, cooperating across whatever 

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boundaries might be there, the organization will emulate those 

qualities of their leadership, and that is why it is so important 

that—it is kind of like, I don’t know if you any of you are parents, 

but you know, kids watch their parents. And if the parents are 

talking the kids pay attention. If the kids think the parents aren’t 

talking, they are going to try to, you know, divide and conquer you. 

But we are here together in this, and you know, not to overblow 

the family analogy, but we are a family. We are a family that is 

dedicated to the results for veterans, and that is pure and simple 

the mission of the family. 

Dr. Ramoni, in NAVREF’s testimony, you asked that the VA 

share the scope, criteria, and assessment for the Nonprofit Program Office’s out brief reviews. Could you please provide those to 

the Committee as well? Second, are these out briefs something the 

VA is willing to share with NAVREF? I mean, again, in the spirit 

of sharing information? 

Ms. RAMONI. Would the out briefs that—excuse me, sir. The out 

briefs at each NPC? 

Mr. BERGMAN. At the reviews, at the review level? 

Ms. RAMONI. Yes. We would leave it to the discretion of the local 

NPC to share those because not every NPC has a relationship with 

NAVREF, but we have no desire to not make those publically available. We would certainly make those available to NAVREF if we 

were given the permission of the NPC. 

Mr. BERGMAN. Okay. Well, it is, you know, again it is going back 

to breaking down those barriers— 

Ms. RAMONI. Right. 

Mr. BERGMAN [continued]. —that inhibit the results and giving— 

Ms. RAMONI. Right. 

Mr. BERGMAN [continued]. —us the, you know, the outcomes that 

we all are striving for, and sometimes outcomes aren’t—isn’t a 

strong enough work. It means results— 

Ms. RAMONI. That is right. 

Mr. BERGMAN [continued]. —related to the veteran. So with that, 

I am going to yield back. Mr. Poliquin, you get the third and final 

strike. 

Ms. RAMONI. Thank you, sir. 

Mr. BERGMAN. Round, I am sorry. 

Mr. POLIQUIN. Thank you, Mr. Chairman, very much. Appreciate 

if you set that clock to eight minutes, instead of five, but in any 

event. 

Dr. Clancy, who oversees the investigators? My—the reason I ask 

that question is my understanding—correct me if I am mistaken, 

is that the investigators or researchers—I am using investigators 

because that is what—Dr. Ramoni taught me that word. 

If these individuals, I believe, are hired by the local VA hospitals 

around the country, so they are employees of the VA, and at the 

same time they might work for a terrific medical institution like at 

Baylor, at Harvard, or at Case Western, whatever it might be. And 

they then have authority to apply for grants, get the grants, and 

then determine where the administrative dollars goes, notwithstanding what 

Dr. Klotman said earlier. 

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So who is overseeing those investigators to make sure everything 

is going the way it should be? 

Dr. CLANCY. Well, as Dr. Klotman pointed out earlier, there is 

a very careful time and attendance record. The VA— actually from 

the time of my earliest training with— 

Mr. POLIQUIN. No, I am not really asking that, 

Dr. Clancy. Thank you for that. What I am asking is, is there 

anybody looking over the investigator’s shoulders to say, ‘‘You 

know, every time you apply for a grant, and I know you work at 

XYU, University,’’ that that grant money goes to XYU because you 

are applying for that and you have to put it on the grant, but the 

administration is also done by that university. Is anybody serve as 

a check and balance to that individual? 

Dr. CLANCY. Well, to some— 

Mr. POLIQUIN. Or are we doing it now? 

Dr. CLANCY [continued]. —extent, we would expect the NPCs to 

do that. I am going to guess that a fair amount of that is delegated 

to the discretion of the investigator—if I could just finish for a moment. 

Mr. POLIQUIN. Sure. 

Dr. CLANCY. If I am splitting my time five-eighths, three-eighths, 

that would be a very common break because you have to be fiveeighths funded to get VA research funding. But if I can say on my 

three-eighths time ‘‘I am applying for a grant from NIH,’’ that 

would be okay the way we have been doing business. 

Mr. POLIQUIN. No, what I am looking for is if you have an investigator—and what Congressman Bergman asked is a really good 

one. Who are these people, where are they located? If you have 

150—oh, I am just choosing a number. I think it is probably pretty 

close. Is that if you have 100 of them that are always doing the 

administrative work, where they work, not at the VA but at their 

research affiliate, their academic affiliation, that would be a concern of mine. 

Dr. CLANCY. I would agree. 

Mr. POLIQUIN. Okay. Good. So there is no one that oversees that 

except us, correct? 

Dr. CLANCY. I think you have brought a unique lens— 

Mr. POLIQUIN. Okay. 

Dr. CLANCY [continued]. —and intensity to— 

Mr. POLIQUIN. Okay. 

Dr. CLANCY [continued]. —our focus— 

Mr. POLIQUIN. Here is why this— 

Dr. CLANCY [continued].—and we appreciate that. 

Mr. POLIQUIN. —matters, Dr. Clancy, and everybody here. Is that 

we have a situation where there is an inherent conflict of interest, 

and we are looking at very big amounts of dollars. A lot of bacon. 

You have $1.2 billion, roughly, of grants that are provided by 

NIH, and the DoD, and others, in one year. And if you say ‘‘roughly,’’ if we use our low-cost provider over here, the NPCs, right, at 

roughly 25 percent, that is roughly $900 million of research, roughly, and about $300 million in one year of administrative overhead 

and so forth and so on, to administrate those—oversee those 

grants, make sure that they get—research gets done. 

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Well, what if you are overpaying? What if it is not 25 percent, 

what if it is double that, like has been discussed here? What if it 

is more than that? That is another $300 million a year. So you are 

getting less research and more overhead. We see that everywhere. 

Everywhere, frankly, in the non-profit sector. Not picking on anybody. 

That is why I want to see the data. I want to see what grants 

were issued, who did the research, how much money for the research, how much money for the overhead, who these investigators 

are, and what their record is of awarding that administrative 

work? 

And on top of that, you have the Inspector General’s report that 

says, ‘‘This ain’t going well,’’ and that just came out. So I am not 

trying to pick on anybody. We are all responsible for taking care 

of our veterans. Thank you. We are not clinicians, but it is our responsibility to make sure that the dollars are going to the right 

place, and we are not overpaying. It is that simple. Yes? 

Ms. RUSCONI. I would like to make a point of clarification which 

is I understand what Dr. Clancy is talking about, that the NPC 

might have an input into where someone, a PI, would submit the 

grant, but the reality is that throughout the country, there are lots 

of times that the NPC isn’t even aware that that grant is being 

submitted. So there is absolutely no way that the NPC could be 

part of it. 

Mr. POLIQUIN. But 30 years ago, you folks were created by Congress specifically to solve this problem, correct? 

Ms. RUSCONI. Correct. 

Mr. POLIQUIN. Well, I would like to know how much of the business you are getting, because you are the low-cost provider. 

Ms. RUSCONI. We would also like to know. 

Mr. POLIQUIN. Good. Pretty simple, Jack. Excuse me, Mr. Chairman. I yield back my time. 

Mr. BERGMAN. Am I now Chairman Jack? Is that what it is? I 

am no longer General Jack? 

Mr. POLIQUIN. It is whatever you would like, sir, as long as the— 

Ms. KUSTER. I vote general. 

Mr. POLIQUIN [continued]. —this summer. 

Ms. KUSTER. Just for the record. 

Mr. BERGMAN. Yeah, so. All right. Well, thank you to all the 

Committee Members for the—this has probably been one of the 

more focused and direct Subcommittee meetings and hearings that 

we have had. So I appreciate everybody’s input, especially all of 

you at the testimony table, because together we do make a difference and we make a positive different. And if it was all easy, 

it would all have been done long time ago and we would all be 

doing other things. 

So I really appreciate your continued intellectual engagement 

here for our penchant for details now that big data allows us to get 

those details in a relatively expeditious and accurate manner. So 

our thanks to all the witnesses today. You are now excused. Ranking Member Kuster, would you like to make any comments before 

we close? 

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Ms. KUSTER. I have a brief closing statement, and one point I 

would like to leave the record open long enough for the VA to respond to the questions that have been asked today. 

The perspectives we heard today are important points of view to 

consider as we ultimately have a dramatic impact on the quality 

of care to our veterans in New Hampshire and all across the country, and to community providers, and indeed, civilians across this 

country. While I appreciate the hard work and dedication of the 

witnesses and organizations that you represent, the testimony 

today does concern me. I appreciate the great work that the VA 

Non-Profit Research and Education Corporations, or NPCs, conduct 

to oversee crucial VA research with frugality. However, it is concerning that the availability of NPCs at all VA medical centers may 

be limited. 

Likewise, I appreciate the robust academic affiliations the VA 

currently enjoys, and as I mentioned in my comments, Dartmouth 

College and Dartmouth Medical School has proven to be a wonderful partner in expanding and improving veterans’ health care in 

rural New Hampshire. However, it concerns me that some academic institutions may charge more than necessary to administer 

Federal research grants, and insuring the most efficient system is 

crucial to maximizing resources this Congress provides to care for 

our veterans. And I think you have heard this as a bipartisan concern. 

I recognize the VA has been unable to provide clear guidance in 

an expeditious manner as to how this research money is to be distributed, and I encourage the VA to vitalize this guidance as quickly as possible, and share that with this Committee. I believe there 

is a great opportunity here for all stakeholders to work together 

and insure that VA’s research regime is efficient and effective. 

To that end, I ask my colleagues to consider joining me in convening a roundtable of relevant stakeholders to further discuss 

these issues, and as I mentioned specifically, I would love to include the bipartisan Heroine Task Force, and both Committees to 

engage in this discussion. 

Our experience with the opioid epidemic has made effective medical research, especially into pain management and substance use 

disorder, an acute concern of members across this country. We 

know the importance of getting new research on pain, addiction, 

and mental health is important. Veterans are uniquely impacted by 

the opioid epidemic because over 50 percent of veterans experience 

chronic pain. Our veterans need the latest in medical research to 

combat this problem, and I hope to advance legislation soon that 

would centralize and improve pain management at the VA by creating centers of excellence. 

Of course, this is hardly the only area in need of additional research. I know veterans with upper body prosthetic needs experience a limited suite of options. Creation of a center of excellence 

on bionics or upper prosthetics is needed to further meet the needs 

of veterans. There is emerging research and technology, and as I 

appreciate your mention in your opening remarks, about the Luke 

arm, but assuring that the VA is adequately able to deploy the latest technology is crucial to improving our veterans’ quality of life. 

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So this serves to underscore my commitment to delivering the 

highest quality of care to our veterans by ensuring that the VA remains a leader in medical research. I thank you for your time, and 

I yield back. 

Mr. BERGMAN. Thank you, Ranking Member Kuster. It has been 

nearly one year after our research hearing last June, and it quite 

frankly, does not appear that the VA has made any improvements 

on its utilization of the NPCs. Budgets are still tight, yet we continue to find examples of VA not utilizing the available options for 

additional funds. 

As we have heard, NPCs have contributed over two billion, that 

would be with a ‘‘B,’’ to VA research over the past decade and could 

contribute more if they were to administer the grants for research 

projects conducted within VA. VA should not be paying overhead 

costs without getting the benefit of reimbursement. 

It is also critical that the research office have access to VBA’s 

data so that it may better meet its mission of veteran centric research. This data would be extremely beneficial in determining 

what diseases and disorders to examine and help guide ongoing 

projects. 

I hope that our discussion will open the door to better communications because quite frankly, I am pretty tired, and I think we 

all are, of hearing about missed opportunities within VA due to one 

office not communicating with another. VA’s research budget exceeds $1 billion annually. So one would think that the accomplishments it has contributed to veterans and the American public 

would be many, but what we have heard here today is that that 

is not the case. 

Certainly, VA can tout some major accomplishments over the 

past several years, but unfortunately, they are not necessarily in 

areas significant to veterans or related to their service. Moreover, 

many of these results are being implemented at only one medical 

center or one VISN which limits the benefits received by veterans 

across the country. 

Simply put, VA research needs to be more focused on specific 

conditions prevalent among our Nation’s veterans, and the department must follow through on projects so that there are actual clinical benefits to show for all of the funding the research program receives. So bang for the buck. It is past time to witness the urgency 

this long-standing problem deserves. 

I ask unanimous consent that all Members have five legislative 

days to revise and extend their remarks, and include extraneous 

material. Without objection, so order. 

I would once again like to thank all of our witnesses and audience members for joining in today’s conversation. With that, this 

hearing is adjourned. 

[Whereupon, at 11:51 a.m., the Subcommittees were adjourned.] 

f 

Statements For The Record 

Submitted by the Coalition to Heal Invisible Wounds 

Roger Murry, Executive Director 

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1The Coalition’s members are Cohen Veterans Bioscience (co-chair), the Military Veterans 

Project, NAMI Montana, Otsuka America Pharmaceutical Inc. (co-chair), and Tonix Pharmaceuticals. 2 John H. Krystal et al., It Is Time to Address the Crisis in the Pharmacotherapy of 

Posttraumatic Stress Disorder: A Consensus Statement of the PTSD Psychopharmacology Working Group, J. Biological Psychiatry (2017) http://www.biologicalpsychiatryjournal.com/article/ 

S0006–3223(17)31362–8/abstract 3 2017 Member Survey; Iraq and Afghanistan Veterans of America.’’ Accessed May 9, 2018. 

https://cultureondemand.github.io/iava-report/ 

Chairman Wenstrup, Chairman Bergman, Ranking Member Brownley, Ranking 

Member Kuster, and Members of the Subcommittees: 

On behalf of the Coalition to Heal Invisible Wounds, thank you for this opportunity to provide written testimony regarding the VA’s research partnerships, priorities and the extent to which the VA effectively translates research findings to the 

clinical setting to the benefit of Veteran patients. We commend the Subcommittees’ 

leadership in addressing these critical issues. 

The Coalition to Heal Invisible Wounds was founded in February 2017 to advance 

policy reforms that widen and expedite the pipeline for new therapies and 

diagnostics for post-traumatic stress disorder (PTSD) and traumatic brain injury 

(TBI). Coalition members innovate at all stages of the therapy development lifecycle and also serve Veterans who most urgently require mental health interventions. 1

According to the VA PTSD Psychopharmacology Working Group: ‘‘The urgent 

need to find effective pharmacologic treatments for PTSD should be considered a national mental health priority.’’ 2 Despite the ‘‘high prevalence and costly impact’’ of 

PTSD in military personnel and Veterans, ‘‘most patients are treated with medications or combinations for which there is little empirical guidance regarding benefits 

and risks,’’ and there is ‘‘no visible horizon for advancements in medications that 

treat symptoms or enhance outcomes in persons with a diagnosis of PTSD.’’ The scenario is similar for TBI and these two conditions often coexist but may also occur 

independently in the VA population. 

The Coalition believes that better diagnostics and therapies will spur more Veterans to seek care. According to a 2017 survey of over 4,000 Iraq and Afghanistan 

Veterans of America (IAVA) members, 46 percent report having PTSD, while 19 percent report having TBI. 3 Only 16 percent of IAVA members believe troops and Veterans are getting the care they need for mental health injuries and stigma remains 

the top reason Service members and Veterans are not seeking care. A major reason 

why IAVA members stop seeking care is that they do not think that the treatment 

will work. 

An implicit promise of world-class health care is a strong research function. Veterans have earned the right to world-class health care. Better research will lead to 

better care of our Veterans who suffer from PTSD, TBI, and other mental health 

conditions that are prevalent among the veteran population. We strongly believe 

that the VA can become a leading partner in delivering new therapies and 

diagnostics; it has many outstanding assets and institutional strengths, as well as 

the desire to overcome the institutional hurdles to establishing advanced research 

partnerships. 

The Coalition seeks to advance discrete reforms at the VA to support cutting-edge 

research partnerships. We focus on enhancing big-data research partnerships, 

standardizing approval and oversight of multi-site clinical trials to accelerate the development of new therapies, and spurring the development of new brain health 

diagnostics for clinical use. Ultimately, the VA can align its management of clinical 

trials much closer to best practices, which will lead to increased clinical trial success 

rates and the accelerated development of new diagnostics and therapies for conditions that disproportionately impact Veterans. We believe that in 2018, with appropriate oversight from Congress, the VA can pursue several targeted reforms that 

would serve as significant first steps in this process: 

1.Permit sponsors to use commercial IRBs accredited by the Association for the 

Accreditation of Human Research Protection Programs (AAHRPP); 

2.Clarify that the Central Office has the authority to determine all information 

security requirements for a multi-site trial, direct the VA to develop a central list 

of compliant vendors and direct the VA to staff the office appropriately; 

3.Direct the VA to study the obstacles sponsors face in recruitment and develop 

a plan to support Veteran participation in clinical trials; 

4.Develop a master plan to support clinical research; and, 

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5.Direct the VA to work with pertinent Federal and non-governmental partners 

to deploy at least two additional brain health diagnostic measurements for clinical 

use at VA facilities before 2023. 

We are grateful for the opportunity in this testimony to describe in more detail 

both these initial steps and the overall trajectory for reform. 

A. Conduct and Support for VA’s Research Partnerships 

We support the work of the Subcommittees and the VA to bridge the gap between 

basic research and clinical research. This work complements ongoing examinations 

within the Office of Research and Development, at NAVREF and their member Nonprofit Research and Education Corporations (NPC), and within the private-sector research community as to how the VA can help get more research into the clinic. 

Major stakeholders share an understanding that the current diagnostic and therapeutic options available to Veterans are not sufficient, and that creating a more predictable and streamlined research approval and oversight process at the VA will attract more investment to address conditions that are specific to or prevalent among 

the Veteran population. Enhancing research pathways also will help the VA deliver 

better care to Veterans. 

An important place to begin bridging the gap is to standardize clinical trial reviews. While some VA clinics have been able to participate in multi-site clinical 

trials, sponsors report a widespread lack of standardization in the approval and 

oversight of sponsored clinical research at the VA. This delays VA trial site start 

dates, increases research costs, and discourages research sponsors from partnering 

with the VA. We encourage the Subcommittees to comprehensively review how the 

VA can streamline the approval process, identify and propagate best practices, and 

develop true continuity in the approval and administration of clinical trials. For 

2018, three reforms, described below, are close at hand and would immediately draw 

more clinical research to the VA. 

1. Institutional Review Boards (IRBs) 

IRB reviews ensure that clinical trials abide by clear ethical guidelines and protect the well-being of research participants, but sponsors need the reviews to be 

prompt and consistent. Despite earnest efforts by many within the VA to standardize and improve the IRB process (namely, by standing up a central IRB), the IRB 

process continues to be a source of major delays for sponsors. In fact, despite a decade or more of work on the central IRB, some multi-site clinical research sponsors, 

due to frustrations with the central IRB, have reverted to using local IRBs. In light 

of the high-quality, private-sector options available, we do not advise further efforts 

to enhance the current IRB process as it relates to sponsored research. Instead, we 

recommend that the Subcommittees move to permit sponsors to use commercial 

IRBs accredited by the AAHRPP. Stakeholders within the NPC, industry and nonprofit communities broadly support this proposal. 

Allowing the use of accredited commercial IRBs would allow for predictable and 

frequent IRB review processes and timelines. In pursuing this reform, it is important to consider and account for, where relevant, how this step would impact the 

role of other review committees, VA requirements for education and training, VAspecific regulatory requirements related to human subjects research, and the workload for the local and NPC IRBs. We believe that each of these considerations can 

be adequately addressed. 

2. Information Security Officer (ISO) Reviews 

ISO reviews seek to ensure the safety of patient data. The reviews are often 

lengthy and unpredictable, leading to security requirements for the same study that 

can differ by VA clinic. Local ISOs are extremely busy and have variable knowledge 

of clinical research data storage and transfer requirements. Guidelines for ISOs can 

be unclear and outdated, while many ISOs feel organizational pressure to pursue 

the most conservative approach, and constrain the VA from participating in cuttingedge research. Further, there is no central list of compliant research vendors, so 

vendors are vetted and re-vetted by local ISOs. 

A centralized information security review for multi-site clinical research would 

allow for a more thorough, standardized, and appropriate review process, while reducing delays that often occur at the local level. The VA has begun to move in this 

direction. The Central Office recently set up an office to assist local ISOs with reviews of multi-site research. However, the Central Office does not have clear authority to manage all information security requirements for a multi-site trial. Congress 

should clarify that the Central Office has the authority to determine all information 

security requirements for a multi-site trial, that it should develop a central list of 

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4 ‘‘Post by Former NIMH Director Thomas Insel: Transforming Diagnosis.’’ NIMB Director’s 

blog. Posted April 29, 2013. Accessed May 9, 2018. https://www.nimh.nih.gov/about/directors/ 

thomas-insel/blog/2013/transforming-diagnosis.shtml 

compliant vendors and direct the VA to staff the office appropriately. These steps 

would standardize the scope and timing of the ISO review process, as well as send 

positive signals to potential research sponsors. 

3. Clinical Trial Recruitment 

Veterans should have the right to be fully informed of all of their treatment options, including the potential benefits and risks of clinical trial participation. This 

allows Veterans the opportunity to benefit personally from cutting-edge research opportunities and assist the wider community as a whole through trial participation. 

In fact, in oncology and increasingly other areas of medicine, clinical trials are now 

the standard of care. Research sponsors report widely varying experiences recruiting 

research participants. Some VA sites, for example, maintain a database of VA patients that have indicated their desire to be contacted about new opportunities to 

participate in a study and allow sponsors to effectively recruit. Other VA sites do 

not offer this or other institutional supports for recruitment, leading to extended recruitment timelines and increased cost of the research. Some sponsors have been 

unable to fill the patient population needed for the trial, compromising the ability 

to understand the efficacy of the treatment being tested. 

Recruitment problems are not unique to the VA. According to researchers at Vanderbilt and Duke Universities, nearly 1 in 5 clinical trials are either terminated for 

failed participant accrual, or are completed with less than 85 percent of the expected 

enrollment. Recruitment challenges increase the cost and reduce the speed with 

which advances in medicine reach Veterans and the general population. 

VA research stakeholders have expressed an array of difficulties related to recruitment, but it is not yet clear what specific reforms the VA could undertake to 

best facilitate enrollment. We would advise that Congress direct the VA to study 

the obstacles sponsors face in recruitment and to develop a plan to support Veteran 

participation in clinical trials. 

B. Translating Research Findings to the Clinical Setting to the Benefit of 

Veteran Patients. 

1. Master Plan to Support Clinical Research 

While improving clinical trial management will spur more private sector activity, 

the VA should also play a direct role in bridging the gap between basic research 

and clinical research. Today, grant money is divided across too many different 

projects, leaving each with too little money to appropriately design and run a clinical trial, and unable to lead to the next step of investigation. The VA should assess 

how federal agencies and the private sector are supporting clinical research into 

new diagnostics and therapies for conditions that disproportionately impact Veterans. The VA should then develop a master plan that provides for strategic support 

of clinical research, including for private sector activity, to speed developments that 

address those conditions. The plan should include innovation grants for external research, such as the Industry Innovation Competition, in which the VA spurs activity 

in the private sector to help solve VA’s most pressing challenges. The plan should 

complement the comprehensive plan for biomarker discovery and validation described blow. 

2. Diagnostics Research Mandate 

As our members engage every day with Veterans suffering from PTSD and TBI, 

they see an urgent need for mechanism-based diagnostic tools to precisely diagnose 

those conditions. Using symptom-based diagnostic tools alone diminishes the ability 

of physicians to effectively diagnose these multi-faceted disorders as well as overcome the known challenges of diagnosis such as stigma and delays in qualified clinical assessment. In 2013, while still serving as Director of the National Institute of 

Mental Health, Dr. Tom Insel stated that ‘‘the diagnostic system has to be based 

on the emerging research data, not on the current symptom-based categories,’’ and 

that ‘‘we must set our sights higher’’ than a 19th century approach. 4 ‘‘Indeed, symptom-based diagnosis, once common in other areas of medicine, has been largely replaced in the past half century as we have understood that symptoms alone rarely 

indicate the best choice of treatment.’’ Clinicians need new tools to more precisely 

diagnose those suffering from PTSD and TBI, which requires the VA to effectively 

translate research findings to the clinical setting for the benefit of Veteran patients. 

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5 ‘‘Biomarkers for Treatment and Diagnosis.’’ PTSD Research Quarterly. Accessed May 9, 

2018. https://www.ptsd.va.gov/professional/newsletters/research-quarterly/V26N1.pdf 

Diagnostics are objective, measurable predictive factors that help doctors improve 

care. For example, the FDA recently approved a blood test to improve the diagnosis 

of concussions, which could eliminate the use of unneeded CT scans in at least a 

third of those with suspected brain injuries. Writing in the VA’s PTSD Research 

Quarterly, VA researchers determined that ‘‘we appear to have reached a watershed 

in the development of biologically-based interventions for the prevention and treatment of PTSD.’’ 5 Further, understanding the multiple and interacting mechanisms 

of malfunction in each stress system will be critical to advance the diagnosis and 

treatment of trauma-related mental health disorders into the precision medicine 

era. 

According to a recent literature search of PTSD biomarker discovery studies, researchers identified over 800 PTSD biomarker candidates, but none have been validated or approved by the FDA for clinical use. There are many reasons for the failure to validate PTSD candidate biomarkers to date, but most can be overcome by 

bringing together large data sets and standardization of research techniques. For 

example, targeted research based on big data analysis is more likely to direct researchers toward plausible candidates that can be replicated and validated. Given 

the state of the science, we believe this is not only possible but also probable by 

2023. 

To bridge the gap between basic research and the needs of Veterans and their 

doctors, Congress should require the VA to work with pertinent Federal and nongovernmental partners to build a comprehensive plan for biomarker discovery and 

validation including the deployment of at least two additional brain health diagnostic measurements before 2023 for clinical use at VA facilities, and funding a 

broader long-term biomarker study through the Department of Defense (DOD). The 

statutory objective would help VA leadership marshal sufficient resources and implement administrative reforms to boost public-private partnerships and power the 

discovery of biomarkers. 

C. Conclusion 

The Coalition to Heal Invisible Wounds thanks the Subcommittees for its work 

to strengthen VA medical and prosthetic research program. We strongly believe that 

the VA has the potential to be a world-class research partner to the private sector, 

enabling better health care for Service members and Veterans, and the initiatives 

proposed above would provide significant initial progress toward that goal. 

. We encourage the Subcommittees to continue to engage with stakeholders to develop a multi-year plan that provides for continual improvements to data-sharing, 

clinical trials and therapy and diagnostics research. Comprehensive reforms would 

address the many other pacing limiters of clinical research, such as limitations on 

protected time for physician-researchers participating in sponsored research, and 

budget and Cooperative Research and Development Agreement (CRADA) negotiations. Comprehensive reform would also advance the best practices that have helped 

clinical trials succeed at the VA, such as the lead site model pioneered by several 

innovative NPCs. 

f 

Rick Weidman 

Executive Director for Policy & Government Affairs 

Regarding 

Department of Veterans Affairs Medical and Prosthetic Research Program 

Good morning, Dr. Wenstrup and General Bergman, and other distinguished 

members of these two very important Subcommittees. Vietnam Veterans of America 

(VVA) is pleased to have the opportunity to present for your consideration our Statement for the Record on the VA’s medical and prosthetic research program. Also, for 

the record, we want you to know how much we appreciate the work you do for our 

nation’s veterans. 

As we all know, VA research is different from research sponsored by other federal 

research agencies. According to the VA it is focused entirely on veterans’ needs. It 

is intramural, and more than 60 percent of VA researchers are also clinicians who 

provide direct patient care. 

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In your letter to VVA you requested that we address three issues related to VA 

research, which we do in this statement. However, we would like to emphasize that 

our biggest issue with the Department’s research program is that it does not fulfill, 

in our minds, the purpose for which it was established. And that is to conduct research that is focused entirely on veterans’ needs. We would, therefore, request that 

you do a few things: 

• Request a Government Accountability Report (GAO) that takes a comprehensive 

look at the VA research program, including projects funded, the amount of funding expended, the source of the funding and bench-to-bedside focused treatments and the reality of that goal in as much as it is accomplished by the VA. 

• We ask that this be a report that takes a retrospective look over the last 5 to 

15 years of the program. 

Issue 1: Department of Veterans Affairs partnership with nonprofit research and 

education corporations, academic affiliates, and other entities regarding administration of research funding as well as to conduct and support research efforts. 

The VA’s total actual budgetary resources for Research & Development for Fiscal 

Year 2017 was $1.8 billion, of which $673 million was direct appropriations. VA’s 

research program also relies on other sources of funding, non-federal as well as federal. For FY’17, in addition to the direct appropriations, the department received 

$535 million for Medical Care Support, $425 million from other federal agencies, 

and $170 million in non-federal funding. Though this pales when measured against 

federal research dollars for the National Institutes of Health, the Congressionally 

Directed Medical Research Programs of the Department of Defense, and the Centers 

for Disease Control and Prevention, it is certainly not insignificant. 

VA proudly, and rightfully, points to some of the major accomplishments coming 

out of its research program, e.g., the heart pacemaker, the nicotine patch, the first 

successful liver transplant, improvements in wheelchair design. However, we must 

question: How much of what VA research has produced recently is of significant 

benefit to veterans? 

Conceptually, VVA has no argument with enlisting outside researchers from notfor-profit research and educational corporations and academic affiliates. For several 

years now, we have proposed the creation of an external entity, headed by a qualified individual who would be confirmed by the Senate, which would engage independent scientists and medical researchers to conduct research on specific health 

conditions of immediate consequence to veterans, conditions stemming from battlefield trauma, e.g., the ingestion of toxic substances from burn pits in Afghanistan 

and Iraq, and other military exposures such as oil well fire, sulfur fire, sand, dust, 

and particulate matter. 

We say this because for several years after the advent of the 21st century, it is 

our understanding that little or no research was conducted, for instance, on the 

long-term effects of exposure to Agent Orange and other toxins that were so liberally sprayed in South Vietnam. When the former head of the VA’s Office of Research and Development was asked pointblank a few years ago if and when Agent 

Orange research would be funded, he replied with empty rhetoric and could not cite 

any specific research program then underway or being planned for the immediate 

future. 

We would urge you to investigate how much money was expended on just what 

specific, peer-reviewed research was conducted that has been of salient benefit to 

our wounded warriors. 

Finally, in brief response to the essence of the first question, VVA has no qualms 

about expanding and enhancing the universe of researchers who would respond to 

a Request for Proposal (RFP) for specific areas of research, as long as there is strict 

oversight by the appropriate staff at the VA and by you in Congress. 

Issue 2: The extent to which VA’s research projects and priorities display a concentrated focus on issues and conditions that are specific to or prevalent among the 

veterans population. 

Much of our answer to this question is alluded to above. Basically, we have not 

seen any concentrated focus in this regard. Why? Because we believe VA researchers have been funded for the most part to conduct research in their individual areas 

of interest which are not always of relevance to specific health conditions unique 

to veterans exposed to the inherent dangers in a combat zone. 

Issue 3: The extent to which VA effectively translates research findings to clinical 

settings to the benefit of veteran patients. 

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1 Johns Hopkins Medicine, May 3, 2016 release 

Again, the nugget of our comment here is in our responses to Issues 1 and 2. This 

is not to say that all research projects funded by the VA are of little consequence 

to veterans. Important research has been conducted in improving prosthetic arms 

and legs, for instance. But this is the exception, not the rule. 

We thank you for the opportunity to submit for your consideration our Statement 

for the Record. Should you have any questions, we would of course be pleased to 

reply. 

f 

Whistleblowers of America 

Jacqueline Garrick, LCSW–C 

Dear Chairman Roe and Ranking Member Walz; 

Whistleblowers of America (WoA) is submitting this statement because we are 

concerned about priorities for further research and the proper management of research funds at the Department of Veterans Affairs (VA). We are grateful for this 

opportunity to share VA insider information with you and the rest of the Committee. 

Sentinel Events: 

Sentinel events usually involve wrongful deaths, surgery on wrong patients or 

body part, loss of function, other surgical errors/retention of foreign body, treatment 

delays or complications, medication mismanagement, falls/injuries, suicides or 

overdoses of a patient in or at a facility, assaults and other crime. According to a 

study conducted by Johns Hopkins University in 2016 1, medical errors would actually be the third leading cause of death in the United States accounting for 220,000 

to 440,000 annual deaths if the Centers for Disease Control and Prevention tracked 

those deaths using the same coding as the study. 

VA does capture some data on sentinel events (also known as adverse events or 

medical errors) through its National Center for Patient Safety. However, VA insiders note that these events are supposed to undergo a root cause analysis (RCA) and 

other administrative reviews but are inconsistently conducted and can be more punitive in nature than corrective. Furthermore, these RCAs rarely generate adequate 

process improvement recommendations that can be monitored, shared and re-evaluated. 

• Congress should require VA to replicate the study conducted by Johns Hopkins 

University and mandate that it provide an annual roll up report of its sentinel 

events and related research on the tools its uses to identify, manage, disclose, 

respond, remediate and re-evaluate these adversities that risk patient safety. 

Opioids and Pain Management Research Translation: 

WoA has provided previous testimony on the problems it sees with opioid use and 

pain management for veterans seeking care at VA. Our belief is that care should 

be holistic and utilize multiple tools and interventions. It should be driven by medical decisions not administrative policies. Those medical decisions should be evidence based and informed, which requires VA to engage in veteran-centric research 

and translational activities to bring research into the patient care environment. 

However translational research is often lacking, and policies made by non-clinical 

managers drive outcomes. VA research and development funding must give veterans, Service members and their families priority. These research dollars must be 

aligned to population data-driven needs. 

WoA understands that pain cannot be managed to zero. However, pain as the 5th 

Vital Sign can be confusing to patients and needs research on alternative interventions to opioids to bridge gaps in prescribing practices. For example, Chronic Pain 

Syndrome can be managed with improved sleep hygiene, dietary changes, exercise 

(physical therapy, yoga, stretching), chiropractic therapy, orthotic intervention 

usage, as well as good calcium and Vitamin D levels. Strong occupational and physical therapy programs as well as dieticians are indicated in thorough pain management. However, these are all underfunded and under studied areas of intervention. 

The Department of Defense (DoD) has done some studies with Service members who 

have benefited from massage, Reiki, yoga, acupuncture, aqua therapy and the 

adaptive sports programs. In the private sector, pain management is an integral 

part of the care management team. This has not been the case with VA and military 

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2The Pain Management Task Force Report: Providing a Standardized DoD and VHA Vision 

and Approach to Pain Management to Optimize the Care for Warriors and their Families made 

109 recommendations. The report was required by NDAA 2010. 

transitioning patients see the disparity in their treatment. VA needs to give more 

attention to these techniques to close the parity gap in pain management care. 

WoA has met with the Veterans Cannabis Coalition because of our shared concerns in addressing the opioid epidemic in America and prescription drug use among 

VA patients. Regarding cannabis research studies, the National Academies of 

Sciences (NAS) found, in a 2017 review of 10,000 existing cannabis studies, conclusive or substantial evidence that cannabis is effective for the treatment of pain in 

adults and limited evidence that it can improve the symptoms of posttraumatic 

stress disorder (PTSD). The NAS report recommendations focus on the broad need 

for improvements to research processes and high-quality clinical trials. The VA is 

uniquely positioned to fully investigate the effects and potential applications of cannabis. The health care needs of veterans, particularly for alternatives to opioids for 

chronic pain management, should make cannabis research a top priority within the 

VA, and Congress should work to remove the existing barriers to research and stigma imposed by the National Institute for Drug Abuse (NIDA). As one physician 

noted to WoA, ‘‘over the years, my practice has changed, based on the changes in 

the medical literature. Cannabis research could someday potentially change what 

the current medical literature states is standard of care regarding pain management.’’ 

As WoA has previously testified, the Federal Government has no Center Of Pain 

Management Excellence (COPE) but could greatly benefit from such a focus. Strategically located COPEs in partnership with DoD were recommended by a joint task 

force report issued by the Army Surgeon General in 2010 2. If this recommendation 

were instituted, VA and DoD could be leading the nation in responding to the opioid 

epidemic as required by President Trump. However, eight years later, we still do 

not have these Centers, proper toxicology or accountability for opioids, or standardized protocols for pain management that could come from the proper research. Congress should ask for an update on these recommendations, especially regarding the 

COPE. 

• Congress should authorize VA to partner with DoD and other entities to establish a COPE. 

• COPE should lead efforts to create, delegate, and integrate further studies on 

alternative to opioids for pain management, including cannabis. 

• COPE should develop and institute plans and strategies to translate research 

into practice. 

Mental Health, TBI, and Suicide Prevention: 

Mental health is the bailiwick of VA, especially related to (PTSD). The VA had 

led the nation in researching PTSD and its treatment. It houses a body of knowledge through the National Center for PTSD that is unexceed anywhere else. However, as reported by the AFGE, there is a high turnover rate among VA providers, 

so there is a constant need for new clinicians to be supported and trained with innovative approaches and techniques, such as with Virtual Environments (VE). For example, these VE can help train providers to deal with difficult subjects to discuss, 

such as Military Sexual Trauma (MST) or sexual dysfunction, or suicidal ideation. 

Social Work students are already being trained in these environments as well as 

military personnel in leadership courses. These tools need further research and development for application in a VA environment, but could expand training capabilities and reduce long-term production costs. 

Although VA collaborates with DoD on issues related to Traumatic Brain Injury 

(TBI) there are still gaps in its ability to understand and treat this range of brain 

damage, especially when there are co-morbid conditions present. For example, in accordance with the VA/DoD Treatment Practice Guidelines, ‘‘For patients with PTSD, 

we recommend individual, manualized trauma focused psychotherapies that have a 

primary component of exposure and/or cognitive restructuring to include Prolonged 

Exposure (PE), Cognitive Processing Therapy (CPT), Eye Movement Desensitization 

and Reprocessing (EMDR), specific cognitive behavioral therapies for PTSD, Brief 

Eclectic Psychotherapy (BEP), Narrative Exposure Therapy (NET), and written narrative exposure.’’ These are excellent standards of care but can be ineffective with 

patients who are cognitively impaired, such as those with TBI or Dementia. Thus, 

the above can leave veterans labeled ‘‘treatment resistant’’ as opposed to 

misdiagnosed. While VA spends on average $30 million a year on brain research, 

DoD spends closer to $80 million. Each agency has different populations it needs 

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3 University of Michigan, School of Public Health 

to study, so researchers trying to deal with aging veterans find shortfalls in their 

capabilities, especially on brain studies involving women veterans, which is why 

Pink Concussion is seeking women veterans to donate their brains. In a 2018 OIG 

report, (15–01580–108) it found problems with providers who could not effectively 

diagnose TBI or differentiate it from PTSD, which negatively impacted veterans’ 

ability to obtain proper service connection disability compensation and access medical care. 

Investments should be made in exploring and testing some of the innovative 

neurotechnologies that are available for identifying brain functioning and treating 

or mitigating TBI impacts. Tools coming to the market include brain performance 

trackers and wearables, neuromonitoring, brain-computer interfaces, neuro-biofeedback, and other cognitive aids that could also be explored for use in veteran populations. 

Research has also already correlated PTSD and TBI to increased risks for dementia. Dementia onset also can stimulate new symptoms or exacerbate existing mental 

disorders as cognitive capabilities degenerate. As the veteran population with these 

conditions continue to age, new protocols are needed to support a healthy aging 

process that enhances the independence and integrity of the veteran while developing and testing tools that can better assist caregivers to allow veterans to age in 

place. 

In 2013, VA, DoD and the Departments of Education and Health and Human 

Services issued a National Research Action Plan (NRAP) for Mental Health. Major 

commitments were made by all of the agencies and entities involved for enhanced 

research coordination and governance, prioritization, innovation and translational 

capabilities. However, over the last five years, there seems to be little reporting on 

the outcomes generated by the NRAP and its partners. 

In July 2017, VA released data on veterans who have died by suicide. Although 

compelling, the problem with the data release was that it is not tied to any VA program outcome data or funding execution information. There is no indication that VA 

uses this report in any meaningful way to target its interventions or other approaches. In fact, there have been several OIG investigations that recommend that 

VA do more targeted outreach at the local levels. However, VA continues to fund 

national awareness campaigns that have no evidence of effectiveness. There is growing research that awareness campaigns do not work or could even have an adverse 

impact because they normalize the behavior they are trying to mitigate. 3 Yet, in the 

last few years, VA has awarded almost $100 million in contracts for ‘‘Make the Connection’’ and the ‘‘Veterans Crisis Line’’ campaigns instead of using those funds to 

address shortfalls at the call center, hire more mental health providers, expand peer 

support or conduct local outreach. Whistleblowers have noted that money gets spent 

on things like videos, posters, dashboards or SharePoint sites that could have been 

allocated for direct patient care, provider training or research. 

Congress passed the Joshua Omvig, Clay Hunt, and the Chris Kirkpatrick Acts 

in attempts to mandate VA suicide prevention efforts. We lost Omvig, Hunt, and 

20 other veterans a day, along with Dr. Kirkpatrick to suicide while VA has struggled to provide evidence-based interventions and support. Ongoing OIG and GAO 

investigations should prove fruitful in identifying suicide prevention improprieties 

and shortfalls along with recommendations for better practices. 

• The Committee should hold a hearing to learn more about these mental health 

and brain treatment technologies to help prioritize their research value. 

• Congress should require VA to lead an effort with its sister agencies to update 

the NRAP goals and objectives and document pertinent outcomes for veterans. 

• Congress needs to hold VA accountable for how it uses the suicide population 

data it collects to inform the programs it creates and how it aligns appropriated 

funds for these purposes. The Committee should hold a hearing on suicide prevention funding to review OIG and GAO findings related to waste, fraud and 

abuse. 

Research Treatment for Tinnitus: 

Tinnitus and hearing loss are the primary service connected conditions adjudicated by the Veterans Benefits Administration. There are double the number of 

veterans who are service connected for tinnitus than there are for PTSD, yet the 

research funding for audiology is minimal. 

Tinnitus, which is a constant ringing or buzzing in their ears, impacts so many 

aspects of a veterans’ quality of life. It is often a side effect within the ear or brain 

from other conditions, environmental exposures (noise in a combat zone), or injury 

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4Martz et al. (2018) 

5 VDBC. Honoring the Call to Duty: Veterans Disability Benefits in the 21st Century. October 

2007. 

(TBI). Depression, anxiety, lack of sleep and difficulty focusing or concentrating are 

associated with tinnitus. Furthermore, tinnitus can exacerbate PTSD because of its 

sensory deprivation implications may impact memory imprints on the brain. A recent study 4 looked at the relationship between Tinnitus and suicide. 

Although symptoms can be managed, there is no cure. The National Center for 

Rehabilitative Auditory Research (NCRAR) at the VA Portland Health Care System 

has been involved with researching transcranial magnetic stimulation (TMS) that 

involves using magnates to nonsurgically penetrate the brain and affect the activity 

of neurons as a new treatment. 

• Congress should request an update from the NCRAR for a status on its research 

portfolio and potential translation capabilities for TMS. 

Homeless Veteran Program Data: 

WoA is aware that VA administrators are intimidating VA employees to match 

homeless Veterans to housing that is grossly inadequate for the veteran and to 

underreport the number of homeless veterans who cannot maintain independent living. They are using the HUD vouchers to get homeless veterans into apartments, 

but then do not have the ability to furnish or provide supplies for them. Many of 

these veterans are chronically mentally ill and need more supervision than can be 

provided in an apartment. The veteran fails to conduct appropriate hygiene, so 

neighbors complain to landlords who evict these veterans. The VA case manager 

should be recording these veterans as homeless, but instead are told to document 

these veterans as transferring and not to report anything until they get the veteran 

into new housing. Additionally, over $1 billion has been provided to community organizations via Supportive Services to Veterans Families (SSVF) grants, with little 

to no performance data produced. 

There needs to be greater accountability for this highly vulnerable population. 

• Congress should require VA to closely document the needs of each homeless veteran, match him or her with the appropriate type of facility, and enhance case 

manager assistance with ongoing issues while the veteran is transitioning from 

homelessness. 

• VA should conduct a long-term ‘‘lifecycle’’ study on homeless veterans to identify 

challenges, complex medical/mental/dental needs and account for accurate 

touchpoints for interventions, services and outcomes of these engagements. 

• VA should be required to report data regarding the number of veterans placed 

in transitional housing and the number who subsequently leave and the reasons 

why they left housing. It should also collect and report SSVF outcome data. 

Congress should authorize VA to conduct a comprehensive review of the Homeless Veteran population and a needs assessment. 

Toxic Exposures and Environmental Hazards Research and Presumption: 

Agent Orange: A primary source of concern for veterans that have contacted 

WoA has been related to toxic exposures and environmental hazards. There are still 

so many Vietnam-era Veterans with Agent Orange related issues that have not been 

appropriately recognized because of the shortfalls in the research, such as Blue 

Water Navy. For example, eye cancers are a continuous issue that lack research 

support. VA continues to deny claims for disability benefits, which in turn blocks 

veteran from accessing care. As the Vietnam generation ages and has more complex 

needs for care, the arguments over probable correlations need to be resolved before 

there is no one left for the science to help. 

Gulf War Illness: Although it has been more than 25 years since the US invaded 

Iraq, the mysteries of Gulf War Illnesses haunt veterans while perplexing VA. A 

July 2017 GAO report concluded that VA is still inappropriately denying veterans 

claims. It found an 80 percent denial rate, which is three times greater than any 

other type of claim denials. Plus, it also took VA longer to adjudicate these benefits. 

This delay means that sick veterans are not fully eligible for VA health care. VA 

has promised better training and to develop a new plan for research. 

Fort McClellan: When the Veterans Disability Benefits Commission (VDBC) 

issued its report, 5 it included the Service members (mostly women) from Ft. McClellan, AL in its recommendation for a presumption framework. The VDBC made 20 

recommendations for improvements to the VA presumption process, the creation of 

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6Olsen, K. the long shadow of Ft. McClellan. The American Legion Magazine. March 2018. 

Pgs. 22–28 7GAO–18–325: Published: Apr 25, 2018. 

a scientific review board, and veteran health surveillance. Over 10 years later, the 

American Legion is still reporting on the ‘‘unknown toxic legacy’’ of Anniston and 

has resolutions that requires a toxic substance national research center, comprehensive examinations for environmental exposures, and improvement in these rules. 6

Camp LeJeune: Due to the water contamination at the Marine Corps Base, 

Camp LeJeune, NC, increased reports of cancers in veterans and their families have 

been document over the last several decades related to the cleaning solvents in the 

water. Referring to the previous notes on Ft. McClellan and the VDBC findings, VA 

would be better situated to address these issues if they were to have a standardized 

process and scientific review board. 

Burn Pit Exposures: Similar to previous generations of veterans, those who 

have served in Afghanistan and Iraq since 9/11 were exposed to a concoction of 

burning substances on military installations that has caused them to raise health 

concerns from cancers to respiratory and gastrointestinal disorders. Although VA 

denies conclusive research for these conditions and does not have a presumption for 

burn pits, it has established a registry. However, this is an area yet again that the 

VDBC recommendation could be informative and assistive to veterans’ wellness if 

implemented. A registry alone assists no one. 

• Mandate VA to establish a Scientific Review Board as described by the VDBC 

for use in considering presumptions related to exposures. A standard should be 

adapted for ‘‘causal effect’’ based on more likely than not broad spectrum of evidence that is either Sufficient, Equipoise and above, Equipoise and below, 

Against. This calculation should include relative risk assessment, epidemiology, 

registries, surveillance data, predictive algorithms and interfaces with DoD. 

Research Waste, Fraud and Abuse: 

WoA has reviewed complaints related to the waste, fraud and abuse of research 

program funds that have gone to universities and other private sector partners. In 

these cases, VA failed to provide proper oversight of government funds or property 

and could not account for items issued to non-government researchers or other staff. 

Property that should have been returned to the government was not and funds 

unexecuted were not returned. 

Much of the $1.9 billion of taxpayer funded VA Research falls outside of the realm 

of ‘‘Direct Veteran Patient Care.’’ There exist little or no oversight to monitor these 

VA funded research activities. VA Medical Centers Research dollars and facility resources are often redistributed towards gaps in Veteran care services, which leads 

to a disparaged and fractured research work environment. These are dedicated VA 

laboratory research spaces intended to support VA funded research that take place 

at more than 80 VA research facilities nationwide. The VA remedy is the wholesale 

issuance of ‘‘100% Off Site Waivers’’ to the Academic Affiliate.’’ VA Rules and Regulations stipulate that ‘‘All VA Funded Grant Activity must take place on VA owned 

property.’’ Local VA ‘‘Nonprofit research Corporations’’ (NPC’s) no longer route Veteran-centric research grant funding through VA and millions of dollars of research 

equipment and space are abandoned to sit fallow. As a result, a ‘‘Boondoggle’’ is created to support an illusion of ‘‘Activity and Accountability’’ as once noted by Congressman Mike Coffman. The end result is displaced VA equipment infrastructure, 

lost technology transfer opportunities, royalties and invention disclosure as reported 

in a recent GAO report. 7

The OIG has conducted several investigations into VA research and development 

and has time and time again found mismanagement issues. For example, it investigated the development of a mobile application by VA and found that there were 

80 potential contracts totaling over $1 billion and VA did not ‘‘pick and stick’’ to 

the line item appropriation, thereby executing funds without the proper congressional authorities and confusing technology and patient care funds. In another investigation, the OIG found that VA did not have proper safeguards with its data 

when sharing information with external entities, such as universities. 

• Considering these research deficits and the lack of VA’s accountability for mismanagement and mishandling of equipment and space in its research program, 

VA should immediately put forth a plan for research oversight and its ability 

to report on executed research funds. 

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48 

Jacqueline Garrick is a former Army social work officer who has worked in the 

Departments of Veterans Affairs and Defense as well as for the House Veterans Affairs Committee. She is a subject matter expert in mental health and program evaluation. She is an advocate for disabled veterans and the use of peer support to improve resilience in traumatized populations. She founded Whistleblowers of America 

in 2017 based on her experience reporting attempted fraud with DoD Suicide prevention funds. 

Whistleblowers of America is a 501C3, EIN 82–3989539. Its mission is to provide 

peer support to employees and veterans who have reported wrongdoing and experienced retaliation. 

Contact: 

Jacqueline Garrick 

jackie@whistleblowersofamerica.org 

202–309–1870 

f 

National Association of Veterans’ Research and Education Foundations 

(NAVREF) 

May 23, 2018 

US House of Representatives 

House Committee on Veterans’ Affairs 

335 Cannon House Office Building 

Washington, DC 20515 

To the Committee Staff: 

In regard to the hearing held May 17th on the Department of Veterans Affairs’ 

medical and research prosthetic program, we would like to make an addition to the 

hearing record. Representative Poliquin asked Ms. Rusconi about the handling of 

unspent funds from an NIH research award. We would like to add the following 

statement to Ms. Rusconi’s response: 

It should be noted that funds drawn from an NIH or other federal grant by an 

NPC include the federally negotiated indirect rate to administer those funds. Those 

administrative funds are used to support the NPC, whose sole mission is to support 

VA research. 

Thank you for holding this important hearing and giving NAVREF the opportunity to represent the perspective of the VA-affiliated nonprofit corporations. 

Respectfully, 

Richard P. Starrs 

Chief Executive Officer 

Robin Rusconi 

Chairperson 

Æ 

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