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HUMAN SUBJECTS PROTECTIONS IN VA

RESEARCH

HEARING

BEFORE THE

SUBCOMMITTEE OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON VETERANS’ AFFAIRS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

JUNE 18, 2003

Printed for the use of the Committee on Veterans’ Affairs

Serial No. 108–18

(
COMMITTEE ON VETERANS’ AFFAIRS 

CHRISTOPHER H. SMITH, New Jersey, Chairman 

MICHAEL BILIRAKIS, Florida 

TERRY EVERETT, Alabama 

STEPHEN E. BUYER, Indiana 

JACK QUINN, New York 

CLIFF STEARNS, Florida 

JERRY MORAN, Kansas 

RICHARD H. BAKER, Louisiana 

ROB SIMMONS, Connecticut 

HENRY E. BROWN, JR., South Carolina 

JEFF MILLER, Florida 

JOHN BOOZMAN, Arkansas 

JEB BRADLEY, New Hampshire 

BOB BEAUPREZ, Colorado 

GINNY BROWN-WAITE, Florida 

RICK RENZI, Arizona 

TIM MURPHY, Pennsylvania 

LANE EVANS, Illinois 

BOB FILNER, California 

LUIS V. GUTIERREZ, Illinois 

CORRINE BROWN, Florida 

VIC SNYDER, Arkansas 

CIRO D. RODRIGUEZ, Texas 

MICHAEL H. MICHAUD, Maine 

DARLENE HOOLEY, Oregon 

SILVESTRE REYES, Texas 

TED STRICKLAND, Ohio 

SHELLEY BERKLEY, Nevada 

TOM UDALL, New Mexico 

SUSAN A. DAVIS, California 

TIM RYAN, Ohio

PATRICK E. RYAN, Chief Counsel and Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

STEPHEN E. BUYER, Indiana, Chairman 

MICHAEL BILIRAKIS, Florida 

TERRY EVERETT, Alabama 

JOHN BOOZMAN, Arkansas 

DARLENE HOOLEY, Oregon 

LANE EVANS, Illinois 

BOB FILNER, California 

TOM UDALL, New Mexico

(II) 
(III)

C O N T E N T S 

June 18, 2003

Page

Human Subjects Protections in VA Research ....................................................... 1

OPENING STATEMENTS 

Chairman Buyer ...................................................................................................... 1

Prepared statement of Chairman Buyer ........................................................ 35

Hon. Darlene Hooley ............................................................................................... 3

Hon. Lane Evans, ranking democratic member, full committee on Veterans’

Affairs .................................................................................................................... 4

Hon. Michael R. McNulty, a Representative in Congress from the State of 

New York .............................................................................................................. 5

WITNESSES 

Bascetta, Cynthia A., Director, Veterans’ Health and Benefits Issues, U.S. 

General Accounting Office ................................................................................... 6

Prepared statement of Ms. Bascetta ............................................................... 37

Koski, Greg, M.D. Senior Scientist, Institute for Health Policy, Massachusetts 

General Hospital, Harvard Medical School ........................................................ 8

Prepared statement of Mr. Koski .................................................................... 55

Roswell, M.D., Robert H. Under Secretary for Health, Department of Veterans 

Affairs; accompanied by Nelda P. Wray, M.D., Chief Research and Development Officer, Department of Veterans Affairs; John H. Mather, M.D., Special Assistant to the Under Secretary for Health, Department of Veterans 

Affairs; David A. Weber, Acting Chief Officer, Office of Research Oversight; 

and John Perlin, Deputy Under Secretary for Health, Department of Veterans Affairs ......................................................................................................... 20

Prepared statement of Dr. Roswell ................................................................. 72

MATERIAL SUBMITTED FOR THE RECORD 

VHA Directive, June 13, 2003: ...............................................................................

Establishment of a Facility Human Protection Program, submitted by 

Dr. Nelda Wray ............................................................................................. 27

Written committee questions and their responses: 

Chairman Buyer to Department of Veterans Affairs .................................... 79

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HUMAN SUBJECTS PROTECTIONS IN VA 

RESEARCH 

WEDNESDAY, JUNE 18, 2003

U.S. HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON VETERANS’ AFFAIRS, Washington, DC 

The subcommittee met, pursuant to notice, at 10 a.m., in room 

334, Cannon House Office Building, Hon. Steve Buyer (chairman of 

the subcommittee) presiding. 

Present: Representatives Buyer, Boozman, Hooley, and Evans. 

Also present: Representative McNulty. 

OPENING STATEMENT OF CHAIRMAN BUYER 

Mr. BUYER. Good morning. Welcome to today’s Subcommittee on 

Oversight and Investigations for the House Committee on Veterans’ Affairs hearing on human subjects protection in VA medical 

research, dated June 18, 2003. 

Today’s hearing deals with very crucial issues that, I believe, demands constant and consistent oversight: the issue of human subjects protection in VA medical research. 

It’s not a new issue, we have looked at this issue in the past, and 

I applaud the VA for taking several positive measures to strengthen its oversight of medical research. But we also have some lapses. 

In fact, the VA announced the establishment of the Office of Research and Compliance and Assurance, an independent oversight 

body, to monitor VA research programs, at our 1999 hearing. Another positive step taken by the VA in 2002 was initiating the accreditation process of its human research protection programs with 

the National Committee on Quality Assurance, NCQA. 

Hopefully, we will receive an update on these and other problem 

areas which Dr. Roswell outlined in previous testimony. When he 

testified at our May 16, 2002 hearing, Dr. Roswell stated that the 

most common deficiencies involved in accreditation are in three 

main areas: one, lack of local facility policy and procedures related 

to IRB structure and operations; number two, a lack of policy and 

procedures related to informed consent process and the conduct of 

informed consent documents; and number three, the evaluation and 

determinations the IRB must make and document during initial review of research programs. 

The subcommittee is also interested in the Office of Research Development’s efforts to provide guidance to VISN directors concerning staffing levels of independent review boards. It is apparent 

that the role of IRBs approving and monitoring research protocols 
2

for all projects at the facility level must have the necessary support 

to fulfill its mission, thereby ensuring that all applicable regulations for the protection of human subjects is adhered to and followed by all VA researchers. 

While the VA has made a good faith effort to address problems 

that are documented dating back to 1993, it does appear that there 

are still some recurring problems that need to be addressed immediately. 

The outstanding questions are, is it systemic? Can more be done? 

The purpose of this hearing is not to question the good faith effort, 

because I think that those who are involved are doing their very 

best. But there are also some who are sometimes are captured by 

their ambition or aspiration, that they are willing to dance upon 

the edge. And there is a human being at stake. 

The groundwork for today’s hearing stems from a hearing held 

by this subcommittee on April 21, 1999, entitled, ‘‘The Suspension 

of Medical Research at West Los Angeles, and the Sepulveda VA 

Medical Facilities and Informed Consent and Patient Safety in VA 

Medical Research.’’ At the hearing, former Chairman, Terry Everett stated, ‘‘The 

subcommittee demands an explanation and accountability. These 

outrageous crimes against our veterans must not happen again.’’ The outstanding question is, has it happened again? 

Since then, several hearings have been held by the subcommittee 

to ensure that necessary actions are taken to ensure that our nation’s most vulnerable veterans are protected, and not subjected to 

any type of abuse, such as the violations imposed upon them at the 

greater Los Angeles medical facilities. 

During today’s hearing, we hope to learn what precipitated recent actions taken by the VA in its organizational restructuring 

within the office of research development. 

I know that we have the same goals that relate to VA medical 

research. We do not want veterans to have their rights denied, or 

to place them in harmful environments. Likewise, we recognize the 

tremendous contributions that have been made by the VA through 

its medical research, and the discoveries of important life-saving 

drug therapies, medical devices that have benefitted not only veterans, but also all Americans and others around the world. 

I also recognize that there is ongoing investigation with regard 

to the facility in Albany, NY. And because there is a criminal investigation, I just caution members to be careful about trying to solicit specific facts from the VA, and that we can sort of speak in 

tongue, vague, in generalities, and dance along the edge. 

And if any of the members want any facts in greater detail, you 

can obtain them through me, through our office. But let’s not get 

too far into that today. 

I would ask unanimous consent that Mr. McNulty be permitted 

to join the subcommittee today, and be permitted to ask questions, 

in accordance with the committee rules. Any objections? 

[No response.] 

Mr. BUYER. Hearing no objection, so ordered. What that means, 

Mr. McNulty, is that you will be recognized after all the members 

of the committee are recognized, and we are pleased that you have 

joined us here today. 
3

Also, before I yield, Ms. Hooley, I want to express to my colleagues on the Energy and Commerce Committee, we are marking 

up the Medicare prescription drug bill, and I believe the first 

amendment up is my amendment. So as soon as I get the notice, 

I am going to have to leave, and then Mr. Boozman, if you could 

then take the chair. 

Ms. Hooley, you are now recognized for an opening comment. 

OPENING STATEMENT OF HON. DARLENE HOOLEY 

Ms. HOOLEY. Thank you, Mr. Chairman. I welcome our guests 

this morning. I also am going to join the Chairman in signing on 

to his bill which calls for oversight research compliance and assurance for the Veterans Health Administration. 

There is a reason why every federal agency has an Inspector 

General. There is a reason why congressional committees have 

oversight and investigative subcommittees. It is our business to 

oversee and investigate the care and treatment of United States 

veterans. And as the VA well knows, this includes continuous scrutiny of VA programs and procedures. 

Human subject research is no exception to this protocol. Fully 

funded robust research enables VA doctors to improve the physical 

and mental health of all Americans. Cardiac and cancer surgery, 

HIV and Hepatitis medication, post-traumatic stress and sexual 

trauma treatment, the final products of VA research are tangible 

examples of assisting those who have borne the battle. 

As GAO points out in their testimony, VA research has a long 

history of success stories: the first liver transplant, the nicotine 

patch, and many other devices, techniques, and medicines that not 

only benefit this country’s veterans, but also improves the lives of 

everyone living in the United States and throughout the world. 

However, VA has not been problem-free in managing human subject research. Past problems closed the program at West Los Angeles. The GAO noted problems in a prior review of VA human subject research programs. There was a death of a human research 

subject in Albany, NY. Today, perhaps, we shall glean the culture 

that permits this type of problem to continue unchecked. 

Writing training plans and promulgating policies is a necessary 

first step. But sometimes, when the issue and the stakes are as 

high as they are for human subject research, you must go and see 

for yourself. It takes robust oversight, supported by adequate funding. It takes vigilant managers at all levels, willing to look, listen, 

and to ask why. 

Where veterans are the test subjects of a VA research, we need 

a no excuses mentality. I am stunned that the first response of VA, 

upon encountering a problem here in the Albany death, was to 

compromise the independence of the oversight agency by placing 

control directly under the office responsible for conducting 

research. 

Regardless of the integrity of the principal parties involved—and 

I am not passing any judgement—but it seems only a matter of 

time until someone might try to attempt to guide or limit some future investigation. This cannot be tolerated, and alignment of oversight under the office of research and development would eliminate 

checks and balances needed for effective and safe management. 
4

Again, what culture produced—an initial solution where independence is compromised. Veterans deserve the best care. Veterans 

who participate in research studies deserve to be treated as more 

than a means to an end. Veterans have protected this country from 

harm on foreign and domestic shores. It is the very least we can 

do to ensure their protection from incompetent and research improprieties. 

And I yield back the remainder of my time. 

Mr. BUYER. Ms. Hooley, thank you for joining on the bill, and I 

appreciate your contribution. This is really, truly a bipartisan effort. Mr. Boozman, do you have any opening comment? 

Mr. BOOZMAN. [Shaking head.] 

Mr. BUYER. Thank you, sir. The chair now recognizes Mr. Evans, 

ranking member of the full committee, for any comments he would 

like to make. 

OPENING STATEMENT OF HON. LANE EVANS, RANKING DEMOCRATIC MEMBER, FULL COMMITTEE ON VETERANS’

AFFAIRS 

Mr. EVANS. Mr. Chairman, there is no question that I value the 

research at the VA. There is also no question of the high duty the 

VA has to protect its human research subjects. 

Human research subjects must be informed of risks and consent 

to those risks voluntarily. Risks must be reasonable in relation to 

anticipated benefits to an individual or to society. The selection of 

research subjects must be fair. The common rule was adopted to 

create a system of protection for human subjects, based on written 

regulations. 

The common rule assigns responsibilities to investigators. It establishes an oversight mechanism for research at the institutional 

level. It also takes agencies like the VA to ensure compliance by 

these other institutions. 

The VA has experienced past problems with management and 

oversight of human subject research. Sometimes research at VA facilities was suspended due to actual harm, or because of the potential for harm. 

VA must adapt rules and procedures that are foolproof, and must 

educate human subjects and researchers to construct a reliable incident reporting procedure. 

The VA must ensure strong and independent oversight of high 

human subject research matters. Policy must translate into real 

oversight at the program level. To accomplish this, I cosponsored 

H.R. 1585. 

I also co-sponsored H.R. 1585 after a recent possible research-related death, because the initial reaction of the VA was to place the 

oversight agency under the control of the very organization that 

they were to hold accountable. 

This would obviously limit independence, and could appear as a 

conflict of interest. While the VA viewpoint has been favorably 

changed, the legislation is still needed. 

Veterans are the beneficiaries of VA research. We must take all 

precautions to prevent them from becoming victims. And I thank 

you, Mr. Chairman, for allowing me the time. 
5

Mr. BUYER. Mr. Evans, you and I signed a letter on April 24, 

2003, to Chairman Simmons, the chairman of the Subcommittee on 

Health, to mark up H.R. 1585. I have not received a response to 

our letter. Ms. Hooley, I thank you for joining us in that. And hopefully, today’s hearing can help get a little more momentum. 

As soon as I get a response, Mr. Evans, I will let you know. 

Mr. McNulty, you are recognized for any comments you would 

like to make. 

OPENING STATEMENT OF HON. MICHAEL R. MCNULTY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW 

YORK 

Mr. MCNULTY. Thank you, Mr. Chairman. I thank you, and the 

ranking member of the subcommittee, the ranking member of the 

full committee, Mr. Boozman, and all other members of the subcommittee, for allowing me to participate today. 

As I get older, Mr. Chairman, I work more diligently on trying 

to keep my priorities straight. One of those priorities is to remember that had it not been for all of the men and women who wore 

the uniform of the United States military through the years, people 

like me wouldn’t have the privilege of going around bragging, as I 

often do, about how we live in the freest and most open democracy 

on the face of the earth. 

Freedom isn’t free. We have paid a tremendous price for it. I try 

not to let a day go by without remembering with deepest gratitude 

all of those who, like my brother, Bill, made the supreme sacrifice, 

and all of those like many people who are in this room, who are 

willing to put their lives on the line, put their lives on the line for 

all that we hold dear, and then, thankfully, came back home, and 

rendered outstanding service in the community, and raised beautiful families to carry on in their fine traditions. 

These are the things that I am most grateful for today. And 

that’s why, when I get up in the morning, the first two things I 

do are to thank God for my life, and veterans for my way of life. 

I thank you for holding this hearing, because it’s a very serious 

subject. I understand the constraints that we are under, and I will 

abide by those. 

I just want to say that I have been in public office for 34 years, 

and throughout that period of time I have been associated with the 

Veterans Administration Hospital in Albany, NY, now named the 

Samuel S. Stratton VA Medical Center, after our late colleague, 

Sam Stratton. And I can say to you, Mr. Chairman, that throughout all those years, that facility, in my opinion, has rendered outstanding service to all of our veterans, and I am deeply grateful to 

all of those who have worked at that VA medical center through 

the years. 

This latest incident which is now under investigation troubles me 

greatly. And that is why I am deeply grateful to you for stepping 

up to the plate, and recognizing this particular problem and others 

across the country, and working to rectify them. 

And as you know, I am already a sponsor of your bill, H.R. 1585, 

and I just wanted to come here today to thank you for stepping forward, along with the other leaders of this committee and the other 
6

members of this committee, to make sure that we continue to provide the best possible health care services to all of our veterans. 

Thank you, Mr. Chairman. 

Mr. BUYER. Thank you, Mr. McNulty. We are really privileged to 

serve on this committee. We sit in this committee room under these 

flags, and some of these flags represent a lot of sacrifice. And especially when you get to see the military’s flags, and you see all of 

those streamers, that’s a lot of battles. I appreciate your being 

here, and I appreciate your cosponsorship. 

We will now turn to our first panel, Ms. Bascetta, from the GAO. 

Ms. Cynthia Bascetta, director of the Veterans’ Health and Benefits 

Issues at the U.S. General Accounting Office. We also would like 

to recognize Dr. Greg Koski, senior scientist at the Institute for 

Health Policy, and the first director of the office of Human Research Protections. Ms. Bascetta, you are now recognized. 

Ms. BASCETTA. Good morning. 

Mr. BUYER. Good morning. 

STATEMENTS OF CYNTHIA A. BASCETTA, DIRECTOR, VETERANS’ HEALTH AND BENEFITS ISSUES, U.S. GENERAL ACCOUNTING OFFICE; AND GREG KOSKI, M.D. SENIOR SCIENTIST, INSTITUTE FOR HEALTH POLICY, MASSACHUSETTS 

GENERAL HOSPITAL, HARVARD MEDICAL SCHOOL 

STATEMENT OF CYNTHIA A. BASCETTA 

Ms. BASCETTA. Mr. Chairman, and members of the subcommittee, I am very pleased to be here today to discuss the 

strengths and weaknesses of VA’s actions to protect the thousands 

of veterans who participate in its research programs. 

While research offers the possibility of significant benefits to individual participants and society, we all recognize that it is not 

without risk to research subjects. VA and other federally-funded research programs are governed by extensive regulations to minimize 

these risks, and to protect the rights and welfare of human subjects. 

Since many veterans are unable to afford private health care, 

and may fear jeopardizing their access to VA care if they do not 

agree to participate in research, VA has a special responsibility to 

safeguard their rights and protect their welfare. 

Nevertheless, serious failures in human subject protections in 

both VA and non-VA research have come to national attention over 

the past several years. In September 2000, we testified before this 

subcommittee about the uneven but disturbing pattern of non-compliance we found in our review of eight VA medical centers. 

We made recommendations to strengthen weaknesses we identified in guidance, oversight, and funding for human subject protection activities. Today, I would like to note the progress VA has 

made in implementing the recommendations we made nearly 3 

years ago, and to comment on VA’s ongoing reorganization of its research offices. 

Mr. Chairman, VA has taken some important steps to strengthen 

aspects of its human subject protections, most notably, through its 

compliance office’s internal oversight activities, and by leading the 
7

research community in instituting an external accreditation 

program. 

On balance, however, VA has not taken sufficient action to respond to our recommendations. VA still needs to update its policy 

to implement governing federal regulations. We learned yesterday 

that they plan to do this within 30 days. 

VA has also not ensured that all personnel involved in human 

subjects research will receive periodic training. And they need to 

ensure that institutional review boards have information that can 

help them interpret reports of actual adverse events, and that sufficient funding is allocated to support human subject protection activities at all medical centers. 

As you know, VA is now in the midst of reorganizing the Office 

of Research Oversight, formerly ORCA, and the Office of Research 

and Development. The reorganization began early this year without adequate planning and notice to affected staff. 

For example, when ORCA was disbanded, the compliance function and staff were initially assigned to ORD. Compliance field personnel began reporting their activities to ORD. This reporting arrangement conflicted with generally-accepted government auditing 

standards requiring that offices with responsibility for assessing 

regulatory compliance be organizationally independent of the offices they review. 

Consistent with the legislation that you introduced, we understand that the compliance office is now accountable to the Under 

Secretary for Health, not the chief officer of ORD. Although our 

concern about independence appears resolved, VA’s reorganization 

raises other questions about the extent of the Office of Research 

Oversight’s authority. 

In the past, ORCA was authorized to perform for-cause investigations of alleged non-compliance, as well as routine inspections. 

Your bill would establish, in statute, the compliance office’s authority to continue to conduct routine inspections. 

Existing memoranda establishing the new compliance office, 

however, are silent on routine inspections. Experts tell us that the 

authority to conduct these inspections is important, because such 

inspections are essential in minimizing risk to research participants, rather than merely addressing instances of non-compliance 

after the fact. 

The reorganization also raises questions about VA’s plans for 

strengthening human subject protections. For example, the reorganization assigns responsibility for education and training to ORD. 

Although officials told us yesterday that the Office of Research 

Oversight would continue to provide guidance regarding specific instances of non-compliance, they have not formalized this responsibility in writing. 

ORD has also been assigned the responsibility for policy development. But existing memorandum have not clarified what role the 

Office of Research Oversight will play in policy development. 

We are concerned that if VA’s compliance and operational research offices do not collaborate on both education and policy, VA 

could miss the opportunity to bring to bear the collective expertise 

of these two offices. 
8

In addition, we are concerned that if ORD takes the lead on policy relating to compliance functions, that could inappropriately 

interfere with the Office of Research Oversight’s ability to independently oversee compliance. 

Mr. Chairman, this concludes my remarks, and I would be happy 

to answer your questions, or those of the other subcommittee 

members. 

[The prepared statement of Ms. Bascetta appears on p. 37.] 

Mr. BUYER. Thank you. Mr. Koski. 

STATEMENT OF GREG KOSKI 

Dr. KOSKI. Mr. Chairman and distinguished members, thank you 

for the opportunity and privilege to appear at today’s hearing. The 

longstanding and continuing commitment of this subcommittee to 

the well-being of research participants is well-recognized and widely appreciated. 

Indeed, it was here in September of 2000 that I, then as the first 

director of OHRP, the new office at the Department of Health and 

Human Services for the oversight of human research, first described to the Congress and the American people the Department’s 

vision for the future of our national system for the protection of 

human subjects. 

Since that hearing nearly 3 years ago, the Department of Health 

and Human Services and the Department of Veterans Affairs, with 

OHRP and ORCA, working hand-in-hand with other federal agencies, have begun to implement a new approach for the protection 

of human subjects in research, one based on the simple concept 

that the first responsibility of everyone involved in the research 

process is to protect the rights, interests, and well-being of the individuals who voluntarily participate as the subjects of studies. 

Among these are veterans who have served America not only in our 

armed services, but also as research subjects in support of the VA’s 

health research programs. 

The new approaches pioneered by HHS and VA are more than 

just an improvement of the former oversight and corrective action 

approach. The represent a new paradigm. They provide a framework for a system that is focused on prevention. Identification, and 

correction of deficiencies after someone has been harmed is simply 

not good enough. We owe the American people, and particularly 

our veterans, more than that. 

Our system must minimize the likelihood that research participants will be harmed. We must have a system that is both 

proactive and interactive, and not reactive. 

The programs that have been developed and implemented by 

OHRP and ORCA are taking us down this new road, where the 

goal is responsible conduct of science, not mere procedural compliance with regulatory requirements. At HHS, this focus on prevention, performance, and quality improvement has been incorporated 

into the Department’s strategic plan, and I believe that there will 

be no turning back. 

Over the past few months, the VA’s human research program 

has again been subject to intense scrutiny, as new allegations of 

non-compliance, abuses of human subjects, and scientific misconduct have come to light. Further, the organizational restruc-
9

turing that last January eliminated ORCA and returned, at least 

in part, oversight of research activities to the Office of Research 

and Development, have been a source of concern. 

The need for—and even more importantly, the value of—independent oversight of research activities has never been more clearly appreciated. Independent objective oversight and evaluation 

builds confidence and trust. We have come to realize all too well 

that it’s erosion of this trust that poses the single greatest threat 

to the continuing vitality and productivity of our health research 

mission. 

Shortly after ORCA was created within VA to provide independent oversight of research activities at VA facilities, a similar 

step was taken at HHS, the creation of OHRP within the Office of 

the Secretary. The creation of OHRP was considered by many to 

be a sentinel event in an effort to reform the nation’s human research system. 

Its creation was recommended in June 1999 by an expert review 

panel convened in response to continuing concerns over the organizational placement, resources, and effectiveness of the Office for 

Protection from Research Risks, OHRP’s predecessor. 

As detailed in that panel’s report, even perceptions of competing 

commitments and conflicts of interest inherent in the placement of 

an oversight office in a subordinate position within the very agency 

that it is supposed to regulate were among the compelling arguments for the establishment of a new organizational structure, an 

autonomous office within HHS. 

The panel’s report is directly relevant to your consideration of 

the optimal placement of human research oversight responsibilities 

within VA, and I would respectfully request, Mr. Chairman, that 

this report be entered into the record of this hearing, along with 

my written statement. 

(A copy of the report can be found at this website: http://

www.nih.gov/about/director/0603996.htm) 

Dr. KOSKI. The programs initiated by HHS and VA address virtually all of the major recommendations of the HHS Office of the 

Inspector General and the General Accounting Office focusing on 

strengthening oversight, but they are still at a very early stage. 

This is a work in progress, and much remains to be done, and the 

resources to accomplish these goals must be forthcoming. 

Upon review of the progress that is being made, it’s clear that 

the important contributions of ORCA have helped us along this 

road. And that calls into question the rationale, motivation, and 

justification for its dissolution. 

Independent oversight is critical to accountability. Unfortunately, 

recent events at some VA medical centers have demonstrated that 

some programs and investigators have yet to embrace their responsibilities. Of course, even the most effective system of oversight 

cannot eliminate the possibility of mishap or misconduct. But the 

research community and the Federal Government cannot tolerate 

those who are unwilling to fulfill their responsibilities. 

Based upon the activities of the VA and HHS, the need for a 

more independent and consistent, integrated approach to human 

research oversight at the federal level has been discussed for sev-
10

1 NSTC: National Science and Technology Council of the White House. (EOP) 

eral years. At the executive branch, the Human Subjects Research 

Subcommittee of the NSTC’s 1 Committee on Science has made a 

valiant effort to proceed with integration under its new charter. 

But I do not believe that it has yet reached its full promise, 

largely because of administrative barriers and conflicting priorities, 

or opportunities within the various federal departments. It may be 

simply impossible to achieve the goals of integration and consistency under the existing federal statutory framework. 

As we have seen in the case of homeland security, the only way 

to achieve these goals may be for the Congress to take action toward creating a comprehensive system for oversight of human research, one that includes a single federal commission that can operate with authority and autonomy that’s unencumbered by competing interests of individual federal agencies trying simultaneously to fund and conduct the research, while also bearing responsibility for oversight of those activities. 

This commission must also be sensitive to the changing environment of science and be responsive to both the public and the research community it serves. 

This was the challenge that fostered the creation of both OHRP 

and the ORCA at VA. Mr. Chairman, the bill that you have introduced with bipartisan support provides a statutory resolution to 

the problem within the VA, but it may not go far enough. 

The American people can reap the benefits of biomedical research 

and technology only through human studies, and they deserve the 

best efforts of Congress and the administration to increase our national investment in research and development. 

But without an effective system for protection of human subjects, 

we risk losing the trust of individuals upon whom our research 

mission is absolutely dependent. As with the creation of OHRP and 

HHS, the creation of an autonomous oversight office within VA was 

and remains today an important step toward ensuring the integrity 

of its human research programs and enhancing the system for protection of human subjects. 

The same must be said for oversight at the federal level, more 

broadly, and I believe that the time for action is not only now, but 

in fact, it’s overdue. 

In closing, I would like to acknowledge and thank the many 

friends and colleagues who have contributed, both inside government and outside, in the private sector, to these efforts over the 

years, and to the ideas that I have expressed and shared with you 

today. 

I am happy to entertain any questions, Mr. Chairman. 

[The prepared statement of Mr. Koski appears on p. 55.]
11

Mr. BUYER. Ms. Bascetta, thank you for your contribution, along 

with Dr. Koski. Dr. Koski, your testimony was excellent. 

You got my attention, Dr. Koski. I take it from your testimony, 

that you would concur that an independent oversight body should 

be codified into law. 

Dr. KOSKI. Yes, Mr. Chairman, I do. 

Mr. BUYER. Now, please specify your recommendations to me 

when you said that, ‘‘I like what you are doing, but you don’t go 

far enough.’’ Please express your opinions and recommendations. 

Dr. KOSKI. Mr. Chairman, I believe that the action that your bill 

would take with respect to VA would address the problem within 

that agency. But the problem that I see is larger than simply at 

one federal agency. 

I think the need is to create a uniform system for oversight of 

human research, all human research, regardless of the source of 

funding, under a common federal regulatory structure, and to have 

an independent, autonomous agency within the government that 

would be subject to the oversight of a board of overseers that would 

include representatives from both the public, as well as the government, in order to ensure that the activities of that commission are 

fulfilling its goals, and also to include an independent advisory 

committee that would be able to provide balanced and authoritative 

advice on the ethical, scientific, and policy issues that are going to 

continue to face us in human research as we go forward. 

Mr. BUYER. All right, help me out here. You were at NIH, and 

then you pulled this out of NIH at HHS, and you are saying, ‘‘Wait 

a minute, Steve, don’t do this just for the VA, think bigger.’’ So, obviously, I serve on the health subcommittee in Commerce. 

So what you are saying is that this bill is too narrow and we 

should go back to the drawing board? 

You know, I feel like I am now going beyond the jurisdiction of 

this committee—but are you also saying that there are concerns 

with regard to how we fund research within NIH and—you name 

it, FDA, DOD? I mean, the list goes on. We fund many types of research out here, and you tell me we are just too narrow and we 

should think in broader terms? 

Dr. KOSKI. Mr. Chairman, I am not the first to voice these concerns about the largely fragmented approach to human research 

oversight across the Federal Government. The National Bioethics 

Commission and several other expert commissions that have been 

convened over the years have recognized the need for greater integration, and the calls for a uniform approach to oversight and independence of the oversight office are not new. 

So, I am simply restating them. And I believe that the experiences that we have seen over the last 3 years, as efforts have been 

made to strengthen these programs, validate the pre-existing concerns, and also the recommendations that have been made. 

Again, not to attack this problem on an agency-by-agency basis, 

but rather, to take a comprehensive and wide-ranging approach 

that would basically provide independent oversight of human research activities across the entire Federal Government in a coordinated and effective manner. 

Mr. BUYER. Well, I didn’t come to Congress to grow government, 

but you have gotten my attention because we fund research in so 
12

many different areas. I never thought about creating a separate 

federal agency. We have the FBI doing one thing, and now what, 

create another agency that has overlapping jurisdictions? 

Not that I am against it, I am just telling you you are taking 

thoughts where I was not prepared to go. I am going to be a good 

listener, though. 

Let me ask this. Of all research—since we place a lot of trust on 

the honesty and integrity of the researcher and their data, could 

ORCA or the Office of Human Research Protection, or any other 

oversight body, actually detect research misconduct in the form of 

data fabrication? Can you actually detect that? 

You are asking us to be proactive. But when you actually go in, 

could you actually catch that ahead of time? 

Dr. KOSKI. Misconduct, in terms of fabrication of data, is something that is, obviously, very difficult to catch, because the very intelligent individual who wants to try to do so is clearly positioned 

in a way to do that. 

However, there are, of course, times in which there are hints 

that some impropriety has occurred, and there needs to be a process that can investigate those when they do occur. And they are 

often painful investigations. 

But to ensure that when there is an allegation or a concern that 

arises—and they usually come from whistle-blowers or publications 

that raise questions about the voracity of the data—the investigatory process has to proceed in a way that the science is—the scientific community is basically removed from the investigation to 

the extent necessary to ensure the autonomy and integrity of the 

investigational process. 

Mr. BUYER. All right. My time has expired. Ms. Hooley? 

Ms. HOOLEY. Thank you. Ms. Bascetta, the Office of Research 

and Compliance and Assurance, ORCA, has been disbanded. And 

the Office of Research Oversight is set up as a replacement for VA 

research oversight. The often referenced catalyst for this change is 

a recent death of a human research subject. 

Your testimony points out that many of the completed recommendations from your 2000 report were fulfilled by the Office of 

Research, Compliance, and Assurance. I want to know that—did 

ORCA need to be revamped, were policies adequate, was training 

adequate, was oversight adequate, were upchanneled communications effective, and will the new management realignment improve 

human subject protection for veterans? 

Ms. BASCETTA. That is a very important question, and we have 

thought about that a lot in the last few weeks, as we have been 

looking at the reorganization. 

We really can’t find a compelling reason for the reorganization. 

We would certainly agree that VA had not done enough to implement our recommendations, but we wouldn’t have foreseen that a 

reorganization would be necessary. We thought that the organization that they had with ORCA and ORD was appropriate, and that 

within that construct, those two offices could have taken the necessary actions to move more quickly to implement our recommendations in all of the areas that you listed. 

Mr. BUYER. Doctor, you have got my head spinning, trying to figure this out. 
13

Mr. BOOZMAN. The question I would have is that there are many 

institutions, you know, that do human testing. Is there a good 

model out there to—I mean, you know, rather than reinvent the 

wheel, is there a good model out there of somebody that does an 

excellent job of doing this? 

Ms. BASCETTA. I think that the federal regulations that govern 

human subject protections are the model. The problem is that not 

enough research is conducted in a manner that complies with those 

regulations, both within VA and outside VA. 

And we have noted within our own work that some of the medical centers that we have reviewed have done a much better job in 

implementing those regulations, and in funding the institutional 

review boards to, in many ways, carry out the most important activities to protect patients’ rights and welfare. 

On the other hand, other organizations that were in the scope of 

our review did a much poorer job. 

Mr. BOOZMAN. Are there strong penalties for those that do falsify, both corporately and individually, that falsify data? 

I mean, you know, we have had instances where people did falsify data. Are there strong penalties for those that do that? Is that 

legislated somewhere? 

Dr. KOSKI. There are penalties, sir, but generally they are an exclusion from participation in various activities within the scientific 

community. They will also carry with them the preclusion of research funding, federal funding for research to an investigator for 

a period of time. But perhaps the greatest penalty that any investigator can, you know, bear is the penalty that comes along with the 

destruction of a reputation and a career as a scientist that almost 

inevitably results after scientific misconduct that includes fabrication of data. 

Mr. BOOZMAN. So, if a person is found guilty of fabrication, they 

can’t any longer work in a federally-funded situation? 

Dr. KOSKI. At least for a period of time, yes. Generally, an investigator who is found to have engaged in misconduct will enter into 

an agreement of some sort with the funding agencies that define 

the conditions under which they will conduct their activities for a 

period of time. 

Mr. BOOZMAN. Is the ORO, is that basically ORCA without the 

training and the things you mentioned, without the training, without the policy component and the spot checks? 

Ms. BASCETTA. Our understanding at this point is that ORO, the 

Office of Research and Oversight, is responsible for the previous 

compliance functions that ORCA had. 

Mr. BOOZMAN. Without those three things? 

Ms. BASCETTA. Correct. 

Mr. BOOZMAN. But everything else is basically the same? 

Ms. BASCETTA. It seems to be. 

Mr. BOOZMAN. Okay, thank you. 

Mr. BUYER. Mr. Evans? 

Mr. EVANS. Thanks again, Mr. Chairman. Ms. Bascetta, VA 

worked with academic institutions to develop an optional webbased training program for researchers requiring a score of 75 percent correct before certification—was an optimal program coupled 

with the 75 percent passing score adequate? 
14

Ms. BASCETTA. It is hard for me to comment on whether the 75 

percent score is a good measure or not. I would really like to examine the test, as well as have a better appreciation for the effectiveness of the testing itself. 

But on its face, it would seem that a higher score certainly would 

not be an inappropriate measure. 

Mr. EVANS. I yield back, Mr. Chairman. 

Mr. BUYER. Mr. McNulty, if you will indulge me for one moment. 

Ms. Bascetta, I want to tap dance around this for a second, about 

the incident in Albany, NY, in thinking about what occurred in Los 

Angeles. Reflecting on my days as a prosecutor at the U.S. Attorney’s office, you know, there is a lot of information that can be 

gathered during a grand jury process, much of which is relevant, 

and then that which is material for the specific charge which may 

be handed down in a specific indictment. 

But there will be a lot of information which is not within the 

public domain. I don’t mind having this public conversation with 

you, because I want to figure out a way in which the subcommittee 

works with you in doing a bottoms-up review. 

Because my instincts are going to tell me that there were perhaps individuals who may have had knowledge, or should have 

known, and perhaps under the criminal aspects of the law. Perhaps 

the prosecutor will exercise a judgement that he could not prove a 

particular charge beyond a reasonable doubt. 

So there is a huge gap between the indictment standards of probable cause, and then actually obtaining beyond a reasonable doubt. 

So the prosecutor will exercise his discretion on whether to ask the 

grand jury to return an indictment on particular incidents. 

That does not mean that this committee is going to let it go. So, 

in regard to the civil side and administratively, I want to work 

with you and with the Department of Justice, for us to gain that 

access to that information, for us to be able to review through it, 

and for us to come to our own judgements about who was responsible within the chain of command. 

I make no allegations. One thing that I know about facts is that 

they are very cold and that they are very stubborn. And you can 

finesse them, you can try to hide them, but they keep coming. They 

don’t go away. 

And when we have an incident like this that erodes the trust and 

confidence of even the human subjects, and by the population at 

large, this subcommittee must act, and GAO, and the VA, and 

those who want to make corrections. And I think it’s the best way 

for us to do it, Ms. Bascetta. 

Do you have any comments, relative to mine? 

Ms. BASCETTA. Only that as Dr. Koski said earlier, it is very difficult to prevent someone who has malicious intent from perpetrating harm. But we do have to wonder whether or not, if the 

human subject protection systems in place are more robust, whether we could detect those kinds of problems more quickly. 

And of course, the quicker we can detect them, the quicker we 

can take patients out of harm’s way. So, I would definitely support 

your action to look on the—I think you called it the administrative 

side, or the civil side, to work this problem from all directions, and 

see how we can improve what is a very grave situation. 
15

Mr. BUYER. You know what I also love about the facts —this is 

my last comment, Mr. McNulty—what I also love about the facts 

is that if individuals have been wrongly accused, those facts are 

able to exonerate them. 

And it is hard for them to refute any attacks or defamations 

upon their character by allegations that others may have made, but 

when we go through this process, it is a way for them to exonerate 

themselves from allegations that have been made against them. 

At the same time, we get to the bottom in finding out who specifically—those who were responsible and accountable. We will let 

the Department of Justice handle one side, but we have a responsibility to clean up the other. Those are just my thoughts. 

Dr. Koski, do you have anything? 

Dr. KOSKI. Well, I would just add that perhaps the best protection, security that there won’t be problems, is when an institution 

or an organization has clearly established a norm of conduct and 

a culture within its own walls, it simply will not tolerate the individuals that may engage in that kind of misconduct. 

And I think, in all honesty, sir, that we are seeing this movement begin at institutions across the country, as they recognize 

their responsibilities and take steps to fulfill them. But it is not 

something that happens over night, so it will take time to do it. 

But I think progress is being made there, and we need to encourage that. 

With respect to the broader issue that set your mind reeling before, I might just mention, in closing, that Representatives DeGette 

and Greenwood last year introduced a bill that, in fact, would move 

very much down the road that I had mentioned of creating an independent oversight office, in a coordinated fashion, under a consistent and uniform regulatory structure. 

Mr. BUYER. That would be very challenging. Mr. McNulty? 

Mr. MCNULTY. Thank you, Mr. Chairman, and I thank both of 

the witnesses for their excellent testimony, and for their care and 

concern for our veterans. 

And let me ask a practical question, which either or both of you 

can respond to. As I said in my opening comments, it has been my 

experience that the vast majority of folks who work, at least at the 

Veterans’ Affairs Medical Center in Albany, are capable, hardworking, caring, giving individuals who do a tremendous job for our 

veterans who need quality health care. 

And what really frustrates me is that when an incident occurs— and as the chairman pointed out, they are actually few and far between, but sometimes they are very serious—that it has an impact 

on the whole system, and all the employees, and their morale, and 

so on. And that troubles me greatly. 

Also in keeping with the chairman’s admonition and not getting 

specific, I know I can say in general terms that there have been 

allegations in particular instances at facilities across the country 

that certain individuals were hired for positions who would not 

have been hired for those positions had their full background been 

known. 

And my question is, just as a practical matter, before we get to 

any new legislation, or any new commissions, or anything like that, 

what can and should be done internally within the Department to 
16

make sure that there is a better job done with regard to researching the background of individuals who are hired for sensitive positions within the VA system? 

Ms. BASCETTA. I wish I had a good answer for you right now. I 

can tell you that we have a current request from the chairman to 

review, top to bottom, their credentialing system, and we will be 

starting that work very soon. 

Dr. KOSKI. There are already in progress efforts to establish 

mechanisms for training and certification of clinical investigators 

that are arising in several organizations across the country. 

And it seems to me that the expertise that is required to be a 

competent clinical investigator who is going to have the well-being 

of subjects in their hands is something that warrants this degree 

of training and certification, and I support those programs. 

Indeed, some would argue that for certain types of a very risky 

human research, it may be very appropriate to not allow individuals who have not achieved a demonstrated degree of competency 

through certification to participate in those activities. 

So, again, we see this developing as the bar is raised for everyone. And again, it will take time. But to me, the most satisfying 

part is that these efforts are arising within the research community itself. These are physicians organizations and others who are 

working to raise the bar and establish these programs. 

I find it ironic that there have been such certification programs 

for clinical research coordinators, research nurses, IRB managers, 

and so on, so that those parts of the system have already responded. And perhaps the latest people to arrive at the party are, 

indeed, the scientists and investigators themselves. But it is good 

to see them doing it. 

Mr. MCNULTY. But it seems to me that there is a problem of mechanics here, because before you even get into the quality of the 

investigators and the investigative techniques and so on, that there 

are instances out there—again, not mentioning any in particular—

where if the investigation had just gone back to the person’s previous job or two jobs, that person never would have been hired. 

So it is not a really complicated thing, as far as the level of investigation, or their certification, or qualifications, or anything like 

that. It seems to me that just making sure that somebody picks up 

the damn phone and calls the previous employer or two employers 

to ask a couple of simple questions could reveal information which 

would prevent the hiring of an individual who could cause harm or 

even death to a veteran. 

Dr. KOSKI. That concern has been expressed more broadly within 

the medical profession, with respect to medical practice, as well as 

conduct of human research. 

Mr. MCNULTY. Thank you, Mr. Chairman. 

Mr. BUYER. Mr. McNulty, I had passed an article to you that outlines some of the investigations we are going to do into these hiring 

practices. 

Mr. MCNULTY. And I thank you for it, Mr. Chairman. I thank 

you for all your work. 

Mr. BUYER. Thank you. Ms. Bascetta, in the GAO’s opinion, if 

the VA had implemented all of your recommendations from your 
17

2000 report on human subject protections, would the VA have been 

better able to respond to the Albany incident? 

Ms. BASCETTA. It is hard for me to know that without knowing 

the specifics of Albany, but I can say that it does make us wonder 

whether or not, if the recommendations had been implemented, 

whether the detection of a problem would have occurred sooner. 

Mr. BUYER. Using the same evaluation criteria GAO used in 

2000, would you find similar, less than, or greater than level of 

patterns of non-compliance with human subjects protections? 

Ms. BASCETTA. Well, unfortunately, I think I have to respond 

that if we were to do a review now, because of the weaknesses that 

still exist, I believe that the pattern of compliance would continue 

to be uneven. So I think it would be similar to 3 years ago. 

Dr. KOSKI. If I may add, please, Mr. Chairman? 

Mr. BUYER. Yes. 

Dr. KOSKI. Over the last 3 years, the Office for Human Research 

Protections engaged in some 300 for-cause compliance oversight investigations. Some of those involved actual site visits, many were 

resolved through correspondence, but they all involved a comprehensive review of the programs where the alleged problems had 

occurred. 

And if one looks at the pattern that has emerged from an analysis of those, there is clear evidence that the research community—

at least at institutions that are under the oversight of OHRP—are 

taking steps to correct deficiencies in their programs, because we 

found that since many of these were investigations of complaints 

that were already 2 years old, they had already taken steps necessary in order to correct those. 

But in the final analysis, I think this—the necessity of direct 

interaction, the need to have people going in one mechanism or another, either through compliance oversight, through quality improvement, or other processes that involve direct interaction and 

evaluation with feedback and all, are absolutely essential. If we 

simply sit in Washington and wait for something bad to happen, 

and then go investigate, we will never get to the point that we will 

have well-functioning systems that achieve their goals. 

Mr. BUYER. Ms. Bascetta, your testimony states that the VA does 

not have a mechanism for handling adverse event reports to ensure 

that the IRBs have the information they need to safeguard the 

rights and welfare of human research participants. Are these 

events reported to the VA’s patient safety center? 

If you do not know, I will ask Dr. Koski. 

Ms. BASCETTA. I do not know for sure, but I would imagine that 

there is duplication of at least serious adverse events, that there 

should be a parallel reporting of those events to both the patient 

safety center in Ann Arbor, as well as to the researchers. 

Mr. BUYER. Since we are going to have Dr. Roswell up here next, 

let me have your opinion, please. I have your statement, we have 

gone over this in the past before, but in an open conversation here 

with me, with Dr. Roswell, and the audience, what should the VA’s 

top priorities be? Give us your one, two, three. What is, quick, the 

one, two, three, the top priorities of the VA for rectifying these deficiencies? What are they? 
18

Ms. BASCETTA. First of all, issue the revised policy, as they told 

us yesterday, within 30 days, so that the current guidance is clear 

and available to everyone. 

Second of all, require training in policy, periodic and recurrent 

training, so that the personnel who are involved in human subject 

research are required to stay current with ways to assure that they 

are complying with all applicable regulations. 

And thirdly, to continue, in a vigilant way, oversight through 

both for cause and prospective inspections. 

Mr. BUYER. Thank you. Dr. Koski, what would be your one, two, 

three recommendations to the VA? 

Dr. KOSKI. I would say requirements for education, training certification of all who are engaged in the human research process, 

continuing with interactive, proactive quality improvement activities in order to help programs improve, and to use compliance oversight tools, both for cause and not for cause investigative techniques or evaluations as necessary, to supplement and actually promote the full adoption of those practices. 

Mr. BUYER. Thank you. I yield to any members who would have 

follow-up questions, a second round. Ms. Hooley? 

Ms. HOOLEY. Yes, thank you, Mr. Chair. Mr. Koski, or Dr. Koski, 

I appreciate your comment in your statement that we must do 

more than just go through the motions regarding compliance. What 

are the tell-tale signs of an organization that is merely going 

through the motions? How do we know? 

Dr. KOSKI. When a program that has a large research endeavor 

underway has very limited resources dedicated to the management 

of that process at their institution, I believe that is as strong a sign 

as any that, in fact, there is a deficiency in the commitment of that 

institution to the necessary process. 

Of course, it could be just a limitation of resources. Those often 

go hand-in-hand in this world of competing interests, financially. 

But nevertheless, I think that, as we have seen time and time 

again, a hallmark. 

The failure of the leaders of institutions to make very clear to 

every member of the organization exactly what the expected norm 

is, to truly lead by example, and convey the message, is another 

tell-tale sign. And increasingly, we are seeing the people at the top 

being the ones to convey the message and set the tone for the institution. I think that’s where it has to come from. 

You know, when there is also a lack of respect for those who are 

actually participating on the front lines for the process, where they 

truly minimize what they need to do in order to meet their obligations and responsibilities, where, in fact, they are simply going 

through the motions, that’s another indicator that, in fact, there is 

not a robust process in place, there is not an appropriate culture 

at that institution. 

Just because you discover those things doesn’t mean that they 

can’t change. But I think that they are tell-tale signs that there 

will be a problem at that institution. 

Ms. HOOLEY. Let me ask you another question. You were at the 

Office for Human Research Protection, HHS. How many research 

improprieties did your office investigate? And do you feel that any 
19

of these could have been prevented by the new approaches implemented by VA? 

Dr. KOSKI. Within HHS, the organizational structure is somewhat different, in that allegations of research impropriety and misconduct are actually carried out by another office, the Office for Research Integrity. So they are separated there, so I can’t comment 

on that. 

I will say, however, that the Office of Research Integrity operates 

under the existing regulations with the actual research sites themselves, with the institutions that make an assurance to the government that they will have an effective process in place for the adjudication of allegations of misconduct in research. 

So that, again, it is a hand-in-hand thing. The institutions bear 

major responsibility in all of these areas, including the oversight of 

animals, human research, and scientific conduct. 

Ms. HOOLEY. Thank you, Dr. Koski. 

Mr. BUYER. I want to thank you both for your contributions here 

today. This is really an important subject. 

I just think it has all been very well said today. And there was 

a word that was used earlier, and it was in your testimony, describing the patients as a ‘‘vulnerable’’ population. It is so true. 

And whether—Dr. Koski, whether they were patients within 

NIH, I have said this before and I have to say it again, you can 

have—because of our compassion and our love, family members 

will do desperate acts, through love, to hold on to life, in that they 

are willing to participate in research, even cutting edge, even having been informed of the risks, for life. So, that makes them vulnerable. 

But when I also then say that that individual is a veteran, to me, 

they are even more vulnerable, because that veteran comes with a 

different dimension. ‘‘I am going to do it not only for myself but 

also for my country,’’ which makes them an extraordinarily vulnerable individual. And for that reason, we are going to be tough. 

And Ms. Bascetta, I look forward to working with you. And we 

are not going to let this one go. Thank you for your testimony. 

Ms. BASCETTA. Thank you. 

Dr. KOSKI. Thank you. 

Mr. BUYER. We now have concluded the first panel. If the second 

panel would come forward, we recognize Dr. Robert Roswell, the 

Under Secretary of Health, Department of Veterans Affairs. 

Also with him will be Dr. Wray, chief of research and development for the VA, and I would ask Dr. Roswell to introduce others 

who will be with him here today. 

Dr. ROSWELL. Good morning, Mr. Chairman. With me today are 

my Deputy Under Secretary for Health, Dr. John Perlin. On my 

left, your right, Dr. John Mather, the previous director of the Office 

of Research, Compliance, and Assurance. On my right, Dr. Nelda 

Wray, the chief officer for—chief research and development officer, 

head of ORD. And to her right, Dr. David Weber, acting director 

of the Office of Research Oversight. 

Mr. BUYER. Very good. Dr. Roswell, you may begin your testimony. 
20

STATEMENT OF ROBERT H. ROSWELL, M.D., UNDER SECRETARY FOR HEALTH, DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY NELDA P. WRAY, M.D., CHIEF RESEARCH AND DEVELOPMENT OFFICER, DEPARTMENT OF 

VETERANS AFFAIRS; JOHN H. MATHER, M.D., SPECIAL ASSISTANT TO THE UNDER SECRETARY FOR HEALTH, DEPARTMENT OF VETERANS AFFAIRS; DAVID A. WEBER, ACTING 

CHIEF OFFICER, OFFICE OF RESEARCH OVERSIGHT; AND 

JOHN PERLIN, DEPUTY UNDER SECRETARY FOR HEALTH, 

DEPARTMENT OF VETERANS AFFAIRS 

Dr. ROSWELL. Thank you, Mr. Chairman. It is a pleasure to be 

here today, and I want to acknowledge your leadership on an issue 

that is very near and dear to my heart, as well. 

Sadly, despite aggressive efforts that date back to 1999 and even 

before, including the creation of an independent office of research, 

compliance, and assurance, VA has continued to experience problems with the conduct of human research that have placed veterans in harm’s way. 

This is simply not acceptable. Accordingly, we are in the process 

of changing our policies and operations to ensure that unethical research behaviors will not be tolerated in this Department. 

We will ensure that patients are optimally informed when they 

consent to participate in research, and that research activities are 

safe and ethical. Thus, we have developed and are implementing 

new programs and training to support successful research conduct, 

management, and oversight at every level of the organization. 

Today, I would like to give you a brief progress report. Just since 

VA announced a research stand-down on March 6th of this year, 

we have made significant changes in the requirements for the conduct of research, many of which have been alluded to by the members of the previous panel and members of the committee. 

First, we have required that leadership at each VA facility that 

conducts human research certify that local institutional review 

boards, or IRBs, and research and development committees are in 

place, are working appropriately, and are effectively overseeing the 

conduct of all human studies. 

Second, we have required training of over 15,000 individuals involved in human study research in good clinical research practices. 

Human studies research personnel are now also required to take 

refresher courses on an annual basis. 

Third, we have required credentials verification, not just on the 

physicians involved in research, where we have always completed 

a credentialing and privileging process and background check, but 

on all research personnel with any degree of patient contact or programmatic responsibility. 

The Office of Research and Development is also creating an electronic means of tracking all employees involved in human subject 

research to facilitate checking these individuals against exclusionary lists. 

Following review of our experience with the external accreditation program for human research programs, revised standards were 

published in April 2003, and the accreditation process that is conducted by the National Committee on Quality Assurance, or NCQA, 

will begin again this summer, and all VA facilities will have 
21

human research programs complete the accreditation process by 

the summer of 2005, an external accreditation process, I might 

point out. 

We have also revised the organizational structure for research 

oversight to align policy and training with the Office of Research 

and Development, and to focus the Office of Research Oversight on 

compliance with regulatory and policy aspects of human subjects 

protections, animal welfare, research safety, and research 

misconduct. 

Since its inception in 1999, ORO’s predecessor, the Office of Research, Compliance, and Assurance, or ORCA, under the leadership 

of Dr. John Mather, contributed in many ways to the improvement 

of VA’s protection of human subjects participating in research. 

ORCA provided prospective compliance consultations, retrospective compliance reviews, a compliance program, and a training, 

education, and development function. 

However, our experiences have compelled us to establish mechanisms for more rapid, broad, and effective development and dissemination of policy and education. These actions are directed to go 

beyond insurance of compliance, and assure adequacy and integrity 

of research programs. 

The VA has established the program for research, integrity, development, and education, or PRIDE, within the Office of Research 

and Development. PRIDE is a ground-breaking program that is responsible for all education, training, and policy development related to human research protection in the VA. 

PRIDE is already serving as a resource for providing guidance 

and policy development for responsible research conduct. These activities coordinate with and require collaboration with the policies 

and work of other agencies and organizations involved in the protection of human subjects, both inside and outside the VA. 

Such entities include NCQA, the Food and Drug Administration, 

the National Institute of Health, the Office of Human Research 

Protection, and other components within VA, as well as quality assurance and patient safety organizations. 

While a new infrastructure has been developed in the Office of 

Research to support effective, rapid improvement in research conduct, VA believes strongly in independent oversight. As described, 

policy and programmatic educational activities now reside in the 

Office of Research and Development. 

Oversight of compliance and—with policy regulation law and ethics is the responsibility of the Office of Research Oversight. All 

human resources of the predecessor office, ORCA, are contained in 

the new Office of Research Oversight, and are now devoted to these 

three oversight activities. 

The activities of the research office and the oversight office are 

increasingly complementary with problems identified through oversight being met with aggressive solutions by the research office. 

The skill set embodied by the oversight office staff, in its five regional offices around the nation, and guided by the central office 

component, is well capable of informed consultative intervention. 

Because of its own oversight mission, the Office of Research 

Oversight will continue to serve as VA’s governing body for Federal 

Wide Assurance for VA facilities, in partnership with the Office of 
22

Human Research Protection in the Department of Health and 

Human Services. 

In our revised program protections, the oversight office will enjoy 

greater role clarity in discharging the oversight functions of its 

predecessor organization. This increased focus on oversight activities will assure that problems are investigated and, with the Office 

of Research as a committed peer office, provided effective and timely policy and training and are corrected. 

Research programs that fail to appropriately safeguard patients 

and the values of ethical research conduct will have funding terminated. We commit to this so that the Department of Veterans Affairs maintains the highest quality research programs in the country, and most responsibly serves the needs of our nation’s veterans. 

Mr. Chairman, my colleagues and I are prepared to answer questions you may have. 

[The prepared statement of Dr. Roswell appears on p. 72.] 

Mr. BUYER. Before I respond to your statement, Dr. Roswell, 

with questions, Dr. Roswell, I have some concerns and haven’t been 

able to discuss this with everyone on the subcommittee, but I bring 

it to everyone’s attention now. 

There is a company called Guidant Corporation that has pled 

guilty to criminal activity, with regard to hiding information and 

data that should have been reported to the FDA. And 12 people 

have died because of their stents. And well over 1,000 patients 

were affected. 

And I have made a request of the VA. I would like to know who 

are veterans, and whether or not the VA had purchased this medical device from Guidant Corporation. And Dr. Roswell, if you have 

any comments with regard to our request? 

Dr. ROSWELL. We are aware of your request. We are aware of the 

circumstances of the product, and it does appear that a number of 

VA patients—a small number—of VA patients, on the order of 15, 

to possibly as many as 30, have received that particular 

endovascular prosthesis. 

We are currently involved in a series of aggressive efforts to 

identify patients who may have received the prosthesis, or the 

endograft, and take appropriate actions. I will ask Dr. Perlin to detail the various databases that are currently being queried to ascertain which VA patients may have received such a product, and if, 

in fact, there have been any adverse outcomes in VA patients. 

Mr. BUYER. At this point, we don’t know whether or not any of 

the 12 deaths, whether any of those were veterans, or received this 

at a VA——

Dr. ROSWELL. We have no indication of a death of any VA patient 

as a result of a defect or malfunction of this product. 

Mr. BUYER. But you are checking the adverse outcomes, Dr. 

Perlin? 

Dr. PERLIN. Mr. Chairman, thank you. As Dr. Roswell mentioned, we have identified that we have purchased 15 of these devices. We also can tell you that we believe we have three inpatients, through a cooperative studies program. 

I can tell you that we are actually working through six discrete 

databases to try to identify any particular patients who may have 
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been affected by any of the endovascular stints, or the specific 

product, in particular. 

In fact, in our RCA database of over 60,000 adverse events in the 

last couple of years, we have identified no patients who have had 

a death attributable to this particular device. 

I have to offer a caveat. The caveat is this device goes into people 

with significant vascular disease, and if they died of a vascular 

cause, it may not flag even the clinician it may be something that’s 

related. So we’re not satisfied that that’s the absolute answer. 

Of the 15 acquisitions we pulled up through our acquisitions and 

prosthetics database—and we’re going in further detail, not only to 

ascertain those before the 2001, before that particular model of the 

device was terminated, but also devices up to the present. 

In addition to the RCA database, the acquisitions and prosthetics 

database, we are working with our national surgical quality 

improvement program, our clinical patient records—computerized 

patient record system, including the surgical package, as well as 

the CPT, or procedure codes, as well as the cooperative studies 

program. 

We are aware of a particular cooperative study trial that randomized patients between a traditional open procedure and the 

stint, and we believe that there were approximately 32 patients 

who got one of the stints, and 3 of those stints are the particular 

model. 

We hope to have all of the information back to you within the 

next 10 days to 2 weeks. And of course, for any patient who might 

have received this device, we will contact them and will relay not 

only the manufacturer’s information, but FDA recommendations regarding not just the particular device in question, but the category 

of devices. 

Mr. BUYER. With regard to VA’s business practices, hypothetically, Dr. Roswell, you and I are in business together in my 

home town, and we are dealing with a business, and we have now 

learned that this business which we were dealing with has pled 

guilty to criminal charges. 

And we purchase their product, and maybe one of our clients 

which we were interlocutor here has been harmed. I don’t think 

you and I are going to be doing business with this individual until 

certain things perhaps have to happen. 

So, with regard to your business practices and your reviews, I am 

curious about what actions are being taken with regard to your relationship with Guidant Corporation for the fact that a corporation 

now has pled guilty to such criminal misconduct. Is a review taking 

place, or what is happening? Could you please tell me? 

Dr. ROSWELL. Well, I would agree, and there is actually precedent where VA has suspended business dealings with——

Mr. BUYER. The VA has suspended business dealings with 

Guidant Corporation? Until what? 

Dr. ROSWELL. In this particular case, the Food and Drug Administration is the responsible government agency with oversight that 

basically licenses, certifies the safety of the product. 

We, obviously, will defer in all cases, to guidance from the Food 

and Drug Administration concerning product safety, particularly in 

plantable devices. 
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Clearly, though, in this case, where there is criminal activity involved, and patients may have been harmed, we are not only following—as Dr. Perlin said—FDA guidance, but we are also identifying patients and contacting them, and are not doing business, 

currently, with Guidant. 

Mr. BUYER. Okay. Thank you very much. Ms. Hooley, you are 

now recognized. 

Mr. HOOLEY. Thank you. Dr. Roswell, VA has not formally commented on H.R. 1585. But after some growing pains, VA seemingly 

has adopted a process that would conform to H.R. 1585. Why did 

it take so long for you to endorse the wisdom of H.R. 1585, and if 

that is not in place, if it doesn’t pass, what would prevent the VA 

from returning to a less rigorous oversight scheme? 

Dr. ROSWELL. Ms. Hooley, I think we do embrace the principles 

embodied in H.R. 1585. I think we have shared that with the committee staff director, Mr. Wu, on numerous occasions since the 

issues came up. 

We have taken what we believe is bold and aggressive action to 

not only refocus and safeguard the safety of veterans, but send a 

loud and clear message to everyone within the Department of Veterans Affairs that this is a very serious issue, and that it requires 

not only responsibility, but accountability at all levels in the organization. 

H.R. 1585 reflects the commitment and the structural changes 

that have already taken place within the Department of Veterans 

Affairs. And so, as I said, we support the concept of the bill. 

Ms. HOOLEY. But—say we don’t pass H.R. 1585; will you go 

back? What is to prevent you from going back to where you were? 

Dr. ROSWELL. Well, it certainly won’t be on my watch. 

Ms. HOOLEY. Okay. Are there any new improprieties that we 

don’t know about? 

Dr. ROSWELL. The short answer is I don’t know about what I 

don’t know about. And I don’t mean to be flip. The problem with 

human research is that it actually affords a better level of care 

when we make it available to our veterans. 

Veterans are very special to me, and I know they are to you, as 

well. 

Ms. HOOLEY. They are. 

Dr. ROSWELL. Participation in human research yields access to 

cutting edge technologies before the Food and Drug Administration 

may have approved them. And as the chairman pointed out, it 

often offers life-saving medications, techniques, and procedures 

where, otherwise, the prognosis is very grim. 

So, to me, it is very important in looking out for veterans, that 

we do everything we can to make research participation an option 

for them. But by the same token, participation in that research 

cannot place them in harm’s way. 

Because of the complexity of research, because of the nuances, it 

is likely that there will be problems associated with human research. But let me point out that human research will have adverse events that may not be the result of misconduct, that may 

not be the result of lack of compliance or oversight, that may not 

be the result of deficient policy, education, or training, because the 
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very nature of disease is that it leads to untoward events, despite 

the best interventions of man. 

So our goal is to safeguard the process, to identify problems 

where they exist, but more importantly, to seek to prevent those 

problems with the emphasis we placed on leadership throughout 

the entire research community and the Department of Veterans Affairs. 

Ms. HOOLEY. Well, I understand about research, and that’s why 

your protocols in oversight and investigation are so important. My 

question is, though, why has it always been reactive instead of 

proactive? 

Dr. ROSWELL. Well, again, I am going to ask Dr. Nelda Wray to 

address that. But I think that it must be proactive, and I think we 

have made some fundamental changes that shift our research oversight towards a proactive approach. 

As I said, the challenge is not only identification, but ultimately, 

it is prevention. And the Office of Research, Compliance, and Assurance was very effective at identification. But research policy, research education, research leadership commitment to safeguard the 

welfare of our patients is the effort that must be focused at prevention, and I have charged Dr. Wray with that responsibility. 

Ms. HOOLEY. Thank you. Go ahead. 

Dr. WRAY. May I answer? 

Ms. HOOLEY. Yes, please. 

Dr. WRAY. Thank you, Ms. Hooley, and thank you, Dr. Roswell. 

First, I want to commend ORCA, the previous institution, because 

they were not just reactive, they did several not-for-cause, but simply on a scheduled basis, site visits to oversee those sites. 

I think the separation, however, of the policing function and the 

education function is very, very important. I want to point out that 

the federal regulations simply categorize what the IRB should be, 

what the membership should be, what the IRB protocols should 

look at, as far as risk/benefit ratios, what informed consent should 

be. 

It stipulates that we, on a regular basis, re-review the protocol, 

and it also stipulates that we look at adverse events. It does not 

stipulate that we do credentialing, it does not stipulate that we do 

quality assurance, it does not stipulate the type of proactive quality 

assurance program that was talked about in the last panel. 

Clearly, that is what we need. We need to start with education 

and training. We have, as Dr. Roswell said, trained 15,000 individuals in the last 6 weeks. We created a software package for good 

clinical practices. We put it—within 2 weeks, we put it up, and now 

we have trained over 15,000. 

I agree with GAO, that we don’t have a policy out yet that requires, but we have guidance out that says they will repeat it every 

year. And before it is time to do it again, I will have that policy 

out. 

Regarding moving towards this compliance program, I took the 

job 5 months and 12 days ago. Since that time, we have put seven 

individuals in the PRIDE office in ORD in Washington, DC. Four 

of those are new hires and three are transfers. I have hired five 

individuals at Little Rock, one of which is considered the leading 

IRB expert within the VA, to create our team for education. 
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I have moved eight individuals from our cooperative trial program, an additional two-and-a-half individuals from an educational 

program, and several large consulting grants into an educational 

effort. If you take that, that’s a salary commitment of approxi- mately $2.2 million I have already committed, and we are still 

interviewing to increase ORD’s commitment to education. 

We have developed an e-mail list of our compliance officers. That 

compliance officer group has 100 names on it. Those are individuals in the field doing compliance. Ninety of our sites already have 

an electronic IRB to be able to quickly manage their IRB. 

So, as of yesterday, we have a formal policy in the field that will 

create an establishment of a facility level human protection program. What I want to make clear—we are moving beyond the federal regulation. We are going to put in place a quality assurance 

program at each site which will establish that culture that the last 

panel talked about that will do ongoing oversight. 

There are two things I think you can do regarding fabrication of 

data. Number one, you can have in place on-site individuals who 

are doing continuous quality assurance, so people are worried 

about falsifying that data. If they don’t think they are going to get 

caught, they may not worry about it. 

And then you provide them the quality assurance itself. You look 

directly at the charts. We found—excuse me—the problem in Albany was found. It was sad that it was so long before those charts 

were reviewed. 

We are going to put in place a procedure which will have quality 

assurance, regularly spot-check for human studies consent, regularly check for the quality of the data, the maintenance of appropriate records on all the studies that are conducted at sites on an 

ongoing basis. 

I don’t want to leave anyone with the impression that we are 

going to look at every patient put into every study, but we are 

going to make sure we do enough of a probability sample by quality 

compliance at each site that we know what is going on. 

If I could just make one other point, and then I will shut up, this 

memorandum, 40 percent of all the human studies that we do in 

the Department of Veterans Affairs are funded by the manufacturing drug industry, yet we have not had a systematic policy to 

ask those to help to fund our compliance problem. 

We do at least $60 million worth of pharmaceutical studies. It is 

not only 40 percent of all human studies, but if you take out the 

chart reviews, it is fully 90 or 95 percent of all the studies that 

have the potential to really put patients at risk. 

What we are doing is starting to charge a compliance fee to the 

pharmaceutical studies which are done in the VA to help fund, at 

the site, in addition to the resources we are going to be putting in, 

help fund at the site the compliance program I have talked about. 

On a yearly basis, every site will have to report to our office the 

monies that they have been able to obtain for this function, and 

their compliance program. So I wanted to make that point. 

Ms. HOOLEY. Thank you. 

Dr. WRAY. Oh, and I can submit this for the record. 

Ms. HOOLEY. Thank you. 

[The information follows:]
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Mr. MCNULTY. Mr. Chairman, I thank the members of the panel. 

I would just with regard to something Dr. Wray just said—and 

again, I want to comply with the request of the chairman about 

being too specific—but you said you caught the problem in Albany. 

Well, the fact of the matter is that if the allegations eventually 

prove to be true—and I’m not prejudging anything—you caught it 

too late. 

Now, beyond that, what I want to say to Dr. Roswell is that I 

am very pleased with both the content and the tenor of your testimony here today. Because with regard to the seriousness of the allegations that have been made in these very limited number of circumstances, and the need to do something about it now, you get 

it. And I am grateful for that. 

And you were in the room during the previous testimony, and I 

expressed my concern about doing things now. I mean, we want to 

do the chairman’s bill, we want to create commissions, and do 

these other things, all of which may have impacts way down the 

line. But I want to see things done now to protect veterans at VA 

medical facilities. And I think you understand that. 

And I am particularly pleased that you have verified what was 

told to me by VA officials in Albany about these background 

checks. Because when I talked to them, I was saying, ‘‘How can 

this happen, and what are we doing about it in the future, and so 

on?’’

And they told me that the background checks on the medical researchers will be strengthened and be more stringent in the future, 

and you have verified in your testimony today that you have ordered that to take place, and that is taking place now. 

And the only question I would have in that context, Dr. Roswell, 

would be I know that you’re saying the background checks on the 

medical researchers, and so on, are more stringent now. Are they 

as stringent as the background check on doctors? Is that something 

that can be compared? 

Dr. ROSWELL. They are as stringent as we can make them. The 

databases that record and track physician training, such as the national practitioner data bank, which is a statutory requirement 

that was implemented and applies to all physicians, there is no 

equivalent counterpart for that for people involved in research who 

are non-physician investigators. 

But by querying a number of existing data banks, looking at exclusionary lists, doing a formal background check, we are making 

the process as rigorous as we can, under the circumstances. 

Mr. MCNULTY. I just want you to know that I am very grateful 

for that, and very grateful for you to take that proactive step, absent any new legislation, or anything like that, because that is 

something that can accrue to the benefit of veterans all across this 

country. I thank you for doing that. 

That is all I have, Mr. Chairman. 

Mr. BUYER. I would like to clarify something. Number one, in response to Ms. Hooley’s question, Dr. Wray, you said within the last 

6 weeks you have trained 15,000 people. In regard to Dr. Roswell’s 

testimony, Dr. Roswell says, ‘‘We have required training of over 

15,000 individuals,’’ which is it? 

Dr. WRAY. Which is true? 
31

Mr. BUYER. Which should I follow? 

Dr. WRAY. Yes. I could get you the absolutely exact number. We 

created what is called a—— Mr. BUYER. No, I just needed to know have you trained them, or 

have you required—— Dr. WRAY. Just less than 15,000 are certified for having been 

trained. 

Mr. BUYER. So Dr. Roswell’s testimony is not accurate? 

Dr. WRAY. I am sorry? 

Mr. BUYER. Sorry, Doctor, but whoever wrote this—this was not 

accurate, then. That’s what I’m correcting, because on page two of 

Dr. Roswell’s testimony, it says, ‘‘Second, we have required training 

of over 15,000 individuals.’’ So what it should say is, ‘‘We have 

completed training of 15,000.’’ Dr. WRAY. That is correct. 

Mr. BUYER. Okay? I just want to make sure. Okay. 

Dr. ROSWELL. Mr. Chairman, I apologize. 

Mr. BUYER. No, that is all right. 

Dr. ROSWELL. We required training of 15,000, we have now a 98 

percent completion rate for that. 

Mr. BUYER. And is this per—I have the memo here that was sent 

from the Secretary of the VA to you, specifically, outlining this 

training program. This is what it is in reference to? And are you 

saying—it is not? 

Dr. WRAY. No. The stand-down requirement, which I believe you 

should have—— Mr. BUYER. Yes. 

Dr. WRAY (continuing). And if not, we will get you a copy of it— required that everybody involved in research receive ethical IRB 

training as one issue, and good clinical practice training. 

The 15,000 researchers we are talking about have received that. 

The letter you have from Secretary Principi required the training 

of VISN directors, the head clinical person of the VISN—— Mr. BUYER. All right. Has this taken place? 

Dr. WRAY. We have given one session of that to all hospital directors, which was 136 individuals who participated at the Ann Arbor 

patient safety meeting on May the 28th and 29th. The last day of 

July and the first day of August, we will train everyone else at our 

senior management conference in Chicago. 

Mr. BUYER. All right. Dr. Roswell or Dr. Wray, when the GAO 

submitted its report in September of 2000, ‘‘While Protection for 

Human Subjects Need to be Strengthened,’’ the VA agreed to 

promptly fill five recommendations. 

The VA agreed to issue a current, comprehensive, and clear guidance, including the new handbook on human subject protections. 

Has that been published? 

Dr. ROSWELL. No, it has not. The—obviously, this is a broad and 

comprehensive document that requires a lot of concurrence. And I 

acknowledge that we have not been as responsive as we should 

have been, under the circumstances, with the hiatus created by the 

organizational change, and refocusing the departmental commitment on research. 

I have asked that we do everything we can to expedite the publication of that research handbook, the policy guidance that——
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Mr. BUYER. What is your time line? 

Dr. ROSWELL. Thirty days. 

Mr. BUYER. Thank you. An additional agreement with GAO is to 

determine the funding levels needed to support human subject protection and insure appropriate allocations of funds. Has the assessment been made? 

Dr. ROSWELL. It has. 

Mr. BUYER. And is this with regard to this new policy about 

charging the pharmaceutical manufacturers a particular fee? 

Dr. WRAY. That is simply the first part of it. We also are currently conducting a survey of all of our sites to determine the volume at each of the sites, and make a plan, which we are doing with 

a process engineer, on exactly how many people need to be at each 

site. 

We will fund this and have it in place by this coming—with the 

distribution of the next fiscal year 2004 budget. 

Mr. BUYER. Dr. Mather, on page six of Dr. Roswell’s testimony, 

he stated that ORO, and its predecessor office, negotiated over 100 

Federal Wide Assurance and related agreements with VA facilities 

to ensure their commitment to carry out the common rule protections afforded to human subject research. 

Can you tell us how many of these agreements were negotiated 

by ORCA? 

Dr. MATHER. The former ORCA negotiated all of those agreements. There are 114 Federal Wide Assurances that we worked 

through. We also have human research protections at HHS to put 

into place. At the same time, the institutional review boards, or the 

IRBs, were simultaneously appropriately registered under those 

Federal Wide Assurances. 

There are two VA medical centers pending that have joint arrangements with their affiliate medical schools. And when those 

are completed some time this summer, all of the 115 or so medical 

centers will hold Federal Wide Assurances which will authorize 

them to conduct human subjects research. 

Mr. BUYER. On page four of the GAO testimony, Dr. Mather, it 

states that the VA awarded a contract to the National Committee 

on Quality Assurance to provide external accreditation of its medical centers, and human research programs in August of 2000. 

How is this process going, and while you were the director? 

Dr. MATHER. Mr. Chairman, I would ask to defer the answer to 

that question to Dr. Wray or Dr. Roswell, since the Office of Research, Compliance and Assurance had no lead responsibility for 

that accreditation program. 

Mr. BUYER. All right. In 20 seconds? 

Dr. WRAY. I am very—Dr. Mather’s report, I agree with much of 

what is in it. I believe that the prior NCQA process was both unfair and irrational. We have met with NCQA extensively since I 

started up here. The process is now both fair and rational. The 

pause has been lifted. The training will start this week. The review 

process starts this summer, and all will be reviewed by 2005. 

Mr. BUYER. All right. Dr. Roswell, in 15 seconds, do you agree 

or disagree with the recommendations by the previous panel regarding their one, two, three? 

Dr. ROSWELL. Yes, we do. 
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Mr. BUYER. The hearing is concluded. 

[Whereupon, at 11:48 a.m., the subcommittee was adjourned.] 

(35)

A P P E N D I X 

PREPARED STATEMENT OF CHAIRMAN BUYER

Hearing on Human Subjects Protection in VA Medical Research 

June 18, 2003

Good morning. Today’s hearing deals with a very crucial issue that demands constant oversight. The issue of human subject protection in VA medical research. This 

is not a new issue. We have looked at this issue in the past and applaud the VA 

for taking several positive measures to strengthen its oversight of medical research. 

In fact, the VA announced the establishment of the Office of Research Compliance 

and Assurance, an independent oversight body to monitor VA research programs, 

at our 1999 hearing. 

Another positive step taken by The VA in 2002 was initiating the accreditation 

process of its human research protection programs through the National Committee 

on Quality Assurance (NCQA). Hopefully, we will receive an update on these and 

other problem areas which Dr. Roswell outlined in previous testimony. When he testified at our May 16, 2002 hearing, Dr. Roswell stated that the most common deficiencies involved in accreditation are in three main areas: 

• Lack of local facility policy and procedures related to IRB structure and operations, 

• The lack of policy and procedures related to the Informed Consent process and 

the conduct of the informed consent document, and 

• The evaluation and determinations the IRB must make and document during 

the initial review of research programs. 

The Subcommittee is also interested in the Office of Research Development’s efforts to provide guidance to VISN Directors concerning staffing levels of Institutional Review Boards. It is apparent that the role of IRBs—approving and monitoring research protocols for all projects at the facility level, must have the necessary support to fulfill its mission thereby insuring that all applicable regulations 

for the protection of human subjects is adhered to and followed by all VA researchers. 

While the VA has made a good faith effort to address problems that are documented dating back to 1993, it does appear there are still some recurring problems 

that need to be addressed immediately. 

The groundwork for today’s hearing stems from a hearing held by this Subcommittee on April 21, 1999, entitled, the Suspension of Medical Research at West 

Los Angeles and Sepulveda VA Medical Facilities and Informed Consent and Patient Safety in VA Medical Research. At that hearing, former Chairman, Terry 

Everett, stated: ‘‘The subcommittee demands an explanation, and accountability. 

These outrageous crimes against our veterans must not happen again.’’

Since then, several hearings have been held by the Subcommittee to insure that 

necessary actions are taken to ensure that our nation’s most vulnerable veterans are 

protected and not subjected to any type of abuse such as the violations imposed 

upon them at the Greater Los Angeles medical facilities. 

During today’s hearing, we hope to learn what precipitated recent actions taken 

by the VA in its organizational restructuring within the Office of Research Development. 

I know that we all have the same goal as it relates to VA medical research. We 

do not want veterans to have their rights denied, or to place them in a harmful 

environment. 

Likewise, we do recognize the tremendous contributions that have been made by 

VA through its medical research and the discoveries of important life saving drug 
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therapies and developing medical devices that benefited not only veterans but all 

Americans. 
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WRITTEN COMMITTEE QUESTIONS AND THEIR RESPONSES
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