Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on 

Veterans’ Affairs, House of 

Representatives

United States General Accounting Office

GAO

For Release on Delivery 

Expected at 10:00 a.m. 

Wednesday, June 18, 2003 VA RESEARCH 

Actions Insufficient to 

Further Strengthen Human 

Subject Protections 

Statement of Cynthia A. Bascetta 

Director, Health Care—Veterans’ 

 Health and Benefits Issues 

GAO-03-917T 
VA has not taken sufficient actions to strengthen its human subject 

protection systems since GAO made recommendations nearly 3 years ago. 

Continuing weaknesses VA has not sufficiently addressed include ensuring 

that 

• its policy for implementing federal regulations for the protection of 

human subjects is up to date; 

• training occurs periodically for all personnel involved in human subject 

protections; 

• those charged with reviewing risks have information that can help them 

interpret reports of adverse events; and 

• sufficient funding is allocated to support human subject protection 

activities. 

VA has taken some important steps to strengthen aspects of its human 

subject protections by providing some necessary guidance and offering 

training to research personnel. Moreover, it strengthened its internal 

oversight and instituted an external accreditation program, with reviews of 

all its medical centers’ human subject protection programs scheduled 

through summer 2005. 

VA is now in the midst of a reorganization of its headquarters research 

offices that was begun without adequate planning and notice. VA did not 

initially ensure the independence of compliance activities although more 

recent actions appear to have restored the integrity of the compliance 

function. VA has not clarified responsibilities for education, training, and 

policy development. Until it does so, it is unclear how the reorganization 

will affect VA’s efforts to further strengthen its human subject protections. 

Every year thousands of veterans 

volunteer to participate in research 

projects under the auspices of the 

VA. Research offers the possibility 

of benefits to individual 

participants and to society, but it is 

not without risk to research 

subjects. VA studies, like other 

federally funded research 

programs, are governed by 

regulations designed to minimize 

risks and protect the rights and 

welfare of research participants. 

VA must ensure that veterans have 

accurate and understandable 

information so that they can make 

informed decisions about 

volunteering for research. 

In September 2000, GAO reported 

on weaknesses it found in VA’s 

systems for protecting human 

subjects. VA concurred with GAO’s 

recommendations that its human 

subject protections could be 

strengthened by taking actions in 

five domainsguidance, training, 

monitoring and oversight, handling 

of adverse event reports, and 

funding of human subject 

protection activities. (VA 

Research: Protections for Human 

Subjects Need to Be Strengthened, 

[GAO/HEHS-00-155, Sept. 28, 

2000]). 

GAO was asked to assess whether 

VA has made sufficient progress in 

implementing the 

recommendations and to examine 

the recent changes in VA’s 

organizational structure for 

monitoring and overseeing human 

subject protections. 

www.gao.gov/cgi-bin/getrpt?GAO-03-917T.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Cynthia A. 

Bascetta at (202) 512-7101. 

Highlights of GAO-03-917T, a testimony 

before the Subcommittee on Oversight 

and Investigations, Committee on 

Veterans’ Affairs, House of 

Representatives 

June 18, 2003 

VA RESEARCH 

Actions Insufficient to Further Strengthen 

Human Subject Protections 
Page 1 GAO-03-917T 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here to discuss the protection of human subjects who 

participate in research conducted through the Department of Veterans 

Affairs (VA). Every year thousands of veterans volunteer to participate in 

research projects under the auspices of VA. Research offers the possibility 

of benefits to individual participants and to society, but it is not without 

risk to research subjects. VA studies, like other federally funded research 

programs, are governed by regulations designed to minimize risks and 

protect the rights and welfare of research participants. VA must ensure 

that veterans who agree to become subjects in VA research are given 

accurate and understandable information about procedures, risks, and 

benefits so that they can make informed decisions about volunteering. 

Concerns about VA’s protection of its human research subjects came to 

national attention in March 1999. At that time, all human research was 

suspended at the West Los Angeles VA Medical Center after officials there 

failed to correct long-standing problems with its system for protecting 

human subjects.1

 Recently, serious concerns were raised about the safety 

of research programs at several VA medical centers, including the Albany 

VA medical center, where the possibility of patient deaths related to 

research is under investigation. 

In September 2000, we testified before this subcommittee on weaknesses 

we found in VA’s systems for protecting human subjects.2

 VA concurred 

with our recommendations to take immediate steps to ensure that human 

subjects would be protected in accordance with all applicable regulations. 

We made specific recommendations for actions in five domains—

guidance, training, monitoring and oversight, handling of adverse event 

reports, and funding of human subject protection activities. You asked us 

to assess whether VA has made sufficient progress in implementing our 

recommendations and to examine the recent changes in VA’s 

organizational structure for monitoring and overseeing human subject 

protections. 

 1

The West Los Angeles VA Medical Center is now part of the VA Greater Los Angeles 

Healthcare System. 

2

See U.S. General Accounting Office, VA Research: System for Protecting Human Subjects 

Needs Improvements, GAO/T-HEHS-00-203 (Washington, D.C.: Sept. 28, 2000) and VA 

Research: Protections for Human Subjects Need to Be Strengthened, GAO/HEHS-00-155

(Washington, D.C.: Sept. 28, 2000). 
Page 2 GAO-03-917T 

My testimony is based on an update of VA’s progress in implementing our 

September 2000 recommendations and a review of VA’s recent and 

ongoing reorganization of its research offices. To do our work, we 

reviewed documents, including VA memorandums, policies, and guidance 

and interviewed key officials in VA headquarters. We conducted our work 

from May through June 2003 in accordance with generally accepted 

government auditing standards. 

In summary, VA has not taken sufficient action to strengthen protections 

for human subjects, although it has made some progress. VA needs to 

address continuing weaknesses we identified nearly 3 years ago. 

Specifically, VA has not revised its policy for implementing federal 

regulations for the protection of human subjects. VA also has not 

established training requirements, in policy, to ensure that all research 

personnel will be informed of, and stay current with, ways to comply with 

all applicable regulations for the protection of human subjects. VA actions 

regarding two other recommendations are incomplete. VA has not ensured 

that those charged with reviewing risks related to ongoing research 

activities have information that can help them interpret reports of actual 

adverse events that research subjects experience while participating in 

studies. VA has also not ensured that sufficient funding is allocated to 

support human subject protection activities. On the other hand, VA has 

strengthened aspects of its human subject protections by providing some 

necessary guidance and offering training to research personnel. Moreover, 

it strengthened its internal oversight and instituted an external 

accreditation program, with reviews of all its medical centers’ human 

subject protection programs scheduled through summer 2005. 

In 2003, VA began a reorganization of its research offices without adequate 

planning and notice. We found that VA did not initially ensure the 

independence of compliance activities although more recent actions 

appear to have restored the integrity of the compliance function. In 

addition, VA has not clarified responsibilities for education, training, and 

policy development. Until these responsibilities are clarified, it is unclear 

how the reorganization will affect VA’s progress in further responding to 

our recommendations to strengthen its human subject protections. 
Page 3 GAO-03-917T 

Conducting research is one of VA’s core missions.3 VA researchers have 

been involved in a variety of important advances in medical research, 

including development of the cardiac pacemaker, kidney transplant 

technology, prosthetic devices, and drug treatments for high blood 

pressure and schizophrenia. In fiscal year 2002, VA supported studies by 

more than 3,000 scientists at 115 VA facilities. VA researchers receive 

additional grants and contracts from other federal agencies, such as the 

National Institutes of Health, research foundations, and private industry 

sponsors, including pharmaceutical companies. 

To protect the rights and welfare of human research subjects, 17 federal 

departments and agencies, including VA, have adopted regulations 

designed to safeguard the rights of subjects and promote ethical research. 

These regulations, known as the Common Rule, establish minimum 

standards for the conduct and review of research to ensure that studies 

are conducted in accordance with certain basic ethical principles. These 

principles require that subjects voluntarily give their informed consent to 

participate in research, that the risks of research are reasonable in relation 

to the expected benefits to the individual or to society, and that 

procedures for selecting subjects are fair.4

The Common Rule creates a system in which the responsibility for 

protecting human subjects is assigned to three groups: 

• Investigators are responsible for conducting research in accordance with 

regulations. 

• Institutions are responsible for establishing oversight mechanisms for 

research, including committees known as institutional review boards 

(IRB), which are to review both research proposals and ongoing research 

to ensure that the rights and welfare of human subjects are protected. VA 

medical centers engaged in research involving human subjects may 

establish their own IRBs or secure the services of an IRB at an affiliated 

university or other VA medical center. 

• Agencies, including VA, are responsible for ensuring that their IRBs 

comply with applicable federal regulations and have sufficient space and 

staff to accomplish their obligations. 

 3

VA’s four core health care missions are patient care, education, research, and backup to 

the Department of Defense health system in war or other emergencies. 

4

38 C.F.R. pt. 16. VA regulations provide additional protections to those participating in 

human subjects research. See 38 C.F.R. §17.85. 

Background 
Page 4 GAO-03-917T 

VA is responsible for ensuring that all human research it conducts or 

supports meets the requirements of VA regulations, regardless of whether 

that research is funded by VA, the research subjects are veterans, or the 

studies are conducted on VA grounds. In addition, two components of the 

Department of Health and Human Services (HHS) have oversight 

responsibilities for some VA research. The Food and Drug Administration 

(FDA) is responsible for protecting the rights of human subjects enrolled 

in research with products it regulates—drugs, medical devices, biologics, 

foods, and cosmetics. HHS-funded research is subject to oversight by its 

Office for Human Research Protections (OHRP). Both FDA and OHRP 

have the authority to monitor those studies conducted under their 

jurisdiction, and each can take action against investigators, IRBs, or 

institutions that fail to comply with applicable regulations. To facilitate 

assurance of compliance with federal regulations for the protection of 

human subjects, VA awarded a contract to the National Committee for 

Quality Assurance (NCQA) to provide external accreditation of its medical 

centers’ human research protection programs in August 2000. 

Two VA headquarters offices have responsibilities that are directly related 

to human subject protections. Responsibility for the administration of VA’s 

research program rests with its Office of Research and Development 

(ORD), which allocates appropriated research funds to VA researchers. To 

help ensure that VA research is conducted ethically, legally, and safely, VA 

created an independent office to conduct compliance and oversight 

activities—the Office of Research Compliance and Assurance (ORCA)—in 

1999. This office was given responsibilities for promoting and enhancing 

the ethical conduct of research and investigating allegations of research 

noncompliance; it reported directly to the Under Secretary for Health. In 

early 2003, VA reorganized its research offices and replaced ORCA with a 

new office, the Office of Research Oversight (ORO). ORCA’s 

responsibilities for education, training, and policy guidance were 

transferred to ORD. ORCA’s responsibilities for compliance activities were 

assigned to ORO. 

In March 2003, ORD issued a memorandum announcing a 90-day national 

“stand down” for VA human subject research to be effective from March 10 

through June 6, 2003, although research was permitted to continue during 

this period. The stand down was intended to focus efforts on identifying 

and correcting problems with VA’s systems for protecting human subjects 

and to notify investigators that disciplinary actions may result from 

noncompliance with federal regulations governing the conduct of their 

research. ORD also asked medical center managers to attest that their 

IRBs are constituted as required by VA regulations and that they meet 
Page 5 GAO-03-917T 

regularly enough to review research protocols and adverse events; that 

their research staff has obtained training in human subject protections; 

and that they have checked the credentials of all personnel involved in 

research, including investigators, research team members, IRB members 

and staff, and research and development committee members. 

In 2000, we concluded that medical centers we visited did not comply with 

all regulations to protect the rights and welfare of research participants. 

Based on our review of eight medical centers, we documented an uneven, 

but disturbing, pattern of noncompliance with human subject protection 

regulations. The cumulative weight of the evidence indicated failures to 

consistently safeguard the rights and welfare of research subjects. Among 

the problems we observed were failures to provide adequate information 

to subjects before they participated in research, inadequate reviews of 

proposed and ongoing research, insufficient staff and space for IRBs, and 

incomplete documentation of IRB activities. We found relatively few 

problems at some sites that had stronger systems to protect human 

subjects, but we observed multiple problems at other sites. Although the 

results of our visits to medical centers could not be projected to VA as a 

whole, the extent of the problems we found strongly indicated that human 

subject protections at VA needed to be strengthened. 

Although primary responsibility for implementation of human subject 

protections lies with medical centers, their IRBs, and investigators, we 

identified three specific systemwide weaknesses that compromised VA’s 

ability to protect human subjects. First, VA headquarters had not provided 

medical center research staff with adequate guidance about human subject 

protections and thus had not ensured that research staff had all the 

information they needed to protect the rights and welfare of human 

subjects. Second, insufficient monitoring and oversight of local human 

subject protections by headquarters permitted noncompliance with 

regulations to go undetected and uncorrected. Third, VA had not ensured 

that funds needed for human subject protections were allocated for that 

purpose at medical centers, with officials at some medical centers 

reporting that they did not have sufficient resources for the staff, space, 

training, and equipment necessary to accomplish their mandated 

responsibilities. 

To strengthen VA’s protections of the rights and welfare of human 

subjects, we recommended that VA take immediate steps to ensure that 

VA medical centers, their IRBs, and VA investigators comply with all 

applicable regulations for the protection of human subjects. The specific 

Earlier Evaluation Showed 

VA Needed to Strengthen 

Human Subject 

Protections 
Page 6 GAO-03-917T 

actions we recommended involved guidance, training, monitoring and 

oversight, handling of information about adverse events, and funding of 

human subject protection activities. VA concurred with our 

recommendations. 

VA has not taken sufficient action to strengthen protections for human 

subjects since we made our recommendations nearly 3 years ago although 

it has taken some important steps. ORD has not revised its policy on 

human subject protections, and it has not established training 

requirements, in policy, to ensure that research personnel obtain periodic 

training. Moreover, VA has not established a mechanism for handling 

adverse event reports to ensure that IRBs have the information they need 

to safeguard the rights and welfare of human research participants and it 

has not ensured that sufficient resources are allocated to support human 

subject protection activities. On the other hand, VA has strengthened 

aspects of its human subject protection systems. ORCA developed a 

training program and conducted oversight activities by investigating 

claims of research improprieties or noncompliance and restricting or 

suspending four medical centers’ research activities when it found 

evidence of serious problems. VA also instituted an external accreditation 

program that has the potential to further strengthen VA’s oversight of 

human subject protections. 

In 2000, we reported that we had found problems with VA’s policy for 

implementing federal regulations for the protection of human subjects. 

These problems included requirements for obtaining and documenting 

informed consent. For example, the policy requires use of a particular 

form to document a subject’s consent to participate in research. This form 

calls for the signature of a witness, but does not indicate who may serve as 

a witness, to what the witness is attesting, or the circumstances under 

which a witness is needed. 

In its comments to that report, VA indicated that ORD was in the process 

of updating its policy on human subject protections and that it expected to 

submit that policy for internal review by the end of August 2000. When we 

followed up in September 2001, VA reported that comments were being 

incorporated into the draft policy. In September 2002, VA reported that it 

was awaiting final review but has not issued its revised policy as of June 

2003. As a result, investigators, IRB members and staff, and other research 

personnel do not yet have a clear, up-to-date policy to follow when 

implementing human subject protections. Consequently, VA cannot ensure 

Insufficient Action 

Taken to Strengthen 

Protections for 

Human Subjects, 

Although VA Has 

Made Some Progress 

Policy for Human Subject 

Protections Has Not Been 

Revised, but Other 

Important Guidance Was 

Issued 
Page 7 GAO-03-917T 

that research staff know what they need to do to protect the rights and 

welfare of human research subjects. 

In addition to the problems we noted with VA’s policy, we reported in 2000 

that VA headquarters had not provided medical center staff with adequate 

guidance to help them ensure the protection of human research subjects. 

VA has made some progress in this area. For example, ORCA had begun 

distributing some information to medical centers in early 2000. By January 

2003, it had posted about 60 information letters and 14 alerts on its web 

page and through electronic mail to research facilities. These letters and 

alerts provide information about new HHS guidance and policies regarding 

human subject protections, reports on research ethics, and problems that 

ORCA staff observed during site visits to VA medical centers. In addition, 

ORCA developed guidance about human subject protections. For example, 

ORCA published a best practices guide for IRB procedures in September 

2001 and a tool for medical centers to use to assess their human subject 

protection programs in October 2001. 

In 2000, we found that VA did not have a systemwide educational program 

focused on human subject protection issues. Although VA’s human subject 

protection regulations do not include any specific educational 

requirements, we concluded that periodic training for investigators, IRB 

members, and IRB staff is necessary to ensure that they can meet their 

obligations to protect the rights and welfare of human research subjects. 

VA has not established training requirements in policy, although on two 

occasions it has issued memorandums that required training. In August 

2000, ORD issued a memorandum to medical center associate chiefs of 

staff for research stating that all VA investigators had to meet specific 

education requirements before submitting research proposals during 2001. 

ORD’s memorandum regarding the March 2003 stand down stated that all 

research personnel must provide documentation that they have completed 

both a course on the protection of human research subjects and a course 

on good clinical practices within the past year; otherwise all research 

personnel must complete this training by June 6, 2003. These additional 

personnel include research coordinators and research assistants involved 

in human research; all members of VA research offices, research and 

development committees, and IRBs; and IRB staff (except secretarial 

staff). According to VA’s policy for distributing information, however, 

memorandums are not used to establish permanent requirements or 

policy, and education and training requirements for investigators were not 

published in a directive or handbook, which are the documents VA uses to 

Training Requirement Not 

Established in Policy, 

Although Training 

Opportunities Offered 
Page 8 GAO-03-917T 

communicate policy requirements. As a result, headquarters cannot 

systematically ensure that all VA personnel involved in human subject 

research will be informed of, and stay current with, ways to comply with 

all applicable regulations for the protection of human subjects. 

Despite the lack of policies requiring human subject protections training, 

both ORD and ORCA have provided information since we made our 

recommendation about available educational programs to investigators 

and other research personnel. ORCA worked with academic institutions to 

develop an optional training program for use by VA investigators, IRB 

members, IRB staff, research administrative staff, and medical center 

officials. This web-based training program includes quizzes after each 

module; certification of successful completion requires achieving a score 

of at least 75 percent correct. ORCA also presented a seminar on research 

compliance and assurance to senior managers of each of VA’s networks,5

and ORD recently began providing training to senior managers about their 

responsibilities regarding human subject protections. 

In 2000, we reported that VA had not identified widespread weaknesses in 

its human subject protection systems because of its low level of 

monitoring. VA has made progress in strengthening its oversight. ORCA, 

which was created in 1999, was charged with advising the Under Secretary 

for Health on all matters related to human subject protections, promoting 

the ethical conduct of research, and conducting prospective reviews and 

“for cause” investigations. Since becoming operational, ORCA has 

investigated claims of improper conduct of research and noncompliance. 

In about a dozen cases, it sent teams to medical centers to conduct 

intensive for cause reviews. ORCA also conducted six on-site reviews to 

follow up on findings from external accreditation reviews. As a result of its 

investigations, ORCA restricted or suspended research at four VA medical 

centers until identified problems were corrected. For example, in March 

2001, ORCA restricted one medical center’s human research activities by 

suspending enrollment of new subjects in research after its investigation 

revealed noncompliance with several regulations pertaining to IRBs.6

 5

VA has 21 Veterans Integrated Service Networks that coordinate the activities of, and 

allocate funds to, VA medical centers, nursing homes, and other facilities in each region. 

6

The IRB of this medical center served as the IRB-of-record for a second VA medical center. 

Therefore, human research at two medical centers was affected. 

Internal and External 

Oversight Strengthened 
Page 9 GAO-03-917T 

ORCA lifted this restriction in February 2002 after the medical center 

corrected the identified problems. 

In addition to its internal oversight mechanisms, VA became the first 

research organization to arrange for external accreditation of human 

subject protection systems. External accreditation has the potential to 

significantly strengthen oversight of human subject protections. In August 

2000, VA awarded a $5.8 million, 5-year contract to NCQA to operate an 

accreditation program to assess medical centers’ compliance with federal 

regulations for the protection of human subjects. VA’s contract with NCQA 

requires it to develop accreditation standards, to conduct a site visit every 

3 years to each VA medical center conducting human research, and to 

decide on the accreditation status of each facility. According to a 2001 

report by the Institute of Medicine, the accreditation standards developed 

by NCQA provide a promising basis for accreditation because they are 

explicitly linked to federal regulations and pay attention to quality 

improvement.7

 The Institute of Medicine recommended that the NCQA 

standards be strengthened, for example, by specifying how research 

subjects will be involved in human subject protection systems. 

NCQA began accrediting VA medical centers and has revised its 

accreditation process. NCQA conducted accreditation visits to 23 VA 

facilities from September 2001 through May 2002. An ORD official told us 

that, of those 23 facilities, 20 were accredited with conditions, 2 were not 

accredited, and 1 withdrew from the process. A facility accredited with 

conditions met most of the accreditation standards. On the basis of its 

experience and feedback on its standards, NCQA proposed—and ORD 

approved—revising the standards. NCQA discontinued accreditation 

reviews while it revised its standards for evaluating human subject 

protection programs. Revisions involved clarification of standards, 

reduction of redundancies, and changes to the scoring system. Some 

revisions were designed to respond to comments from the Institute of 

Medicine. For example, NCQA adopted standards to encourage a facility 

to obtain input from research subjects to improve its human subject 

protection system. ORD approved a new set of standards in April 2003. 

Site visits are expected to resume in October 2003, with accreditation 

reviews of all VA facilities involved in human subject research planned for 

completion by summer 2005. 

 7

Institute of Medicine, Preserving Public Trust: Accreditation and Human Research 

Participant Protection Programs (Washington, D.C.: National Academy Press, 2001). 
Page 10 GAO-03-917T 

In 2000, we reported that IRBs have difficulty handling adverse event 

reports and often lack key information necessary for their interpretation. 

Since then, VA has not developed a mechanism for handling adverse event 

reports to ensure that IRBs have information that can help them interpret 

reports of actual adverse events that research subjects experience while 

participating in studies. Federal regulations require investigators to report 

to the IRB unanticipated problems involving risks to subjects. In turn, 

IRBs are to review these adverse event reports as part of their continuing 

assessment of the adequacy of a study’s protections for human subjects. 

ORD issued guidance stating that analyses of adverse events should be 

provided to IRBs for those clinical trials that VA funds at multiple medical 

centers. ORCA staff participated in interagency discussions about how to 

help IRBs handle adverse event reports and developed guidance regarding 

what adverse events IRBs are to report to ORCA. As of June 2003, this 

guidance has not been issued and VA still lacks comprehensive guidance 

to help IRBs interpret reports of adverse events. 

In 2000, we reported that VA did not know what level of funding was 

necessary to support human subject protection activities and research 

officials at five of eight medical centers we visited told us that they had 

insufficient funds to ensure adequate operation of their human subject 

protection systems. In May 2000, ORD provided networks with suggestions 

for the level of administrative staffing of IRBs. ORD also commissioned a 

study of the costs of operating IRBs within VA, which was completed in 

June 2002. On June 13, 2003, VA issued a policy regarding funding for 

human subject protection programs that medical centers are to obtain 

from external sponsors of VA research. Specifically, the sponsor of each 

industry-funded study is to be charged 10 percent of the direct costs of the 

study or a flat fee of $1,200, whichever is greater, by the medical center to 

help cover the costs of the human subject protection program. We have 

not had the opportunity to study the potential for this mechanism to help 

ensure sufficient funding. VA has not specified a procedure for ensuring 

that its medical centers—which conduct VA-funded research and research 

funded by federal agencies and research foundations as well as 

industries—-will be allocated the funds necessary for their human subject 

protection programs. 

Actions Regarding Adverse 

Event Reports and 

Funding for Human 

Subject Protection 

Activities Are Incomplete 
Page 11 GAO-03-917T 

In 2003, VA began a reorganization of its research offices without adequate 

planning and notice. We found that VA did not initially ensure the 

independence of compliance activities, although more recent actions 

appear to have restored the integrity of the compliance function. In 

addition, VA has not clarified responsibilities for education, training, and 

policy development. 

VA’s initial action to reorganize its research offices failed to ensure the 

independence of compliance activities. In January 2003, officials 

announced that the existing compliance office, ORCA, would be disbanded 

and the compliance function and staff reassigned to ORD. As a result, 

compliance field personnel began reporting their activities to ORD, 

potentially compromising the independence of their compliance 

investigations. In a series of memorandums issued from March through 

May of 2003, VA announced that a new office, ORO, would replace ORCA. 

VA memorandums indicated that ORO, like ORCA, would be independent 

of ORD, and that ORO would be organizationally responsible to the Under 

Secretary for Health. 

According to generally accepted government auditing standards, offices 

with responsibility for assessing regulatory compliance should be 

organizationally independent of the offices they review and should report 

to, and be accountable to, the head or deputy head of the government 

entity.8

 Because VA considered making ORD responsible for compliance 

activities—where its independence would be compromised—legislation 

was proposed in the House of Representatives to establish an independent 

office within VA to oversee research compliance with federal regulations.9

According to VA memorandums and discussions with agency officials, 

ORO will have responsibility for investigating allegations of research 

noncompliance, misconduct, and improprieties. However, it is not clear 

whether ORO will have authority to review a medical center’s human 

subject protection program in the absence of a prior allegation of a 

problem; that is, whether it can conduct prospective investigations. While 

 8

HHS separated its compliance office from its administrative office after we voiced similar 

concerns about independence. As a result, instead of reporting to the National Institutes of 

Health, which conducts and funds research, OHRP has been reporting to HHS’s Assistant 

Secretary for Health since June 2000. See U.S. General Accounting Office, Scientific 

Research: Continued Vigilance Critical to Protecting Human Subjects, GAO/HEHS-96-72

(Washington, D.C.: Mar. 8, 1996). 

9

H.R. 1585, 108th Cong. (2003). 

Recent 

Reorganization 

Appears to Maintain 

Independent 

Compliance Function, 

but Other Roles and 

Responsibilities 

Unclear 
Page 12 GAO-03-917T 

VA memorandums indicate that ORO will have the same compliance 

responsibilities that ORCA had and specify that for cause inspections will 

be conducted; they are silent on routine inspections. Experts in human 

subject protections have said that these routine inspections, sometimes 

referred to as prospective inspections, are an essential way to help prevent 

noncompliance. As of June 2003, a directive to formalize the authorities 

and responsibilities of ORO has not been issued. Consequently, ORO’s 

compliance responsibilities remain unclear. 

Other roles and responsibilities are also unclear. For example, ORCA 

previously had responsibilities for education and training. VA’s 

reorganization now assigns these responsibilities solely to ORD. The 

implications of this transfer of responsibilities for strengthening human 

subject protections are unclear. For example, when ORCA conducted 

compliance reviews or followed up on results of accreditation reviews, it 

provided instruction about what steps would be necessary to correct 

identified problems. It is not clear whether or to what extent such 

instruction, including technical assistance regarding a specific area of 

noncompliance, would be considered to be education and training and 

therefore not within ORO’s responsibilities. 

ORCA also had responsibility to participate in the development of policies 

involving human subject protections. Under the reorganization, ORD 

would have responsibility for policy development. Existing memorandums 

are silent on whether ORO will have any role in, or can contribute its 

expertise to, policy development. ORCA had been created with the 

understanding that it would collaborate with ORD on dissemination of 

information, communication, and policy development. It is not clear to 

what extent VA’s efforts to strengthen its human subject protections will 

bring to bear the collective expertise of the staff in its compliance and 

operational research offices. However, having ORD take the lead on 

policies regarding compliance functions or activities could be 

inappropriate to the extent that it interferes with ORO’s independence in 

executing its compliance functions. 

Mr. Chairman, this concludes my prepared remarks. I will be pleased to 

answer any questions you or other members of the subcommittee may 

have. 
Page 13 GAO-03-917T 

For further information regarding this testimony, please contact Cynthia 

A. Bascetta at (202) 512-7101. Kristen Joan Anderson, Jacquelyn Clinton, 

Pamela Dooley, Lesia Mandzia, Marcia Mann, and Daniel Montinez also 

contributed to this statement. 

Contact and 

Acknowledgments 
Page 14 GAO-03-917T 

Human Subjects Research: HHS Takes Steps to Strengthen Protections, 

but Concerns Remain. GAO-01-775T. Washington, D.C.: May 23, 2001. 

VA Research: Protections for Human Subjects Need to Be Strengthened. 

GAO/HEHS-00-155. Washington, D.C.: September 28, 2000. 

VA Research: System for Protecting Human Subjects Needs 

Improvements. GAO/T-HEHS-00-203. Washington, D.C.: September 28, 

2000. 

Scientific Research: Continued Vigilance Critical to Protecting Human 

Subjects. GAO/T-HEHS-96-102. Washington, D.C.: March 12, 1996. 

Scientific Research: Continued Vigilance Critical to Protecting Human 

Subjects. GAO/HEHS-96-72. Washington, D.C.: March 8, 1996. 

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