oversight

VA Research: Actions Insufficient to Further Strengthen Human Subject Protections

Published by the Government Accountability Office on 2003-06-18.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                           United States General Accounting Office

GAO                        Testimony
                           Before the Subcommittee on Oversight
                           and Investigations, Committee on
                           Veterans’ Affairs, House of
                           Representatives
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
                                                June 18, 2003


                                                VA RESEARCH
                                                Actions Insufficient to Further Strengthen
Highlights of GAO-03-917T, a testimony          Human Subject Protections
before the Subcommittee on Oversight
and Investigations, Committee on
Veterans’ Affairs, House of
Representatives




Every year thousands of veterans                VA has not taken sufficient actions to strengthen its human subject
volunteer to participate in research            protection systems since GAO made recommendations nearly 3 years ago.
projects under the auspices of the              Continuing weaknesses VA has not sufficiently addressed include ensuring
VA. Research offers the possibility             that
of benefits to individual
participants and to society, but it is
not without risk to research                    •   its policy for implementing federal regulations for the protection of
subjects. VA studies, like other                    human subjects is up to date;
federally funded research                       •   training occurs periodically for all personnel involved in human subject
programs, are governed by                           protections;
regulations designed to minimize                •   those charged with reviewing risks have information that can help them
risks and protect the rights and                    interpret reports of adverse events; and
welfare of research participants.               •   sufficient funding is allocated to support human subject protection
VA must ensure that veterans have                   activities.
accurate and understandable
information so that they can make               VA has taken some important steps to strengthen aspects of its human
informed decisions about
                                                subject protections by providing some necessary guidance and offering
volunteering for research.
                                                training to research personnel. Moreover, it strengthened its internal
In September 2000, GAO reported                 oversight and instituted an external accreditation program, with reviews of
on weaknesses it found in VA’s                  all its medical centers’ human subject protection programs scheduled
systems for protecting human                    through summer 2005.
subjects. VA concurred with GAO’s
recommendations that its human                  VA is now in the midst of a reorganization of its headquarters research
subject protections could be                    offices that was begun without adequate planning and notice. VA did not
strengthened by taking actions in               initially ensure the independence of compliance activities although more
five domainsguidance, training,                recent actions appear to have restored the integrity of the compliance
monitoring and oversight, handling              function. VA has not clarified responsibilities for education, training, and
of adverse event reports, and
                                                policy development. Until it does so, it is unclear how the reorganization
funding of human subject
protection activities. (VA                      will affect VA’s efforts to further strengthen its human subject protections.
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.
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 1                                                                   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 2                                                           GAO-03-917T
                 Conducting research is one of VA’s core missions.3 VA researchers have
Background       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.



                 Page 3                                                                         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 4                                                          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.


Earlier Evaluation Showed   In 2000, we concluded that medical centers we visited did not comply with
VA Needed to Strengthen     all regulations to protect the rights and welfare of research participants.
Human Subject               Based on our review of eight medical centers, we documented an uneven,
                            but disturbing, pattern of noncompliance with human subject protection
Protections                 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

                            Page 5                                                         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
Insufficient Action        subjects since we made our recommendations nearly 3 years ago although
Taken to Strengthen        it has taken some important steps. ORD has not revised its policy on
                           human subject protections, and it has not established training
Protections for            requirements, in policy, to ensure that research personnel obtain periodic
Human Subjects,            training. Moreover, VA has not established a mechanism for handling
                           adverse event reports to ensure that IRBs have the information they need
Although VA Has            to safeguard the rights and welfare of human research participants and it
Made Some Progress         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.


Policy for Human Subject   In 2000, we reported that we had found problems with VA’s policy for
Protections Has Not Been   implementing federal regulations for the protection of human subjects.
Revised, but Other         These problems included requirements for obtaining and documenting
                           informed consent. For example, the policy requires use of a particular
Important Guidance Was     form to document a subject’s consent to participate in research. This form
Issued                     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

                           Page 6                                                          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.


Training Requirement Not   In 2000, we found that VA did not have a systemwide educational program
Established in Policy,     focused on human subject protection issues. Although VA’s human subject
Although Training          protection regulations do not include any specific educational
                           requirements, we concluded that periodic training for investigators, IRB
Opportunities Offered      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

                           Page 7                                                         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.


Internal and External    In 2000, we reported that VA had not identified widespread weaknesses in
Oversight Strengthened   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.



                         Page 8                                                                        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 9                                                                    GAO-03-917T
Actions Regarding Adverse   In 2000, we reported that IRBs have difficulty handling adverse event
Event Reports and           reports and often lack key information necessary for their interpretation.
Funding for Human           Since then, VA has not developed a mechanism for handling adverse event
                            reports to ensure that IRBs have information that can help them interpret
Subject Protection          reports of actual adverse events that research subjects experience while
Activities Are Incomplete   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.




                            Page 10                                                          GAO-03-917T
                       In 2003, VA began a reorganization of its research offices without adequate
Recent                 planning and notice. We found that VA did not initially ensure the
Reorganization         independence of compliance activities, although more recent actions
                       appear to have restored the integrity of the compliance function. In
Appears to Maintain    addition, VA has not clarified responsibilities for education, training, and
Independent            policy development.
Compliance Function,   VA’s initial action to reorganize its research offices failed to ensure the
but Other Roles and    independence of compliance activities. In January 2003, officials
Responsibilities       announced that the existing compliance office, ORCA, would be disbanded
                       and the compliance function and staff reassigned to ORD. As a result,
Unclear                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).



                       Page 11                                                                      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 12                                                         GAO-03-917T
                  For further information regarding this testimony, please contact Cynthia
Contact and       A. Bascetta at (202) 512-7101. Kristen Joan Anderson, Jacquelyn Clinton,
Acknowledgments   Pamela Dooley, Lesia Mandzia, Marcia Mann, and Daniel Montinez also
                  contributed to this statement.




                  Page 13                                                       GAO-03-917T
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             Page 14                                                       GAO-03-917T
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