This statement was prepared for a hearing before the Senate

Committee on Health, Education, Labor, and Pensions,

Subcommittee on Public Health, that was originally scheduled for

May 23, 2001.

Statement

Of Janet Heinrich

Director, Health Care—Public Health Issues

United States General Accounting Office

GAO

May 2001 HUMAN SUBJECTS

RESEARCH

HHS Takes Steps to

Strengthen Protections,

But Concerns Remain

GAO-01-775T
Page 1 GAO-01-775T

May 23, 2001

Considerable attention to the protection of human subjects in biomedical

research was sparked in the mid-1990s following disclosures of federally

sponsored experiments in which research investigators did not properly

obtain the consent of the subjects.1

 Congressional concern was heightened

after the death in September 1999 of Jesse Gelsinger, an 18-year-old

participant in a gene transfer trial funded by the National Institutes of

Health (NIH) in the Department of Health and Human Services (HHS).

Responsibility for the protection of human subjects in biomedical research

exists at three levels: at the federal level are agencies, such as HHS; at the

institutional level are research institutions, including universities and

academic medical centers; and at the individual investigator level are

physicians, scientists, and other professionals. Each level plays a role in

meeting federal requirements for protecting human research subjects or in

ensuring that the requirements are met. However, with the Gelsinger death

and other instances of research misconduct, questions are being raised

about the progress of federal efforts to ensure the safe and ethical conduct

of biomedical research.

This summer we will report in more detail on federal efforts to protect

human subjects in biomedical research, including efforts to address

financial conflict of interest issues. This statement focuses on HHS’ efforts

to date to address human subjects protection issues at the federal,

institutional, and individual investigator levels and on areas of concern

that remain. My comments are based on interviews with key officials at

HHS agencies and other organizations, reviews of recent reports on human

subjects protection, and an analysis of relevant HHS regulations and

policies. We conducted our work from September 2000 through May 2001

in accordance with generally accepted government auditing standards.

In summary, at the federal level HHS is seeking to strengthen protection of

human subjects in biomedical research by enhancing the visibility of its

human subjects protection activities, improving its monitoring of

compliance with relevant regulations by institutions and investigators, and

strengthening enforcement of those regulations. HHS has also issued new

 1

Advisory Committee on Human Radiation Experiments, Final Report (Washington, D.C.:

Oct. 1995). Scientific Research: Continued Vigilance Critical to Protecting Human Subjects

(GAO/HEHS-96-72, Mar. 1996).
Page 2 GAO-01-775T

guidance and is collecting information intended to improve oversight and

monitoring at the institutional level. HHS activities directed at the

investigator level consist largely of educational efforts to heighten

investigators’ awareness of and compliance with ethical policies and

practices in conducting research. Overall, HHS’ actions appear promising,

but we have some concerns about the pace and scope of the department’s

efforts to ensure the safety and protection of participants in clinical trials.

A significant proportion of biomedical research is conducted through

clinical trials, which involve testing new drugs, devices, or treatments with

human subjects. Many of these trials are spread across hundreds of sites,

sometimes at sites outside of the United States, and are performed not

only in academic medical centers but also by physicians and other

providers in the community. Although there are no comprehensive data on

the number of individuals enrolled in research studies, this number has

likely increased as federal spending for medical and health research has

doubled in recent years and industry spending has been growing even

faster.

The principal federal policy for protecting human research subjects is

called the Common Rule. It is a set of requirements, embodied in

regulation, agreed to by 17 federal departments and agencies, including

HHS,2

 and applies only to federally funded or sponsored research. Broadly

speaking, the Common Rule focuses on

• obtaining the research subject’s voluntary, informed consent by

specifying, among other things, that subjects must be told of the expected

benefits and potential risks to which they could be exposed;

• setting criteria for review panels—known as institutional review boards

(IRB)3

—that are responsible for performing initial and ongoing reviews of

research; and

• obtaining a formal written assurance of compliance with federal standards

from institutions engaged in research studies.

 2

HHS regulations contain additional protections not included in the Common Rule for

research involving certain vulnerable populations—namely, pregnant women, children,

fetuses, subjects of in vitro fertilization research, and prisoners.

3

Some IRBs are associated with particular universities or research institutions. Others are

independent for-profit or not-for-profit entities.

Background

Common Rule

Requirements for

Protecting Human

Subjects in Federally

Supported Scientific

Research
Page 3 GAO-01-775T

A federal agency cannot change the Common Rule without the agreement

of the other 16 agencies that agreed to and are governed by the rule. Thus,

to adapt regulations to emerging ethical issues or new scientific

developments, some agencies have issued their own regulations or

guidance, which has produced a varied array of policies across the federal

agencies.

Major responsibility for federal oversight of human subjects protection in

HHS-related clinical research rests with three entities: the Office for

Human Research Protection (OHRP), NIH, and the Food and Drug

Administration (FDA). OHRP oversees all research conducted or funded

by HHS that uses human subjects. OHRP’s oversight activities are directed

chiefly at HHS-supported research, including research conducted at

universities, hospitals, and other medical and behavioral research

institutions. One of OHRP’s principal duties is to approve and renew an

institution’s “assurance,” which is a written and signed agreement that

details the terms of the institution’s promise to comply with federal human

subjects protection requirements and policies. In addition, OHRP

investigates problems involving noncompliance with human subjects

protection that have been identified at institutions and conducts

occasional on-site evaluations.

NIH, the principal federal agency that provides funds for biomedical

research, is charged with ensuring that the research it funds is in

compliance with HHS regulations and with any additional terms it

negotiates with an individual research institution. NIH also issues its own

guidelines for certain aspects of human subjects research, such as data

and safety monitoring and the education of investigators.

FDA is responsible for ensuring the protection of the rights and welfare of

human subjects enrolled in research on the products it regulates—drugs,

medical devices, biological products,4

 foods, and cosmetics. It oversees

public and private research investigators, sponsors of research, such as

pharmaceutical companies and biotechnology companies, and IRBs that

review FDA-regulated research. Some of this research is not federally

funded and thus does not fall under the Common Rule, but FDA has

 4

A “biological product” means “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,

blood component or derivative, allergenic product, or analogous product, . . . , applicable to

the prevention, treatment, or cure of a disease or condition of human beings” (42 U.S.C.

Section 262(i)).

Structure in Place to

Oversee Human Subjects

Protections in HHSRelated Research
Page 4 GAO-01-775T

adopted a separate set of human subjects protection regulations that are

similar, but not identical, to the Common Rule that apply to the research

on products it regulates. A primary concern for FDA is assuring the quality

and integrity of research data involved in the testing or licensing of

medical products. FDA enforces compliance with its regulations through

on-site inspections of IRBs, clinical investigators, and sponsors.

In recent years, a number of concerns have been raised about human

subjects protection. In a 1996 study, we found that various time, resource,

and other pressures had reduced or threatened to reduce the effectiveness

of oversight by federal agencies and IRBs.5

 Two years later, a series of

reports issued by the HHS Office of the Inspector General (OIG)

confirmed the intense pressures on IRBs and the limitations of their

effectiveness and made specific recommendations for action.6

 In April

2000, the OIG reported that HHS had taken few actions in response to

these recommendations.7

In 1999 the National Bioethics Advisory Commission (NBAC) was asked to

conduct a thorough review of the federal oversight system for human

subjects protection.8

 NBAC has released a series of drafts of its report

entitled “Ethical and Policy Issues in Research Involving Human

Participants” and is scheduled to issue a final report in the summer of

2001. NBAC’s report is expected to address all federal oversight for

research involving human participants, and NBAC is not expected to limit

its recommendations to areas within HHS’ purview.

 5

GAO/HEHS-96-72.

6

Institutional Review Boards: A Time for Reform (OEI-01-97-00193, 1998); Institutional

Review Boards: The Emergence of Independent Boards (OEI-01-97-00192, 1998);

Institutional Review Boards: Promising Approaches (OEI-01-91-00191, 1998); Institutional

Review Boards: Their Role in Reviewing Approved Research (OEI-01-97-00190, 1998).

7

Protecting Human Research Subjects: Status of Recommendations (OEI-01-97-00197,

2000).

8

NBAC was established in October 1995 to advise the National Science and Technology

Council and other government entities regarding bioethical issues arising from research on

human biology and behavior.

Recent Studies

Highlighting Human

Subjects Protection

Concerns
Page 5 GAO-01-775T

In response to concerns raised by Congress and the research community,

HHS, in particular, three of its components—OHRP, NIH, and FDA—has

begun several initiatives to enhance the protection of subjects in HHSfunded and FDA-regulated research. These efforts are largely in the initial

stages of implementation.

HHS has taken steps to give the issue of human subjects protection greater

prominence. Until recently, NIH’s Office for Protection from Research

Risks (OPRR) was responsible for oversight and enforcement of

regulations when HHS funding was involved. Because the office was

located at NIH, it was not clear that its authority extended beyond NIHfunded research. There was also the perception that its autonomy was

compromised by its location within an agency that also funds research. To

address these concerns about authority and autonomy, HHS established

OHRP in the Office of the HHS Secretary, Office of Public Health and

Science in June 2000, enhancing the status and visibility of human subjects

protection activities. OHRP assumed the human subjects protection

functions of the former OPRR. OHRP has a 2-year plan to organize and

coordinate the department’s diverse human subjects protection activities

and reengineer the system for protection of human subjects in research.

In March 2001, FDA formally elevated and centralized its human subjects

protection activities by creating the Office for Human Research Trials and

locating it in the Office of the Commissioner. At FDA, human subjects

protection activities previously were diffuse, dispersed across various

centers and the Office of the Commissioner. The new office is involved

with intra-agency coordination of policy, education, and oversight relating

to human subjects protection. OHRP, FDA, and NIH officials told us they

are now working together more closely to coordinate and utilize resources

for human subjects protection activities.

The three HHS components have also sought to improve the mechanisms

they use to conduct oversight and enforcement activities related to human

subjects protection. To reduce regulatory burden and enhance its

oversight capabilities, OHRP has recently revised its assurance process.

The research community had concerns about the assurance approval and

renewal processes. They contended that the processes had been

unnecessarily burdensome and created disproportionate workload

demands on HHS and research institution staff who are needed to meet

other, equally important and time-consuming human subjects protection

HHS Components

Seek to Improve Their

Diverse Federal

Oversight Efforts

Efforts to Enhance

Visibility of Human

Subjects Protection

Activities

Efforts to Improve

Oversight, Compliance,

and Enforcement
Page 6 GAO-01-775T

requirements. To address these problems, OHRP undertook, as one of its

first major initiatives, implementation of a simplified assurance process

that is less administratively burdensome. The streamlined assurance

process, which is currently being phased in, is designed to reduce the

paperwork burden that characterized the former process.

OHRP, in collaboration with FDA, has initiated IRB registration as another

step to improve its ability to conduct oversight and facilitate compliance.

Previous HHS efforts to monitor IRBs and communicate with them about

policies and guidance had been hampered because HHS did not have a

comprehensive list of all IRBs, estimated to number in the thousands. As

part of the new assurance process, institutions will be required to register

their IRBs.9

 Registration will enable HHS to build an IRB database, which

will facilitate the identification of and communication with officials who

actively review projects using human subjects.

OHRP also seeks to enhance IRB compliance by adopting a monitoring

and quality improvement strategy intended to prevent problems before

they occur. We and others have reported that this office’s predecessor

made few site visits to review compliance. Those conducted, moreover,

were “for cause,” that is, in response to complaints of noncompliance.

OHRP has plans to conduct quality improvement evaluations (although not

necessarily through site visits) at every major medical school in the United

States within the next 18 months, insofar as resources permit. OHRP seeks

to expand its compliance activities through enhanced coordination and

communication with FDA’s inspection program. In fiscal year 2000, NIH

also began a process of not-for-cause site visits, intended to assess

institutional understanding of federal policies and regulations (including

those involving human subjects protection), minimize or eliminate

noncompliance, and foster a productive partnership between NIH and its

grantee institutions. To date, it has completed 10 of these visits; NIH

officials told us that more are planned for fiscal year 2001.

HHS is also considering ways to address the research community’s

concerns that its range of options for enforcement of regulations is too

limited. In the event that serious violations are uncovered, OHRP can

restrict or suspend an institution’s assurance. Such an action would

 9

This registration procedure seeks for the first time to register all IRBs overseeing HHSfunded research, whether independent or based at academic institutions. The new

procedures do not, however, require all IRBs to register. FDA intends to require

registration by all IRBs that are subject to its regulation.
Page 7 GAO-01-775T

seriously disrupt ongoing research at that institution because federally

funded human subjects research cannot be conducted without an

assurance in place. FDA can withhold approval of new studies, withhold

approval for enrollment of new subjects, and terminate studies. FDA can

also issue warning letters and restrict or disqualify investigators, IRBs, or

institutions from conducting or reviewing research. As a granting agency,

NIH can place a restriction on an award if the grantee institution is not in

compliance with regulations. Nonetheless, some critics have argued that

there are too few sanctions to match the range of violations that occur.

Acknowledging this problem, HHS is considering a proposal for legislation

that would enable FDA to levy civil monetary penalties for violations of

the informed consent process and other important research practices.

HHS has taken some actions to improve the review and monitoring of

clinical trials by research institutions. HHS has taken steps to improve

institutional research reviews while reducing IRB workload by issuing

guidance regarding adverse events and financial relationships. It is also

initiating efforts to develop standards for evaluating IRBs.

Recent HHS guidance regarding IRB use of information from other entities

involved in monitoring research has the potential to improve IRB reviews

and reduce their workload. Our 1996 report noted that workload and other

demands impaired IRB oversight, and subsequent studies found that

review of adverse event reports presents a particular challenge to IRBs.

Adverse event reports describe untoward occurrences experienced by

research subjects during the course of a clinical trial. IRBs have been

overwhelmed by large numbers of adverse event reports from

investigators, as can happen when clinical trials are conducted at multiple

sites. IRB review can be difficult because adverse event reports can lack

key information, such as whether the individual experiencing the adverse

event was part of the trial’s treatment group or control group. One

mechanism that is sometimes used to help evaluate data collected during a

trial is data and safety monitoring boards (DSMB). These are special

committees composed of statisticians and other scientists that monitor

information about the safety and effectiveness of clinical trials and that

may recommend that a trial be continued or stopped. Because DSMBs

have access to adverse event data, they are in a good position to assess

Recent and Planned

Protection Efforts

Involve Strengthening

Oversight Performed

by Research

Institutions

Efforts to Improve

Institutional Review and

Monitoring of Research
Page 8 GAO-01-775T

certain risks to subjects. Until recently, however, IRBs were to review a

clinical trial’s adverse event reports even if a DSMB had also evaluated

them.

In May 2000, OHRP’s predecessor issued guidance stating that an IRB, in

its continuing reviews of a trial, could rely on a statement by a DSMB

attesting that it had reviewed a trial’s adverse event reports, interim

findings, and any recent literature that may be relevant to the research.

This policy expedites the IRB’s own review of adverse event reports, thus

freeing IRB resources to concentrate more appropriately on assessments

of other potential study risks. Recognizing the potential benefits of

DSMBs, both NIH and FDA are taking steps to encourage their use when

appropriate. For example, NIH, which had issued guidance in 1998

directing the use of DSMBs in certain NIH-funded multisite trials,10 issued

new guidance in June 2000 suggesting in part that DSMBs be used for

additional studies, such as early-stage clinical trials that employ

particularly high risk interventions or use vulnerable populations. FDA,

which recommended DSMBs for certain studies in 1998 guidance, is

currently developing additional guidance on their use, which is expected

to be released for comment this summer.

HHS’ anticipated guidance on financial relationships may also facilitate the

ability of IRBs to appropriately review research. In today’s environment,

financial relationships sometimes exist between investigators, institutions,

and industry sponsors.11 These relationships have the potential to

inappropriately influence the professional judgment and independence of

those responsible for the protection of human subjects. In particular, they

can affect the study’s recruitment, enrollment, conduct, and analyses of

results in ways that would financially benefit the investigator or

institution, and IRBs must ensure that such financial relationships do not

pose a risk for human subjects. As financial relationships continue to

multiply, IRBs may need to address an increasingly complex range of

issues associated with possible conflicts of interest. Some research

institutions have special committees to examine financial relationships in

 10NIH’s 1998 guidance reaffirmed a 1979 policy directing the use of DSMBs in certain NIHfunded multisite trials.

11The Bayh-Dole Act (P.L. 96-517, Section 6(a)), which was designed to allow universities,

not-for-profit corporations, and small businesses to patent and commercialize their

federally funded interventions, has fostered ties between industry and clinical

investigators.
Page 9 GAO-01-775T

detail, and these committees may be able to supplement IRB review in this

area.12 In January 2001, HHS developed Draft Interim Guidance on

Financial Relationships, which discussed points that IRBs and other

participants in the research process should consider when addressing

issues of financial interests and human subjects protection. This document

generated a broad range of reactions and debate, and HHS is currently

revising the document to address those comments.

HHS has initiated efforts to develop standards for accreditation and

evaluation of IRBs, standards that might help improve performance by

allowing assessment of strengths and weaknesses. The OIG has stated that

oversight at the federal or institutional level is not geared toward

evaluating IRB effectiveness and that little is known about how well IRBs

are accomplishing their mission to protect human subjects. As a first step

toward evaluating the effectiveness of IRBs, HHS requested that the

Institute of Medicine (IOM) explore the option of accreditation for IRBs

and other human research protection entities. IOM released its report in

April 2001, recommending pilot testing of accreditation by

nongovernmental organizations.13,

14 HHS also asked IOM to conduct an

analysis, scheduled for completion in 2002, of the structure and

functioning of IRBs and other entities involved in ensuring protection of

human subjects and to develop criteria for evaluating their performance.

These efforts constitute a preliminary step toward establishing

benchmarks for IRB performance.

 12Institutions receiving research funds from the Public Health Service or the National

Science Foundation are required to have policies and procedures to examine financial

relationships. Institutions must ensure that any significant relationships are managed,

reduced, or eliminated.

13IOM, Preserving Public Trust, Accreditation and Human Research Participant Protection

Programs (Washington, D.C.: National Academy Press, 2001).

14NIH plans to have its intramural human subjects program evaluated later this year using

draft accreditation standards issued by the Association for the Accreditation of Human

Research Protection Programs. The Department of Veterans Affairs has contracted with

the National Committee for Quality Assurance to develop an accreditation process for the

IRBs it uses.

Efforts to Develop

Standards for IRBs
Page 10 GAO-01-775T

HHS has efforts under way to improve investigators’ understanding of and

compliance with human subjects protection requirements. The efforts

focus on instructing clinical trial investigators on the ethical conduct of

research, including pertinent regulations, proper ways to obtain informed

consent from research subjects, and obligations to report adverse events.

HHS has taken several recent actions to inform investigators about human

subjects protection policies and practices. We, OHRP, and OIG have all

noted that educational programs are critical to ensuring that investigators

understand their responsibilities to protect human subjects. Some recent

instances in which investigators violated informed consent or adverse

event reporting may have been due to a lack of understanding of key

issues by investigators. In June 2000, NIH established an education

requirement for all investigators submitting NIH applications for grants

and proposals involving human subjects. Effective October 1, 2000, NIH

grantees are required, as a condition of project funding, to attest to having

received training—through on-line workshops, published materials, or live

presentations—on the protection of human subjects. In February 2001,

OHRP held an educational “summit” of key agency officials and

representatives of the research community to develop an educational

initiative, possibly as a public-private partnership.15 HHS has taken some

steps to improve awareness through education, which build on previous

educational efforts sponsored by OHRP’s predecessor. This past year,

FDA, OHRP, the Department of Veterans Affairs, and others jointly

sponsored educational workshops on human subjects protection in

Washington, D.C., and Newark, New Jersey, and held a town meeting in

Dallas, Texas for investigators, IRBs, and others on human subjects

protection issues. Plans are in place for continuing these joint educational

workshops and town meetings in the coming year. In addition, FDA is

conducting educational programs for clinical investigators, jointly

sponsored with industry and academic representatives.

HHS has some plans to address concerns relating to investigators’ practice

of obtaining informed consent. Experts have suggested that some

investigators may tend to emphasize the disclosure of information and

documentation of consent, rather than ensuring that participants fully

understand the risks and benefits of the study and that their participation

is voluntary. Over the years, HHS components have provided information

 15The summit was co-hosted by the Office of Research Integrity, a separate HHS

component that directs research integrity activities on behalf of the HHS Secretary.

HHS Initiates Efforts

to Raise Investigators’

Awareness of Human

Subjects Protections
Page 11 GAO-01-775T

and guidance on informed consent. For example, OHRP’s predecessor

discussed informed consent in its IRB Guidebook and other supplemental

materials. NIH’s institutes and centers have provided guidance to their

grantee investigators and to in-house clinical researchers and IRBs. FDA

informed consent guidance has been issued to IRBs and clinical

investigators in the form of “Information Sheets.” While the guidance and

information on informed consent are extensive, NBAC has suggested that

in general, the federal guidance continues to emphasize documenting the

subject’s consent rather than focusing on the ethical practices for

obtaining this consent.

FDA officials told us they are revising all of the agency’s Information

Sheets for investigators and IRBs, including the guidance on informed

consent. The revised guidance is intended to emphasize the importance of

informed consent as a process of achieving understanding and voluntary

participation. It will also address issues involved in obtaining consent from

study participants who might not be able to provide consent on their own

behalf. Beginning in 1999, NIH has funded 12 studies on informed consent

and research ethics. The studies include an evaluation of the cognitive

ability required to comprehend different aspects of a research project and

an analysis of how potential participants weigh risks and benefits; the

results are not yet available.

Some HHS efforts are aimed at improving investigators’ understanding of

adverse event reporting obligations. Although the ultimate responsibility

for reporting adverse events in clinical research lies with investigators,

they have sometimes misunderstood their responsibilities because there

are inconsistencies between HHS and FDA regulations and guidance.

These differ in what is to be reported, the entity to which it should be

reported, and the required time frames for reporting. NIH is planning to

make its adverse event reporting requirements—as they apply to gene

transfer research—compatible with those of FDA.16

 16In the specific area of human gene transfer research, the NIH has special guidelines

regarding reporting of serious adverse events that are different from FDA’s requirements.
Page 12 GAO-01-775T

Although problems with the oversight of human subjects protection have

received increasing attention since the 1990s, it is only recently that HHS

has made a concerted effort to address these issues. We have some

concerns, however, that the pace of some actions is too slow and that gaps

remain at each of the three levels of oversight we reviewed.

At the agency level, for example, HHS has not increased OHRP’s budget in

proportion to the office’s increased scope of work—including its quality

improvement evaluations at medical schools—and the office has not been

able to hire the staff it planned to because of the federal hiring freeze that

went into effect in early 2001. OHRP is still addressing a backlog of

compliance cases. In addition, NIH appears to have lost momentum

regarding its not-for-cause site visits. In the first two-thirds of fiscal year

2001, it has not made any not-for-cause site visits. FDA officials told us

that HHS has not finalized a legislative proposal that, if enacted, would

broaden FDA’s authority to apply civil monetary penalties for investigator

violations. Furthermore, FDA units that monitor and inspect clinical trials

are seeking additional resources. According to an FDA acting associate

commissioner, in 2000 the agency inspected fewer than 800 clinical

investigators, or about 2 percent of an estimated 35,000 clinical sites.

Although the agency has asked for additional resources to allow it to

increase the number of inspections by 275, this would extend the

inspections by less than 1 percentage point.

At the research institution level, HHS’ efforts to support IRBs and enhance

their performance appear promising, but the subject of financing IRBs

remains largely unexplored. Although institutions bear the ultimate

responsibility for supplying needed resources for IRBs, HHS can help

facilitate the appropriate allocation of resources by providing information

about resource benchmarks. HHS officials have acknowledged that little is

known about the actual cost of the human subjects protection process,

and there is debate about what constitutes appropriate funding and what

the sources of funding should be. A Regulatory Burden Working Group at

NIH has begun to study IRB operations and intends to address these

financing questions. In addition, while HHS has begun to examine the

issues relating to financial conflicts of interest at research institutions, it is

not yet clear how, or how quickly, the department plans to move to

address these serious concerns.

At the investigator level, HHS has taken little action to improve the

informed consent process and to clarify adverse event reporting

requirements. A year ago, HHS announced that it would issue new

guidance on informed consent, but it has not yet done so. OHRP officials

Concerns Remain

Regarding the Pace

and Scope of HHS’

Actions to Protect

Human Subjects
Page 13 GAO-01-775T

told us that other issues, such as implementing the new assurance process

and educational initiatives, have higher priority and that they need time to

get expert and public input on the informed consent process and how it

can be improved. Despite concerns about problems with adverse event

reporting and confusion among investigators over differing requirements,

HHS has not yet taken any steps to address these concerns. The only

announced plans to improve this process have been limited to

harmonizing the gene transfer research reporting requirements.

The actions of HHS components to improve oversight are in the right

direction, but in some areas, the extent of change could be greater. At the

three key levels of human subjects protection—federal agency, research

institution, and individual investigator—more could be done to fill the

gaps in protection efforts.

For future contacts regarding this testimony, please call me at (202) 512-

7119 or Marcia Crosse at (202) 512-3407. Individuals making contributions

to this statement are Anne Dievler, Romy Gelb, Kristen Joan Anderson,

and Hannah Fein.

Concluding Remarks

GAO Contacts and

Acknowledgments

(290070)

This statement was prepared for a hearing before the Senate

Committee on Health, Education, Labor, and Pensions,

Subcommittee on Public Health, that was originally scheduled for

May 23, 2001.