United States General Accounting Office

GAO Report to Congressional Requesters

August 1995 HEALTH RESEARCH

MISCONDUCT

HHS’ Handling of

Cases Is Appropriate,

but Timeliness

Remains a Concern

GAO/HEHS-95-134

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

B-258102 

August 3, 1995

The Honorable Nancy Landon Kassebaum

Chairman, Committee on Labor and

 Human Resources

United States Senate

The Honorable William S. Cohen

Chairman, Oversight of Government

 Management and the District of

 Columbia Subcommittee

Committee on Governmental Affairs

United States Senate

The Honorable David H. Pryor

Ranking Minority Member

Post Office and Civil Service

 Subcommittee

Committee on Governmental Affairs

United States Senate

The federal government spends billions of dollars annually to fund

research on cures for chronic diseases and preventive treatments. Federal

support for these efforts is channeled to institutions primarily through the

National Institutes of Health (NIH) and other offices within the Department

of Health and Human Services’ (HHS) Public Health Service (PHS). For fiscal

year 1995, NIH funding for health research totaled about $11 billion, most of

which supported extramural research by more than 50,000 scientists

working at 1,700 institutions across the United States.1

The Congress has become increasingly concerned that federal dollars are

being misspent on inappropriate research practices. This concern

heightened after widely publicized reports of research fraud and other

scientific misconduct, such as the recent detection of falsified data in

federally funded breast cancer research.

HHS’ Office of Research Integrity (ORI) was set up to foster confidence in

federal health research programs in two ways: through direct

investigations of misconduct allegations within intramural and extramural

research programs and through oversight of investigations conducted by

1

Intramural programs provide funding for research conducted within federal government facilities.

Extramural programs provide funding to research institutions that are not part of the federal

government.

Page 1 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

extramural research institutions. Because of your concerns about the

effectiveness of ORI, you asked us to determine whether (1) ORI has

appropriate policies and procedures for handling misconduct allegations,

(2) ORI follows appropriate investigative practices, (3) ORI is handling its

caseload in a timely manner, and (4) any staffing issues may be adversely

affecting ORI’s responsiveness.

To assess ORI procedures for conducting and monitoring misconduct

investigations, we reviewed the 10 investigations that were opened since

ORI’s establishment in May 1992 and completed by the time of our review.2

ORI conducted 4 of the 10 investigations; the other 6 were done by

extramural institutions and reviewed by ORI. We also reviewed case files

for 30 misconduct allegations handled by ORI that did not proceed to the

inquiry phase. Appendix I describes our scope and methodology in more

detail.

Results in Brief ORI has made progress in its handling of misconduct cases since its

establishment in May 1992. However, it still faces a substantial case

backlog and lengthy delays in completing its work.

By November 1992, ORI had developed and implemented procedures for

handling misconduct cases, which we believe conform to established

federal standards for investigations. Specifically, ORI’s procedures and

federal standards address similar elements, such as the qualifications of

staff needed for investigations; the level of independence and professional

care needed to conduct investigations; and other qualitative

standards—namely planning, executing, and reporting investigation

results.

We were unable to fully assess how well ORI investigators followed

appropriate procedures in all misconduct cases. However, our reviews of

30 initial allegation3

 and 10 investigation case files, as well as interviews

with ORI investigators, raised few concerns about the techniques used in

handling cases.

2

During this period, ORI closed an additional 34 investigations that had begun prior to May 1992.

3

The term “allegation” refers to all misconduct queries or complaints made to ORI that are logged in

and assigned a control number. In some instances, the query can be resolved by an explanation of the

PHS definition of scientific misconduct and ORI’s standard procedures without a formal allegation

being made.

Page 2 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

Despite its success in implementing procedures for handling misconduct

cases, ORI continues to experience delays in closing cases. Our review

showed that more than half of ORI’s open allegations had not been resolved

6 months after being reported. In addition, for the 10 investigations we

reviewed, ORI took far more than the targeted time (120 days) to close

them. During our review, ORI took steps to reduce its case backlog, for

example, developing indicators to measure timeliness, setting priorities for

cases, and providing additional guidance to extramural institutions.

ORI currently has 43 employees, down from 50 in 1994. Only 11 of ORI’s

workforce, however, are directly involved in handling misconduct cases;

the others have responsibilities either in support of the investigative

function or in other integrity areas such as policy development and

education. Given that it faces a substantial case backlog and takes so long

to close cases, ORI needs a comprehensive assessment of its resources. ORI

also needs a plan for reducing its case backlog to a more manageable level

and for responding to cases in a more timely manner. In response to our

findings and an HHS Office of the Inspector General (IG) report, ORI has

initiated a number of actions to improve productivity and plans to refine

its planning processes during this fiscal year.

Background ORI is an independent group within HHS; its Director reports to the

Secretary. Created from a merger of two offices within HHS,

4 ORI’s mission

is to oversee and direct PHS research integrity activities, which it does

primarily through its handling of scientific misconduct investigations. In

fiscal year 1994, ORI had a total operating budget of $4 million and

maintained a staff of about 50 employees; currently, it has 43 employees.

Although ORI investigates misconduct related to intramural research

programs, about three-fourths of its caseload in 1994 related to oversight

of extramural integrity reviews conducted by grantee institutions. ORI

generally monitors the progress of an extramural investigation and

reviews the institution’s final report.5 ORI also presents the results of

4

ORI replaced the Office of Scientific Integrity, within the NIH Office of the Director, and the Office of

Scientific Integrity Review, within the Office of the Assistant Secretary for Health. The NIH

Revitalization Act of 1993 designated ORI as an independent entity within HHS.

5

ORI may conduct extramural investigations in cases where the institution is unwilling or unable to do

so or if the case involves special circumstances such as multisite clinical trials.

Page 3 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

misconduct investigations in administrative hearings before the HHS

Departmental Appeals Board6 if ORI’s decisions are challenged.

Besides its investigative function, ORI performs other research integrity

activities. These efforts include developing model policies and procedures

for handling allegations of scientific misconduct; evaluating institutional

policies and processes for conducting investigations; investigating

whistleblower retaliation complaints; and promoting scientific integrity

through educational initiatives and other collaborations with universities,

medical schools, and professional societies.

Most allegations of scientific misconduct are made directly to the

institutions conducting the research. Responding to an allegation involves

a two-step process: an inquiry and, if necessary, an investigation.

Institutions have the primary responsibility for responding to allegations

involving extramural research; ORI’s role in these instances is usually that

of reviewing the institution’s investigation report. ORI generally does not

review institutional inquiries because an institution is not required to

inform ORI that an inquiry is under way nor to submit a report at its

conclusion.

ORI does, however, review all investigations. Institutions must inform ORI

when they begin an investigation and submit a report at its conclusion. ORI

reviews the final report, the supporting materials, and the determinations

to decide whether the investigation has been performed with sufficient

objectivity, thoroughness, and competence.7

ORI plays a more direct role in responding to scientific misconduct

allegations in PHS intramural research programs. It reviews all misconduct

inquiries conducted by PHS agencies and conducts all investigations when

they are needed. ORI’s handling of intramural scientific misconduct cases

can be a complex undertaking that may involve collaborations among ORI

staff, other agencies, and institutions performing research.

In general, for intramural research allegations, the review process begins

when an individual making an allegation (referred to as a complainant)

alleges to either ORI or a PHS agency that another researcher (a respondent)

6

Persons found by ORI to have engaged in scientific misconduct can appeal such decisions to this unit

within HHS.

7

ORI may accept or reject the findings, ask for additional information, request further investigation, or

begin its own investigation.

Page 4 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

committed scientific misconduct.8 If a misconduct allegation is made to

ORI, an investigator within ORI’s Division of Research Investigations (DRI)

conducts an initial screening primarily to determine if PHS funding is

involved and whether the allegation falls within the PHS definition of

scientific misconduct. Allegations that do not meet these criteria result in

no action or are referred outside of ORI for consideration.9

When allegations do fall within PHS’ definition of misconduct, ORI forwards

them to the PHS agency that funded the research and directs that agency to

conduct a formal inquiry. This involves gathering information—including

interviewing the subjects involved—to determine the nature of evidence

available to support the allegation. ORI investigators may monitor inquiries

and advise PHS agencies on matters such as procedures for sequestering

laboratory research notebooks. They often directly assist the agency in

sequestering the research data and other evidence.

If the results of an inquiry suggest that misconduct may have occurred, ORI

then opens a full investigation to determine the existence and magnitude

of misconduct. An investigation could involve an extensive review of

experiments and other scientific data as well as interviews with all parties

involved with the research. The ORI investigator assigned to the case may

seek assistance from a staff biostatistician and other in-house experts.

Also, ORI may elicit assistance from outside scientists who have expertise

in subject areas that ORI staff lack. Investigators produce a written report

with findings. The report is reviewed by ORI management, its legal staff,

and the respondent before being issued by the ORI Director. For

investigations that result in a finding of misconduct, the ORI Director, in

combination with the HHS debarring official, determines possible sanctions

against the respondent, which may include debarment from receiving

federal grant or contract funds for a specified period.10

8

The PHS definition of misconduct in science is fabrication, falsification, plagiarism, or other practices

that seriously deviate from those that are commonly accepted within the scientific community for

proposing, conducting, or reporting research. The definition does not include honest error or honest

differences in interpretation or judgment of data. Moreover, according to ORI documents and officials,

disputes over credit or authorship generally do not fall under the definition of scientific misconduct.

9

After initial review and screening, only about 18 percent of the allegations received in 1994 led to a

formal inquiry or investigation. About 30 percent resulted in a detailed allegation assessment or formal

referral to other HHS offices, including the Food and Drug Administration, the Office for Protection

from Research Risks, and the IG.

10A respondent charged with misconduct may be required to correct the relevant research literature,

withdraw from participating in PHS-funded research and PHS advisory committees, or a combination

of these and other actions.

Page 5 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

ORI’s Procedures

Conform to Generally

Accepted Standards

ORI developed procedures for handling scientific misconduct cases and

implemented them in November 1992. These procedures detail ORI’s

process for receiving and assessing misconduct allegations, reviewing PHS

agency inquiry reports, conducting investigations, and overseeing

extramural investigations. The procedures were developed by a task force,

consisting mainly of ORI management (in consultation with officials from

PHS agencies) and the HHS Office of the General Counsel and the IG.

We compared ORI’s policies and procedures with investigation guidelines

established by the President’s Council on Integrity and Efficiency (PCIE).

The PCIE guidelines apply to federal government investigations and

generally outline issues and procedures for handling matters such as

background and security inquiries as well as special investigations

requested by any appropriate authority. These standards were established

through a collaborative effort of staff from various inspector general

offices throughout government.

We found ORI’s procedures for handling scientific misconduct cases to be

consistent with PCIE standards. Specifically, ORI procedures meet the PCIE

standards by containing explicit statements on the qualifications of staff

needed to handle investigations; independence required to conduct

investigations; due professional care needed for the work; and other

qualitative standards, such as planning, executing, and reporting

investigation results.

Investigation

Techniques Applied

Appropriately

ORI investigators handling misconduct cases are scientists with doctoral

degrees who were engaged in scientific research prior to their tenure with

ORI. They represent varied scientific disciplines, such as biochemistry,

genetics, biomedical engineering, and nutritional science. At the time of

our review, each investigator had received the introductory investigation

course given to most federal law enforcement agents. Supervisory

investigators had taken some of the more advanced courses as well.

Our assessment of case files confirmed that ORI investigators documented

the work performed and followed established procedures in screening

allegations and handling misconduct investigations.

Allegations Screened and

Closed Appropriately

ORI investigators appeared to be making appropriate decisions as to which

allegations did not merit further examination beyond their initial

screening. We reviewed ORI case files on 30 allegations made to ORI since

Page 6 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

June 1993 that were closed without a formal inquiry. We sampled these 30

cases from a universe of 113 such closures. In each case, investigators

followed established procedures and appropriately followed up on leads,

and logically closed out the screening process.

Our interviews with four individuals who had contacted ORI revealed a

general satisfaction with ORI’s handling of their allegations or requests for

information. For example, a scientist who had asked whether a laboratory

chief could take authorship credit for research conducted in his facility

told us he accepted ORI’s explanation that his inquiry did not constitute

misconduct. The scientist added that the ORI investigator handling the call

provided useful information on NIH guidelines for research collaborations.

Investigations Handled

Appropriately

ORI investigators also appeared to have followed established procedures

for the 10 investigations we reviewed. However, two limitations on our

analysis should be noted. First, at the time of our review, ORI had opened

and closed only four intramural investigations since its formation in

May 1992. Second, these four investigations did not require investigators to

apply sophisticated investigative or scientific techniques. (For example,

two of them related to alleged falsification of academic credentials.) The

remaining six cases involved possible misconduct in extramural research

in nonfederal institutions. In these six cases, ORI’s role was that of

oversight, reviewing the institutions’ investigations.

We concluded from our review of case files for the four ORI-led

investigations that ORI investigators employed appropriate techniques.

Specifically, investigators developed investigation plans, interviewed

relevant individuals, analyzed scientific data where appropriate,

coordinated with other HHS offices, appropriately followed up on leads,

and wrote reports with evidence supporting their decisions.

ORI investigators also appeared to have followed proper procedures in

reviewing the extramural investigations. Our examination of the six

extramural case files revealed that ORI investigators adequately

documented their work and included relevant documents, such as copies

of the inquiry and investigation reports, in case files. We observed from

our review of documentation in the case files that investigators generally

followed the steps outlined in the ORI procedures manual. For example,

investigators made appropriate contacts with institutions and took steps

to ensure that the institution conducting the investigation properly notified

the complainant and respondent at various stages of the investigation.

Page 7 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

Delays in Closing

Cases Contribute to

Backlog

ORI’s procedures specify time frames for screening allegations and for

conducting inquiries and investigations. These procedures state that

screening should be completed within 30 days of receipt of the allegation.

Inquiries are generally to be completed within 60 days of their initiation

and investigations within 120 days.

We observed delays in ORI’s handling of misconduct cases. ORI’s inability to

close current cases in a timely manner has contributed to a backlog, some

of which it inherited from its predecessor offices. When ORI was

established, it inherited 70 active cases (inquiries and investigations) and

about 420 more allegations which had apparently not been reviewed or

screened. Although it has made progress in working through these

inherited cases, ORI still has a substantial backlog. On April 30, 1995, ORI

reported 169 active cases, including 71 inquiries and investigations.

Many Allegations Still Not

Screened After 6 Months

Although ORI completed the initial screening on 208 of the 288 misconduct

allegations it received between June 1, 1993, and December 6, 1994, ORI

investigators had not completed the screening process for the remaining

80 allegations, even though most of them had been unresolved for more

than the 30 days allotted. More importantly, a majority of these (45 of

80) had remained open for over 6 months.

Investigators and supervisors we interviewed attributed the backlog to

competing work priorities. Our discussions with investigators and analysis

of their workload indicated that, generally, investigators are each assigned

6 to 10 allegations to review in addition to their caseload of open

investigations, inquiries, and oversight of extramural investigations.

Although none of the investigators indicated that the workload was too

high, they expressed concern about the backlog of initial allegations.

Closures of Investigation

and Oversight Cases Take

a Long Time

For the four ORI-led investigations we reviewed, ORI went well beyond the

targeted 120 days to complete them. Although we could not determine the

actual staff time spent on these cases, the elapsed calendar time ranged

from about 6 to 13 months. In two instances, investigators took what

appeared to be an inordinate amount of time to complete relatively

straightforward cases. For example, ORI took over a year to investigate and

adjudicate a case of alleged falsification of academic credentials in several

NIH grant applications. In another case, ORI took about 6 months for an

investigation in which the respondent submitted a statement partially

admitting to the misconduct prior to ORI’s opening an investigation.

Page 8 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

ORI investigators indicated that higher priority cases prevented them from

closing these cases more expeditiously. The investigators also gave

specific reasons for each case. In the first case, investigators wanted to

establish a pattern of falsifying credentials to counter the respondent’s

claim that the incident was not common. In the other case, ORI initiated an

investigation because it wanted to ensure that appropriate procedures

were followed and that the full extent of the respondent’s misconduct was

identified.

We also observed a lack of timeliness in closing extramural investigations.

The six cases we reviewed were open for about 9 to 13 months. The time

spent on four of these cases can be partly attributed to additional work ORI

did on these cases after the institutions completed their investigations.

ORI Efforts Improve Case

Handling

During the course of our review, ORI officials took various steps to reduce

the case backlog and improve ORI’s work. These actions ranged from

giving greater attention to setting priorities among cases to providing

increased guidance to extramural institutions.

Priority Setting—ORI has begun holding frequent management meetings to

systematically review all open cases. The point is to decide which cases

can be closed and to set priorities among the open cases.

Early Settlement Agreements—ORI has also begun to seek earlier

resolutions of cases through advance settlements with respondents

(generally referred to as voluntarily exclusions). When respondents

voluntarily agree to or accept ORI’s early disposition of a case, further

pursuit of an investigation or appeal can be avoided. Significant savings in

investigative and litigation resources may result.

Reassigning Program Analysts—ORI has assigned a program analyst to

expedite allegation assessments by performing initial tasks, such as

securing research articles and grant information. Managers and

investigators indicated that this effort has proven useful and support the

increased use of program analysts for this purpose.

Guidance to Institutions—In an effort to better educate intramural and

extramural institutions on handling scientific misconduct, ORI has

instituted formal processes for communicating with these entities. ORI now

issues a quarterly newsletter, conducts seminars, and posts notices on an

HHS computer bulletin board. Additionally, in November 1994, ORI issued

Page 9 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

draft model policies and instructions for handling misconduct cases to

extramural institutions. In their present form, the guidelines are intended

to assist institutions in complying with federal regulations. ORI sent these

draft procedures to officials at 40 extramural institutions requesting their

review and comment. We interviewed four of these officials, and the

consensus was that the draft procedures would have a positive effect by

giving institutions improved guidance for investigations.

Although these measures appear to have helped ORI improve its handling

of cases, additional efforts are needed to more effectively respond to

workload demands.

Further Efforts

Needed to Effectively

Respond to Workload

Demands

Facing a substantial case backlog and lengthy delays in completing its

work, ORI needs additional management tools to meet its workload

demands. Specifically, ORI still needs strategic planning and resource

assessments to decide how to most efficiently and effectively deploy its

staff.

For example, 11 of ORI’s staff (within DRI) are directly involved in

investigations full time.11 The remaining 32 staff members (about

75 percent of total staff) are either professional or administrative staff who

support DRI or are devoted to other ORI functions, such as policy

development and education. Investigative work is not ORI’s only

responsibility. Given the case backlog, however, ORI’s current staff

allocation to investigations may not be sufficient even with the recent

improvements ORI has made.

ORI also needs a system to track the amount of time investigators spend on

cases. Generally, each investigator handles 6 to 10 initial allegations of

misconduct, 1 to 3 investigations, and 1 to 4 oversight cases. Some

investigators we interviewed expressed occasional uncertainty about

whether their use of time coincided with management’s priorities.

Planning processes, such as routine staffing assessments, could help ORI’s

management team systematically gauge the appropriate balance between

ORI’s needs and resources. Staffing assessments might also help identify

ways to augment ORI’s skill base—for example, identifying the need for

different disciplines and backgrounds among the staff, such as trained

11DRI’s full-time investigative staff consists of seven scientist/investigators, two supervisory

scientist/investigators, a deputy division director, and the director.

Page 10 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

criminal investigators. Such assessments might also help management

determine ways to better use its administrative staff.

The HHS IG reached a similar conclusion in its November 1994 report on

ORI’s staffing and management. The IG recommended that ORI develop a

strategic plan to help it “be better prepared to handle fluctuations in its

work load and to provide a balance between its roles in stewardship and

research integrity education.” The plan, according to the IG, should detail

objectives in specific, measurable terms and show how resources and staff

should be allocated to accomplish these objectives. The IG’s report made a

number of other recommendations designed to improve ORI’s productivity.

Another deficiency noted in the IG’s report was the absence of a structured

timekeeping system. The report concluded that implementing such a

system would greatly aid in determining whether ORI needs additional

investigative staff. The IG recommended that ORI set and enforce

performance measures for its staff regarding the quality, quantity, and

timeliness of work conducted.

Our work supports the IG’s conclusion that ORI needs a strategic plan and

specific performance measures for its staff. Such a plan—particularly if it

includes (1) a comprehensive assessment of ORI’s workload and staffing

requirements and (2) measures to reduce the case backlog and close cases

more quickly—should help ensure an optimum use of resources.

Among its fiscal year 1995 management initiatives, ORI has started work on

a strategic plan and will begin setting specific performance measures.

Additionally, ORI officials told us they had initiated a two-pronged pilot

study for tracking investigators’ time. One part of the pilot requires

investigators to track time spent on an investigation. The second part

requires investigators to record the time they devote to the specific tasks

they perform, such as interviewing and analyzing research experiments, in

addition to the total time spent.

Conclusion Since its inception, ORI has made progress in improving its handling of

scientific misconduct cases. By continuing to follow sound investigative

procedures and striving to improve its handling of cases, the office will

gain increased public trust as a preserver of federal interest in biomedical

research. However, persistent delays in case handling and deficiencies in

its management systems are barriers that ORI needs to overcome if it is to

Page 11 GAO/HEHS-95-134 HHS’ Office of Research Integrity
B-258102 

effectively fulfill its mission in the future. ORI’s management team must

confront these challenges and develop strategies to address them.

Agency Comments HHS provided comments on a draft of this report, which we incorporated

where appropriate (see app. II). HHS generally agreed with our findings and

representation of its current efforts to improve productivity. HHS also

described planned efforts to reduce the “management superstructure of

ORI,” which should result in productivity gains. We incorporated technical

comments provided by HHS, but did not include them in the appendix.

As arranged with your offices, unless you publicly announce its contents

earlier, we plan no further distribution of this report until 30 days after its

issue date. At that time, we will send copies to interested parties and make

copies available to others on request.

Please call me on (202) 512-7119 if you or your staff have any questions

about this report. Other major contributors are listed in appendix III.

Mark V. Nadel

Associate Director, National and

 Public Health Issues

Page 12 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Page 13 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Contents

Letter 1

Appendix I 

Scope and

Methodology

16

Appendix II 

Comments From the

Department of Health

and Human Services

18

Appendix III 

Major Contributors to

This Report

21

Abbreviations

DRI Division of Research Investigations

HHS Department of Health and Human Services

IG Office of Inspector General

NIH National Institutes of Health

ORI Office of Research Integrity

PCIE President’s Council on Integrity and Efficiency

PHS Public Health Service

Page 14 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Page 15 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Appendix I 

Scope and Methodology

To assess ORI’s process for handling misconduct cases, we reviewed its

written guidance and examined how it screens allegations and conducts

investigations and oversight functions. We compared ORI’s written policies

and procedures for handling misconduct allegations and investigations

with guidelines established for federal agencies that engage in comparable

activities.

In examining how ORI handles and screens misconduct allegations, we

reviewed case files for 30 of the almost 300 allegations received from

June 1993 to December 6, 1994. We selected cases that did not proceed to

the inquiry phase. For four of these cases, we interviewed the individuals

who made the allegations to obtain their perspectives on how well ORI

handled them. We selected these particular individuals primarily because

their case files did not contain sufficient information for us to determine

whether ORI had completed its work responding to the allegations.

To assess ORI procedures for conducting and monitoring misconduct

investigations, we reviewed the 10 investigations that were opened since

ORI’s establishment in May 1992 and completed by the time of our review.

ORI conducted 4 of the 10 investigations; the remaining 6 were done by

institutions and reviewed by ORI.

12 We did not review cases initiated and

conducted primarily by ORI’s predecessor offices because ORI had not

implemented its current investigation procedures when these cases were

opened. In addition, we neither independently verified the information ORI

investigators used to reach their conclusions nor conducted our own

investigation of cases. We supplemented our reviews of ORI case files with

interviews with the seven investigators, two supervisory investigators, and

the DRI Acting Director. We primarily sought to further our understanding

of the investigative techniques used in handling misconduct cases,

particularly the cases that presented greater technical challenges for

investigators. As part of our interviews, we discussed procedures being

used for cases currently under review.

We interviewed officials at intramural and extramural institutions to gain

their perspectives on ORI guidance for handling misconduct and on the

quality of ORI investigations. We sought to obtain their views on ways in

which ORI could improve its handling of misconduct cases.

We also analyzed ORI’s automated case tracking system, which contains

misconduct allegations. Finally, we interviewed ORI’s Deputy Director and

12During this period, ORI closed an additional 34 investigations that had begun prior to May 1992.

Page 16 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Appendix I 

Scope and Methodology

the DRI Acting Director to ascertain current strategies to improve

misconduct case management.

We did not independently verify the accuracy of the data in ORI case files

or automated databases. We did our work between July 1994 and

April 1995 in accordance with generally accepted government auditing

standards.

Page 17 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Appendix II 

Comments From the Department of Health

and Human Services

Page 18 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Appendix II 

Comments From the Department of Health

and Human Services

Page 19 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Appendix II 

Comments From the Department of Health

and Human Services

Page 20 GAO/HEHS-95-134 HHS’ Office of Research Integrity
Appendix III 

Major Contributors to This Report

Barry Tice, Assistant Director, (202) 512-4552

Glenn Davis, Evaluator-in-Charge, (312) 220-7600

Fred Chasnov

Woodrow Hunt

Cameo Zola

(108997) Page 21 GAO/HEHS-95-134 HHS’ Office of Research Integrity
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