Health Research Misconduct: HHS' Handling of Cases Is Appropriate, but
Timeliness Remains a Concern (Letter Report, 08/03/95, GAO/HEHS-95-134).

Pursuant to a congressional request, GAO determined whether the
Department of Health and Human Services' (HHS) Office of Research
Integrity (ORI): (1) has the appropriate policies, procedures, and
investigative practices for handling misconduct allegations in a timely;
and (2) has any staffing issues that may adversely affect ORI
responsiveness.

GAO found that: (1) ORI has developed and implemented procedures for
handling misconduct cases by assessing the qualifications of its
investigative staff, the level of independence and professional care
needed to conduct investigations, and other qualitative standards for
planning, executing, and reporting investigation results; (2) the
techniques ORI uses in handling misconduct cases raises a few concerns;
(3) despite ORI success in implementing procedures for handling
misconduct cases, it continues to experience delays in closing cases;
(4) ORI needs a comprehensive assessment of its resources since it faces
a substantial case backlog; and (5) ORI has initiated a number of
actions to improve productivity and plans to refine its planning
processes during fiscal year 1995.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-95-134
     TITLE:  Health Research Misconduct: HHS' Handling of Cases Is 
             Appropriate, but Timeliness Remains a Concern
      DATE:  08/03/95
   SUBJECT:  Health research programs
             Federal funds
             Research program management
             Fraud
             Medical research
             Standards evaluation
             Investigations by federal agencies
             Ethical conduct

             
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Cover
================================================================ COVER


Report to Congressional Requesters

August 1995

HEALTH RESEARCH MISCONDUCT - HHS'
HANDLING OF CASES IS APPROPRIATE,
BUT TIMELINESS REMAINS A CONCERN

GAO/HEHS-95-134

HHS' Office of Research Integrity


Abbreviations
=============================================================== ABBREV

  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

Letter
=============================================================== LETTER


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 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. 


--------------------
\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. 

\2 During this period, ORI closed an additional 34 investigations
that had begun prior to May 1992. 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

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 allegation\3 and 10 investigation case files, as well
as interviews with ORI investigators, raised few concerns about the
techniques used in handling cases. 

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. 


--------------------
\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. 


   BACKGROUND
------------------------------------------------------------ Letter :2

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 misconduct investigations in administrative
hearings before the HHS Departmental Appeals Board\6 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) 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


--------------------
\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. 

\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. 

\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. 

\10 A 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. 


   ORI'S PROCEDURES CONFORM TO
   GENERALLY ACCEPTED STANDARDS
------------------------------------------------------------ Letter :3

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
------------------------------------------------------------ Letter :4

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
---------------------------------------------------------- Letter :4.1

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 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
---------------------------------------------------------- Letter :4.2

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. 


   DELAYS IN CLOSING CASES
   CONTRIBUTE TO BACKLOG
------------------------------------------------------------ Letter :5

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
---------------------------------------------------------- Letter :5.1

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
---------------------------------------------------------- Letter :5.2

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. 

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
---------------------------------------------------------- Letter :5.3

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 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
------------------------------------------------------------ Letter :6

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 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. 


--------------------
\11 DRI's full-time investigative staff consists of seven
scientist/investigators, two supervisory scientist/investigators, a
deputy division director, and the director. 


   CONCLUSION
------------------------------------------------------------ Letter :7

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 effectively fulfill
its mission in the future.  ORI's management team must confront these
challenges and develop strategies to address them. 


   AGENCY COMMENTS
------------------------------------------------------------ Letter :8

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. 


---------------------------------------------------------- Letter :8.1

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


SCOPE AND METHODOLOGY
=========================================================== Appendix I

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 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. 



(See figure in printed edition.)Appendix II

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


COMMENTS FROM THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES
=========================================================== Appendix I



(See figure in printed edition.)



(See figure in printed edition.)


MAJOR CONTRIBUTORS TO THIS REPORT
========================================================= Appendix III

Barry Tice, Assistant Director, (202) 512-4552
Glenn Davis, Evaluator-in-Charge, (312) 220-7600
Fred Chasnov
Woodrow Hunt
Cameo Zola

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