MARCH   MISCONDUCT IN SCIENTIFIC

RESEARCH

Richard P. Kusserow 
INSPECTOR GENERAL 
OAI-8S-Q7 -00420  MARCH 1989  ....... ............ ......... ............... . ....... ............... ... . ...... ......... ....... .. ............ ....... .................. 
.... ........................  ...... ....... .... ............. ........  ......... .... ...... ...... ... ...... ....... ... 
TABLE OF CONTENTS 
EXECUTIVE SUMMARY 
INTRODUCTION 
Purpose ...... 
.............................. ............... 1

The Problem of Scientific 
Misconduct............................................... 1

Federal Involvement in Scientific Research 
...................................... 1

Federal Action on the Problem of Scientific Misconduct 
..................... 2

Scientific Community Actions on the Problem of Misconduct 
............... 3

Methodology........................ ............  .................. 4 
FINDINGS AND RECOMMENDATIONS 
Role of NI H. ...... 
Absence of Proced ures................. ....  e............... 8"8..... 8 
Nature of Procedures ......................................................all..................... ....... j 0

Problems with Investigations and Detection ........................................

Estimate of Occurrence of Cases ...................................,...............................

Need for Prevention and Ethics .......................................................

AGENCY COMMENTS AND OIG RESPONSE..............................................

APPENDICES 
Appendix A. Telephone Survey Methodology 
Appendix B. Areas Incorporated in Procedures/Policies 
Appendix C. The Emerging Area of Preventive Measures 
Appendix D. References

Appendix E. Agency Comments  EXECUTIVE SUMMARY 
PURPOSE 
To determe: (1) the extent to which the National Institutes of Health (NIH) and its grantee 
institutions have developed and implemented policies and procedures to prevent, detect and 
handle scientific misconduct cases; and (2) what selected grtee institutions have learned and 
implemented as a result of their cases of impropriety in scientific research. 
BACKGROUND 
The most commonly accepted definition of "scientific misconduct" involves plagiarsm and 
fabrication, falsification, and misrepresentation of data. Isolated cases of such practices sur
faced from the mid-1970' s through the early 1980's. The NIH, the primary funder of biomedi
cal research, received a growing number of reports of alleged misconduct among its grantees. 
At that time, research institutions were not prepared to deal with cases of deliberate deception 
because they lacked procedures for handling such allegations. The cases of misconduct which 
have recently emerged have greatly sensitized the scientific community to the problems and 
complexities which musrbe resolved when misconduct occurs in the scientifc setting. 
Severa grtee institutions have now developed procedurs to handle allegations of miscon
duct. 
Congress has perceived the increased volume of reported cases of misconduct as a threat to 
biomedical researh. In an attempt to address the issue, Congress passed a 
the public trst in 
section withn the Health Research Extension Act of 1985 (Public Law 99-158) to deal with 
the problem. The law required those applying for NIH funds to submit with their application 
an assurance that they have procedures in place for dealng with scientific misconduct. They 
also must have an admistrative process to review reports of misconduct and to repon to the 
Secretar of the Deparent of Health and Human Services (HHS) investigations which 
produce substatial evidence of unscientific practices. The Department has not yet finalized 
regulations on scientific misconduct to implement these requirements. 
METHODOLOGY 
We conducted this inspection in three phases: (1) we held discussions on selected iss ues wi th 
HHS officials, scientific societies and associations, and other knowledgeable individuals; (2) 
we conducted a telephone survey of a random sample of NIH grantee institutions; and (3) we 
visited nine grantee institutions to lear from their experience with scientific misconduct cases.  FINDINGS 
With the Deparent there is no centr locus of responsibility or accountability for 
scientic misconduct.

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The  has been slow in fonnalizing policies and procedures for dealing with scien
tific misconduct and handles investigations of allegations on an ad hoc basis resulting in 
inconsistencies. 
Only 22 percent of NIH grtee institutions overall have policies and procedures in 
place to deal with cases of scientic misconduct, as required by law. However, 93 per
cent of grantee institutions with 100 or more awards do have such policies and proce
dures. 
Grantee institutions are awaiting guidance from NIH to develop their policies and proce
dures for scientic misconduct, although 53 percent overall say the development of pro
cedures is primary their responsibility. 
Scientific misconduct procedures that ar in place are generally not comprehensive and 
are limited.

VIrally all of the grantee institutions' procedures include steps for investigating allega
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tions. However, most do not provide for notifying  at the initiation of an investiga
tion. Al of the large grtee institutions considered investigations their responsibility, 
although only 54 percent of the small grtee institutions shared this view. 
Grantee institutions stress the complexities of conducting scientific misconduct inves
tigations and want flexible procedures. Hal of the grtee institutions with 100 or 
more awards have used outside expenise. 
Grantee institutions say that detecting actual misconduct is problematic, and there is 
heavy reliance on the "whistle blower." They also say it is not possible to guarantee 
confidentiality and to protect the whistle blower. 
Thir-six percent (17 0(47) of the grtee institutions with procedures reported cases 
of misconduct which required the use of their procedures. Sixteen of the 34 cases (47 
percent) investigated by these 17 grantee institutions were substantiated. Over half of 
these institutions are revising their procedurs. 
10.	 A few grtee institutions have developed or ar developing guidelines for preve:1tive 
and ethical scientific practices. Grantee institutions have expressed interest in receiving 
guidance in this emerging ara.  11.	 Grantee institutions say that the principal investigator has a major responsibility for 
fostering scientific integrty and that scientific misconduct would be less likely to occur 
if the pricipal investigator adequately perfonns his/her responsibilities. 
RECOMMENDA TIONS 
The Secretar should prov  e for independent oversight, and develop a more fonnalized 
and centralized process to deal with scientific misconduct including the following ele
ments: (1) an independent third par to act as a fact gatherer and collect, retain and 
analyze investigative data; (2) an independent scientic review board to assist in analyz
ing infonnation concerning scientific misconduct; and (3) an independent decision 
makng authority or ombudsman tye function. This is especially importt given the 
congressional concern regarding the lack of independence of investigative units. 
The Deparent should expedite completion and publication of a final regulation on the 
responsibilties of Public Health Service (PHS) awardee and applicant institutions for 
dealg with and reportng possible misconduct in science, as required by law. This will 
development of procedures by grantee institutions. 
faciltate the 
The Deparent should require all applicant institutions to submit their scientific mis
conduct procedurs on an annual basis to assure compliance with the law. The PHS 
should review the procedures on a sample basis and also in all instances where scientific 
misconduct cases are reported to assure that essential areas ar covered. 
The first line of responsibilty for conducting an inquir and/or investigation into an al
legation of misconduct restS with the grantee institution. However, regulations issued 
by the Deparent should require that grtee institutions immediately notify the 
Deparent whenever they detect or receive an allegation of scientific misconduct, 
maintan records of all inquiries and investigations and provide the Deparment with pe
fres 
riodic status reports. The regulations should specify time  for reporting and con
ducting inquires and investigations. Although we recognize the grantee institutions are 
concerned about flexibilty, these requirements ar, nevenheless, necessar to assure 
adequate monitoring and oversight by the Deparent. 
The Deparent should keep complete and unifonn records concerning investigations 
underten by the grtee institutions and PHS in order to maintain baseline data on the 
incidence of cases. This infonnation could also be used in refining guidance and direc
tion to grantee institutions in conductig future investigations. 
The Deparent should encourage individuals with infonnation about instances of pos
sible scientific misconduct to come forWard. Grantee institutions should be infoI1ed of 
the Office of Inspector General (OIG) Hotline, which receives allegations concerning 
frud and abuse in the Deparment s programs.  : .
The Depament should explore ways to protect the "whistle blower " since detection of 
possible scientific misconduct relies so heavily on individuals willng to make an allega
tion. Curntly Federal employees who engage in "whistle blowing" are protected by 
law. Simiar protection should be provided to individuals reponing possible scientific 
misconduct by grtees. 
The Depament should explore alternative methods of detecting possible misconduct. 
Examples of possible methods ar spot audits of scientific data, or special reviews by 
scientic joumal 
editors of 
The Depament should develop a table of penalties, such as the model adopted by. the 
Office of Personnel Management, to assur that sanctions are applied consistently and 
misconduct. 
faily in cases of scientific 
10.	 The PHS should assume a leadership role and provide guidance to the grantee institu
tions in matters related to scientific misconduct. 
The PHS should sponsor a consensus conference to develop model guidelines 
for use by grantees in addressing all relevant areas of scientific misconduct. 
The PHS should continue its efforts in the area of prevention, such as the 
InstitUte of Medicine to develop scientific standards for the 
contrct with the 
conduct of responsible science. The PHS should develop model preventive 
that institUtions adopt these measures as a condition of 
guidelies and require 
funding. 
AGENCY COMMENTS 
The Public Health Service (PHS) indicated that the OIa draft report on Misconduct in Scien
rific Researh was "a useful discussion of some imponat issues related to allegations of mis
conduct in PHS extramur progrs." The PHS provided genera and specific comments on 
the drt of this report which ar included in appendix E. In response to these comments, we 
made revisions where appropriate in the final report.  INTRODUCTION

PURPOSE 
To determe: (1) the extent to which the National Institutes of Health (NIH) and its grantee in
stitutions have developed and implemented policies and procedures to prevent, detect and 
handle scientific misconduct cases; and (2) what selected grantee institutions have learned and 
implemented as a result of their scientic misconduct cases. 
THE PROBLEM OF SCIENTIFIC MISCONDUCT 
Although the precise definition of scientific misconduct is at issue, it is generally understood 
to involve deceit rather than error. The Public Health Service (PHS) policy defines miscon
duct as "serious deviation, such as fabrication, falsification, or plagiarsm, from accepted prac
caring out research or in reponing the results of research. . .  misconducr 
tices in  " Scientific 
can have serious consequences and weakens the knowledge base upon which future experi
ments are perfonned. It divens research funds from the work of ethical scientists and under
mines public confidence in scientific research. Most alaningly, if it goes undetected, 
scientic misconduct can lead to dangerous changes in clinical tratment and medical prac
tices. 
Traditionaly, the scientific community has relied upon two defenses against misconduct: (1) 
the integrty of its scientists and (2) the scientific principle which gives credence only to 
results which can be replicated by other researchers. These defenses have not proved impreg
nable. Like al fields, scientic research has attrcted a very small miority of unethical in
dividuals and replication is not always an effective defense. 
reponed scientific misconduct cases during the 
Despite the intensifyig public focus on the 
1980' s, no consensus has emerged on the proper way to deal with the problem. Some of the is
sues in dispute ar the precise definition and prevalence of scientific misconduct, the most ef
fective way to detect and prevent misconduct, the practices to promote responsible conduct of 
research, and the proper proedures for handling allegations of misconduct. 
FEDERAL INVOLVEMENT IN SCIENTIFIC RESEARCH 
The NIH, an agency of the PHS in the Deparment of Health and Human Services (HHS), is 
charged with fostering the public health through research and research training conducted or 
funded by its 16 bureaus, institutes and divisions. The NIH is the largest funder of biomedical 
researh in the world. In Fiscal Year 1986, the NIH awared 23,445 grants totalling over $3. 
billon to 1,303 institutions. Approximately one-thir of this money went to indirect costs for 
housing the  admnistrtion, plant and equipment, quality control, and 
grt, includig genera 
costs for dealng with scientific misconduct. In Fiscal Year 1987, over $4.4 bilion in research 
grants was awarded.  grt 
Each NIH component uses some varant of the same  application and monitoring process. 
This process strsses the scientific merit of the proposals and accounting for the expendiwre 
of Federa funds. Grat applications undergo an external scientific peer review that judges 
qualities, and a subsequent review by institute advisory councils 
scientic merit and technical 
that addresses whether the proposed research wil benefit public health. While receiving 
Federa funds, grantees are requird to provide progress repons. In addition, Nll grants 
progr 
management and  offcials review the programatic progrss and business manage
ment of grants. 
Issues of research integrty and quality control are not explicitly addressed during the grant ap
proval and management process. They are considered the responsibility of the grantee institu
tion and caned out by the principal investigator. The Nff becomes involved only when a 
grantee institUtion has notified NIH that one of its researchers has committed an act of miscon
duct, or when NIH believes that a grantee institution has failed to fully investigate an allega
tion of misconduct. Since Januar of 1982, Nll has received 102 allegations of scientific 
misconduct and the Deparent 
has issued a sanction or taken formal cocrective action in 21 
cases. The sanctions may include debanents from receiving future funding for a specified 
tie. 
period of 
FEDERAL ACTION ON THE PROBLEM OF SCIENTIFIC MISCONDUCT 
In 1981 the Subcommttee on Investigations and Oversight of the House Committee on 
Science and Technology heard testiony from scientists and philosophers interested in the 
legal, ethical, and scientific consequences of scientific misconduct. The hearng demonstrated 
that neither grtee institUtions nor Nll had procedures for dealing with allegations of miscon
duct in federaly funded research. The subcommttee found that there had been instances of 
NI 
misconduct but that  handled each of them in an ad hoc, case-by-case basis. 
In 1985  Congrss passed "The Health Researh Extension Act" (the Act). The conference 
Nll 
report accompanying the final legislation refecred to the  scientific misconduct procedures 
in place at that tie as "informal" and "ad hoc." It noted that Nff, even in cases of admitted 
wrongdoing, took over a year to complete reviews and impose sanctions. The report also ar
gued that sanctions should include the recovery of misspent Federal research dollars. The 
major provisions of the Act require that: (1) the Director of Nff establish procedures to en
sure prompt response to information regaring scientific fraud, faciltate the receipt of such in
formation, and expedite appropriate action with respect to misconduct; (2) the Secretar of 
HHS establish regulations requirng those applying for NIH funds to submit with their applica
tions an assurance that they have procedurs for dealing with scientific misconduct; and (3) ap
plicants have an admnistrative process to review reports of misconduct and report to the 
Secretar investigations which uncover substatial evidence of unscientific practices. 
Subsequently, representatives from the PHS agencies developed a set of interim guidelines 
The Policies and Procedures for Dealng with Possible Misconduct in Science, II which were 
approved in 1986. . These interim guidelines set fort awardee obligations as follows: (1) as
sume primar responsibilty for preventing, detecting, and dealing with misconduct; (2)  develop policies and procedures for dealing with possible scientific misconduct; (3) inform 
PHS of the initiation of any fonnal investigation of possible maleasance; and (4) maintain a 
fact-finding system, which generaly consists of an "inquiry" to detennine whether an allega
wart 
tion has substance enough to  an investigation, and an "investigation" which is a for
mal evaluation of all relevant facts to detennine if misconduct has occurred. However, until 
PHS publishes final regulations, these requirements are not binding on the grantee institution. 
Under these guidelines Nll has  e following options: (1) accept the grantee institution s in
vestigation report, if it believes the report is factual, fair to all concerned, and addresses all 
misconduct issues; (2) conduct its own review if it has reason to believe that the institution 
report is incomplete or unreliable; or (3) begin an investigation if it feels that the grantee in
stitution is not satisfactorily pursuing an allegation of misconduct. 
The NIB usually conducts its investigations by appointing a panel of scientific peers to review 
the case. Panel members ar primarly drawn from outside of Nll. Usually they have exper
tise in the subject matter of the research being questioned and should not have real or per
ceived conflict of interest with the accused. 
In Apri 1988, two congressional committees held hearngs on scientific misconduct. Both of 
these commttees were concerned over allegations that significantly more cases of misconduct 
exist than ar reported and investigated. Durig the heargs committee members questioned 
the capabilty of grtee institutions to handle allegations of misconduct and to conduct inves
tigations of alleged improprieties. Members criticized the Deparent about the lack of 
resources, lack of tiely resolution of cases, treatment of whistle blowers and the lack of ap
preciation of conflct of interest with respect to selection of panels of scientifc peers. A hear
. ing was also held in September of 1988 to furer explore these issues as well as to inquire 
into potential conflct of interest cases in academic research. The committee members indi
cated that they intend to introduce significant legislation unless the Deparent 
corrects the 
perceived deficiencies. 
In September 1988, prior to issuing a final regulation implementing the Health Research Ex
tension Act, the PHS published a notice of proposed rulemakng (NPRM) on the respon
sIbilties of PHS awardee and applicant institutions for dealing with and reporting possible 
misconduct in science. Simultaneously, PHS published an advanced notice of proposed 
rulemakng (ANPRM) to aid in the development of 
futue regulations protecting against mis
conduct in research. Also in September 1988, the PHS published two Grants Admnistration 
Manual Issuances, providing the basis of deparental procedures for dealing with instances 
of alleged misconduct in science. 
SCIENTIFIC COMMUNITY ACTIONS ON THE PROBLEM OF SCIENTIFIC MIS-
CONiJUCT 
In the early 1980's two organizations, the American Association of Universities (AAU) and 
the Association of American Medical Colleges (AAMC), published guidelines for maintaining 
integrty in scientific research. While in genera these guidelines do not offer specific proce- . ,
dures, they do addrss the primar areas that institutions need to consider in developing proce
dures. Curntly, the AAU and the AAMC are collecting procedures from varous institutions 
to establish a base of informtion on the  in use throughout the countr. 
tyes of procedures 
Recently, a consortum of educational organizations under the direction of the AAU has 
developed a framework, or model guidelies, for institutional policies and procedures to deal 
with scientific misconduct. 
1987 the American Association for the Advancement of Science (AAAS) and the 
In the fal of 
American Bar Association (ABA) held a National Conference of Lawyers and Scientists. The 
parcipants, from universities involved in allegations of misconduct, NIH, and the National 
Science Foundation, exchanged problems, experiences, and information. Subsequent con
ferences wil addrss policies and procedures for handling allegations and some of the broader 
issues involved in scientific misconduct. 
Little information exists on the extent to which grantees have policies and procedures, since 
very few studies have been done in this area. A survey conducted from 1982 to 1984 found 
that only 23 percent of academic institutions and hospitas had wrtten rules for dealing with 
allegations of fraud.

METHODOLOGY 
This study was conducted in thre phases. First, we held discussions on selected issues with 
HHS officials, representatives of scientific societies and associations, grantee institutions, and 
other knowledgeable individuals. Our contacts included the Society for Research Ad
ministrators, Institute of Medicine, Association of State Colleges and Universities, American 
Association of Medical Colleges, and the American Association for the Advancement of Scien
ces. Addtionaly, we reviewed pertent literature, including journal anicles, books, legisla
tion, regulations and Government manuals and guidelines. 
In the second phase we surveyed a random sample of Fiscal Year 1986 NIH grantee institu
tions by telephone to determine the extent to which NIB grantee institutions have established 
policies and procedures relating to scientic misconduct. We also requested each grantee in
stitution to send us its scientific misconduct policies and procedures. 
The telephone survey was completed through interviews with representatives of the sampled 
universities or institutions. The initial contacts with the varous institutions nationwide re
quested access to the individual knowledgeable about admnistration of scientific misconduct 
procedurs for NIB research grants. Telephone interviews at the institutions were held with 
deans, assocate deans and admnistrators of researh and/or grants progrs; vice chancel
lors, associate and vice provosts; professors and principal investigators; and corporate offcers. 
The sample was divided into three strta: 30 grantee institutions with 100 or more research 
awards which represented 86 percent of all award money in the sample; 31 grantee institutions 
with 10 to 99 research awards representing 11 percent of the funding; and 28 grtee institu
tions with less than 10 research awards which made up less than 2 percent of the funding.  Those with more than 100 research awards were generaly large universities with considerable
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fundig in their biomedical research deparent or medical school. State universities 
teaching hospitals, and research foundations comprised most of the institutions receiving 10 
through 99 research awards. The institUtions with less than 10 research awards consisted 
mainly of small corporations, hospitas, and regional universities. Geogrphically, over one-
third of the institUtions in all thee strata were located in the Northeast and the West. For a full 
discussion of the surey methodology, see appendix A. 
The third phase of the stUdy consisted of site visits to nine grtee institutions which had ex
perience with scientic misconduct cases. These grantee institutions were not necessarly a 
par of the random sample for the telephone survey. Discussions with individuals at the gran
tee institUtion included the following topics: (1) definition of misconduct, (2) development 
and use of procedurs, (3) prevention and detection, (4) role of the principal investigator, and 
(5) lessons leared. Discussions were held with provosts, deans, principal investigators, legal 
counsel and administrators. At some institutions, we also met with individuals against whom 
allegations of misconduct had been made, as well as some whistle blowers.  FINDINGS AND RECOMMENDATIONS 
ROLE OF NIH 
Within the Departent there is no central locus of responsibility or accountability 
for scien
tific misconduct. 
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Severa  components and PHS agencies ar curently responsible for handling allegations 
and investigations of misconduct or other improprieties. Consequently, the responsibilties are 
diffuse. The designated units within Deparent ar as follows: 
Extrural 
The Office for  Research in NIB has been delegated the responsibility to 
develop and assess policies and procedures for preventing, detecting, reportng, and 
handling instances of alleged scientific misconduct The diector of this office is the 
PHS misconduct policy officer. Although this office oversees and coordinates PHS 
activities related to misconduct, only two full-time professionals, who had additional 
responsibilties, were assigned to this area at the time our study was conducted. Since 
that time two professionals and one secretar have been added to the NIB offce that 
handles alegations of misconduct in science (See Agency Comments). 
The Offce for Protection from Research Risks in NIB has the responsibility for human 
subject protection and animal welfare. This office investigates alleged or apparent 
violations of Federal regulations governing the protection of human subjects or PHS 
anmal welfare policy in cases involving PHS funded research. These violations are 
included in the PHS definition of scientific misconduct. 
The Division of Management Survey and Review in NIB manages the PHS ALERT 
system which collects, controls and disseminates infonnation about institutions or 
individuals under investigation for possible scientific misconduct or sanctioned for 
misconduct. The PHS offcials use this infonnation to make infonned decisions 
regarding funding, although such infonnation does not automatically result in the 
withholding of funds. This unit also reviews allegations of grantee fiscal improprieties 
and has audit responsi)Jilties over grantees. 
The Offce of Inspector General (OIG) also has audit responsibilities for 
grntees, as 
well as investigative responsibilty for those scientific misconduct cases with potential 
crminal violations. The Inspector General Amendments Act of 1978, P.L. 95-452, as 
amended, provides that the OIG have the responsibilty to supervise, coordinate, and 
provide policy diection for auditing and investigative activities relating to programs 
and operations of the Deparment; and to prevent and detect fraud and abuse in its 
progrs 
and operations. However, the Secretar has not delegated the overall 
responsibilty for scientific misconduct to the OlG.  Each PHS agency (including the Nll; the Alcohol, Drug Abuse and Mental Health Ad
ministration; the Food and Drug Administrtion; the Centers for Disease Control and the 
Health and Resources Admnistration) also has a misconduct policy offcer who, among other 
duties, provides leadership to ensure appropriate agency implementation policies and proce
and prompt handling of instances of alleged or apparent misconduct. 
dures for the fai 
Allegations of scientic misconduct are cUIntly received by the varous offces discussed 
above, as well as the grts projec;  officers in the many institutes and other components in 
some allegations are received by the OrG hotline. (The 
each of the agencies. Additionally; 
PHS has recently developed a reorganization proposal to deal with allegations of scientific 
misconduct, which has not yet been approved. This proposal was described in their commen 
drt 
to the  report, dated Januar 30, 1989. 
As noted earlier, Congrss has held hearngs on the issue of scientic misconduct and the 
Dep3.ent's abilty to deal with allegations and investigations of scientific misconduct. A 
major focus of those heargs was the diffusion of responsibilty for dealing with scientific 
misconduct as well as the inherent conflict of interest by the placement of this activity within 
the funding agencies. Some members of Congrss have called for an independent and objec
tive screening and review of allegations of scientific misconduct: 
The NIB has been slow in formalizing policies and procedures for dealing with scientific 
misconduct and handles investigations of allegations on an ad hoc basis resulting in incon
sistencies. 
Until recently, the NU relied upon interim guidelines, entitled, "Policies and Procedures for 
Dealing with Possible Misconduct in Science," issued in 1986, for determning how PHS 
handles cases of scientific misconduct. In accordce with the requirements of the Health Re
search Extension Act of 1985, the gudelines indicated that severa steps would be taken 
promptly to formalize this proess, including: (1) incorporatig sections on scientic miscon
duct into standard gudace documents such as the "Grats Admnistrtion Manual;" (2) 
publishing a notice of proposed rulemakng to implement grtee responsibilities as required 
by law; and (3) establishing a PHS committee on scientific misconduct to exchange informa
tion about investigations and discuss relevant policy proposals. 
In September 1988, the PHS published two Grants Administration Manual Issuances, which 
put into place fully binding depanmental policies on scientific misconduct. Additionally, a 
notice of proposed rulemakng (NPRM) on the responsibilities of PHS awardee and applicant 
institutions for dealing with and reportng possible misconduct in science was published in the 
Federa Register. A final rule is expected to be published by the middle of this year. Also, the 
first meeting of the PHS committee on scientific misconduct was held in December 1987. 
The Grats Administrtion Manual Issuance on misconduct in science closely resembles the 
interim guidelines and provides genera principles rather than an explicit procedure with 
specific standads and criteria. Although the publication of the Grats Administrtion Manual 
Issuance fonnized the process, the manual issuance has the same deficiencies as the interim  Nll 
guidelines. Therefore, the same weakesses identified by  staff with the interim 
guidelines, described below, wil contiue to persist. 
Accordig to key Nll staf, Nll handles investigations of scientific misconduct on an ad hoc 
basis. They charcteried the process as infonnal and stated that they did not always follow 
interi 
the  guidelines, because the guidelines were broad and offered few specifcs. Inconsis
tencies occurd because the interim guidelines did not include stadards for prompt and com
plete reviews, i.e. tie frames for Gonducting an investigation are not specified. Further, the 
guidelines did not offer explicit crteria for detennining, among other things: (1) when PHS 
should initiate its own investigation or (2) how to select scientific review panels, which review 
grantee institution s repons of investigations and sometimes conductNIH investigations. 
Nll 
Some grantee institutions said that  is inconsistent and should examne its own proce
dures. Others said that Nll' s handling of investigations is greatly influenced by the media, 
and that this results in inconsistencies.  commented that NIB' s investigative 
Stil others 
process is disorganized and slow, and that Nll' s procedures could be more explicit. 
Funher, criteria to detenne appropriate sanctions or debarent periods have not been estab
lished. After an alegation has been substantiated, sanctions are imposed on a case-by-case 
basis. Some grtee institUtions commented that sanctions, debarent periods and especially 
the decision to recoup funds appear to be inconsistent. Additionally, the Conference RepoI1 
Nll 
for the Health Research Extension Act of 1985 states that the  procedures should include a 
mechanism for the recovery of Federal funds. Since 1982, PHS has only recovered a total of 
$382,000 from four institUtions. 
Recommendation: The Secretary should provide for independent oversight, and develop a 
more formalized and centralized process to deal with scientifc misconduct including the fol
an independent third party to act as a fact gatherer and collect, retain 
lowing elements:  (1) 
an independent scientifc review board to assist in analyz
and analyze investigative data;  (2) 
an independent decision making 
ing information concerning scientific misconduct; and  (3) 
authority or ombudman type  is especially important given the congressional 
junction. This 
concern regarding the lack of independence of investigative units. 
Recommendation: The Department should develop a table of penalties, such as the model 
adopted by the Offce of Personnel Management, to assure that the sanctions are applied con
sistently and fairly in cases of scientifc misconduct. 
ABSENCE OF PROCEDURES 
percent of NIB grantee institutions overall have policies-and procedures in place to 
Only  22 
percent of grantee 
deal with cases of scientific misconduct, as required by law. However,  93 
institutions with 100 or more awards do have such policies and procedures.  The Nll has delegated the primar responsibilty for preventing, detecting and addressing 
its grtee institutions, as required by the Health Research Extension 
scientic misconduct to 
Act of 1985. All applicants wil be required to make assurces that they have procedures in 
place to deal with scientic misconduct, as required by law, when regulations are published. 
Only 22 percent of the Nll grtees overal have procedures in place to deal with cases of 
scientic misconduct. In the group of grtee institutions with 100 or more awards and 86 
percent of the fundig, 93 percen (28 of 30) have procedurs. This stil means that two in
stitutions with over 100 awards from Nll have not yet developed prQcedures. In addition, the 
majority of Nll grantee institutions are small, having less than 10 awards. In this group only 
11 percent (3 of 28) had developed procedures. 
Grantee institutions who have had experience with cases of misconduct stress the imponance 
of having policies and procedures in place prior to the occurrence of an allegation. Most of 
the nine institutions visited had developed procedures in reaction to cases of misconduct at 
other institutions where no procedures existed. As a consequence, when cases occurred at 
their institution, they were prepared to deal with them. These institutions also pointed out that 
having wrtten procedures helps to prevent the appearance of a cover-up or of persecuting an 
individual. 
A few grtee institutions in our telephone survey who had developed procedures remarked 
that they had not done so until a substantial charge of misconduct had been alleged, at which 
time painstakg effort was requird on the par of faculty members and committees to 
develop misconduct procedures. This furter supports the need for wrtten procedures  before 
cases occur.

Grantee institutions are awaiting guidance from NIH to develop their procedures, although 
53 percent overall say the development of procedures is primarily their responsibilty. 
When asked who should have primar responsibility for developing procedures, 53 percent 
grtee institution should have the primar responsibilty. However, a number of 
said the 
grantee institutions indicated that they are looking to the NIB for more guidance on develop
ing misconduct procedures and on deciding what should be included in the procedures. 
Severa of the grtee institutions said that the NIB and the institutions should work together 
in developing a misconduct policy. Also, some institutions commented that because of the 
heterogeneity of the grtee institutions, the NIB should review applicants ' procedures to 
detennne that the appropriate issues were addrssed. 
Nl 
Although  has developed interi guidelines in resp9nse to the Act, final regulations im
plementing grtee institution responsibilties have not been published. Some say they are 
waitig for final regulations to be published before developing procedures. Of the grntees 
with procedurs, 23 of 47 had developed their procedures prior to the Act and 20 have 
developed procedures since then - - after NIB' s interim guidelines were issued. Four grntees 
did not know when their procedures had been developed. Grantee institutions have delayed 
action in developing procedures, waiting for final rules.  ' "
Some of the small grantee institutions indicated that they were unaware that misconduct proce
dures wil need to be in place in order to receive NIB funding. A few of the small institutions 
were unconcerned about misconduct, stating that this would not happen at their institution be
cause of their small size. Other small grantee institutions are panicularly concerned regarding 
the development of procedures and future requirements. Only 44 percent of the grantee in
stitutions with less than 10 awards, that do not have procedures, said they intend to develop 
procedurs. 
Recommendation: The Departent should require all applicant institUtions to submit their 
scientific misconduct procedures on an annual basis to assure compliance with the law. The 
PHS should review the procedures on a sample basis and also in all instances where scientifc 
misconduct cases are reported to assure that essential areas are covered. 
Recommendation: The Department should expedite completion and publication of a final 
regulation on the responsibilties of PHS awardee and applicant institutions for dealing with 
and reporting possible misconduct in science, as required by law. This wilfaciUtate the 
development of procedures by grantee institUtions. 
NATURE OF PROCEDURES 
Scientific misconduct procedures that are in place are generally not comprehensive and are 
limited. 
We compared the grtee institutions' procedures in place to the recommendations of the NIH 
interi guidelines and other areas identified as imponant by the Association of American 
Medical College s "The Maintenance of High Ethical Standards in the Conduct of Research" 
and the Association of American Universities  Repon of the Association of American Univer
sities Commttee on the Integrty of Researh. " We asked if the procedurs covered the fol
lowing areas: inquires and investigations of allegations of misconduct; specified time frames 
for conducting inquires and investigations; reponing to the NIB; protection of confidentiali ty 
for the accused and the individual makg the accusation; due process and appeals; retention 
storage, and ownership of data; validation of research results; retraction of published arcles 
shown to be fraudulent; and responsibilty of coauthors. 
Based on this analysis, few grntee institutions covered all the elements noted, and less than 
half include provisions for the retention, storage and ownership of data; validation of research 
results; retraction of arcles; or responsibilty of coauthors. See appendix B for areas incor
porated and percentages of grantee institutions whose procedures included those elements. 
Well over thre-founhs of the grntee institutions with procedures have provisions for con
fidentiality for the whistle blower and the accused. In many procedures there was -a general 
refert?nce to "the protection of the reputation of those who, in good faith, report misconduct 
or an admonition that confidentiality must be maintained at all times during both levels of in
quir. It should be noted that grntee institutions expressed equal concern for the prorection 
of the accused. Although many institutions have measures to prOtect confidentiality, all agree  " "
that confidentiality cannot be guarteed. Also, three-founhs of the grantee institutions in
clude provisions for due process and appeals and almost all institutions provide for internal 
sanctions in cases of wrongdoing, includig penalties for those who make false accusations. 
Procedures in place at the grtee institutions we visited, also were vared and somewhat 
limited. However, half the institutions had developed separate policy statements addressing 
most of the elements listed above. Most commented that they prefer a flexible policy, since 
ases ar ale. Therefore, grntee institutions claim a 
their combined thinkng, no two 

frework 
for a varety of cases is. necessar. 
Virtually all of the grantee institutions' procedures included steps 
for investigating allega
tions. However, most do not provide for notifying NIH at the 
initition of an investigation. 
All of the large grantee institutions considered investigations their responsibility, although 
percent of the small institutions shared this view. 
only  54 
Almost all (99%) of the grantees ' procedures included steps for investigating allegations. All 
of the large grantee institutions considered such investigations their responsibility. However 
only 54 percent of the small institutions shared this view, and most of these institutions would 
suppott a more active NIH role in investigating allegations. Somt? of the grntee institutions 
sureyed, felt that small institutions should not handle their own cases, and a few recom
mended that other entities, such as 
arbitrtion panels, address serious cases. 
Procedures established by most of the grtee institutions included two levels of response to 
allegations: an inquir and a fonnal investigation. Generaly, the deparent in which the al
leged misconduct occurd handles the fit step by tring to detenne if there is substance to 
the charge. The number of parcipants at this point is smal in order to ensure confidentiality 
and to protect the accused and the accuser. Most of the misconduct procedures designated a 
second level of review which was identified as a fonnal investigation. 
Procedures vared on whether or not they reponed to NIH after the first level of inquiry. Over
the-
founs of  grtee institutions, and approximately half of the institutions over
the large 
all, do not repon to the fundig agency after the fist level of inquir, which is set fonh in cur
rent PHS guidelines. Most grtee institutions felt that NIB should not be infonned until 
misconduct was substantiated. 
Most of the procedures reviewed did. not provide specified time frames for conducting an in
quir or an investigation, although procedures referrd to pursuing investigations "expeditious
ly,  rapidly," or "as soon as possible. " If time frames were given, the initial allegation was 
usually reponed, reviewed and decided upon within 10 work days. The investigation phase 
fre 
was someties given a time  of 120 days. However, a representative of a large institu
fres 
tion stated that time  were inappropriate: "in complicated cases the only way to go 
about it is a dogged, time-consuming effon. " Many grantee institutions noted that the com
plexity of scientic misconduct cases, and the amount of resources (staf, time and money) re
quird to investigate such cases made it diffcult to establish time frames.  Recommendation: The PHS should sponsor a consensus conference to develop model 
guidelines for use by grantee institutions in addressing all relevant areas of scientifc miscon
duct. 
Recommendation: The first line of responsibilty for conducting an inquiry and/or investiga
tion into an allegation of misconduct rests with the grantee institution. However, regulations 
issued by the Department should require that grantee institutions immediately notify the 
Department whenever they detect or receive an allegation of scientifc misconduct, maintain 
records of all inquiries and investigations and provide the Department with periodic status 
reports. The regulations should specif time frames for reporting and conducting inquiries 
and investigations. Although we recognize the grantee investigations are concerned about 
flexibilty, these requirements are, nevertheless, necessary to assure adequate monitoring and 
oversight by the Department. 
PROBLEMS WITH INVESTIGATIONS AND DETECTION 
Grantee institutions stress the complexities of conducting scientific misconduct investiga
tions and want flexible jJrocedures. Half of the grantee institutions with 100 or more 
awards have used outside expertse. 
Grantee institutions expressed the need for flexible procedures to encompass the complexities 
and unqueness of each individual case. We were told that initialy after an allegation is 
raised, a grantee institution must decide who should provide the substantiation, and what and 
how much substantiation is required to initiate a fonnal investigation. 
This vares from case 
to case. 
When the fonnal investigation is initiated, if there are enough scientists with appropriate ex
pertse and without conflct of interest available within the institution, the institution wil con
duct its own internal investigation. The grtee institution may request assistance, if 
necessar, from others within the institution with scientific expertse, such as nurses and tech
nicians. However, some grantee institutions may need to elicit expert from outside the institu
tion to avoid conflct of interest or to obtan the necessar expertse in a very specialized area. 
Half of the grantee institutions with 100 or more awards said that outside expenise was used 
when investigating cases. However, all the institutions emphasized that only scientists were 
able to conduct the investigations. 
We were told that an investigation consumes an 
extrordinar amount of resources including 
time, money and labor. Investigators must search for raw data, review the data, review medi
cal records and other documentation, interview knowledgealJle pares and must duplicate ex
perients. Sometimes, the investigation includes reviews of earlier publications as well. 
These may go back severa year in time. Additional time may be spent seeking retrctions of 
fraudulent arcles.
 . .
If the accused leaves the institution before or during the investigation, this may complicate the 
case even furher. However, 93 percent of the grantee institutions indicated they would con
tinue to pursue an allegation of misconduct if the accused left the institution. 
Grantee institutions say that detecting actual misconduct is problematic, and there is heavy 
reliance on the "whistle blower. " They also say it is not possible to guarantee confiden
tiality and to protect the whistle blower. 
Grantee institutions say that detection of scientic misconduct is dificult and they must rely 
on the "whistle blower. " Two-thirds of the grtee institutions said that pricipal investigators 
would report peers or subordiates engaged in misconduct, although some noted that reponing 
might depend on the severity of the situation or the relationship of the pares involved. Some 
grantee institutions felt that the pricipal investigator would resolve the problem in the 
laboratory settng if at all possible and only notify the deparent head if the dispute could not 
be settled. 
However, some grantee institutions stated that young researchers are afraid to "blow the 
whistle," not wanting to jeopardize their careers, and that it is parcularly difficult for 
graduate students to report a superior. Although many institutions have measures to protect 
the whistle blower, al agree that confidentiality cannot be guaranteed. A few grntee institu
tions suggested that an ombudsman be designated to receive allegations. 
Grantee institutions expressed concern regarding their heavy reliance on "whistle blowers 
" to 
detect misconduct. Even so, they did not consider other methods, such as scientific data 
audits by outside reviewers, to be cost-efficient or effective. 
Grantee institutions noted that detection may be one of the most vexing issues. Most indi
cated that the past OCCUInces of misconduct could take place agai and that anyone who is 
detennned to commt scientific misconduct wil initially get away with it However, ultimate
ly the grtee institutions believe it would be detected. 
We leared that in cases of substantiated misconduct, astute reviewers detected the misconduct 
due to statistical naivete and data that was "too clean." In a few cases, misconduct was 
detected through replication of .the experiment. 
Recommendation: The Department should explore ways to protect the "whistle blower 
since detection of possible scientific misconduct relies so heavily on individuals willng to 
make an allegation. Currently Federal employees who engage in "whistle blowing " are 
protected by law. Similar protection should be provided to individuals reporting possible 
scientific misconduct by grantees. 
Recommendation: The Department should exlore alternative methods of detecting possible 
misconduct. Examples of possible methods are spot audits of scientific data, or special 
reviews by editors of scientific journals.  Recommendation: The Department should encourage individuals with information about in
stances of possible scientific misconduct to come forward. Grantee institutions should be in
formed of the OIG Hotline, which receives allegations concerning fraud and abuse in the 
Departent s programs. 
ESTIMATE OF THE OCCURRENCE OF CASES 
of the grantee institutions with procedures reported cases of 
Thirt-six percent  (17  of  47). 
misconduct which required the use of their procedures. Sixteen  percent)
of the  34  cases  (47 
grantee institutions were substantiated. Over half of these grantee 
investigated by these  17 
institutions are revising their procedures. 
Even though detection is problematic, 36 percent (17 of 47) of the grntee institutions with 
procedurs have had cases of misconduct which required the use of these procedures. These 
17 grtee institutions reported a total of 34 cases, or an average of 2 cases per institution 
which were investigated under their procedures. Over half of these grtee 
institutions are 
revising their procedurs to provide for more comprehensive, precise and clear direction. 
ar 
Some of the grantee institutions visited  makng revisions based on their experiences in ad
dressing actual cases of misconduct. 
Curntly there is no cumulative infonnation concerning the number of cases of alleged scien
Nl 
tific misconduct that have been investigated by  grtee institutions. Based on the 
or the 
number of cases reported by the grtee institutions in our sample, we estimate that 95 cases 
(47 substatiated and 48 unsubstatiated) have been addrssed by NIB grntees. This figure 
is simiar to the number of cases reported to NIB since 1982. According to NIH, 102 cases 
have been investigated by the grtee institutions and reponed to the agency during that time 
period. 
We cannot gauge the extent of scientific misconduct 
accurtely. Our estimate does not repre
sent an annual incidence of cases, but rather a cumulative occurrnce of 
cases reported, since 
the data reponed was for inconsistent time periods. Also, it should be noted that some grantee 
institutions were reluctant or hesitant to repon this infonnation and a few institutions did nOt 
know. 
The estimate of 95 cases does not represent an estimate of the actual  prevalence  of scientific 
misconduct. In fact, the grtee institutions were about evenly split on whether or not more 
misconduct occurs than is reported. 
Recommendation: The Department should keep complete and uniform records concerning in
vestigations undertaken by the grantee institutions in order to maintain baseline data on the 
incidence of cases. This informtion could also be used in refining guidance and direction to 
grantee institutions in conducting future investigations.  NEED FOR PREVENTION AND ETHICS

Afew grantee institutions have developed or are developing guidelines for preventing scien
tific misconduct. Grantee institutions have expressed interest in receiving guidance in this 
emerging area. 
Of the grantee institutions sureyed, 21 percent have measures intended to prevent scientific 
misconduct. The most common examples include orientation programs or semiars focusing 
on ethcs and misconduct issues (usually aimed at new researchers) and traiing programs for 
pricipal investigators. 
In general, while grantee institutions stressed the need to raise the consciousness of facul 
and students about prevention programs, they spoke in tenns of guidelines for scientific prac
tices and ethics rather than preventive measures. Most grantee institutions do not believe that 
misconduct can be prevented. Rather, they believe that emphasizing responsible scientific 
practices wil deter sloppy science which can lead to misconduct. 
Severa grtee institutions, moreover, alluded to the resistance of faculty to deal with prac
tices they believed were aleady a pan of research activity, to handle additional paperwork, 
and to cope with a "police state" mentality. However, most commented that if the scientific 
community does not tae some action, it wil be imposed from the outside. 
Only a few grtee institutions have developed or ar developing actual guidelines for scien
tifc practices to ensur the quality and integrty of researh, although this ara is receiving in
creased attention. (See, for example, "Fraud in Biomedical Research: A Time for 
Congressional Restrnt,  June 2, 1988, which commends 
New England Journal of Medicine, 
Harard Medical School for developing preventive guidelines but calls for even more strn
gent measures such as requirg the adoption of these stadads. Appendix C contains the 
journal editorial and the Harard Medical School "Guidelines for Investigators in Scientific 
eRemseaerh.r ")g Soimeg g ranateer inastit.uti ons
  have expressed interest in guidance from NIH in this
The tyes of provisions we found in the preventive guidelines developed by a few grantee in
stitutions were quite simiar to those developed by Harard Medical School. These provisions 
include: (1) closer supervision of research trainees; (2) more careful gathering and storage of 
primar data; (3) validation of research results; (4) explicit criteria for authorship of a scien
tific paper; and (5) an emphasis on quality rather than quantity of publications. 
Grantee institutions say that the prinCipal investigator has a major responsibility for foster
ing scientific integrity and that scientific misconduct would be less likely to occur if the prin
cipal investigator adequately performs his/her responsibilities. 
Severa grtee institutions  the responsibilty of the principal investigator for 
gratly stressed 
teaching integrty in research. In addition to the many competing roles of a principal inves
tigator such as identifying researh funds, managing grants, overseeing multi-site projects and  institutions said that the principal investigator should continually 
trating patients, grantee 
monitor and be constatly involved in the research effort. Grantee institutions commented 
that if the pricipal investigator was adequately perfonning his/her duties, misconduct would 
be less likely to occur. 
The grantee institutions described the following practices that a pricipal investigator should 
follow to foster scientic integrty in the laboratory includig: serving as a mentor or desig
nating among the senior researchers a mentor for the inexperienced researcher to work with on 
a daiy basis; maintaning open coinunication; reviewing and signing off on all wrtten 
material that leaves the lab; reviewing all raw data; screening all research applicants carefully; 
developing a system of data retention and storage; and conducting fonnal staff assessments for 
junior researchers.

The pricipal investigators who had dealt with a case of scientific misconduct in their 
laboratory told us they had experienced a change of attitude. Pror to the case, they had been 
more trsting, but afterwards, they had become much more cautious and no longer assumed 
the trstWonhiness of another scientist Also, their approach to supervision in the laboratOry 
became more strctued and disciplined. 
The PHS should continue its efforts in the area of prevention, such as the 
Recommendation: 
contract with the InstitUte of Medicine to develop scientific standards for the conduct of 
responsible science. The PHS should develop model preventive guidelines and require that 
grantee institUtions adpt  a condition of funding. The role of the principal
these measures  as 
investigator should be adressed in the preventive measures.  AGENCY COMMENTS AND OIG RESPONSE

The Public Health Service (PHS) indicated that the oro draft report on Misconduct in Scien
tic Research was "a useful discussion of some important issues related to allegations of mis
conduct in PHS extramur progrs." The PHS provided general and specific comments on 
the draf of this report which are included in appendi E. In response to these comments, we 
made revisions where appropriate in the final report. The comments PHS made with regard to 
the oro recommendations ar discussed below. 
DIG Recommendation

The Secretary should provide for independent oversight, and develop a more formalized 
and centralized process to deal with scientifc misconduct including the following ele
an independent third party to act as a fact gatherer and collect, retain and 
ments:  (1) 
an independent scientifc review board to assist in anaLyz
analyze investigative data;  (2) 
ing informtion  an independent decision 
concerning scientific misconduct; and  (3) 
making authority or ombudman type  is especially important given the 
function. This 
congressional concern regarding the lack of independence of investigative units. 
PHS Comment and OIG Response 
The PHS agrees that greater central management is needed in the Deparment to deal with 
scientic misconduct and therefore has developed a reorganization proposal involving the
NI 
as well as the Office of the Assistant Secretar for Health (OASH). The proposal calls 
for establishing a new Offce of Scientifc Integrty within NIH with the operational respon
conducting investigations. Another offce would be established in the Office of the 
sibilty for 
Assistat Secretar for Health to oversee operations of the research agencies and to review 
and propose policies. 
The new Offce of Scientic Integrty, reportng to the Dirctor of NIH would have the ongo
ing operational responsibilties of monitoring investigations initiated by awardee institutions 
as well as conducting independent investigations. The office needs to assure that the scientific 
panels convened to conduct independent investigations do not have real or perceived conflict 
of interest with the accused. The individuals selected should be knowledgeable about the 
scientific area of inquiry but should not be involved with the research in question and should 
have no ongoing close professional, academic or financial relationship with the accused. 
Although including the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) 
extramural researh in the scope of responsibilty of the office within the NIH wil help to 
centrize this function, this anangement may have logistical problems. 
The PHS indicates that the office also plans to foster 
scientic integrty by developing preven
tion and education program to be conducted by the extrmura research offces throughout  Nll and ADAMH. We encourage the PHS in this effort. However, the PHS must assure 
that adequate resources are allocated to this offce to deal with the range of issues regarding 
scientific misconduct and to provide a "prompt and appropriate" response to allegations as re
quird by the Health Research Extension Act of 1985. 
The office to be established at the GASH level, which would be outside of the funding com
ponent, would oversee operations of the research agencies and would adjudicate cases inves
tigated by NU or ADAMH and impose sanctions if warted. The PHS is also considering 
the establishment of an outside advisory group to review and evaluate PHS policy and proce
dures governing scientific integrty. We believe this would provide an additional perspective 
to the process. The advisory group should involve a varety of paricipants, including repre
sentatives frm the scientic community as well as public members. 
We look forward to reviewing the complete reorganization proposal and functional statement 
and monitoring its implementation. 
DIG Recommendation

The Department should expedite completion and publication of a final regulation on rhe 
responsibilties of PHS awardee and applicant institutions for dealing with and report
ing possible misconduct in science, as required by law. This wil facilitate the develop
ment of procedures by grantee institutions. 
PHS Comment and OIG Response 
The PHS concUIed that the publication of a proposed rule was urgently needed and long over
due. As of September 1988, two Grats Adminisn-tion Manual Issuances were published. 
Additionaly, a notice of proposed rulemakng (NPRM) on "Responsibilities of PHS Awardee 
and Applicant Institutions for dealing with and Reportng Possible Misconduct In Science 
was published in the Federal Register in September 1988. Currently, the PHS is in the process 
of preparng a final rule to be published. 
Final regulations implementing these requirements wil be published some time this year. 
Since Congress has raised questions about the adequacy and effectiveness of the current self-
regulatory system in dealing with allegations of scientific misconduct, we believe that more 
explicit and strcter regulations ar needed. We ar pleased that PHS has already strngthened 
some provisions of the NPRM based on our recommendations. We believe that there is still 
need for improvement, as discussed in the recommendations that follow. 
DIG Recommendation

The Department should require all applicant institutions to submit their scientifc mis
conduct procedures on an annual basis to assure compliance with the law. The PHS  should review the procedures on a sample basis and also in all instances where scien
tifc misconduct cases are reported to assure that essential areas are covered. 
PHS Comment and OIG Response 
In our draft report we had recommended that policies and procedures be submitted with each 
grant application. We agree with the PHS that annual submissions would be sufficient for 
monitoring puroses and have revised our recommendation accordingly. 
DIG Recommendation

Theftrst line of responsibilty for conducting an inquiry and/or investigation into an al
legation of misconduct rests with the grantee institution. However, regulations issued 
by the Department should require that grantee institutions immediately 
notif the 
Departent whenever they detect or receive an allegation of scientifc misconduct, 
maintain records of all inquiries and investigations for a specifed time period and 
provide the Departent with 
periodic statu reports. The regulations should specif 
ment. 
time frames  inquiries and investigations. Although we 
for reportng and conducting 
recognize the grantee institutions are concerned about flexibilty, these requirements 
are, nevertheless, necessary to assure adequate monitoring and oversight by the Depart
PHS Comments and OIG Response 
The PHS indicated that immediate notification of all allegations of scientific misconduct to the 
Deparent appears too broad to be practical. We disagre. 
Under the proposed rules, the awardee institution must complete an inquiry of an allegation or 
other evidence of misconduct within 60 days. The funding agency is only notified of allega
tions if an institution detennines that an investigation is waranted. The rules do not require 
the reportng of all allegations to the funding component. 
We believe al alegations, which reach a certain level within the academic institution such as 
the dean, the deparent head or other official designated by the institution, should be 
reported regardless of whether an investigation is pursued. This would assure adeq!.ate 
monitoring and tracking of cases by the Deparent. The PHS should review, on a sample 
basis, wrtten report of the inquires of those cases that ar not investigated. Additionally, 
knowing the number of substantiated cases as well as the total number of allegations would 
provide some perspective to the problem. MOle importantly, reportng allegations at an early 
stage of development should be considered in the best interest of the grantee institution. Early 
notification wil prevent charges of cover-up against the grtee institution since there is an in
herent appearce of impropriety when a grantee institution investigates itself.  DIG Recommendation

The Department should keep complete and uniform records concerning investigations 
undertaken by the grantees and/or PHS in order to maintain baseline data on the in
cidence of cases. This information could also be used in refining guidance and direc
tion to grantee institutions in conducting future investigations. 
PHS Comment and OIG Response 
The PHS concurs that complete and unifonn records are highly desirable for the reasons out
lined in the repon. The PHS has also established a data base, in addition to the PHS-wide 
ALERT system, to trck open cases and to archive key infonnation about cases that have al
ready been closed. As pan of our oversight responsibility we wil detennine whether the PHS 
is documenting and maintaining adequate records concerning investigations. 
DIG Recommendation

The Department should encourage individuals with information about instances of pos
sible scientific misconduct to come forward. Grantee institutions should be informed of 
. the OIG Hotline, which receives allegations concerning fraud and abuse in the 
Department s programs. 
PHS Comments and OIG Response 
The PHS concurs with our recommendation and indicates that notices regarding the reporting 
of misconduct wil be published in the Nll Guide for Grats and Contracts on an annual basis 
as well as the notice of a grant award. 
DIG Recommendation

The Department should explore ways to protect the "whistle blower, 
" since detection of 
possible scientific misconduct relies so heavily on individuals wiling to make an allega
tion. Currently, Federal employees who engage in "whistle blowing " are protected by 
law. Similarprotection should be provided to individuals reporting possible scientific 
misconduct by grantees. 
PHS Comment and OIG Response 
The PHS concurs that improved protection for "whistle blowers" is essential to the integrty 
the process and is in the process of examining additional means of providing proper protec
tion. Perhaps the PHS should prohibit awardee institutions from taking retaliation against an 
employee that has made an alegation in good faith at the risk of losing their 
funding. Another 
protection for the accuser could be exemption from liabilty or requirng the institution to  defend the whistle blower if any legal proceedings are initiated. We agree with the PHS that 
appropriate protection for the whistle blower wil require legislation. We understand legisla
tion may be introduced in this area. 
DIG Recommendation

The Department should explore alternative methods of detecting possible misconduct. 
Examples of possible methods are spot audits of scientifc data or special reviews by 
editors of scientific journals. 
PHS Comments and OIG Response 
The PHS concurs in principle regarding this topic, although they do not believe that data 
audits are feasible. Also, the PHS is not clear as to what is meant by special reviews by 
editors of scientific journals. We have suggested this because we believe that journal editors 
who have access to key scientific papers could perfonn a radom audit of research papers sub
mitted for publication. This has also been suggested by the deputy editor of the Journal of the 
American Medical Association (JAMA). The purpose of the audit would be to detennine 
whether or not basic infonnation exists such as whether or not records and patients really 
exist. 
As noted by PHS, while it is not appropriate for the Federal Government to specify that jour
nal editors conduct special reviews, we believe that it is proper to encourage them to do so and 
to suppon other appropriate proposals to deter scientific misconduct suggested by editors sllch 
as arhiving data. As stated by the deputy editor of JAMA, joural editors are independent of 
the research institutions and are interested in assurng the integrty of what they publish. 
Therefore, an audit supervsed by joural editors would be impanal and fair. Such an ap
. proach would not requir settng up a large bureaucracy. 
DIG Recommendation

The Department should develop a table of penalties, such as the model adopted by the 
Offce of Personnel Management, to assure that sanctions are applied consistentLy and 
fairly in cases of scientific misconduct. 
PHS Comments and OIG Response 
The PHS concurs with the thrust of this recommendation, but doubts that they can develop a 
fonnula or a table. We believe that a table of penalties, which would include acceptable stand
ards of conduct and sanctions that may be imposed for failure to meet those standards is essen
tial in assurng consistency and fairness.  . .
10.  DIG Recommendation 
The PHS should assume a leadership role and provide guidance to the grantees in mat
ters related to scientific misconduct. 
The PHS should sponsor a consensus conference to develop model guidelines 
for use by grantees in addressing all relevant areas of scientific misconduct. 
The PHS should coritinue its efforts in the area of prevention, such as the 
contract with the Institute of Medicine to develop scientific standards for the 
conduct of responsible science. The PHS should develop preventive guidelines 
and requir that institutions adopt these measures as a condition of funding. 
PHS Comments and OIG Response 
The PHS concurs with this recommendation. We encourage PHS to sponsor the conference to 
develop model guidelines in the near future, since regulations requiring institutions to develop 
policies and procedures wil be effective soon. As PHS stated, such model guidelines would 
help to assur more consistency in procedures, policy and protections. Additionally, smaller 
institutions, as noted by PHS and supported by our findings, ar looking for additional 
ara. 
guidance in this 
The PHS agrees that it should have a role in supportng education regarding ethical issues of 
science and should continue its efforts in this area. However it notes that the imposition of 
such guidelines may not be desirble or enforceable. Recently, the Institute of Medicine is
sued their report of the study to develop scientific standards for the conduct of responsible 
Nll 
science. Similar to our recommendation, the report recommends that the  require all in
Nll 
stitutions receiving  grants to have wrtten policies and procedures in place for promoting 
quality and integrty in research practices.  . .
APPENDIX A 
Telephone Survey Methodology  Telephone Survey Methodology

The surey used a strtified random sampling method. A list of all 1986 research 
grantees was 
obtained from the NIH. The list included the tota number and amount of research awards for 
each grtee. By eliminating all foreign institutions, the population was limited to 1 214 in
stitutions. Ths population was then divided into thee strata, those with 100 or more awards 
per institution, those with 10 thugh 99 awards per institUtion and those with fewer than 10 
sumpzes 
awards. The following table  the results of this stratification. 
SELECTEe INFORMATION ON NIH GRANTEE INSTITUTIONS BY STRATUM 
No. of  Tot. No.  Total  Amt. Per  Amt. Per 
Strata  Instit.  Awards  Amounts  Instit.  Award 
100+  15,243  $2,599,810,599  $35, 132 575  $170,558 
10- 186  003  890,293,363  768,523  148,308 
954  985  232 690,637  243,911  117 ,225 
214  23,231  $3,722 794 559  $ 3,066,552  $160 251 
Systematic radom sampling was used to select approximately 30 institutions from each 
strata. The following table summarzes the results of the samplig process. 
SELECTED INFORMATION ON SAMPLED NIH GRANTEE INSTITUTIONS BY STRATUM 
No. of  Tot. No.  Total  Amt. Per  Amt. Per 
Strata  Instit.  Awards  Amounts  Instit.  Award 
100+  097  311,966,670  $43,732 222  $184 862 
10- 005  155,964, 189  031  103  155, 188 
30*  991,209  299,707  136, 230 
168  $1,476,922,068  $ 3,695,259  $142 082 
* Only 28 of the 30 institutions could be reched by telephone.

bas 
** Weighted average  upon weight derived from the population of institutions.

The sample consists of 40 percent of the institutions with 100 or more awards, 16. 1 percent of 
the institutions with 10 through 99 awards, and 3. 1 percent of the institutions with 9 or fewer 
awards. The sample slightly overestimates the average award amounts but is stil within sam
pling varations. Because the surey used a sample, weighted averages and totals were lIsed 
for projectig to the universe of the institutions. In the following table, the weights are the 
proporton that each strtum is of the universe of institutions.  Number in  Number in 
Strata  Universe  Sample  Weight 
061 
186  153 
III  954  28*  786 
Total  214 
* Only 28 of the 30 institutions could be reached by telephone.  . '
APPENDIX 8

Areas Incorporated in Procedures/Policies  Areas Incorporated in Procedures/Policies 
Telephone Survey Of Grantees 
100+  10 to 99  -=10  Weighted 
Awards  Awards  Awards  Average 
Investigations  27 (96%)  16 (100%)  3 (100%)  99% 
into allegations 
of misconduct 
Time frames  13 (46%)  10 (63%)  35% 
for inquires 
and investigations 
Do not alert NIB  23 (82%)  4 (33%)  1 (33%)  47% 
at initiation of investigation 
Alertng NIB  23 (82%)  11 (69%)  3 (100%)  84% 
at anytime 
Prtection of  23 (82%)  16 (100%)  2 (67%)  83% 
confidentiality 
Due Process  21 (75%)  14 (88%)  2 (67%)  76% 
and appeals

Retention.  7 (25%)  7 (44%)  1 (33%)  35% 
storage and 
ownership of data 
Validation of  9 (32%)  7 (44%)  1 (33%)  37% 
researh 
Retraction of  14 (50%)  6 (38%)  1 (33%)  39% 
published arcles

shown to be fraudulent 
Responsibilty  11 (39%)  6 (38%)  24% 
of coauthorship 
This is based on the number of grtees that reported having policies and procedures in place 
to deal with scientific misconduct: 28 (93%) with 100+ awards; 16 (52%) with 10 to 99 
awards; and 3 (11 %) with awards.  . .
APPENDIX C 
The Emerging Area of Preventive Measures:

Fraud In Biomedical Research: A Time For Congressional Restraint,

and 
Guidelines For Investigators In Scientific Research"  -, 

.,  ' '
.. ..,  . . '--
:. -".".y .. .. . ...----.. 
.._ .. --""
,.  ,-. -  -- -=- -  ..  -,  ,. 
EW &. GLA"iD JOt.1L"iAl OF' MEDICI:-E	 June ::. 198
1+62	 THE 
matico When theY are confrmed, such obser.ations  federa goverment to monitor the intC!ty oi the bio
wil n  to be rel  ted to l'ent findings on the role of  medica-reearch enterrie in th way? First. bv IU 
pron
ceruin metabolites of procnamide. such a.  nature such an attempt woRulcd e&.:meosrt  c::univ be 
lo and the niC'so  sev 
amide hvdroxvlamine deri..-ative,  clumsy and bure.ucntic.  alead., bur
which  bind to histones.  dened by havingr toe prrte pare  endless gTant 
Continuing study of these sydromes should d  applications and  would probably acquire still 
in th cue 
en our understadig  more paper obligations  designed to 
not only of these clnical syn
dromes but alo of systemic lupus erematosus.  dc:onstr.ue thei honesty. Wore, if the hearigs 
Physicians should be on the lookout for reteant drug  themelves ar an indicartioen cof: t he govemmen t ' s un
and environmenta associations and bring them to the  dertading of the way  is done. the govern
attention of those concered with undertading these  ment s attempt might be badly miinformed. Tne
beags  err 
syndromdes.o- often seeed to equate  with f  ud. and 
sae 
the  indignation was shown toward both. ErTr 
MI GI calesnes 
Ci.  due to  is culpable, a. Engler et al. have 
OM "'%67	 lUas
EvnYN HES, M. pointed out, I but honest errr is nort.e Tche: l a.tter is at 
leat as mucn a pan of scientific  a. trth. 
I. Hhto	Ii  IJ.  S'L. ..i  A.n1I  IoD d.- - 1Sa1a; 5i1,;1 cCI.   EDmvoeet nnbta w vtoiinth gm  tmhaeae eb b eaito nem fefonerrdt.i,  cnTaoh  ussc,i eenfotirt ta nby b netho cete  ogrntonlvy e oorff 
aJ,D H. YJ. IL THaAu. P e HM J.r..  8M cCfI .ID   195;  bud but of ercre asy we ll wroeeaur ld crte a clmate 'that 
diuae 
11:1.29 039.  would alost  young peple frm 
3.  N Ea J ,. It6  recac:, 
267: 1A3T".  1c'.  - i8 --	 beming biomedca  at a tie when our 
. T- 1%E7M1..  MR. aA.S . FEJr J1rF.P. .'  1uf IB. .D i11:1  1S .9 f.1a  "U'-la. IU.I. .PU..  S frt.1 .) a9I'tD1 .   pctho:elFd  geo dfoe ennmrue wroec  wv:frteag nudhdto -itesf   m"anil ogrseth cdthc aybv: Cede  wtaw b idsultoitnr ing tg t.hc e raeortd.  Fini'tf n itti,st  
6. 1.  A4 L. Zi  19C %1ft  %7. ar  overight efort; wimes the Pentan s monitoring of 
7. FnIZ18l  AIo.r . T aD EMp AI lAI" " HD.  HaI Eu. I8 e198n1 .%..4.:1.0.1... .0 1
  dinef aenle f iceelndtsr ocft oernsd.e aSvecoor.n dT,h emri cmoanyd ubcte  ilse sins eovft aitb ilne  
I. T---- cMe.a Ta D" 'fS	M.J  MCi cNa EM1.9 1I8t: IRL t I'  at 1-bIo  scentific: reea th in other fidds. The National 
I..  Institutes of Heath (NIH), which suppon the wor!t 
1C-H2 wa 
190..  p.II I	.I  N'J  	EU. aR-IM AJDe.   MI8C1I8ti   I1t E9M"U=S :M  31. 1 c:1:_- 43i.1HA042s-4.Ha.2 . . .1.1.9 J8H _Ce\  TE_aV .aS iM1r. uItO  oaiinnfv  giat,Spe  operrf  oxcoxotfi mruourna ltyre  lhly po 5rtwo0o  ,2m0g00 arn yes  c;ir niwtete na ohtifcat vaSeel e  rnogeoef v dwb emauy id aco o f ynmedoauwlcyt  
WuI. D  I  a, fa  I..' Ii   supeed. go un
191: 1':J  reea 
11.  FP. 	 .. pa 
 . J'O  f' Ea 11 191;  pitoSiMn ttaendni tyoi uodtn etsfhe ton dfs cepiree onrcf e rt heisee  siwcnt: ea-gnctdny  -oonfp ge beys v ainehda  ivtse  
reuient of veribilty. Furerore, the peal
dfeae bah
.. ry for frud is los of reutation and 
RECH
 ment &om the scientic communiry  censc:uc:ce: 
FRUD IN BIOMEICA 
evc:c:es. we have probably
Rest
 tbht efew  wtoould  rik.  saegar: 
A TUDe for Coagrsioaa  comptloac emt ainy r eryeigt  onin tthaescec   
we have see  pret  in which 
Congr 
IN Apri the U.s.  held tWO set of hear
 they have failed to  or detc:  ous dis
ingsr teo einave stigate the cctent of fraud in biomedi
 honecsryh, an.d  to may ditory investigations of ser
ca  and the rense of the scc:tific cem ous 
reea 
munity to iL Clealy, some ,mc:be of Congres  The  community thc:ore caOt aford to
beeve tht ther is a go dea. of fraud and. more  dimi the conce tht ba  l'ent 
impobrtte,  that the scientific cemmubnrye  resnse to  heags. rCeoenag  is repondinggi vteon  ar wieid teos ptrheea d view 
it ba  inadequate. Ther have  suggestions tht the  cemmunry bsae DlOyt t aen the epi
tht the biomedica-rec: enterprie requir some soes of dihonesty in itS midst  enough. that 
son of policing by the goverment, sice we have we have be "Stonewaling" the prblem. Ther 
seed unwillig or unable to  some trth to this chl'e. When the fit highlv publi
polio: oundves. 
laton have even suggested tht a separte overignt  cied etuoes of fraud em  in the late 19705 and 
agency be established for tht purpe and that re  c:iy 19805, we wer reiuc:tant to give them due atten
secher thought guilty of miconduct be subjec to  tion: we wanted to beliC'e that each wa an islated 
crminal indictment.  abetion that wouid not rer. In addition. rerch 
What would be the reults of an attempt by the  intitutions did not h  e est:1biished proedure for  ....   ----  .---   -.- -. 
.. =- ".  ... ..--
j.  . .  -. -  -..  -. 
Vol. 318 
 o. 2:	 S:'Z:HTO R!J. L. 
dweaidngl ewidch  o
 n an ad ahtoico nbsa soiis .f roaiutedn.  sboy  e3.cn epUoe was  d'"o  nuororv..  cIm:r p(iuejm weornkt:i nogn  ttbbee  erxehetmr. md1eenv daaret iocon c iooi i c In
tht  pepie so dose tbe
ithnet esrittu.a .tion  cbere was an innernt ccnnic! oi R:aard guidelines would be an importnt step te
ward  ng this situation. For tbis proposal co be
goSin cdea lch eanb.o uchte  d!e'ea:lgc: w citohm mCurnuid . ' Shoan l eaf3teera e ane   etifoi ns: i"a"beo vine  fcohset esrriinpgul aqtuead ltnyu mbe shoutlidt. .r ,e cpeuibvliec an.o  
Danee ase in 1981, a numbe of o  tions and  attention. To emphasize substac:e over number even
intitutions. including che NTH ahd the .  ocation of furter. citations of reerences in proposals for aa
Ameran Medica CoUeges. deve!ope p.edu  for demic: appointment and gnnt a.pplications mighc be
reponding to alegtions of frud. Thesepl'edur  reuire to include brief summaries of the content oi 
inwcohripdr 'ce due con  for boen the acced and tbe e:ch arcle, together with explanations of iu contr

blower. " and in. some C3es provide for p bution tHo thae rfie ld. 
ticipation in che investiption 
itnhti tUyetiao nt ihne q Iunetsetirotni ocnoa fla cCioitmamteiext optbeejere  coovfui arMyi.d eeEd iactibayel   fteimTt phsteeae tpio, nr etor eCsUetgn tuc oidamene rlisinm eisnp.  aboiltrohtmote uedgfihfco :trhtl  t"oe 3carorcenh tor.on llT ydh 1.ee.  
Jionu rdneala nEdgi t..otnh i tshued  guideHnes for editon to follow Insetute of Medicine of che National Aademy of Sci
problem. J With proedure in  tH. is alo 
enc:=. under ene sponsorship of the 
e3iier fiounder in hadli 
plac:e- institUtions that  scud  ing ways in which the s 
stem could be reformed 
cues of fraud have more recendv !'olved tbem 
to discourage miconduct in biomedica !'earc:h. 
ctivueiv  and in an orderi ' Way. However, these later Even the' most suic:y monitored system an 'never
pubHc:h'a sv ed peehamps d for acunrtaeobelivlte3yd   itnoo t hper sitpeeld .i gT hoef  cs:mein actoem omccuaniiotyn aial eeipfi csaod edso  omfu cCrhu dto.  rbeuutc teh teh ereir  
CD doUa on biomedica 
reea  is after al. Iq;ti incidenc:e and facilitate their detecon. M Goverment 
mat  the  community must not omy 
iue  poHce ca have its most vauable roie her by enuring chat
but be see to do so.  reeach inticutions m:eiving govement 
Guideies isued to  pros  sUpport
date bave manlv coHn  ar bave appropriate 
the  rtfH"  to bud. In Mar of th y  plishing these purpses. Congesetsa blhiash ead 1feo:r  acW:coemn  
siM13  eedc at rSecoe. oT.l h iessuee dc a:  sfeotr o df ogsuedr esluinceesr .d-ieiaonng  owf irteh  9an9 1im58p) othrattt  aSnteyp  oinr gtnhiisz ationt iaopnp lbyyi nrge ufoirrn rges (ePar.ch
primar data  more  caui  cheri2' a.nd Slong!! o  funding pmrusot p rovide asSUt'c:es that it ha esab
czr the establihment by deparents of lihed a  for responding to alegtions of fraud
:I"d m  "in2fi cntm:a in!" 2m+'''n and tht it wi ren  sec 
hi of  to the  of the Depar
scebnlr.i."c ,,p"a.p er,y ta'Mnd  a  iation on fj,.. """' 01 of ment of Haith and Human Serc:= when an invesri
fn" r:iQUev acooincmem or pro ption is ben.2 It must be 
motion. The incruc:on to the gudc:nes emphasizes  the job itsel canot be done ufnrdoemr toouoa.id eh QthWee vr er,e cuht  
tht they Han ejurs t tht, not rues. benc:: they an not =mmunty without jeopardizng th from cht
CbDidmipnlgis.h  tsheip plu  lriees.  oinneti ocuf ttihoenirs  wweibaaevsee tso. d Tevoe !aocp-  rreeueir:e t cafoomgr mr eueniacyc his  twoil tlf"o!u ars.hnd.  ablTeh teo  bpoiloicm:ee dicaeaif
ntoa bees  snoomt ewhat mguoired edleest.e dan. d these rues wi have  and is  Sterpss to  dwo is og imeo rceh d Iperaoeel s.  tLieet 
us hope tht Con
"! OHne aofr th 'e renably  iicic remmendations of  to work. 
the  gudeles is tht the number of publia
dons reewed for 
faculry appoincment or promotion MAJtCA ANczu, 

be limited. They suggt, for exple.  RzAcaO:L
D S. 
' that no more  1U,
th 5 pape be reewed for appoaincsmtenet t o the posi
atinn  of asiscazu proft:r, 7 for  profesor. I.  o- IC  !I  loiI 
wiely1 0a dfooprt perdo fesobry.  SIf tsuudcyh s eaa roenmsm aet nthdea tNiotHn  i3  311:13'3R L  rw.  tI 18  Pf.  PS. l'  i8A JM .1 So 1.981: 
dwee pase b y the medc: schools  it will be a sha 1. -I.,... ..Jt0  -.S-. ..  $8 H-li	 _e- a..i
 R-
frm the preent sytem of reyig iaeiy  191. ""...  Co- --atHa_Ha_-s.19881.:.
M8 Jc EM 
oa the  sie of the biblioV3phy in evaluatig cadi 3.  1o0 (  of 
dasa cferus eafonnr c inpyrtoe amnse op tooio1rnbe iuoerr.  eafu nonddn ia giln.m  +o sTrth i cpe  nrdliya nlcee ab0W h  4. L.1 91 S91. 0A6II t:e.i .i an.  019.1. :! o 1Ja0 t1: 9h.1:.M   il  .J607.  A8 .. M8
piness an  haos co more :!erious m;""Mt' ct. It  &. WcD PK!. PIN 1D  aM hM il  AI I- 1o 1986 
106:
al prouc= a bia in the system favoring !'tively  1. H_!.. s. 	 .4"	 "-I- M8 
II 
D"' pl.. ,rudies tht ca be comcleted racidly over  .98: 106:m.
n2'  . difcut  bese t ht may be more importt. Ia  106: JC ID  A8  1o 191 
e:c::. we  v:e o n the ogniev higa din.v tehesyt iatCr ne xap ceoenda ' 190..  A	 . MAAS   ""''J!. 	 aa - Al1. -If  eM.8 J  1W981  110961,:: aJI.O: 
1-41j.1.  !: 
;)  -' ':  .. 
-"um 
.. y. d  Gazette June' 
SQ.
I8 . -'  C""  iI 
pr 
ra.t .eT 1 rtp_bctmii  t 
MTis tehoI Db aI rUll'lfDrr  i itaoa  cmef  la aioia darely  atI ia8rraob ec mnieDb yl p rdar Iu. r arat   itnabt  JcFCIouciiiftti.yc 
fr wfe f  of ia  tilaacro n co a foruals  na bu ra&h as pidlinc
iu oWn Ie oflplC pne.
me quity ID uuelrty of iu 
S., J pr 
D. Ca 
iait 
me  SI  di pn01 rD.e  idai  rnia.teo1n Dby  dcib c aiti: l is iD di ba iDr
addi n eiry  COunity. Th coplex. 
dica o.f  IteD   di De  (or ca..im il  poible amiguous
pror ia me  for  ne sUwiIs\rlrKil:aaJt oarasy sTish  arll ereu   IC(i  role (or the 
Icomeo  pid  a0( rniD  is pajcuWy cr in th DOC un-
ia laratocirra y scce.  0(  who  ia I  unir wirbr  nce 
I. Th resibilicy  ecaa l'  snd 
asillne co soe (acu(olirr y8 mepbe i oU so (  juaior .ia.i t til.rorr a  be spcific:1l1
2. Th rario osfc trcaii c  ,sn rrue    shold be asmaUp =m qh thr clopse inr&c " 1ion U
p3.o Tibhle p fraerp  or sD  u well u  of di  Ir all srales
quinl, rerdda.i    di dep  at  pr  aDp di rr  of ae:.
IllbCheo  i"l*q  to rdi eeeudini,. r iUl oDfll alcll uPsa fdn ..o1D   sarDraiOl   cn c(a&dre  :(Ai ru  -rwabinal el)limiiru
,I.D T Ihf pb ear bDerJ d I Gs pbr p biroaoo t or  cpae D n'eM titao.  Ydi eIpCl I(C   difoDn 0t1 idi  reu
snt. posrdora
Ielowh, or jauai o facy) wi  ID 
I'  slUie ia  apUc1e  ioi
occ:   at 1 hedty  or pariea. 
Db_  1Iim 
subsraes an  DNA 
to.
DL DM  Jt" "
SC 
A comon deminator in mosr cue of alleerde set:ieiru ifie: lDonuc: ha ben the 
erentrirsnitnc em aoufle sat   crhoemapu leltuea issca  :o=fs  utoun 0h1a is/lh iemrti aopbrlieoli dnraatc  a(o Tr dhi   or oo(f  aJcCan1leCly  qirauiourr. d A  asnctJ
cct:yu.d Minco.r beuv eD. OC lIimni lme acyo .b dei smei smuakle nm (aoyr  amrersiu .slwsU iUsCr b  wIhDtYo   imp'icio10 o  f improinn-
prerliuo nar  ouf nda a iliarb sleb. (n  abded uitiosn  iwn tm' e dezp .,iMicat aJI anCaJy sias sim sw ere pen raimsr ian r im ne est phe evimlnutaeercn.iotanl 
of  lIs. 
1f I 

CII 
I.  oncn prma  rein 
wtid th aoIfr aI Up .n l.e .  dara mil be  by di IIr in
hihe OW  An in"Ctigaror lDay mde  0(  me prma dau (or 
2tr.e MOb argaui  mpapr a p-oa.1  o8AJ 0r iea u  ssabbtd   bbee  l1mi1ewn  b f pro iblea iac b o boks
b3. o.  be  10  01 IG f8lirdarie  1a 11D0p DOl.' 
sD 
4. Prma dara  i'ain in !b 1a  Ur an sbd 
oswa1hrwsIi ;l 1lleeoo  irmrnn \'lduel ras iisll o a dlrnmio'Creyes   eibod(y  i  dswri ae nu(ynf ierltte r ebt gJolI G ulpe Is   iuonrrn  srdtea aad tesae.tu  o h  oomp(w( erOpCr-r Yy1ud 0.a  altsl iarhsnf.a    r T(eophru  Id l riJem( iav ya dn(ar  nraucami a sbd beiq ed ue0(ytei dan
Iv  A8 
A grdual diffio o( reibilcy for muhi-aure or c:Uabnci  stie 
led in reenl yean (0  aulr "u  has
th pulie:arion of papes a(oer p.,tahd l no single  pre
ospcfa iamen mJc itafoinc tu arskecenn (pust Jt lha rIer  i(tabhiielsl a iwet:Ittyihv.ien  -Tpahwniiocs i/pcahrleiro nis copf.i  caajdil y IR anianu  mtmeh epou rbdl ieicniac lvnioean f1yioinng o0 1tf h oaanct ecp uaanunce.
thor ..ho is responsible (or th  vaiidity of the enure manuscnpl.  .._ . .
Re  de 
.Atli 
sb 
re  maus1'  an annoed
erI. iaC  rciteiae fonr tauc hnon f  0(  unit Th Comminec bcea idcrs th only reable crite
co-auchr ha mad a sipifcant intellecnal or pnctical concrbu

10 be tht the 
lion. Th cOf  osf 'h"r va asu thrsip" is  Ionble.

p!. Tehe  tthint ts alhueth hr a reiewe aU tthh  hpeardi mofa e adcahta  roens wcahirc hu nthit  orre dreta irsm beant  cahnir


de1'ion of  iatinaio conabratios.

p'3hr.e v A. i'pdinpei.  uar  bIrnev1fe0 s utgh:eu toirn  In dcr2fcth e oainfce sh!t bictu osmt-iaouanr.t nhesrlfi.lu 1el(d'I  n asp mnbwr teia - bpseru. os s itIaD m sIeD&ts11)C
 1  f10r 
'1 ......"m.t  ';;jl.inl tht iI be 
estet possible.P sirvat dindiviua 
Va.n TPhU  irCc omemia8e  bdac o
l ftorl ow . ocbo pwiee caepimsa peuwn  s deat  aa&ebs  niit pcfWd1C 1l pfaCiocratie  tbh p aiate liedcrat a
with  ta  a aSI Nreu.c bailait yt ohr   acllluillUiatp  6 slii la  or ma
qmruius p0te(iuo f  nncdmwiff  erinell   isd deisafcI lrCyilb  seci loib mddeiypn  eine ccyo. ttewhL Ms ftata bsst u&ithi bc r an=ly s wewuae d  ipffat aara ywiseaael  o &lr byiD wp.opro 
prialet chol usio wer drwn. Invetiaaton  reew  manus1' 
wRithe  cnpruinclipile  in mind
I The number of  reviewe at lime of facwty apnunnt or pro 
sbd  publications 10 be 
motion  be limned 1ft ordr 10 encou&ed ani  rewar biblio,nphes cioatatianin g 
fleiawl.e frn baum menotreed  sTus'tratt iv(eIt  phual bicaet iossu ratteb  (or uIbamsep il8ct:u1db ilnI lmlfoyre s teb  five 
pape be reiewed (or aptmt as Astat Pres. lI ma dL  for 
Asiate Prfesr. an no mo th 10 for Parbensrc.   manus  jols

2. Simultaus sumissio of mulliple similar  or  10 
Imp,.r.

Jd 
VI.  re:u 
Beaus each  unit  differnt scientific prolems with different 
me:h..-ds. eal.:h unit ihuld develop its own spifirce lauricde linc to idtify prac:tI:es 
Ih;u ;cm mo t lik.ely 10 enh:ac:e the quality of  conducted by Its member.. 
up 
Th\ 'e ';'Jic.elin  should be provIded to the ne  invc'Sug:uor  't:!rtln  ...'r!t  ., . 
.. ,. -  . - -. . .
APPENDIX D

REFERENCES  , " , "
REFERENCES 
SELECTED 
Marcia Angell, M.D. and Arold S. ReIman, M.D. "Fraud in Biomedical Research--A Time 
for Congressional Restrait,  The New England Journal  June 2, 1988. 
of Medicine. 
Marcia Angell, M.D. "Publish or Perish: A Proposal,  Annals of Internal Medicine.  Febmary 
1986. 
Barbar 1. Culliton  Random Audit of Papers Proposed,  Vol. 242, November 1988.
Science, 
Robert L. Engler, James W. Covell, Paul J. Friedman, Philp S. Kitcher, and Richard M. 
Peters, "Misrepresentation and Responsibilty in Medical Research  The New England Jour
November 26, 1987. 
nal of Medicine. 

Penelope J. Greene, Jane S. Durch, Wendy Horowitz, Valwyn Hooper  Policies for Respond
ing to Allegations of Fraud in Research " Harard University, Division of Health Policy Re
Vol. XXlI1 , No. 2, Summer 1985. 
search and Education. Reprinted from  Minerva, 
Institute of Medicine, "The Responsible Conduct of Research in the Heath Sciences, 
Division of Health Sciences Policy, 1989.

Robert G. Petersdorf, M.  The Pathogenesis of Fraud in Medical Science,  Annals of Inter
Februar 1986. 
nal Medicine. 

Public Law 99-158, "Health Research Extension Act of 1985. 
Mark B. Roman, "When Good Scientists Turn Bad,  Discover.  April 1988.
S. Deparent of Health and Human Services, "National Cancer Institute Grants Process, 
National Cancer Institute. NIB Publication No. 86-1222, Revised November 1985; Printed 
Januar 1986. 
S. Deparent of Health and Hman Services, "NIB Guide for Grants and Contracts: 
Policies and Procedurs for Dealing with Possible Misconduct in Science, 
" Vol. 15, No. 11. 
July 18, 1986. 
Deparent of  PHS Grants Administration Manual, 1988. 
Health and Human Services, 
S. Deparent of Health and Human Services,  PHS Grants Policy Statement,  January 1 
1987. 
S. Deparment of Health and Human Services, "Summar of NIH Fiscal Year 1986 Ex
tramural Awards, " National Institutes of Health. December 16, 1987.  United States Genera Accounting Offce, "Biomedical Research: Issues Related to Increasing 
Size of NIH Grant Awards, " GAOIH-88-90BR, May 1988 
FEDERAL REGULATIONS 
Admnistration: Alert Records Concerning Investigations or Detennnations of Misconduct 
by Curent or Potential Recipients ofFunds for Biomedical Research " DHHS/NIHOD. 
Notice. Federa Register. Vol. 48, No. 320. November 29, 1983. 
Debarent and Suspension from Eligibility for Financial Assistance.  Federal 
" Final Rule. 
Vol. 45, No. 198. October 9, 1980.

Register. 
Government-wide Debarent and Suspension (Nonprocurement)." Notice of Proposed

Vol. 52, No. 202. October 20, 1987. 
Rulemakng.  Federal Register. 
Office of the Assistant Secretar for Health; Privacy Act of 1974; System of Records. 
Notification of altered Prvacy Act Systems of Records.  Federal Register.  Vol. 52, No. 1 02.

May 28, 1987.

42 CFR Ch. 1 , Par 50, Subpar D - Public Health Service Grant Appeals Procedures. Oc

tober 1, 1986 Edition.

45 CFR Subtitle A, Par 74 - Admnistttion of Grants. October 1, 1986 Edition.

45 CFR Par 16 - Procedurs of the Deparental Grant Appeals Board. October 1, 1986 Edi

tion.

42 CFR Par 52 - Grants for Research Projects. October 1, 1986 Edition.

42 CFR Par 52h - Scientific Peer Review of Researh Grant Applications. October 1 , 1986

Edition.

45 CFR Par 46, Subpar A - Protection of Human Subjects. October 1 , 1986 Edition.
 . .
APPENDIX E

AGENCY COMMENTS
 ''' . . .~:.:~..,~. :::.
'''YlCI'' 
DEPARTMENT OF HEATH &. HUMAN SERVICES  Public Health Service 
Memorandum 
..a 
Date  JAN 3 0 1989

From

Assistant Secretary for Heal 
Subject  PHS -C8om8me-n0ts7 o-n 0OI0G4 D2ra0ft  Report "Misconduct in Scientific Research 
OAI 
Inspector General , as

Attached are the PHS comments on the subject OIG draft program

inspection report. 
Robert E. Wi ndom, M.

Attachment 
,t.;
""1 
i::' 
'-.1  ----
a: 
GEO FD THR P URBL IE C H "F MTH ISSEROVI C E ON TH OFF I CE OF  NSPrx
IN SCIENIFIC RESEA" 
, SEPER 
OAI-88-07-00420  1988 
General Cbmments

In its report, the DIG attempts to determine (1) the extent to which the 
National Institutes of tIealth' (NIH) and its grantee institutions have developed 
and imp lemented pol i ci es and procedures to prevent, detect, and handle 
scientific misconduct cases; and (2) what selected grantee institutions have 
learned and implemented as a result of their investigations of alleged
scientific misconduct. 
In general, the Public Health Service (PHS) views this 
draft report as a useful discussion of some importani issues related to 
allegations of misconduct in PH extramural programs. -.We believe, however, 
Jhat many of the recommendations merit further careful analysis and discussion 
because of their potential impact on the relationship batween the university
comunity and the Federal Government. The need for open communication cannot 
higly 
--overemphasi-zed, especiall-y---in-this sensitive 'and  visible area  This 
recomendation to 
is especially true for the  establish an independent oversight 
body for scientific misconduct investigations. While the feasibility of 
establishing such an office has not been established, it is imperative that 
such an office not be divorced from the scientific community, as the expertise 
and experience of scientists are vital to the development of responsive and 
misconduct. 
responsible policies and procedures in the area of scientific 
The impl icat ions of the study' s findings have not been fully assessed in the

text of the report. 
In developing its final recommendations, DIG should

compare the ramificat ions 
of strengthening the current NIH program, versus

those of diminishing NIH's responsibilities and establishing a central locus

elsewhere in the 
Department. The current draft does not examine the various

strategies that might be adopted to strengthen the overall role of the

Department in dealing wi th scientific misconduct issues. Such an in-depth 
analysis would make recommendations emerge more clearly.

In the area of "findings," some of the statements are not actually factual
findings but are 
judgmental interpretations that have reference to an unstated 
standard. We question whether these statements add anything meaningful to the 
report. We also note that some of the recommendations have been ovetlken by 
events; for example, the Notice of Proposed Rulemaking on grantee 
responsibilities and the Advance Notice of Proposed Rulemaking were published 
on September 19. This recommendation should be revised accordingly. 
Some aspects of the methodology were not explicit.  have 
For example, we 
validi ty of the 
some concerns about the  telephone survey methodology. The 
report does not provide any information regarding positions and titles of 
those who participated in the 89ntelephone interviews. This is particularly 
important since it appears that some ,of the respondents approached the survey 
as individuals rather than as representatives of their institution. Neither 
the background of the interviewers was described nor what the interview 
schedule was. In addition, the gamut of experience of the respondent could 
very well influence the nature of individual responses. Was t-h-e  more tlfan 
one respondent from each institution? Which institutions had more than one 
allegation or  ase from which to draw? The reliability of the statistics 
provided in the DIG study depend on the  onsistency between interviews.  -:-------
Page 2

-..O 
Add itionally, the information gleaned from the telephone surveys and the site
visits is not clearly distinguished. 
Since one of the two main objectives of 
the OIa study was to determine what selected grantee inst i tut ions have learned 
from their investigations of a-rleged misconduct and whether their experiences 
might be useful 
have caused them to modify their institutional guidelines, it 
to present information obtained from the nine site visits in a separate section 
it as sqch. 
and clearly identify  Furthermore, it would be easier for the 
reader to distinguish data obtained from the nine site visits from that 
gathered in the 89 phone interviews if each finding that is currently prefaced 
- wi th " some grantees" or "a number of grantees" or "a few grantees" is

substituted with statistics (e.g., 4/9, 3/30, etc.

We are also concerned about  he emphasis on numbers of grantees not having 
procedures, particularly in view of the sampling naturet so.f  the survey and the 
absence at that time of speci fic reg  tory requi reme  PHS shares OIG' 
concern that the 1986 guidelines are not being implemented by a majority of the 
institutions receiving NIH grants. However, the key finding that 93 percent of 
NIH grantee institutions holding 100.-01' more-aards -dve-suc-policies- and 
procedures should not be underemphasized. 
The survey resul ts tend to support 
our experience that the research-intensive institutions are increasingly well 
prepared to deal with allegations of misconduct. 
It appears that the authors of the report may have misinterpreted some of the 
information provided about NIH procedures. The variability cited in the 
inconsistencies;  rather, it 
handling of cases does not necessarily result in 
represents an effort to fine-tune procedures based on accumulated exper i ence
and i ndi vidual ci rcumstances. 
OIa Recommendat ion

The Secretary should provide for independent oversight and develop a more 
formalized and centralized process to deal with scientific misconduct including
the following elements: 
(1) an independent third party to act as a fact 
gatherer and collect, retain and analyze investigative data; (2) an independent 
scient i fic review board to assi st in analyzing informat ion concerning 
scientific misconduct; and (3) an independent decision making authority or 
function. This is 
ombudsman type  especially important given the congressional 
investigative units._-
ern regarding the lack of independence of 
PH ComeR 

e agree that greater central management is needed to deal with scientific

nduct. 
sco PHS has develop d a reorganization proposal which would make 
changes both at NIH and in the Office of the Assistant Secretary for Health. 
This has been presented to the Under Secretary but not yet approved. 
At NIH we would establish a new Office of Scientific Integrity reporting to the 
Director of NIH. This office would have operational responsibility for 
conducting independent inves  ations when needed and monitoring investigations 
institutions. Its 
undertaken by awardee  scope would include the Alcohol, Drug
s (AD) 
Abuse, and Mental Health Administration  extramural research 
activities as well as  . On the positive side, the office would foster
 - --
--- --- -- -. -- --.-.
----. --.
Page 3

sclentlTIc Integrity by developing prevention and education programs to be 
conducted by the extramural research offices  The 
throughout NIH and 
office would also develop and propose policies and procedures for approval by
initial 
the Assistant Secretary for Health (AS)  The office would have an 
staffing of six full-time employees.

At the AS level, 
an office  Quld be established to oversee operations of the
research agencies and review pol icy proposals from NIH before they are 
submitted to ASH for approval. In addition, the office could independently 
propose policies for ASH approval. Finally this office would adjudicate cases 
and impose sanctions if warranted. This would 
investigated by NIH or 

assure appropriate independence of the adj  dicative process. The staffing 
level for this office has not been determined. We are also considering the 
establishment of an outside advisory group to review and evaluate PHS policy 
and procedures governing scientific integrity 
OIG Recommenda t ion 
The Department should expedite completion and publication of a regulation

addressing scientific misconduct, as required by law. This will facilitate the

development of procedures by grantees. However, the Department' s reI iance on

the PHS interim guidelines in developing regulations may be unwarranted in

light of the current concerns about scientific misconduct.

PHS Commen t 
We concur that the publication of a proposed rule was urgently needed and long
overdue. The interim guidelines,  1986, were to be in 
which were published in 
effect only until policies could be put into place. This occurred recently, on 
September 1, 1988, with the publication of two Grants Administration Manual 
Issuances. Hence, fully binding policies now are in effect and communicated 
via the Notice of Grant Award. 
We are optimistic that a firm regulatory base 
will encourage and guide grantees in their efforts to deal with allegations of
misconduct. 
Moreover, the comment about the Department's reliance on PHS' 
interim guidelines is inaccurate in view of the pending Advance Notice of

Proposed Rulemaking' s invi tat ion for coment on a broad range of pol icy and 
procedural opt ions. These comments were due by December 19, a d final rules

regarding pr  edures should occur soon after that. 
OIG Recommendat ion-

The Department should require grantees to attach scientific misconduct 
procedures to the grant application  assure compliance with the law. The PHS 
should revi  the procedures on a sample basis and also in ' all instances where 
scientific misconduct cases are reported to assure that essential areas are 
cover ed. 
PHS Comment

We concur that grantee i nst i tut ions should be requi red to submi t copies of
their. mj$Conduct  ocedures. However, we recommend that this be modified to 
applimt 
request submissions from all  institutions to the funding agencies on  . .
--- -
Page- 4

a yearly basis. It is not realistic to request that this information be sent 
with each application: it would be at odds with the Paperwork Reduction Act 
titutions since it is 
and would generate duplication of effort at grantee 
often the case that more than one application is submitted by the same grantee
institution. 
In addition, attachment of this information to each application 
would unnecessarily complicate application processing and expenses at the NIH 
Daipvipsiloinc oaf tRieosenarsc.h  Grants, :Which annually receives approximately 35 000
OIG Recommenda t ion 
The first line of responsibility for conducting an inquiry and/or 
investigation into an allegation of misconduct rests with the grantee. 
However, regulat ions issued by the Department should- requj re that grantees 
immediately notify the Department whenever they detect or receive an allegation 
of scientific misconduct, maintain records of all inquiries and investigations 
and provide the Department wi th periodic status reports. The regulat ions
shoula-speci fy time frames -tor -report ing and conducTing lnqui r ies ana 
investigations. Although we recognize the grantees are concerned about 
flexibility, these requirements are nevertheless necessary to assure adequate 
moni tor ing and oversight by the Department. 
PHS Conmen t 
We concur that all allegations should be reported to the Department if they are 
found by the institution to warrant a formal investigation. However, the 
Summary Recommendat ion statement that  . regulat ions issued by the 
Department should requi re that grantees immediately not i fy the Department 
whenever they detect or receive an allegation of scientific misconduct 
appears to be too broad to be practical. The insti tutions are likely to 
object strongly to such a requirement prior to their having any evidence of 
substance to the allegation. Furthermore, a requirement for such early -
reporting probably would not be feasible from the point of view of the Federal 
Government, as it would probably lead to Federal involvement prematurely in 
local disputes or personal conflicts.

We also agree that time frames for reporting and for conducting inquiries and
investigation  needed. The issue of timing is-ealt with in t  Notice of 
Proposed Rulemaking. 
It is important to emphasize the need for flexibility in 
timing, because the nature and complexity of investigations sometimes 
necessi tate a longer invest igat ional per iod. Grantees should, however , provide 
stigation
regular status reports to the funding agency if an inquiry or an inv 
takes longer than the speci f i ed per iod. 
Certainly, individuals should have easy access to the PHS personnel responsible 
issues. 
for dealing with misconduct  In addition, institutions should report 
immediately any allegations of scientific misconduct that could have 
potentially particularly serious ramifications, such as the health or well 
being of human or animal subjects. 
set  forth 
In any case, we question whether the early reporting requiremen1 as 
- the legislative history of 
in this recommendation is consonant with
L. 99-158-;
 ...-.---
Page 5

DIG Recommenda t ion 
The Department should keep complete and uniform records concerning 
investigations undertaken by the grantees and PHS in order to maintain baseline 
data on the incidence of cases. This information could also be used in 
rienfivniengs gtuiigdaancte iaondn dsir.e ction to grantees in conducting future
PHS Commen t 
We concur that complete and uniform records are highly desirable for the

reasons outlined in the DIG's report and as a basic safeguard for equitable

handling of investigations. In addition to the PHS-wide ALER system for 
tracking individuals who are either ineligible to receive PHS AfunDds  or for whom

funding de isions are subject to special review, both NIH and  have 
established data bases that are designed both to track  pen cases and to 
archive key information about cases that already have been closed. The

tracking  sy-m for 
open cases includes time schedules for processIng as well 
as the status of individual cases under investigation. The trend in developing
procedures and records has been toward increased standardization and 
compl  teness of information collected. We welcome CIG' s advice on improvements
in th 
is area. 
DIG Recommenda t ion 
The Department should encourage individuals wi 
th information about instances of 
possible scientific misconduct to come forward. Grantees should be informed of 
the CIG Hotline, which receives allegations concerning fraud and abuse in the

s programs. 
Department' 
PHS Comment

We concur wi th the recommendation to encourage individuals to come forward wi 
allegations of misconduct; this already is being done. 
The funding agency
should be notified regarding possible misuse of funds, and the DIG should be

notified in the case of possible criminal violation. For the last 5 years,

notices of a grant award include information about the CIG Hotline; however

this information does not  ecessarily reach all individuals assoc ated with a

research project. We a5ree that more needs to be done to educate researchers 
students, and administrators in this regard. We will publish notices 
regarding the reporting of misconduct on at 
least an annual basis in the NIH 
Guide for Grants and Contracts, which reaches 
over 30 000 recipients. 
CIG Recommenda t ion 
The Department should explore ways to protect the "whistleblower 
" since 
detection of possible scientific misconduct relies so heavily on individuals 
allegation. 
willing to make an  Currently Federal employees who engage
whi st leblowing" are protected by law. Simi lar protect ion should be provided
to individuals reporting possible scientific misconduct by grantees.  -- 
.. --.
Page 6

PHS Commen t 
We concur that improved protection for "whistleblowers ' is essential to the 
integrity of the process. 
PHS is aware of the need to protect the 
whistleblower.  Some protection currently is provided to "whistleblowers, " by 
the acceptance of anonymous allegations. PHS currently is in the process of 
This is occurring 
providing proper protection. 
examining additional means  at 
by communication with the research community, including direct discussions with 
whistleblowers.  An important aspect of this effort is the need to encourage 
discourage the 
and maintain responsibility in whistleblowing efforts and to 
use of the misconduct reporting system for the resolution of personal or 
profess i onal di sputes. Appropr ia te protect Lon for the "wh i stleb lower" wi 11 
require legislation. 

OIG Recommends t ion 
The Department should explore al ternat ive methods of detect ing possible 
- -mi sconduct. Examp les of possible methods are spot audi ts of s  i ficlda ta or 
journals. 
special reviews byueditors of scientific 
PHS Commen t 
We concur in principle regarding this complex topic. We would support 
exp lorat ion of reasonable "methods to detect mi sconduct. Indeed, exi st ing 
tr i als of invest iga t ional drugs and other i ntervent ions al ready have audi t 
procedures bui 1 t into thei r design, and several instances of mi sconduct have 
been detected in this way. 
However, we are skeptical about the utility of 
large- the di ff icul ty of interpret ing large volumes of 
scale audi ts, given 
original data. 
Recommendations such as this, which would dramatically affect 
the relationship between the university community and the Federal Government, 
should receive further public coment and discussion. While we do not believe 
such data audi ts are feasible, any serious considerat ion to perform such 
audits should not occur without input from the grantee community. 
In addition, it is not clear what is intended by "special reviews by editors of 
scientific journals.  It is unlikely that editors would be willing to serve as
agents of the Department. There is, however, considerable evidence that 
journal edit  needed. Scientific 
are aware that greater vigilance is 
misconduct was the topic of a rece"\t meeting sponsored by the Editorial Policy 
the COci 
Commi ttee of  1 of Biology Edi tors, Inc. Whi Ie it would not be 
appropr ia te for the Federa 1 Government to speci fy that journa 1 edi tors conduct 
speci al reviews, the Federal Government should work wi th the edi tors to 
- encourage theJJ rev ewers to become mote vigi lant and involved in reviewing 
manuscripts for discrepancies. 
OIG Recommendat ion 

The Department should develop a table of penalties, such as the model adopted 
by the Office of Personnel Management,  assure that sanctions are applied 
misconduct. 
consistently and fairly in cases of scientific  ---
- .-.---.-
Page 7

PHS Commen t ------

We concur with the thrust of this recommendation. The PHS interim policies as

lance between consi stency
developed and implemented are intended to provide 

and the need for flexibility. While we doubt that these considerations can be 
reduced to a formula or table, the continued accretion of experience will no 
into 
doubt improve the process. At this stage, we have grouped the sanctions 
levels of severity, and furth r experience may permit us to develop an 
appropriate model. 
OIG Recommenda t ion 
The PH 
should assume a leadership role and provide guidance to the grantees 
matters related to scientific misconduct. 
The PHS should sponsor a consensus conference to develop model

guidelines for use by grantees in addressing all relevant areas of

scient i f ic mi sconduct. 
The PHS should continue its efforts in the area of prevention, such as 
the contract with the Institute of Medicine to develop scientific 
standards for the conduct of responsibl  science. The PH should 
develop model preventive guidelines and require that institutions adopt 
these measures as a condition of funding. 
PHS Corren t 
PH 
We concur.  has exercised a leadership role in this area and will continue 
to do so. It is worth noting that the grantee comunity has welcomed and 
sought leadership from PH, 
as indicated by invitations to present at national
association and professional society meetings, extensive formal and informal 
iries about the status of regulations. With regard to 
consultation, and inq 
f ic 
the speci  recommendat ions: 
We believe that both PH and the private sector have provided ample 
opportunity for public discussion of model guidelines. Clearly, there 
are areas in which consensus has not been achieved, e.g., the timing
nd threshQld f  reporting allegations of misconduct and the proper 
balance between due process and expdi t ious resolut ion of cases. 
addition, the process-4nitiated with the publication of the Advance 
full 
Notice of Proposed Rulemaking continues the opportunity for 
historical 
discussion of these issues. On the other hand, viewed in 
erspective, th 
e is an impressive degr e of consensus about 
institutional responsibilities. 
We support the recomme  dation for sponsorship of a conference at the 
appropriate time. This would be particularly helpful to smaller 
institutions, which would appear to welcome additional guidance in this 
area. 
Such model guidelines would help to-ensure more consistency 
procedures, policy, and protections.  . . 
. .
Page 8

The PHS believes that it should have a role in supporting education-
regarding ethical issues of science and should continue its efforts in 
this regard, in cooperation with the private sector, in identifying and 
promoting the responsible conduct of research.' The PHS will continue 
its discussions with outside groups who are experienced in dealing with 
that 
effective educational procedures. It is unlikely, however, 
Nor is 
preventive guidelines could adequately cover every situation. 
it clear that the imposition of guidelines is desirable or enforceable. 
It should be noted that the Department permits considerable variations 
in financial accountability procedures, provided the procedures allow 
for sound management and audi t trai Is in grant transactions. Given the 
complex nature of scient i fie accountabi 1 i ty, it seems reasonable to 
allow comparable flexibility in that area, provided basic fiduciary 
- ob 1 i ga t ions are met. 
It is important to recognize that discussions already are ongoing under

--ariety-
of sponsorships (e.g. ,  American Association  f Universities, 
American Association for the Advancement of Science, Institute of 
Medicine) and in response to our own Advance Notice of Proposed 
Rulemaking and Notice of Proposed Rulemaking announcements that were 
published recently. A "framework" document to provide guidelines for
insti tutions is being developed, which involves input from a large 
number of different agencies. The National COnference of Lawyers and 
All 
Scientists is continuing a dialogue on this proposed framework. 
these mechanisms provide effective interactions between Federal and

non-Federal personnel. One goal of this interaction is the development

of model prevent i ve guidel i nes and appropr iate procedures for deal ing 
wi th mi sconduct. 
Technical COmments

Page 1, Purpose

report that 
It should be stated in the  at the time of the study grantees were

not yet requ i red by regulat ion to have  procedures in place but, nevertheless,

the Office of Inspector General wanted to determine to what extent such

procedures have been dev loped.

Page 
Whi Ie we recognize that this report focuses on NIH, many of the requirements

also apply to other agencies of PHS. 
We bel ieve it would be more accurate to

add a statement to this effect at the beginning of the report.

Page 1, The Problem of Scientific Misconduct

In the last paragraph, the report refers to "  . the increasing number of

reported scientific misconduct cases during the 1980' s. .  " We have no

evidence of such an increase. Furthermore, the report should be clarified to

state that these represent a minuscule fraction of investigators supported by

NIH.  Page 9

Page 2, Federal Involvement In Scientific Research

reflect 
Paragraph 2 should be revised to  (1) that issues of research integrity 
and quality control are addressed during the grant approval and management 
process, e.g., in clinical trials, plans for quality control and monitoring are 
considered during review and post award, and (2) PHS agencies become involved 
if allegations are reported directly to the agency and during monitoring of the 
status of inquiries and investigations before a finding of misconduct is 
confirmed. The statement in this paragraph regarding sanctions or formal 
corrective actions should be clarified to state whether this refers only to 
agencies. 
actions by the Secretary or also to actions by the 
Page 2 , Paragraph 2, Third Sentence

The-entence states that  internal  scientific 
"Grant-applications undergo an 
external  y peers of tbat 
review. . . .  Grant applications undergo an  reVIew 
scientist who have been determined not to have a con lict of interest with the

principal investiga  or grantee institution. In addition to an assessment of

the scientific merit and technical qualities of the research proposal, the 
reviewers consider the background, training, and track record of the
investigator(s). 
In addition to the peer review and subsequent review by the 
institute advisory council, the application receives review by NIH grants 
whether appropriate 
management and scientific program personnel to determine 
considerat ion has been given wi th respect to human and animal subjects as well 
as fiscal considerations and overlap with other research support. NIH 
programmatic personnel, who are trained scientists, and grants management 
specialists review all noncompeting renewal as well as competing applications. 
ow scientific 
The programatic personnel apply their  background and experience 
toward making the best funding decisions with respect to the science. They 
also monitor scientific progress, read the scientific literature, attend 
scientific meetings when funds permit, and generally are alert to detect 
irregularities. 
misconduct or other 
While it is true that NIH normally gets involved in an allegation of misconduct

only after the completion of the ini tial inquiry or after receipt of

communication from the "whistleblower," NIH will continue to monitor cases at

an earlier stage when circumstances require it , for example if NIH learns that

a grantee institution is less than  ully prepared to deal with an allegatJon of

research mi sconduct. 
Page 2, Federal Action on the Problem of Scientific COnduct

The report states that NIH has been perceived as having moved slowly in 
basis. 
handling allegations and in functioning on an ad hoc  Yet, both NIB 
personnel and the institutions agree that individual cases differ considerably, 
and their experience so far has occurred within a relatively limited number of 
cases. 
Moreover, in order to provide at least the elements of due process, 
such as review and rebuttal of findings from all parties to an investigation 
in handling allegations. 
the PHS agencies have emphasized accuracy and fairness 
Certainly, it is important to examine what patterns can be learned from  . . .
Page 1 
individual cases, whar-procedures work best, and what sanctions should be 
applied.  inappropriate,  at thi 
However, it is difficult, and probably  s stage 
to try to constrain a diverse group of cases into a constricted or limited 
approach. 
rect 
Indirect costs are narrowly defined and might or might not be of di 
assistance in monitoring and investigating cases of alleged research
mi sconduct. .

Page 3 , Paragraph 4

Since NIH does not always conduct its investigations by appointing a panel of

scientific peers, we suggest that the first sentence be changed to read "The

NIH usually conducts its investigations. 

Pages 3 and 4

The following paragraph,  which refers to the Institute of  edicine study.-Ws 
draft.-
omi tted from the final 
has: 
issued 
"Since the passage of this legislation, the Department 
"The Policies and Procedures for Dealing wi th Possible Misconduct in 
Science" (di scussed above); establ i shed the "PHS COmmi ttee on 
Misconduct in Sc ience" to exchange information about investigations and 
discuss relevant policy proposals; been developing the regulations 
called for in the bill; been developing criteria/guidelines on 
appropriate debarment periods for misconduct in science; and contracted 
wi th the Inst i tute of Medicine to identify ways for NIH to encourage 
comunity to engage in reasonable and responsible 
the scientific 
conduct focusing on preventive measures. 
This paragraph describes actions that the Department has implemented since

passage of the Health Research Extension Act. We believe it should be included

in this report to provide an accur te picture of current Federal efforts.

Page 4, Last Paragraph

report that the si 
There are clear indicat!ons in this  tuation reported by 
Penelope J. Greene, et aI, in "Policies f-e Responding to Allegations of Fraud

in Research," Harvard University, Division of Health Policy Research and

Education, is vastly different today, and there is general agreement that much

has changed.

ullet 
Page 6, 

At the time of the OIG interviews, there were two full-time professionals
assigned to the office which deals with misconduct. This is in addition to the 
Di rector of the Off ice of Extramural Research, who serves as the PHS Mi sconduct 
Policy Officer. To provide the reader with the current status of NIH staffing 
in the misconduct area, we recommend that you indicate the assignment of

area. 
additional professLonal staff to the misconduct  Since the time of the

been-aed to 
OIG interviews, two professionals have  the NIH office that
 Page 11

handles allegations of misconduct in science, the Institutional Liaison 
Office. 
This increases the core staff of that office to five full-time 
equivalent positions, including the following: Chief , Institutional Liaison 
Office; Health Scientist Administrator; Examiner; Program Analyst; and

secretary. The main responsibility of the Chief and the entire responsibility

of the Health Scientist Administrator and of the Examiner are with scientific

misconduct investigations, while the responsibilities of the Program Analyst

and of the secretary are divi  ed between misconduct investigations and

publication of the NIH Guide for Grants and COntracts.

Page 8, Paragraph 2

This paragraph should acknowledge that investigations of misconduct are handled 
on an individual basis, as the cir  umstances of each case vary. However , to 
the extent that simi lar allegat ions or problems have been deal t wi th, NIH does 
use past experience in guiding future actions. PHS guidelines (NIH Guide to 
Grants and COntracts, July 1986) provide specific guidance as to what steps 
staff are to undertake when allegations. are received.

Page 9 , Absence of Procedures

Since the estimates in the report are based on a sample survey and derived

report. Since the 
weighted estimates, this should be made explicit in the 
number of grantee institutions contacted is relatively small, it would be

useful to provide the numbers which correspond to the stated percentages,

thereby giving the reader a better sense of the context of the estimates.