Report of the Department of Health and Human 

Services Review Group on Research Misconduct and 

Research Integrity 

I. BACKGROUND 

The Department of Health and Human Services (HHS or Department) is one of the nation's largest 

funders of research and is the largest funder of biomedical research. The Department has a 

responsibility to exercise appropriate oversight over the expenditure of public funds, and to assure 

the integrity of the scientific record created through research supported by these funds. 

HHS has long-standing authority to address misconduct in research conducted by the Department 

agencies or funded by HHS under its discretionary grant authorities. In addition, the Department 

has authority under federal criminal and civil fraud statutes related to research misconduct. The 

Department has been formally involved in addressing allegations of research misconduct since 

1981 when this work became the responsibility of the Institutional Liaison Office, Office of 

Extramural Research, National Institutes of Health (NIH). 

The first specific statutory authority on Public Health Service (PHS)1

 research misconduct matters 

was enacted in 1985.2

 This provision amended the PHS Act and directed the Secretary to 

promulgate regulations requiring entities that apply for PHS research funds to establish a process 

for reviewing reports of "scientific fraud"4

 and to report investigations to the Secretary.3 The PHS 

Act further instructed the Director of the NIH to establish a process for responding to reports of 

scientific fraud. 

On August 8, 1989, HHS published its final regulation regarding research misconduct.5 The 

regulation sets out the "responsibility of PHS Awardee and Applicant Institutions for Dealing With 

and Reporting Possible Misconduct in Science," and defines misconduct in science as: "fabrication, 

falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within 

the scientific community for proposing, conducting, or reporting research. It does not include honest error or 

honest differences in interpretations or judgments of data."6

 

The definition of research misconduct and procedures for addressing allegations set forth in the 

regulation apply by their terms only to extramural scientists who conduct PHS-supported research 

with funds under PHS grants and cooperative agreements. However, PHS administrators have 

applied an identical definition of research misconduct, and similar procedures for addressing 

allegations,7

 to intramural scientists who conduct research in PHS 8laboratories. The intramural 

procedures were revised most recently in 1994.9

 

In June 1992, the Office of Research Integrity (ORI) was created to replace prior organizational 

units.10 The NIH Revitalization Act of 1993 (NIH Act) established ORI as an independent entity 

reporting to the Secretary.11 ORI is organizationally located in the Office of Public Health and 
Science, Office of the Secretary, and is administered on a day-to-day basis by the Assistant 

Secretary for Health (ASH). 

In November 1992, the PHS announced an interim procedure that gives respondents an 

opportunity to appeal adverse findings by ORI of research misconduct in a de novo administrative 

hearing before the HHS Departmental Appeals Board (DAB).12 Respondents are entitled to a 

hearing regardless of whether the level of sanction that is imposed at the conclusion of the ORI 

process is an administrative sanction, such as required supervision, or debarment from eligibility 

for federal grants and contracts.13 

According to the Conference Report of the NIH Act,14 ORI's statutory mandate is to maintain 

"confidence in the integrity of the scientific process, in individual researchers, and in institutions 

which accept Federal funds," so that research can continue to enjoy public support.15 The 1993 

legislation establishes the qualifications for the ORI director, and requires the establishment of a 

definition for research misconduct. The statute contains details on the administrative processes 

that must be established by institutions as a condition for receiving PHS funding, including the 

establishment of a process to be followed for responding to information regarding research 

misconduct. In addition, the statute requires ORI to establish procedures for: receiving reports 

from recipients of PHS funds; conducting investigations; and, taking actions to remedy misconduct. 

Further, the statute requires ORI to: monitor the administrative processes that have been 

established, or carried out, by institutions receiving federal funds; establish regulations designed to 

protect whistleblowers; and, remedy institutional defects in whistleblower protection. Regulations 

have not been issued implementing the amendments to section 493 enacted in 1993.16 

In August 1996, at Secretary Shalala's request, Dr. Philip R. Lee, then the ASH, convened a group 

of HHS officials to examine the role of the ORI in handling allegations of research misconduct in 

research funded or conducted by HHS programs. The Secretary's charge to the ASH was to: 

• Review and analyze the Department's processes for handling allegations of research 

misconduct from a policy perspective, and make appropriate recommendations aimed at 

improving quality, effectiveness, and efficiency of the processes; and, 

• Consistent with the policy recommendations, suggest organizational arrangements for the 

Department that would facilitate achievement of the recommendations and the objectives of 

improving quality, effectiveness, and efficiency of the processes. 

This examination of ORI activities was designed to enable HHS to respond effectively to the 

recommendations of the Commission on Research Integrity, known as the Ryan Commission, 

named for its chair, Dr. Kenneth Ryan. The Ryan Commission presented its report to the Secretary 

in late 1995, and the Secretary's Science Advisor, Dr. William Raub, created the Implementation 

Group on Research Integrity and Misconduct to evaluate these recommendations for the Secretary. 

This review of Departmental policies and procedures complements that effort. 

Additionally, in 1996, the White House Office of Science and Technology (OSTP), through the 

Committee on Fundamental Science (CFS) of the National Science and Technology Council (NSTC), 
established a working group comprised of representatives from the major research agencies 

(including HHS), to develop a government-wide policy on research misconduct. The NSTC goal was 

to develop a definition of research misconduct and a set of guiding principles for Federal agencies 

and the funded institutions, and to enhance the uniformity of definitions and underlying principles 

applied by Federal agencies. In May 1999, after an extensive agency review and clearance process, 

NSTC approved the proposed government-wide policy, which consists of a definition of research 

misconduct and guidelines for handling allegations of research misconduct. The NSTC plans to 

publish the proposed policy for comment in the Federal Register. Agencies will be directed to 

implement the policy, following final publication. HHS intends to coordinate implementation of the 

recommendations in this report with any final action taken by NSTC. The recommendations in the 

ORI report are consistent with -- and substantially similar to -- the government-wide policy 

proposed by NSTC. 

The focus of the HHS Review Group has been on evaluating current procedures and exploring ways 

to improve Departmental action in the area of research misconduct. The Review Group first 

examined Departmental experience accumulated through the operation of the ORI and its 

predecessor the Office of Scientific Integrity (OSI). Members of the Group received detailed 

briefings that addressed ORI operations, statistical analyses of ORI cases, the types of ORI cases, 

processing times, their dispositions, and educational and outreach activities. Additionally, the 

Review Group met with representatives of the DAB and the HHS Inspector General. The Review 

Group consulted and met with experts outside the Department and government, including the 

Inspector General of the National Science Foundation and administrators and faculty of various 

research institutions having experience in handling allegations of research misconduct. Throughout 

the review process, ORI continued to emphasize its oversight and educational functions and many 

of the changes anticipated by the report recommendations are underway. 

The Review Group recognizes that legislative and regulatory changes may be necessary to 

implement its recommendations. Additional coordination and consultation with parties affected may 

also be required to refine specific means of implementing the Review Group's recommendations. 

II. FINDINGS AND RECOMMENDATIONS17 

The Review Group finds that over time there have been significant improvements in the 

Department's handling of issues of research misconduct. Although there have been highly 

publicized reversals of a few cases, a rigorous review of the entire record of the Department's 

performance leads to the conclusion that the systems and processes have generally performed 

well. This same review also leads to the conclusion that performance can be further improved and 

the HHS role in the process potentially streamlined. 

A. Recommendations Pertaining to the Definition of Misconduct 
Recommendation 1. 

HHS should adopt a revised definition of research misconduct. 

The Review Group recommends that HHS adopt the following definition of research misconduct: 

Research18 misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing 

research, or in reporting research results. 

• Fabrication is making up results and recording or reporting them. 

• Falsification is manipulating research materials, equipment, or processes, or 

changing or omitting data or results such that the research is not accurately represented 

in the research record.19 

• Plagiarism is the appropriation of another person's ideas, processes, results, or 

words without giving appropriate credit, including those obtained through confidential 

review of others' research proposals and manuscripts. 

• Research misconduct does not include honest error or honest differences of 

opinion. 

While the proposed definition is slightly different from that currently used by HHS, the Review 

Group views the proposed definition as an improved version, focusing attention on improper 

behaviors that are specific to the conduct of research. Moreover, the public comment process will 

offer the opportunity for further consideration and refinement. 

Recommendation 2. 

Protections for human research subjects and animal welfare are covered through other specific regulatory 

mechanisms and should not be considered to be within the scope of the Department's definition of research 

misconduct. 

The Review Group concluded that the other mechanisms now in place that address human research 

subject and animal welfare protections involve processes familiar to the research community. 

Adding conduct relating to these issues to the scope of a definition of research misconduct is 

unnecessary. 

Recommendation 3. 

Improper acts and misbehaviors in the conduct of scientific research that do not fit within the proposed definition of 

research misconduct should be handled through the existing mechanisms of an awardee institution20 or other 

responsible organization21 or through other appropriate mechanisms of redress. 

Other improper acts or misbehaviors may be associated with or may form part of complaints or 

accusations of research misconduct. Examples include theft of property; sexual harassment; and, 

other types of impermissible discrimination.22 While such acts, if proven, are deplorable, they are not 

specific to science. Complaints and accusations about these types of activities should be handled 

through existing mechanisms of an institution or responsible organization, or through other generally 

available and appropriate mechanisms. Although these behaviors are not appropriately addressed as 

research misconduct, all intramural HHS organizations and extramural institutions receiving HHS 

research funding should have procedures that address these behaviors. 

B. Recommendations Pertaining to Inquiries and Investigations 
Recommendation 4. 

The fact-finding processes of inquiry and investigation should be the responsibility of and conducted by an awardee 

institution or by a responsible organization under a set of policies and procedures approved by HHS. 

The Review Group recommends that both the inquiry and investigation phases of the fact-finding 

process should be conducted by awardee institutions or other responsible organizations. This 

institutional role places the fact-finding processes as close as possible to the site of the alleged 

misconduct where research standards and practices are understood in context and access to evidence 

is facilitated. This recommendation makes clear that fact-finding at the federal level will not routinely 

occur. 

The Review Group has carefully considered and weighed the possible issues that might be raised by 

placing full responsibility for the fact-finding stages with the awardee institution(s). The Review Group 

recognizes that it is plausible to predict that bias could affect awardee institutions' and responsible 

organizations' responses to an allegation of research misconduct. One extreme might be the "white 

washing" of allegations of misconduct by viewing events and behaviors in the light most favorable to 

the accused. Alternatively, awardee institutions and responsible organizations could respond with 

over-zealous pursuit of allegations in order to protect the reputation of the institution at the expense 

of the alleged transgressor. 

The Review Group is persuaded by its consultations that it is in the best interests of awardee 

institutions -- and thus, of persons accused -- to respond to allegations of research misconduct in a 

documentable, even-handed, and fair manner. While isolated problems may arise, the recommended 

actions, carried out within appropriate policies and procedures, should provide adequate checks and 

balances to assure a fair and even-handed approach. Additionally, the Review Group was impressed 

with the success of awardee institutions' handling of the fact-finding components of NSF's misconduct 

processes. 

Additional support for the Review Group's high level of confidence regarding the fairness of 

institutional fact-finding comes from a review of the policies and practices of several large research 

institutions and from the experience of ORI. The Review Group consulted administrators and faculty 

from awardee institutions and responsible organizations that receive substantial HHS grant awards. 

The Review Group was particularly impressed by the universal commitment to even-handedness in 

fact-finding as an essential element of maintaining the reputation and credibility of an institution or 

organization. 

The Review Group's consultations also support the conclusion that most research-intensive institutions 

and organizations have the capacity, through infrastructure currently in place, to conduct inquiries and 

investigations in a competent manner. Where institutions do not have that capacity, institutional 

representatives with whom the Review Group consulted have cited the availability of reasonable 

alternative mechanisms to provide these services. HHS would also assist institutions and responsible 

organizations in developing and securing such alternatives where necessary or indicated (see 

Recommendation 5). 

The policies and procedures of awardee institutions and responsible organizations conducting inquiries 

and investigations will have to meet published HHS standards. Institutions and organizations would be 

required to provide assurances to that effect to the HHS granting organization in the same manner 

that current assurances are provided on policies applying to research on human subjects, for example. 
Recommendation 5. 

HHS should encourage the development of consortium-based approaches to be used by awardee institutions that do 

not have the capacity to conduct the fact-finding process, or at which there is otherwise inadequate institutional or 

organizational capacity. 

The Review Group recommends that awardee institutions have the primary responsibility for 

conducting inquiries and investigations (the two phases of the fact-finding process) into allegations of 

research misconduct under the general oversight of HHS. Federal fact-finding, other than when 

conducted within intramural organizations, should be rare. To reduce further any need for federal factfinding other than for intramural components and to improve the ability of small to middle-sized 

institutions to discharge their responsibility, HHS should encourage the formation of consortia that can 

conduct the fact-finding process when establishment of an individual institutional or organizational 

process is impractical. 

The Review Group envisions consortia potentially taking many forms. Consortia may be groups of 

awardee institutions; groups formed by professional organizations; or mixed groups formed for the 

specific purpose of providing for the conduct of fact-finding processes on behalf of awardee 

institutions. The key is that the consortium will be organized to assist a responsible awardee 

institution that otherwise cannot properly conduct fact-finding. Awardee institutions that engage 

external fact-finding capacity remain responsible for meeting their obligations with regard to scientific 

misconduct correction. 

The Review Group also envisions consortia as partners in Federal educational efforts. Currently, 

several professional organizations have committees specifically constituted to address issues of 

research misconduct. Some of these organizations have already established training and education 

programs designed to improve institutional capacities to prevent and avoid the occurrence of research 

misconduct and to perform inquiries and investigations as needed. Although the Review Group sees 

the educational mission as a fundamental federal responsibility that is tied to the standards setting 

process, collaboration between consortia and a redesigned ORI charged with oversight is expected to 

produce valuable results. 

Recommendation 6. 

Federal fact-finding23 should be conducted only where all other options fail or where there is compelling reason to do 

so. Federal fact-finding should be conducted by the HHS Office of the Inspector General augmented, as appropriate, 

by scientific personnel. 

Situations may arise in which it is necessary for HHS to assume the responsibility 

for fact-finding. It has been noted by the NSF24 that investigations conducted by a federal body may 

be indicated when: allegations of misconduct also involve a crime; the close association of individuals 

in a small institution may tarnish the actual or perceived objectivity of an investigation; or when 

allegations involve institutional officials in the wrongdoing.25 Additionally, complex cases involving 

conflicts of interest, multiple institutions, or a subject who no longer has an institutional affiliation can 

provide reason for fact finding to be taken on in a specific case by a federal body. 

The Review Group recommends that inquiries and investigations which must be conducted by a federal 

entity be performed by the HHS Office of the Inspector General (OIG), with appropriate additional 

scientific advisors/consultants as necessary. The OIG is accustomed to conducting investigations and 

maintains a skilled staff. However, such staff must be augmented, in some cases, by scientifically 
knowledgeable persons. The OIG can expedite fact-finding by the use of its subpoena powers. The 

Review Group believes that the maintenance of a cadre of investigators apart from the OIG cannot be 

justified on a cost basis. Also, with the limited number of cases anticipated, the skills of investigators 

cannot reasonably be maintained. Additionally, separating the federal investigation from any part of 

the Federal adjudication process would produce a process that is consistent with other inquiryinvestigation-adjudication processes in research misconduct. 

The Review Group emphasizes, however, that an OIG investigation should be necessary only in very 

unusual instances. Any awardee institution that cannot or will not conduct the fact-finding process 

should be assisted to develop its own capacities or to affiliate with an entity or consortium that can do 

the work. In the view of the Review Group, an institution that fails to discharge its responsibility to 

perform fact-finding, refuses to perform fact-finding, or fails to conduct the process in an acceptable 

manner after receiving technical assistance should be reviewed to determine its suitability for 

continuing eligibility to receive awards. 

C. Recommendations Pertaining to Procedural Issues 

Recommendation 7. 

Fact-finding processes in cases of potential research misconduct should be clearly separated from administrative 

decision-making and adjudicative processes. 

There are two essential phases of fact-finding. One is the inquiry phase and the other, the 

investigative phase. In the inquiry phase, allegations are examined to determine if there is sufficient 

basis to warrant an investigation. Where no such basis is found to exist, a matter should be dismissed 

at this stage. Where the inquiry phase finds sufficient evidence to warrant an investigation, ORI should 

be so notified, and the case should proceed to investigation. 

In processing cases, fact-finding should be separated from decision-making at both the responsible 

organization and the federal levels. For example, the report and recommendations of an inquiry panel 

from an awardee institution should be forwarded to an institutional or agency official who had not 

been involved with the inquiry. That official will make the decision to accept, reject, or modify that 

panel's recommended action(s). Similarly, the report of an investigative panel at an awardee 

institution should be forwarded for review to a senior official who had not been involved in the conduct 

of the investigation. When an inquiry ends with the decision that there is no reason to open an 

investigation, the matter ends there. ORI need not be informed of that determination. 

When an inquiry ends with a decision to move a matter to investigation, that decision should be 

reported to ORI. Thereafter, the awardee institution will investigate the matter and recommend either 

to exonerate or to sanction the accused. 

If the investigation results in a finding of no misconduct, ORI should be notified of the investigation's 

conclusion and the reasons that support it. ORI will review the record of the investigation to 

determine, inter alia, that the record supported the outcome and that the procedures used were 

thorough, objective and competently applied. The ASH will retain the authority to reverse the finding 

and/or to request that a new fact-finding process be undertaken. 

If the investigation concludes with a finding of misconduct, ORI should be notified of the finding and 

reasons in support of it as well as any institutional sanctions. If the investigating institution 
recommends federal action, that recommendation will be forwarded to ORI for review along with 

supporting documentation. 

ORI will have to develop procedures for reporting by responsible organizations of all the decisions 

above-identified as appropriate for ORI notification. 

ORI would review the forwarded documents and make sanction recommendations to the ASH who will 

then issue a decision regarding the proposed sanctions. Vesting such decision-making responsibility in 

the ASH rather than the PHS agency heads would do much toward ensuring consistent consideration 

across cases and over time. The decision of the ASH would be appealable to the DAB. 

Recommendation 8. 

Guidelines that outline reasonable expectations for the allowable time for each step of the process need to be 

developed. 

Clear expectations for the timely processing of allegations should be developed and published. Several 

problems associated with the present process stem from the inordinate amount of time that has been 

taken to address allegations from start to finish. Timely conduct of the inquiry, investigation, and 

adjudication phases must be a clear commitment among Federal and institutional partners. 

Additionally, defined time limits for the accused to respond or contest decisions should be established. 

The Review Group recognizes that actual time frames may vary from case to case because of 

complexity, collection of evidence, or other factors, and so does not propose adoption of a binding, 

universal set of time constraints. Nonetheless, the Review Group believes that describing time goals 

will provide an incentive for expeditious handling of cases. 

Recommendation 9. 

The role of the complainant, whether at the level of the awardee institution or the responsible organization, or when 

the case is being handled within HHS, is that of a witness only. Once the complainant has made a formal allegation 

that research misconduct has occurred, that person should not participate in the fact-finding phase, or in any other 

aspect of the determination of misconduct, other than as a witness. 

On occasions in the past, the complainant has become a more significant part of the investigative 

process to the net detriment of the efficiency and effectiveness of the procedure. The approach 

recommended here is based on and consistent with the approach employed by the HHS Office of the 

Inspector General. This recommendation is consistent with the provisions of section 493(e) of the PHS 

Act which require the Secretary of HHS to promulgate regulations to protect whistleblowers from 

retaliation for having made an allegation of research misconduct or cooperated with an investigation of 

research misconduct. Proposed regulations implementing this mandate are forthcoming. 

Recommendation 10. 

A determination that research misconduct has occurred must be established by a preponderance of the evidence. 

As stated in the Government-wide debarment and suspension regulations, debarment26 and other 

sanctions are used to protect the interest of the Federal Government and to assure that it conducts 

business only with responsible persons. Debarment and other sanctions are taken to protect the 

public's and the Federal Government's interests, not for purposes of punishment.27 The debarment 

regulations appropriately adopt an evidentiary standard of preponderance of the evidence, the usual 

standard of proof in civil actions. Awardee institutions, responsible organizations, and HHS should 
apply this standard in evaluating whether research misconduct has occurred in a particular instance. 

The Review Group also considered the appropriateness of applying the more rigorous standard of clear 

and convincing evidence given the significant reputational interests at stake for scientists found to 

have engaged in misconduct. Because the government's purpose in imposing debarment or other 

sanctions is to protect its interest in conducting business only with responsible persons, the Review 

Group concluded that requiring the application of a more demanding evidentiary standard before 

sanctions for research misconduct could be imposed would not adequately serve that governmental 

interest. 

D. Recommendations Pertaining to Special Considerations 

Recommendation 11. 

The principal responsibility for oversight of institutional processes, education, standards setting, and attention to 

HHS's interests in policing research misconduct should be vested in ORI. The role, mission, and structure of ORI 

should be changed to become one principally of oversight, education, and review of institutional findings and 

recommendations. 

Although inquiries and investigations should be the province of awardee institutions, there are several 

responsibilities and functions that are exclusively federal in nature, the most obvious of which is the 

decision to recommend a federal sanction as the result of an investigation that finds that research 

misconduct occurred. This function should be assigned to the ASH. Oversight, education, standards 

setting, and other functions which do not require a decision to sanction should be conducted by a redesigned ORI. The Review Group recommends that the role, mission, and structure of ORI change to 

become one of preventing misconduct and promoting research integrity principally through oversight, 

education, and review of institutional findings and recommendations. 

A redesigned ORI would have the principal responsibility for providing model guidance to awardee 

institutions on matters including, but not limited to, the conduct of inquiries and investigations, 

expectations regarding the various roles to be fulfilled, and the treatment of the accused and 

witnesses, including the accuser. The ORI would provide educational and consultative aid regarding 

expectations, as well as guidance on investigative procedures and techniques. 

The most substantial federal function assigned to the ORI, however, would be the review of cases in 

which the institution has conducted an investigation and reached a conclusion about whether or not 

research misconduct occurred. Each such case record would be reviewed to determine whether the 

record supported the outcome and that the process was thorough, objective and competently done. 

ORI would be empowered to examine cases and recommend to the ASH that a finding be accepted or 

rejected. ORI would also be independently empowered to request additional information or 

explanations from an awardee institution that had performed a case investigation. 

It is important to note that the Review Group does not envision or recommend that a redesigned ORI 

undertake investigations or make final decisions on sanctions. Its role in the processing of cases would 

be to assess the record of the institutional fact-finding phases for content, to assure compliance with 

proper processes, and then to recommend sanctions to the ASH. The Assistant Secretary for Health 

would review the record of the institutional investigation and the proposed action(s), and, after giving 

the accused the opportunity to respond in writing to such proposed action(s), including proposed 

sanctions, would make a determination to accept or reject the conclusions and to impose sanctions. In 
making her or his determination, the ASH will consult any persons within HHS whose expertise or 

assistance the ASH deems necessary or appropriate. 

This decision would be final, unless contested where debarment is the sanction imposed (see 

Recommendation 13.). When the sanction imposed is debarment, the decision of the ASH would be 

considered a recommendation to the Deputy Assistant Secretary for Management and Budget (Grants 

and Acquisition Management) who makes the final debarment decision. 

Recommendation 12. 

Institutions and members of awardee institutional inquiry and investigational panels28 should be provided qualified 

immunity from tort or related actions for accepting the responsibility of reviewing allegations of research misconduct 

in connection with the receipt of federal funds pursuant to the HHS policy. 

The performance of inquiries and investigations by the awardee institution can expose panel members 

and institutional investigators to personal legal actions. These legal actions can be a significant 

disincentive to persons asked to serve as members of inquiry or investigation panels. Although a few 

states provide qualified immunity for faculty at public universities who engaged in such service, most 

do not. 

The nature of inquiries and investigations dictates that the best and most highly qualified and 

respected persons be available for service. If increased responsibility is to be borne by awardee 

institutions, the Federal Government must make every effort to enhance the ability of institutions and 

organizations to draw on the assistance of their own faculties and employees in the investigation of 

allegations of research misconduct.29 

Recommendation 13. 

The Departmental Appeals Board (DAB) should continue to provide hearings for individuals who contest findings of 

scientific misconduct. Three years after this Report is implemented, HHS should examine and consider whether 

hearings in non-debarment cases should be eliminated. 

Currently, all individuals found by ORI to have engaged in research misconduct are afforded the 

opportunity to challenge the findings and proposed administrative sanctions in hearing before the 

Departmental Appeals Board (DAB).30 The accused are permitted "to be represented by counsel, to 

question any evidence and witnesses presented by ORI, and to present evidence and witnesses in 

rebuttal to the findings and proposed administrative actions." The DAB's decision to accept or reject 

ORI's decision at the end of the hearing constitutes final agency action, except in cases involving 

debarments. DAB debarment proposals are considered recommendations to the Deputy Assistant 

Secretary for Grants and Acquisition Management who makes the final debarment decision. This 

official may reject the DAB's conclusions only after determining that they are arbitrary and capricious 

or clearly erroneous. 

31 If HHS determines that the DAB is to remain the locus for hearings relating to research misconduct, 

enhanced procedural and evidentiary rules will be needed to streamline and improve the process. 

Further, the level of scientific expertise on the panels that hear scientific misconduct cases needs to be 

increased. 

The Review Group believes that, with the following changes, the DAB remains the best institution for 

managing appeals from decisions to impose sanctions for research misconduct. DAB hearing panels 
should be comprised of one DAB member or Administrative Law Judge (ALJ) and two scientists. The 

DAB would develop a panel of scientists from which two scientists would be selected to serve on 

research misconduct appeals panels. This change would ensure that each case is heard by panels of 

which the majority of members are respected scientists, thus ensuring credibility for DAB 

determinations in the government and in the scientific community. The DAB member or ALJ member 

of the panel would ensure that each panel had the benefit of a person experienced in the legal issues 

presented by administrative hearings. A decision to debar reached by the DAB, as is the case with the 

current process, would serve as a recommendation to the Deputy Assistant Secretary for Grants and 

Acquisitions Management. 

The Review Group also recommends that HHS promulgate procedural and evidentiary regulations to 

govern the conduct of DAB proceedings. As part of the three year evaluation suggested in 

recommendation 14 of this report, a determination should be made as to whether or not the 

procedural and evidentiary processes then in effect adequately strengthen the hearing process. If not, 

HHS should consider requiring that each DAB panel include an Administrative Law Judge. In addition, 

HHS may wish to seek legislative changes to permit the DAB to compel witnesses and the production 

of documents in these cases. Such authority would ensure that all relevant evidence is available to the 

DAB, thus enhancing the integrity of the process and the credibility of the result. 

In addition, the Review Group recommends surveying the due process protections afforded by 

institutions during the investigative process. Awardee institutions conducting investigations vary 

widely in the scope and amount of due process afforded those facing allegations of scientific 

misconduct. Although all institutions provide the respondent with an opportunity to comment on the 

final report before it is sent to ORI, some provide an early opportunity to confront the evidence 

compiled and others, though not many, provide a full-scale hearing. The Review Group believes that 

strengthening procedures used by institutions in developing the record during the fact-finding stage 

and enhancing due process protections afforded the accused will help minimize the number of cases in 

which findings of misconduct are contested. Moreover, improving the procedures used during the 

institutional stage will help ensure a fair process and a stronger record on which the ORI and the ASH 

can rely during the adjudicative stages of the process. 

Although the Review Group recommends, for now, maintaining the current practice of making DAB 

hearings available in all cases where a finding of scientific misconduct is made, it is important to note 

that not all such hearings are required by law. HHS is required by the U.S. Constitution to provide 

respondents facing a recommended sanction of debarment with an opportunity for a hearing. The 

Department is not, however, required to provide such hearings to respondents facing non-debarment 

administrative actions such as prohibition against service on advisory bodies, required certification of 

data or sources, plans of supervision, or retraction or correction of published materials. These 

administrative actions generally do not constitute a deprivation of a liberty or property interest for 

which the due process clause of the Constitution would require a hearing, accompanied by the right to 

be represented by counsel and to confront and cross examine adverse witnesses. 

These recommendations may produce significant changes at the institutional level. As the system 

matures and improves, full hearings in all non-debarment cases may no longer be appropriate. Three 

years after the changes recommended in this report are implemented, as part of the evaluation 

suggested in Recommendation 14, HHS should reconsider whether or not the opportunity for a full 

DAB hearing should be provided for all non-debarment cases. 
Recommendation 14. 

The plan proposed in this report should be independently evaluated three years after its implementation. 

The Review Group recommends that an evaluation be made of the operation of the system proposed 

here for addressing scientific misconduct in research funded or undertaken by the Department. In 

order to gather adequate data for a reliable evaluation, some time will be needed both to put the new 

system in place and to gain experience with its operation. The Review Group proposes, therefore, that 

at the end of the third year of operation under the system proposed here, an evaluation be done by an 

independent organization (e.g., the National Academy of Sciences) or by an agency of the Federal 

Government outside the Department (e.g., the Office of Science and Technology Policy). The 

evaluation may produce recommendations for change, if necessary, to redirect the Department's 

activity to assure that misconduct in science is addressed effectively, efficiently and fairly, consistent 

with the principles described in this report. 

III. Conclusion 

The Review Group believes the acceptance and implementation of these recommendations would 

improve HHS's performance in dealing efficiently and equitably with allegations of research 

misconduct. Most large universities and awardee institutions already have some capacity to conduct 

inquiries and investigations and already do so as a matter of routine. The Review Group envisions a 

transition period of one to two years in which significant development activities would need to be 

undertaken. During this period, new rules and regulations would need to be written, proposed, and 

adopted; ORI would need to be reorganized and restructured; new model policies and procedures for 

adoption by awardee institutions would need to be developed; and, an aggressive effort to develop 

consortia to assist grantee institutions that either do not have or do not wish to develop internal 

capacities would be needed. The rapid establishment of an expanded educational structure in 

combination with an oversight structure in ORI would be key to implementing these recommendations. 

The Review Group understands that additional resources will be needed to implement its 

recommendations, and that other resources will need to be redeployed during the transition period. 

However, the Review Group believes that the plan recommended here will vastly enhance the mission 

of confronting scientific misconduct in an effective, efficient and equitable way. 

1. The Public Health Service (PHS), with the Secretary of HHS as its head, consists of the 

Agency for Health Care Policy and Research; the Agency for Toxic Substances and Disease 

Registry; the Centers for Disease Control and Prevention; the Food and Drug Administration; 

the Health Resources and Services Administration; the Indian Health Service; the National 

Institutes of Health; the Substance Abuse and Mental Health Services Administration; the 

offices of the Regional Health Administrator in each of the ten HHS regions; and, the Office of 

Public Health and Science, OS. 

2. Public Health Service Act § 493, 42 U.S.C. § 289b ("the PHS Act"). 

3. PHS Act § 493(a) (1985). 

4. Id. § 493(b). 

5. 42 C.F.R. Part 50, Subpart A: 54 Fed. Reg. 32446. 

6. 42 C.F.R. § 50.102. In accordance with the legislative history of the PHS Act, the regulation 

substituted the term "misconduct in science" for the statutory term, "scientific fraud." The 
definition of research misconduct adopted in the regulation essentially codified the policy that 

had been followed by the PHS since the early 1980's. 

7. When this report refers to "HHS-funded" or to "awardee institutions", the reference should 

be construed to apply both to HHS intramural research entities and to extramural entities that 

receive HHS funding. 

8. Intramural laboratories operated by the NIH, the Centers for Disease Control and 

Prevention, and the Food and Drug Administration are included. 

9. "General Procedures for Dealing with Possible Scientific Misconduct in PHS Intramural 

Research." 1994; "Instructions for Assessing Allegations and Conducting Inquiries in Cases of 

Scientific Misconduct in PHS Intramural Programs" (1994). 

10. 57 Fed. Reg. 24262. 

11. NIH Act § 161, 42 U.S.C. 289b; 59 Fed. Reg. 2856 (1994). 

12. 57 Fed. Reg. 53125. 

13. Id. See also, 45 C.F.R. Part 76, 48 C.F.R. Subparts 9.4 and 309.4. The hearing 

procedures were revised on May 5, 1994. 59 Fed Reg. 29809 (1994). 

14. H.R. Conf. Rep. No. 100, 103rd Cong., 1st Sess 19 (1993). 

15. Id. at 107 

16. PHS Act § 493, 42 U.S.C. § 289(b). 

17. These findings and recommendations do not affect, alter, or modify the Food and 

Drug Administration’s authority under the Federal Food, Drug, and Cosmetic Act and the Public 

Health Service Act to regulate products within its jurisdiction or to conduct investigations of 

research activity involving such products. 

18. Research, as defined herein, includes all basic, applied, and demonstration 

research in all fields of science, engineering, and mathematics. 

19. The research record is defined as the record of data or results that embody the 

facts resulting from scientific inquiry, and includes, for example, laboratory records, both 

physical and electronic, research proposals, progress reports, abstracts, theses, oral 

presentations, internal reports, and journal articles. 

20. An awardee institution is that institution which is the recipient of record of HHS 

funds. 

21. Responsible organizations may be consortia or other institutional units that are 

qualified to conduct inquiries and/or investigations on behalf of an awardee institution. See 

Recommendation 5, infra. An awardee institution would remain accountable in the case where 

a responsible organization acts in its behalf. 

22. The proposed definition of research misconduct does not encompass all acts or 

behaviors that might be considered incompatible with responsible conduct of research. For 

example, "research misconduct" as proposed does not include honorary authorship (claiming 

or accepting co-author status for a report on research in which one had only an 

inconsequential role or none at all) or bibliography inflation (multiple reporting of the same 

research results without clear and explicit disclosure of the replication). DHHS recognizes that 

responsible conduct of research entails more than refraining from fabrication, falsification, and 

plagiarism. Nevertheless, DHHS also recognizes that research institutions, scientific societies, 

refereed journals, and other entities within the scientific community are the appropriate parties 

to address apparent or alleged research improprieties that fall short of research misconduct. 

23. Other than those conducted as a part of an intramural process in an HHS operating 

division. 

24. Investigating Misconduct in Science: The National Science Foundation Model. 

Herman, K.G., et al. Journal of Higher Education, Vol. 65, No. 3 (May/June 1994), page 395, 

endnote 14. 
25. The NSF also notes that it will initiate its own investigation when an institutional 

investigation is deemed to be inadequate. 

26. The Government-wide debarment and suspension regulations define debarment as 

"an action taken . . . to exclude a person from participation in covered transactions." 45 C.F.R. 

§ 76.105(f). "Covered transactions" include grants, cooperative agreements, scholarships, 

fellowships, contracts of assistance, and any non-procurement transaction between a Federal 

agency and a person. 45 C.F.R. § 76.110. 

27. 45 C.F.R. 76.115. 

28. Panels that operate as a part of a responsible organization acting on behalf of an 

awardee institution would be treated in the same manner for purposes of limited immunity. 

29. A useful model for such a statute can be found in provisions that provide qualified 

immunity for medical professional peer review activities in the Health Care Quality 

Improvement Act, 42 U.S.C. § 11101, § 11111. 

30. The current policy of providing a de novo hearing opportunity for anyone found to 

have engaged in scientific misconduct is not a regulatory creation. The opportunity for a 

hearing was announced in the Federal Register as an "interim procedure." 57 Fed. Reg. 53125 

(1992). 

31. 57 Fed. Reg. 53125 (1992). See 45 C.F.R. Part 16 and DAB Guidelines for Hearings 

Before the Research Integrity Adjudications Panel, published June 4, 1994.