American Journal of Law & Medicine

The unending saga of legal controls over scientific misconduct: a clash of cultures needing resolution.(Law, Medicine and Socially Responsible Research)

I. INTRODUCTION

There are a remarkable number of similarities between science and the law. Each discipline sets as a gold standard a search for precision. For example, scientists utilize the scientific method--a specific set of principles and procedures designed to aid them in a systematic pursuit of knowledge. Following the scientific method involves the recognition and formulation of a problem, the collection of data through observation and possibly experimentation, the formulation of a hypothesis and the testing and confirmation of the hypothesis formulated.(1) The law, in turn, seeks its form of precision through the careful use of words, as in finely crafted statutes or regulations and contractual language that seek to eliminate the possibility of vagueness or confusion. Each discipline utilizes an approach or methodology that strives to minimize or eliminate the possibility of error and to arrive at a form of "truth" that it recognizes as being maximal within the confines of the rules it has established, be they rules of scientific method or legal rules of evidence.

At the same time, however, there is a notable clash of cultures between the disciplines of law and science, and nowhere is this clash more evident than in the lengthy--but still very current--battle over appropriate definitions, rules and procedures concerning legal controls over scientific misconduct. For well over a decade, this dispute has been played out, in large measure, through rulemaking and agency adjudication within the federal regulatory process, as well as in the political arenas of congressional hearings, statutory mandates and claims of key roles for self-appointed monitors of scientific integrity. The ultimate penalty on a finding of research misconduct is debarment from participation in federal grants and contracts,(2) but the long-term implications for the professional reputation and careers of those disciplined may be even more significant.(3)

Currently, the scientific and legal communities are awaiting action by the Secretary of the Department of Health and Human Services (DHHS) on a series of proposed regulatory changes based on a study mandated by congressional action.(4) This issue is critical for approximately 200,000 researchers supported by Public Health Service (PHS) grants--researchers who "want the government to leave them alone but also want it to protect them against false or frivolous accusations of misconduct."(5) The general trend over the past decade has been away from a primarily scientist-run process toward one in which lawyers have played an increasingly crucial role.(6)

This Article reviews the history of government responses to scientific misconduct and lays out the current regulatory mechanisms for its monitoring and control. The Article then details a number of the cases and incidents that have demonstrated significant dissatisfaction--on the part of scientists, their attorneys, government regulators and elected officials--with some of current regulatory approaches. After describing proposed alterations to the current regulations, this Article evaluates the proposed changes in light of the various investigations of alleged instances of scientific misconduct that have has transpired to date. It concludes by suggesting that the movement toward a more legalistic approach in dealing with allegations of scientific misconduct is appropriate.

II. HISTORY

Prior to the 1980s, allegations of scientific misconduct apparently were handled by the institutions in which the cases arose, either on an ad-hoc basis or through review processes established by the institutions themselves.(7) The incentive for action lay both in the institutions' desire to maintain the integrity of their research programs and in their concern that failure to do so could jeopardize funding for such programs. Ultimately, even absent the more particularized government process described below, control of scientific misbehavior is intimately connected with the supervision of federal research project funding. Thus, DHHS has long had the power to punish researchers for scientific misconduct by making them ineligible for government grants and contracts, and it in fact has used this power.(8) Moreover, because it is typically the institution, such as a university, that technically receives the grant or contract, oversight has been viewed as both an institutional and a government responsibility.(9) Within DHHS, two agencies have principal responsibility for federal funding of scientific research: the National Institutes of Health (NIH) and the National Science Foundation (NSF). Because most of the more interesting cases and sources of controversy have arisen in the context of NIH-funded research, this Article focuses on this area.(10)

Public disclosure in 1980 of scientific misconduct at a variety of major research centers ultimately prompted Congress to include in the 1985 Health Research Extension Act a requirement that institutions seeking federal research grants establish "an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by" the institution and "report to the Secretary [of Health and Human Services] any investigation of alleged scientific fraud which appears substantial."(11) In addition, the statute required the Director of NIH to "establish a process for the prompt and appropriate response to information provided to the Director [of NIH] respecting scientific fraud in connection with projects for which funds have been made available under this chapter ... and taking appropriate action with respect to such fraud."(12)

Subsequently, in September 1988, PHS issued an Advance Notice of Proposed Rulemaking in which it indicated that the government wanted to formulate regulations on a variety of issues surrounding scientific misconduct, and that it was seeking comments from the public on these matters. Among others, the Advance Notice identified the following issues for determination: (1) an appropriate definition of scientific misconduct; (2) the responsibilities of institutions receiving federal funds in the identification, reporting and taking of actions in instances of alleged or apparent scientific misconduct; (3) the responsibilities of PHS and DHHS in assessing institutional practices and imposing sanctions--and in developing appropriate structures and programs for so doing; (4) possible areas of joint DHHS-awardee institution responsibility, such as in the areas of whistleblower protection and prevention of scientific misconduct; and (5) the propriety of government-wide policies on scientific misconduct.(13) The Advance Notice stated:

[E]ven a small number of instances of scientific misconduct is

considered a threat to the continued public confidence in the

integrity of the scientific process and in the stewardship of

Federal funds. The traditional safeguards such as peer review

and guidance from professional organizations must be

supplemented by explicit institiutional [sic] commitment to

high ethical standards in research.(14)

With its Advance Notice, PHS issued a proposed rule designed to deal primarily with the second of the issues listed above: the responsibilities of institutions receiving federal funds.(15) In March 1989, PHS created an Office of Scientific Integrity Review (OSIR) within the Office of the Assistant Secretary for Health (OASH). It also created an Office of Scientific Integrity (OSI) within NIH.(16) OSIR was designed (1) to establish overall PHS polices and procedures for dealing with scientific misconduct; (2) to oversee the activities of PHS research agencies such as NIH and the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) to ensure implementation of PHS-established policies and procedures; and (3) to review final reports of misconduct investigations, make final recommendations on imposition of sanctions and conduct independent investigations.(17) OSI was designed to oversee implementation of PHS policies and procedures on scientific misconduct, monitor investigations conducted by institutions receiving PHS funds for research and conduct investigations as necessary.(18) OSI was staffed primarily by scientists to enable peer evaluation according to scientific norms.(19) The OSI investigation process was modeled on academic committee investigations of alleged academic misconduct or review of tenure disputes.(20) The mandate of OSI staff was to ascertain the truth of scientific disputes without permitting the accused to confront their accusers or even necessarily to examine the entire body of allegedly incriminatory evidence.(21) Although OSI was thus designed to play a prosecutorial role in situations where the result could be the expulsion of scientists from their professions, the Office was conceived by scientists who wanted to avoid lawyers and legal procedures. Inattention to a variety of due process considerations in devising the system, however, has resulted in many of the problems discussed below.

In June 1992, OSI and OSIR were consolidated into the Office of Research Integrity (ORI), which was then transferred entirely out of NIH and into OASH.(22) Investigatory responsibility was removed from NIH and placed in a different arm of DHHS. Apparently, these changes were in response to congressional criticism that investigations had not been pursued with adequate vigor because universities and NIH were incapable of investigating their own scientists.(23) Shortly thereafter, ORI authorized a standing DHHS appeals board, consisting of lawyers, to review findings of misconduct in a more legal-like setting.(24)

In January 1994, pursuant to requirements of the National Institutes of Health Revitalization Act of 1993,(25) ORI was made an independent entity in DHHS (though remaining within OASH for budget and general administrative purposes), with its director reporting to the Secretary of DHHS.(26) In November 1995, responsibility for ORI was moved to the Office of Public Health and Science within the Office of the Secretary of DHHS.(27)

III. CURRENT REGULATORY SCHEME

PHS issued a Final Rule in August 1989 (effective in November 1989) that, with the exception of some minor changes, mirrors the language of the original proposed rule.(28) The Final Rule sets forth requirements for handling and reporting possible instances of scientific misconduct by institutions applying for or that have been awarded PHS research funding. In addition, in June 1991, PHS issued a Notice of Policies and Procedures announcing its plan to promulgate a lengthy set of Policies and Procedures for Dealing with Scientific Misconduct in Extramural Research.(29)

Subsequently, PHS indicated that it would issue a revised final rule on the document as a Notice of Proposed Rulemaking.(30) To date, however, it has not issued any subsequent version of the Policies and Procedures, presumably in order to incorporate some of the recommendations of the Ryan Commission.(31) It did, however, provide for a procedure for an individual to seek a hearing on ORI findings of scientific misconduct.(32) These policies and procedures are designed to govern how PHS itself deals with scientific misconduct allegations at its own facilities or at grantee institutions when such allegations are reported after inquiry by the institutions or PHS. In detailing how intramural investigations are to be conducted, this document, by its own terms, significantly tracks and makes applicable to PHS the provisions of the previously published Final Rule that were applicable to awardee institutions. In February 1997, ORI issued an ORI Handbook for its officers. The handbook was designed to "facilitate the collaborative effort required between institutions and the ORI to pursue allegations of scientific misconduct efficiently and effectively.... [It] describes the respective roles of institutions and the ORI in implementing the PHS regulation."(33)

A. DEFINITION OF SCIENTIFIC MISCONDUCT

Among the more critical aspects of the Final Rule as adopted is a definition of "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." Misconduct in science "does not include honest error or honest differences in interpretations or judgments of data."(34)

B. THE ASSURANCE MECHANISM

As a mechanism for maximizing compliance with the substantive provisions of the Final Rule, PHS also created an "assurance" process under which institutions applying for PHS grants or contracts are required to have in place a mechanism-utilizing the broad steps outlined in the Rule--for reviewing reports of misconduct.(35)

The assurance process mimics the one established earlier by DHHS in connection with its efforts to ensure that proposals for funding research involving human subjects be reviewed by an institutional review board (IRB) at each institution. The IRB would analyze the proposal in terms of potential risk/benefit ratios and provision of adequate informed consent by subjects.(36) Similarly, the Animal Welfare Act protects animals involved in research and requires institutions to provide assurances to the federal government that animals are maintained in a humane fashion.(37)

While NSF has not adopted a similar assurance process for its awardee institutions, it does rely on the institutions to undertake a process very similar to that described for PHS awardees.(38) Thus, applicant and grantee institutions must establish policies and procedures for investigating and reporting allegations of scientific misconduct involving research, research training or related activities for which PHS funds have been requested or awarded.(39) The Rule specifies the appropriate time and procedure for notifying PHS of possible misconduct and requires that if there is a reasonable indication that a criminal violation has occurred, the DHHS Office of Inspector General (OIG) will be notified within twenty-four hours.(40) In addition to the assurance process, ORI requires institutions to file Annual Reports of Possible Research Misconduct.(41) Moreover, ORI staff can conduct institutional compliance reviews on both institutional administrative policies and procedures and the conduct of active inquiries or investigations?

C. INSTITUTIONAL PROCEDURES

The critical provisions of the Final Rule essentially require institutions to develop a two-step process to deal with allegations of misconduct. Initially, institutions must conduct an "inquiry" (generally to be completed within sixty days of initiation) under which information is gathered and there is initial fact-finding (in the nature of a probable cause finding) "to determine whether an allegation or apparent instance of misconduct warrants an investigation."(43) This inquiry results in a written report detailing the evidence reviewed, summarizing the interviews conducted and indicating the conclusions reached.(44) The respondent is given an opportunity to review and comment on this report.(45) If the inquiry leads to a conclusion that the allegation is unfounded, no report need be made to ORI.(46) However, the institution must maintain documentation of the inquiry to enable ORI to engage in a "later assessment of the reasons for determining that an investigation was not warranted."(47)

If after initial inquiry an institution concludes that an "investigation" --that is, a "formal examination and evaluation of all relevant facts to determine if misconduct has occurred"(48)--is warranted, initiation of the investigation must be reported to ORI.(49) At this point, ORI places into the PHS ALERT System the names of both the individual being investigated and the investigating institution.(50) The information is maintained in the system until ORI or the DHHS Department Appeals Board (DAB) concludes that a finding of misconduct is not supported, or until the term of any administrative action taken by the government expires.(51)

The formal investigation that follows usually must involve a review of all documentation, including relevant research data and proposals, publications, correspondence and memoranda of telephone calls. All individuals involved in making the allegation, or against whom the allegation is made, must be interviewed, and summaries of these interviews must be provided to the subjects for comment or revision.(52) The Rule requires institutions to maintain documentation to substantiate investigation findings so ORI can decide whether to proceed with its own investigation or to act solely on the basis of the institutions' findings.(53) Ultimately, if misconduct allegations are substantiated, institutions must impose appropriate sanctions on the individuals involved, and they may be required to assist ORI in implementing any sanctions ORI might impose.(54) In any event, ORI must be notified of the final outcome of the investigation.(55) Throughout the investigation process, institutions are required (1) to secure the expertise necessary to carry out any inquiry or investigation;(56) (2) to attempt to avoid real or apparent conflicts of interest in the investigation process;(57) and (3) to take necessary interim actions to protect federal funds,(58) Moreover, the Rule requires that, "to the maximum extent possible, the privacy of those who in good faith report apparent misconduct" be protected.(59) Investigations are to be conducted in a confidential fashion and are to be prompt and thorough.(60) If misconduct allegations are not confirmed, institutions must endeavor to restore the reputations of persons charged and also must attempt to protect the positions and reputations of those making the good faith allegations.(61)

D. REPORTS TO ORI

If whistleblowers contact ORI directly, ORI refers their allegations to the institutions for investigation, because the institutions are considered primarily responsible for finding and punishing scientific misconduct.(62)

The rules lay out in some detail how institutional investigation reports to ORI are to be made.(63) Institutions' final reports must describe the "policies and procedures" regulating their investigations, how and from whom information was obtained, investigation findings and sanctions imposed, and the position taken by any individuals found to have engaged in misconduct.(64)

E. ORI INTERNAL PROCEDURES

When ORI receives a final investigation report, it reviews the report to determine whether the investigation was timely and adequate.(65) ORI can request from institutions further explanation or additional information and can conduct its own investigation at any point in the process if it determines that such an investigation is necessary.(66)

ORI's "oversight" reviews of institutional reports are directed at determining whether an institution's findings are "defensible, well supported by the evidence and acceptable as a final resolution of the allegations."(67) If there is a finding of scientific misconduct, ORI must evaluate whether the institution could meet its burden of proof if the matter should be litigated on an appeal to a DAB.(68) This involves reviewing all the documents used by the institution during the investigation, including grant applications, publications, computer files, research data, slides, letters, memoranda, transcripts, summaries of interviews, and so forth.(69) ORI may request that investigating institutions provide it with additional information, consider additional questions or do further analysis. ORI may reanalyze data or perform new analysis of data in deciding whether to accept an institution's report.(70)

Typically, the oversight review results in agreement between the institutional and ORI findings, but if ORI reaches a different conclusion, it may decide not to pursue the allegation or to open its own investigation.(71) On concluding its oversight review, ORI prepares a report describing the investigation process (institutional and/or ORI) and its conclusions on the issue of misconduct. If ORI does not find scientific misconduct, a copy of its report is sent to the institution, which is requested to notify both the respondent and the whistleblower of the outcome of the investigation.(72) If ORI proposes a finding of misconduct, the respondent and the institution are notified and the respondent is advised of his or her opportunity to request a hearing.(73)

ORI may conduct its own inquiries(74) and investigations for a variety reasons, including the following: (1) a finding by ORI that the institutional investigation was inaccurate or incomplete;(75) (2) a request by the institution that ORI conduct its own investigation;(76) (3) alleged scientific misconduct at a PHS facility? and (4) involvement of multi-site clinical trials.(78) In conducting its own inquiries and investigations, ORI typically will notify the institution, the whistleblower and the respondent that an inquiry or investigation is being conducted. ORI will also advise the respondent of the nature of the allegations, his or her right to seek counsel and other procedural matters.(79) ORI will ask the institution to sequester evidence relevant to the allegations.(80) In conducting an inquiry or investigation, ORI will appoint one or more scientific experts to assist it, interview all relevant witnesses, review and analyze the relevant evidence and prepare a report.(81) ORI will send a draft report to the respondent for comments, and ORI will consider these comments in drafting its final report.(82) Whistleblower comments are also solicited and considered where the whistleblower has provided evidence and complied with ORI procedures regarding confidentiality.(83)

On issuing of its final report, the institution, whistleblower and respondent are notified and the file is closed if misconduct is not found.(84) If misconduct is found, the respondent is notified of the proposed administrative actions to be taken and is informed of the right to request a hearing before DAB.(85) If no hearing is requested, or the findings of scientific misconduct and proposed administrative actions are affirmed by DAB, sanctions are imposed and the various methods of publicizing the decision are instituted.(86) If debarment is proposed, the approval of the Deputy Assistant Secretary for Grants and Acquisition Management, DHHS' debarring official, must be obtained.(87)

F. APPEALS TO RIAP

Under procedures instituted in November 1992, individuals have the right to an administrative hearing on ORI findings and proposed actions. Such hearings are to take place before a Research Integrity Adjudications Panel (RIAP) operating under the direction of DHHS DAB.(88) This administrative hearing step was added in response to claims, by several accused scientists and their lawyers, that OSI (and later ORI) investigation and sanction procedures violated the respondents' due process rights by giving them little opportunity to confront their accusers or to rebut the evidence against them.(89) Dr. Bernadine Healy, the director of NIH when the appeals board was instituted, said she insisted on the change because she "came full circle to thinking that an adversarial system was necessary. It had become obvious that this was a totally polluted system where these scientists got behind closed doors and worked out their venom, taking down their colleagues. It was a star chamber, a hideous travesty of justice."(90)

Although appeals initially were to be conducted according to DAB procedures for other grant disputes,(91) guidelines published in 1994 set forth in some detail specific provisions for RIAP proceedings.(92) The stated intention of the procedure is to combine, whenever possible, hearings on misconduct findings and proposed administrative actions with RIAP hearings to which respondents are otherwise entitled as a result of a debarment proposal.(93)

Within thirty days of receipt of ORI's proposed findings, a respondent must request a RIAP hearing from DAB. The request must identify specifically the factual findings and proposed administrative actions disputed, as well as any legal issues the respondent intends to raise.(94) DAB is composed of five DHHS attorneys.(95) The chair of DAB then designates from this group a presiding panel member to hear and decide the case, and another attorney to serve as a contact for parties on both sides.(96) The presiding panel member sets hearing procedures, presides at the preliminary conference and hearing, and generally "leads development of the case."(97) Two additional members are appointed to RIAP, and on request by either party, one of them can be a scientist or other expert from outside DAB.(98) At the preliminary conference, issues such as the following are addressed in an effort to increase fairness and efficiency: specificity of the findings; designation of disputed facts; identification of documents to be submitted; date, location and anticipated length of the hearing; names of witnesses and the general nature of their proposed testimony; the need for briefing of issues prior to the hearing; and possible stipulations or admissions of undisputed facts.(99) Peculiarly, only the presiding panel member is required to attend the hearing; other panel members may attend as much or as little of the hearing as they wish, although they do have access to hearing transcripts.(100) At the hearing, although formal evidentiary rules do not apply, the presiding panel member is authorized to refer to the Federal Rules of Evidence for guidance.(101) The proceeding is in the nature of a de novo review.(102) That is:

[The RIAP] decision is not a review of what ORI did during its

investigation or whether what ORI found was reasonable based on the

evidence ORI considered. Rather, ... the Panel is to determine whether

ORI proved the findings of scientific misconduct which ORI made, and

which were appealed, and to determine the appropriateness of the

proposed administrative action.(103)

In addition to evidence submitted for the original investigation, ORI can present other relevant evidence if it identifies such evidence in a timely fashion. During the hearing process, parties can file motions and pleadings, make legal arguments and request discovery.(104) They can give opening and closing statements and present and cross-examine opposing witnesses--although RIAP members may also participate in questioning. …

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