The Commission on Research Integrity Ryan Commission Figure

In 1993, as part of the Act that continued funding for the National Institutes of Health (NIH), the US Congress mandated the formation of a Commission, charged with considering the whole field, from the definition of misconduct, through the process of handling cases, to whistleblower protection. The Commission, of which the two of us were members, held 15 open meetings in five different cities across the US, and heard hundreds of witnesses "including scientists, whistleblowers, attorneys, institutions, scientific organizations, the press, interested citizens and government officials."12 The number and severity of the cases presented to the Commission was impressive.

At the end of 1995, asserting that the US Federal Government had an interest in professional misconduct involving the use of federal funds in research and which could affect the public health, the Commission recommended that the definition of research misconduct (Figure 2.1) should be "based on the premise that research misconduct is a serious

1. Commission on Research Integrity's Definition12

Research misconduct is significant misbehavior that improperly appropriates the intellectual property or contributions of others, that intentionally impedes the progress of research, or that risks corrupting the scientific record or compromising the integrity of scientific practices. Such behaviors are unethical and unacceptable in proposing, conducting, or reporting research or in reviewing the proposals or research reports of others.

Examples of research misconduct include but are not limited to the following: Misappropriation: An investigator or reviewer shall not intentionally or recklessly a. plagiarize, which shall be understood to mean the presentation of the documented words or ideas of another as his or her own, without attribution appropriate for the medium of presentation; or b. make use of any information in breach of any duty of confidentiality associated with the review of any manuscript or grant application.

Interference: An investigator or reviewer shall not intentionally and without authorization take or sequester or materially damage any research-related property of another, including without limitation the apparatus, reagents, biological materials, writings, data, hardware, software, or any other substance or device used or produced in the conduct of research.

Misrepresentation: An investigator or reviewer shall not with intent to deceive, or in reckless disregard for the truth, a. state or present a material or significant falsehood; or b. omit a fact so that what is stated or presented as a whole states or presents a material or significant falsehood.

2. Other Forms of Professional Misconduct a. Obstruction of Investigations of Research Misconduct

The Federal Government has an important interest in protecting the integrity of investigations in reported incidents of research misconduct. Accordingly, obstruction of investigations of research misconduct related to federal funding constitutes a form of professional misconduct in that it undermines the interests of the public, the scientific community, and the Federal Government.

Obstruction of investigations of research misconduct consists of intentionally withholding or destroying evidence in violation of a duty to disclose or preserve; falsifying evidence; encouraging, soliciting or giving false testimony; and attempting to intimidate or retaliate against witnesses, potential witnesses, or potential leads to witnesses or evidence before, during, or after the commencement of any formal or informal proceeding.

b. Noncompliance with Research Regulations

Responsible conduct in research includes compliance with applicable federal research regulations. Such regulations include (but are not limited to) those governing the use of biohazardous materials and human and animal subjects in research.

Serious noncompliance with such regulations after notice of their existence undermines the interests of the public, the scientific community, and the Federal Government, and constitutes another form of professional misconduct.

Figure 2.1 The US Commission on Research Integrity's definition of research misconduct.

violation of the fundamental principle that scientists be truthful and fair in the conduct of research and the dissemination of its results."12 The Commission, which we will hereafter in this section call "we", strongly recommended the development of a common federal definition of research misconduct and other forms of professional misconduct related to research. With its definitions, we put forward examples within the report (Figure 2.1).

By defining the central terms used in the definition of misconduct, we obviated the problem endemic in institutional proceedings in which every investigative panel secured a dictionary and defined for itself key elements upon which its findings depended. This common and understandable impulse all too frequently compromised the integrity of individual misconduct proceedings, as the resulting ad hoc definitions did not pass the "laugh", let alone the "red-face", test. In addition to providing a fuller internal definition of plagiarism, our proposed definition explicitly addressed other issues upon which faculty review panels repeatedly stumbled. For example, we incorporated misconduct in reviewing manuscripts or grant applications into the definition of offenses outside acceptable professional conduct.

We also researched and then recorded the legal reality in the US that the "standard of proof" required in civil proceedings is the "preponderance of the evidence", not the higher standards of "clear and convincing" or "beyond a reasonable doubt".These issues had derailed many an institutional proceeding and prevented them from reaching a finding. Another very important component of the Ryan Commission's work was the declaration that, whilst intent should be a necessary requirement for a finding of fabrication or falsification, a finding of carelessness suffices to support a finding of plagiarism.

We broadened the definition beyond the then-prevailing standard of "fabrication, falsification and plagiarism" to include other forms of unethical behaviour not then governed by any specific regulations (Figure 2.1). Guided by actual cases, we defined research misconduct as:

1 misappropriation (including plagiarism);

2 interference (for example, tampering with someone else's research), and

3 misrepresentation.

In addition, we included categories of lesser misconduct that, whilst not "scientific misconduct", still warranted response. These included:

• obstruction of misconduct investigations;

• retaliation against those participating in investigations, and

• non-compliance with research regulations.

We recognised that, although research institutions might make their own rules, the governmental definition had, after 1989, become de facto the one in general use.

In our report, we did not merely list bad acts, but laid out the rights and responsibilities of scientists. We recommended that educational programmes on research integrity should be required in institutions receiving federal money. We wanted:

• to assure that information about good professional conduct be provided as a fundamental element of education;

• to make discussion of these matters more common and less threatening;

• to make it possible for the powerless to ask questions, and

• to make it harder for the clever sociopath to slide by.

We recommended that there be "Funding for scholarship, teaching, and research in science ethics. Such funded research should include an experimental audit of the prevalence of data misrepresentation." We also recommended that "professional societies each adopt a code of ethics in research" and initiate "activities that will further promote the ethical conduct of research and professionalism in science."

Recognising that whistleblowers provide an important quality control mechanism in science, and mindful of the numerous examples of abuse of whistleblowers who had brought forward well-founded allegations, we set forth a detailed appendix to the report Responsible whistleblowing: a whistle-blower's bill of rights (Figure 2.2). We spelled out the rights and responsibilities of whistleblowers, of the accused and of their institutions. Institutions should deal with "retaliation against whistleblowers as rigorously at the inquiry, investigation, and adjudication stages as they do in cases with research and other professional misconduct"; and that institutions that performed competent investigations should be protected from adverse use of their findings in litigation.12

Our Commission made a number of recommendations, based upon our collective experience, the testimony presented at our meetings, our research, and information presented by commissioned papers, about how misconduct proceedings should be conducted. For example, we advised that investigation and subsequent adjudication should always be separated organisationally; that "legal, law-enforcement, and scientist-investigator staff participate in each federally conducted investigation and ensure that scientists participate in hearings and appeal procedures"; that "those conducting investigations have subpoena power over persons and documents"; and that "authorship or collaborative" disputes (those previously dismissed by the Office of Research Integrity, for administrative reasons) should be addressed by institutions and by federal funding agencies.

While our proposals protected institutional decisions from second-guessing, if properly conducted, they recognised the built-in conflicts that institutions can face when investigating their own scientists, some of whom might be influential and bring in large amounts of money. We proposed "widespread, systematic public disclosure of all outcomes of federal research and research-related professional misconduct cases, with detailed, specific statements of their rationale, in view of the strong public interest in the disclosure of information underlying such cases."12

We articulated the elements required for fair process, by articulating the various interests at stake in these proceedings - including those of the accused, whistleblowers, witnesses, and funding agencies. We recommended internal checks and balances throughout, even for the federal agencies providing the funding for research. We suggested approaches for streamlining processes, made numerous recommendations to improve the a. Communication: Whistleblowers are free to disclose lawfully whatever information supports a reasonable belief of research misconduct as it is defined by PHS policy. An individual or institution that retaliates against any person making protected disclosures engages in prohibited obstruction of investigations of research misconduct as defined by the Commission on Research Integrity. Whistleblowers must respect the confidentiality of sensitive information and give legitimate institutional structures an opportunity to function. Should a whistleblower elect to make a lawful disclosure that violates institutional rules of confidentiality, the institution may thereafter legitimately limit the whistleblower's access to further information about the case.

b. Protection from retaliation: Institutions have a duty not to tolerate or engage in retaliation against good-faith whistleblowers. This duty includes providing appropriate and timely relief to ameliorate the consequences of actual or threatened reprisals, and holding accountable those who retaliate. Whistleblowers and other witnesses to possible research misconduct have a responsibility to raise their concerns honorably and with foundation.

c. Fair procedures: Institutions have a duty to provide fair and objective procedures for examining and resolving complaints, disputes, and allegations of research misconduct. In cases of alleged retaliation that are not resolved through institutional intervention, whistleblowers should have an opportunity to defend themselves in a proceeding where they can present witnesses and confront those they charge with retaliation against them, except when they violate rules of confidentiality. Whistleblowers have a responsibility to participate honorably in such procedures by respecting the serious consequences for those they accuse of misconduct, and by using the same standards to correct their own errors that they apply to others.

d. Procedures free from partiality: Institutions have a duty to follow procedures that are not tainted by partiality arising from personal or institutional conflict of interest or other sources of bias. Whistleblowers have a responsibility to act within legitimate institutional channels when raising concerns about the integrity of research. They have the right to raise objections concerning the possible partiality of those selected to review their concerns without incurring retaliation.

e. Information: Institutions have a duty to elicit and evaluate fully and objectively information about concerns raised by whistleblowers. Whistleblowers may have unique knowledge needed to evaluate thoroughly responses from those whose actions are questioned. Consequently, a competent investigation may involve giving whistleblowers one or more opportunities to comment on the accuracy and completeness of information relevant to their concerns, except when they violate rules of confidentiality.

f. Timely processes: Institutions have a duty to handle cases involving alleged research misconduct as expeditiously as is possible without compromising responsible resolutions. When cases drag on for years, the issue becomes the dispute rather than its resolution. Whistleblowers have a responsibility to facilitate expeditious resolution of cases by good faith participation in misconduct procedures.

g. Vindication: At the conclusion of proceedings, institutions have a responsibility to credit promptly - in public and/or in private as appropriate -those whose allegations are substantiated.

Every right carries with it a corresponding responsibility. In this context, the Whistleblower Bill of Rights carries the obligation to avoid false statements and unlawful behavior.

Figure 2.2 Responsible whistleblowing: a Whistleblower's Bill of Rights.12 22

effective oversight of institutional performance, and broadened the array of sanctions that could be applied against those found guilty of misconduct, and against institutions failing to carry out investigations properly.

The Reaction

Although the Commission's report was characterised by a disinterested observer, the editor of The Lancet, as "a superb piece of analysis",13 and many academics pronounced themselves content with the commission's definition,14 it met with widespread condemnation by the scientific establishment. The Commission consisted largely of scientists (as well as ethicists, administrators, and lawyers), but the reaction from the scientific elite in the US was immediate, loud, defensive, dismissive, confused, and self-contradictory. Given that the reaction was in response to a careful report based on the articulated "fundamental principle that scientists should be truthful and fair in the conduct of research and the dissemination of research results," this reaction seemed at times hysterical. The President of the Federation of American Societies for Experimental Biology (FASEB) wrote to the Secretary for Health and Human Services that the "Commission's report is so seriously flawed that it is useless as a basis for policy making and should be disavowed... We find the definition to be unworkable, and therefore unacceptable."15 He was quoted in the press as calling the report "an attack on American science".13 The same letter objected to what was called an expansion of the definition of plagiarism, even though the Commission had been guided in its definition by the Academy's own report, Responsible science,16 a report the latter strongly endorsed.

The NAS leadership also wrote a letter criticising the Commission report. Whilst acknowledging that the Commission "repeatedly states that the primary investigative responsibility rests with the research institutions",17 it brushed these statements aside in raising the bogeyman of a vast expansion of an intrusive federal bureaucracy, if the Commission's recommendations were to be implemented. The NAS nowhere acknowledged that it was the abject failure of many research institutions to respond appropriately to allegations of misconduct that led to the Commission's original formation by the Congress. The NAS failed to say that the report called only for government agencies to investigate allegations in certain very limited circumstances: in cases involving more than one institution, or where the institution had not conducted a proper investigation.18 Nor did it note that the government already had such an oversight role, which would, if anything, be diminished if the commission's recommendations were followed.

In hindsight, what was most threatening in the Commission Report was the Whistleblower's Bill of Rights.12 The Commission was accused of failing to "protect adequately the rights of scientists who are accused of misconduct." Yet what moved the Commission was not the rights of scientists who were accused, who already had excellent protections, but the plight of accusers, who blew the whistle in good faith, and who were later proved right, but who suffered considerable harm, often from the guilty and their institution. The Commission had heard testimony from a great many in this position.

Perhaps the most persistent, extraordinary and revealing criticism of the report, and, indeed, of any proposed regulation, was the continuing allegation that regulation would impede scientific progress, because truly original science might easily be labelled misconduct. In hundreds, even thousands of cases, this has never happened.

Finally some scientists still claimed that, because science is "self-correcting", no rules were necessary. The corollary of this position is that it doesn't matter if the record is never put right. In the medical field alone, however, the truth is that much science is never replicated, and this assertion says nothing about the costs - institutional and human - imposed by gross fraud, nor the abuse of, and loss of morale among, co-workers, the anger on the part of the public and politicians, and the outrage of the media.

Our report grew out of the failures of the past, including the failure of the 1989 government definition to stand up to legal challenge and to work effectively when applied to real cases.The vehemence of the reaction to the report, which proposed that scientists should be truthful and fair, and which was crafted to make it work in the real world of research and of lawyers, was telling. So was its widespread misrepresentation. Upon reflection, we conclude that this must stem from the fact that few of the scientists who objected had much experience in dealing with allegations of misconduct. Together, they suggest that scientists continue to feel threatened by the spectre that malicious allegations might be brought against them. Above all, objecting scientists failed to grasp the fact that, in this real world, legal challenges dominate the field, and that, in response to these realities, the Ryan Commission introduced precision - which in turn provides protections for those involved in misconduct proceedings, most especially the accused scientist.

We have presented this aspect of the US response in some detail because these sorts of reaction to any regulation may be predicted in the UK, given the striking similarities between the Ryan Commission's "fundamental principle" (above) and the Edinburgh Consensus definition of misconduct as "behaviour that... falls short of good ethical and scientific standards." (see Figure 2.4)5

While more than a year has passed since the Edinburgh meeting, it is also worth noting that five years passed from the delivery of the Ryan Commission report until the most recent - and non-controversial - US government regulations.

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