Misconduct in Research and Scholarship

Introduction

The missions of education, teaching and research of Tufts University are built upon the principles of honesty and openness in the pursuit of academic excellence within an environment of public trust. Faculty, staff and students are selected based upon their intellectual and personal strengths and qualities that will contribute to the continued growth of a fine institution steeped in traditions of inquiring minds, compassionate spirits and intellectual freedom. The commitment to a strong and principled work ethic within the institutional partnership is a requirement of all who join the programs of Tufts University. The character of the University is a reflection of that of each individual who is a member, in whatever capacity, of Tufts. The integrity of each individual is critical to the success of the University and all of its programs within its campuses and as part of the global community of which Tufts is an active participant.

Within these institutional values, there remains an understanding that dedicated individuals may not achieve desired results, may make mistakes in their various pursuits, and may create honest error while pushing intellectual limits in the pursuit of answers to important questions. While working within local or broader teams and partnerships, these same individuals may have differences of opinion about what is the correct methodology in teaching or research, or in interpreting experimental results. Failures, over time, may make as significant contributions to the advancement of science as successes. There must be no intent to limit healthy debate. Academic freedom is the key to furthering the knowledge base and quality of life for humankind.

The policy that follows is intended to describe the process that will be undertaken when allegations of misconduct in research or scholarship come to the attention of the University administration and to inform members of the scientific community of the appropriate channels for bringing such matters to the attention of the administration for resolution.

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Background

The basis for the Tufts University Policy on “Scientific Integrity and the Consequences of Misconduct in Research or Scholarship” is the Federal Government’s “Public Health Service (PHS) Policies on Research Misconduct,” 42 CFR (Code of Federal Regulations), Part 93, as described in its Final Rule publication in the Federal Register May 17, 2005 (Volume 70, Number 94, Pages 28369-28400). The Final Rule became effective June 16, 2005. Although compliance with this ruling is required by the Federal Department of Health and Human Services (HHS) only for PHS-supported biomedical or behavioral research, biomedical or behavioral research training, and activities related to that research or research training, and even though other funding entities may have their own policies, Tufts University has determined that 42 CFR Part 93 is the comprehensive policy that will be applied as the minimum standard to all allegations of misconduct in research or scholarship, regardless of the funding source(s).

Institutional response to allegations in areas not PHS-supported, will follow the same principles except for the actual involvement of PHS should an allegation reach the stage of investigation. Should any research sponsor have additional requirements to those covered by the Tufts policy, those will be reviewed by the Vice Provost for Research or her designate prior to acceptance of such funding and all research funded by that source will be subject to those additional requirements.

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Definitions

Complainant: The individual bringing forth to the Institutional Official an allegation of misconduct in research or scholarship. It is assumed that the complainant reports a misconduct allegation in good faith, even if the allegation is proven to be a misunderstanding, misinterpretation or miscalculation of the facts, and that no misconduct was committed. “Good faith” means having a belief in the truth of one’s allegation or testimony that a reasonable person in a complainant’s or witness’s position could have arrived at such a conclusion based on the information known to them at the time. If it is determined that the claim was made frivolously, vindictively, maliciously, or with knowledge that the claim was not true, serious consequences may occur for the complainant, including dismissal, if an employee or faculty member, and/or civil action.

An Environment of Scientific Integrity: The requirement that institutions promote responsible conduct of research or foster a climate or environment of scientific integrity reflects the University’s commitment to the highest standards of excellence and values as stated in the “Introduction” to this policy. Federal funding agencies have assigned institutions the primary responsibility for investigating allegations of misconduct, and require that those institutions have pertinent policies and procedures in place. These agencies see the preservation of the integrity of science as a partnership with institutions…a “shared responsibility for the integrity of the research process”.

Evidence: Any document, tangible item, or testimony offered or obtained during a misconduct in research or scholarship proceeding that tends to prove or disprove the existence of an alleged fact. Preponderance of evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not. The burden of proof rests with the University or with HHS for making a finding of misconduct in research or scholarship. The respondent has the burden of proof for all affirmative defenses.

Fabrication: Making up data or results and recording or reporting them.

Falsification: 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.

Inquiry: Preliminary information-gathering and fact-finding after the Institutional Official receives a credible allegation of misconduct in research or scholarship.

Institutional Officials: Reports of misconduct in research and scholarship may be made to the dean of the school where the misconduct occurred, to the director of the USDA HNRC where appropriate or to the vice provost for research of the University. A Dean/Director who receives an allegation of misconduct in research or scholarship will immediately notify the Vice Provost for Research, who will be responsible for overseeing the process, convening the investigation if warranted, and making required reports to relevant federal agencies. The Dean/Director will be responsible for appointing a fact finder, making a determination upon conclusion of the inquiry phase of whether the matter must be forwarded for investigation, and providing a report from the inquiry phase to the Vice Provost for Research. If the matter proceeds to investigation, the investigating committee will make a recommendation to the Provost who will make the final determination on the finding of misconduct and related actions to be taken by the University.

Investigation: The formal development of a factual record and the examination of that record leading to a decision not to make a finding of misconduct in research or scholarship or to a recommendation for a finding of misconduct in research or scholarship, which may include a recommendation for further actions, including administrative actions and hearings by HHS.

The Office of Research Integrity: ORI is the administrative office of HHS to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities. Its URL is http://ori.hhs.gov.

Ombudsperson: A former faculty member or alumni of Tufts University who has received specialized training in scientific integrity and misconduct in research or scholarship policies and procedures who is available to potential complainants, prior to his/her making an allegation, for advice and counsel in total confidence.

Plagiarism: Appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

Public Health Service (PHS): Within HHS, the Office of Public Health and Science, the Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.

Research: A systematic experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) by establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanism relating to, matters to be studied.

Misconduct in Research or Scholarship: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. This includes oral presentations. Misconduct in research or scholarship does not include honest error or differences of opinion. Failure to comply with federal, state, and municipal statutes and regulations governing scientific research is unlawful and may be pursued by the University as a violation of the scientific integrity process.

Respondent: The individual against whom a complainant has brought forth an allegation of misconduct in research or scholarship, or who is the subject of a misconduct in research or scholarship proceeding. If an allegation moves from the inquiry into the investigative stage of a misconduct proceeding, ORI (or equivalent office at other relevant federal funding agency) will be given the name of the respondent.

Research Records: Record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, including both physical and electronic data, computers and scientific equipment used, progress reports, abstracts, theses, oral presentations, internal reports, journal articles and the like. This also includes documents and materials of research fact provided by the respondent at any point during the misconduct proceeding. It does not include notations, interpretations or analyses performed by the complainant in support of his/her allegation of misconduct.

Research Record Retention: Records and data, or copies thereof, essential to the inquiry, investigation and determination stages of an allegation of misconduct must be kept in a secure location under the control of the Vice Provost for Research for seven (7) years. Specific security requirements, such as double-locking, vary by funding agency and will be observed as appropriate.

Retaliation: There is a zero tolerance policy against adverse actions of any kind taken against complainants, respondents, witnesses, or inquiry/investigative committee members during the misconduct in research or scholarship proceedings because of their status as complainant, respondent, witness or committee members. The University encourages the reporting of any incident of detected or perceived misconduct. A respondent is free to defend him/herself against allegations without fear of reprisal for such defense. This definition does not include University personnel actions that may be taken against a respondent to protect the integrity of the research and safety of any research subjects.

Spoliation: Destruction, mutilation or alteration of records or materials unfavorable to the party causing the spoliation.

Statute of Limitations: Allegation must be received within six (6) years of the alleged act of misconduct in research or scholarship for it to be viable for institutional consideration. The exceptions to this limitation are that the claim would be viable if the data involved in the allegation were cited, republished or otherwise used or referenced during that period of time by the individual against whom the allegation is made, or the health or safety of the public is in jeopardy. In the case of the former, the six year limitation period would begin at the time of last citation, republication or reference. In the case of the latter, there is no time limit.

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The Terms of the Policy

It is the responsibility of University faculty, staff and students to report any incident of misconduct in good faith and in accordance with the definitions and terms of the Tufts University Policy on “Scientific Integrity and the Consequences of Misconduct in Research or Scholarship.” It is also incumbent upon them to promote scientific integrity, to protect the health and safety of the public, and to conserve public funds that support research.

  1. Reporting Misconduct in Research or Scholarship
    Any incident of misconduct in research or scholarship should be reported to the dean of the school where the research occurred, to the director of the USDA Human Nutrition Research Center when the alleged misconduct happened there, or to the vice provost for research of the University. Each allegation must be made in good faith and substantiated with documented observations, documents of fact, witness statements, or some other form of proof from which the receiving person can begin an official and confidential inquiry. Allegations are not required to be in writing, but are preferred, as are witness statements. Confidentiality will be maintained and the identities and reputations of the complainant and respondent will be protected to the extent practical. Should the proceeding advance to an investigation stage, the name of the complainant will be submitted to the Office of Research Integrity (ORI), along with the name of the respondent. All HHS administrative hearings are open to the public, though University proceedings are private. It is to be understood by all that complainants are witnesses, not participants in the investigation or adjudication process.The University Scientific Integrity Ombudsperson is available for advice and counsel at any time before an allegation is made.

  2. A Finding of Misconduct
    Misconduct in research or scholarship can occur in applications or proposals for research, in the review of applications or proposals for research, in publications, intramural or extramural research and research training, tissue and data banking, mentoring or other related activities in the areas of research and research training. In order for a “finding of misconduct” to be made, the following criteria must be met:

    • There must be a significant departure from accepted practices of the relevant research community.

    • The misconduct must have been committed intentionally, knowingly, or recklessly.

    • The allegation must be proven by a preponderance of the evidence. Although the University or HHS has the burden of proof for making a finding of misconduct, the destruction, absence of, or respondent’s failure to provide research records adequately documenting the research in question will be considered evidence of misconduct in research or scholarship where the University or HHS establishes by a preponderance of evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them; had the opportunity to maintain the records, but did not do so; did not produce the records s/he had in a timely manner; or behaved significantly outside of the bounds of commonly accepted practices of the relevant research community.

  3. Response to Allegation of Misconduct

    • Response will be thorough, competent, fair, objective, and timely.

    • Individuals charged with the response will have the requisite scientific and/or administrative expertise, be cleared by the vice provost for research as having no personal, professional or financial conflicts of interest with the complainant, witnesses or respondent, and commit to preserving the confidentiality of the proceedings and reputations and positions of those involved during those proceedings.

    • All reasonable and practical steps will be taken to ensure the cooperation of respondents and other institutional members in obtaining information, records, and evidence.

    • Best efforts will be made to preserve the integrity of the research in question during the proceedings, and to minimize the interference with concomitant research and collegial requirements.

    • Cooperation will be extended to HHS during all appropriate proceedings and in any administrative actions that may be imposed on any institutional member.

    • An annual assurance of compliance will be actively maintained and reported, including keeping the relevant policies and procedures current and enforced.

  4. The Inquiry Process

    • Dean/Director in consultation with the Vice Provost for Research determines if the behavior alleged meets the definition of misconduct in research or scholarship as detailed in the University Policy and is sufficiently credible and specific so that potential evidence of misconduct in research or scholarship may be identified. Additional information will be requested from the complainant if the issue of credibility remains in question.

    • If the Dean/Director determines that the alleged behavior meets the definition and is sufficiently credible and specific, a fact finder will be appointed by the dean/director to conduct an inquiry.

    • The Dean/Director will contact the department chair of the respondent and arrange for immediate securing of research records of the respondent, and any other evidence needed to conduct the misconduct in research or scholarship proceeding prior to or at the time of notification of the respondent. If the respondent is a department chair, the Dean/Director will take appropriate action to secure the records while avoiding opportunity for tampering with the records by the respondent. All reasonable attempts will be made to protect the confidentiality of all of these activities and persons involved. Access to the records, or copies, thereof, will be provided wherever possible for other members of the research team, and to the respondent, while under supervision. The act of the Dean/Director taking custody of the records is to protect all parties to the proceeding. All records and evidence will be kept locked in a secure location within the offices of the Dean or Vice Provost for Research.

    • The respondent will be notified of the allegation by the Dean/Director in parallel to taking custody of the records. A certified letter detailing the allegations will also be sent to the respondent at his/her home address. The respondent will be notified that this is only an inquiry phase, and s/he will be given sufficient opportunity to respond to the allegations. If the allegations cannot be substantiated, the inquiry phase will end, and no notification of the inquiry will be made to the research sponsor (unless the sponsor brought forth the allegation and requires the outcome of the inquiry phase). The respondent will also be briefed on the consequences of spoliation. At any point in the process, the respondent is free to obtain outside legal counsel at his/her expense, although this is not a requirement of the process.

    • The complainant, respondent, and witnesses will be interviewed individually, and in confidence, by the fact finder. An initial review of the evidence presented will be undertaken.

    • The fact finder will consider all statements and evidence initially reviewed and will recommend to the dean whether or not the allegation falls within the definition of misconduct in research or scholarship, and whether or not the allegation may have substance. The purpose of the inquiry, according to the ORI, is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible. It is to determine if there is sufficient reason to convene an investigation. The fact finder prepares a written report for the dean/director which will become a permanent part of the record. This report must be in sufficient detail to allow the dean/director to make a determination of whether or not a full investigation is required. A copy of the report will be provided to the respondent for comments. Relevant portions of the report will also be provided to the complainant for information and/or comment as deemed appropriate by the dean/director. The respondent and complainant must be given 10 days for their responses. Any comments by the respondent or complainant will be included in the final inquiry report to the dean/director and will remain part of the inquiry document as it moves through the investigation and decision phases. THE ENTIRE INQUIRY PROCESS FROM INITIATION POST ALLEGATION TO SUBMISSION OF THE INQUIRY REPORT TO THE DEAN/DIRECTOR MUST BE COMPLETED IN SIXTY (60) CALENDAR DAYS. Any request by the factfinder for an extension must be justified and included in its final report. The Vice Provost for Research will make the determination about extending the 60 day period, but only if exigent circumstances exist.

    • If the dean/director determines that the allegation does not fit within the definition of misconduct, or cannot be substantiated, all parties will be notified and a concerted effort will be undertaken to restore the reputations of any individuals who may have been adversely impacted by the allegation and the proceedings. The research records will be restored appropriately as well. Copies of the inquiry report and supporting documents and decision-making must be retained for seven (7) years. No further action will be taken by the institution and no reports will be made to funding agencies unless they are specifically required under the circumstances of the allegation or unless the funding agency is aware of the allegation.

    • If the fact finder finds that there is substance to the allegation within the definition of misconduct in research or scholarship, or if the dean/director determines that further investigation is warranted, the vice provost for research will be notified and an investigation convened. If the fact finder is unable to make a determination, one way or the other, an investigation must be conducted unless the respondent admits to the allegation.

  5. The Investigation Process

    • WITHIN THIRTY (30) DAYS OF THE DETERMINATION THAT AN INVESTIGATION IS WARRANTED, THE INVESTIGATION MUST BE STARTED. This may be approximately 90 days since the allegation was determined to be credible and an inquiry initiated.

    • The investigation will be conducted by the standing committee on research integrity. This committee will consist of at least three members selected from among the full-time faculty of Tufts University and appointed by the Provost. In situations where investigation of an allegation requires expertise not already present among the regular committee members, the Provost may appoint an additional member or members as needed to serve for the duration of that investigation. The committee may call upon outside experts for assistance as needed.

    • Within the above-cited 30-day period following a determination that an investigation is warranted, ORI must be provided with the written finding of the inquiry phase if PHS is a sponsor of the research; otherwise the appropriate sponsor may be alerted to the initiation of an investigation. The Dean may choose to restrict the respondent’s participation in University activities during the investigation phase, or initiate other personnel actions as s/he determines are in the best interest of research subjects, the public and University programs. At all times, the health and safety of the public and University personnel will be the paramount determination for all subsequent notifications and actions by the University.

    • The written inquiry report sent to ORI (or appropriate sponsor) must include: Name and position of respondent; description of allegations; listing of any PHS (or other) support involved; listing of relevant or potentially relevant publications; the basis for initiating the investigation phase; and comments on the inquiry report by the respondent and/or complainant.

    • If requested by ORI or appropriate sponsor, the University must provide a copy of its Scientific Integrity policies and procedures that guided the inquiry; research records and evidence; transcripts or recordings of the inquiry committee proceedings; and the charges to be investigated.

    • Any additional research records, documentation or evidence must be secured as soon as the investigation has been determined to be undertaken.

    • The respondent must be notified in writing of any new charges of misconduct in research or scholarship that may occur during the investigation and be permitted to respond.

    • The investigation process will include a detailed, thorough review of all research records, documentation, publications, evidence, co-workers (current and past, as necessary), witnesses, department chairs. Outside expertise and assistance, including that from ORI, will be sought if needed.

    • ALL INVESTIGATION COMMITTEE PROCEEDINGS WILL BE TAPE RECORDED, INCLUDING ALL INTERVIEWS OF RESPONDENT, COMPLAINANT, WITNESSES, CO-WORKERS, AND ANY RESEARCH SUBJECTS. THESE RECORDINGS WILL BE SECURED AND RELEASED ONLY UPON REQUEST FROM LEGALLY-SANCTIONED ORGANIZATIONS, SUCH AS ORI AND HHS.

    • The committee must give a copy of the committee’s draft final investigation report to the respondent for comment, as well as a copy of, or supervised access to, the evidence on which the report is based. The respondent must be given 30 days to comment on the draft final investigation report or its relevant portions.

    • The final report of the investigation along with comments from the respondent will be forwarded to the Provost who will make the final decision. The Provost may decide to accept the findings and recommendations of the committee, to reach a different finding, or to return the report to the committee for further deliberation or fact finding. In the event that the Provost’s determination varies from that of the investigation committee, he or she must explain in detail the reasons for rendering a different decision in his or her letter notifying ORI of the outcome of the investigation. The Provost’s decision will be the final institutional action, subject to acceptance by the ORI.

    • THE FINAL INVESTIGATION REPORT MUST BE IN WRITING AND SUBMITTED TO THE VICE PROVOST FOR RESEARCH IN A TIMELY FASHION SUCH THAT THE PROVOST MAY REVIEW THE REPORT, DETERMINE WHETHER TO ACCEPT IT AS WRITTEN OR TO RETURN IT TO THE COMMITTEE FOR FURTHER DELIBERATION OR FACT FINDING AND ALLOW FOR SUBMISSION OF THE REPORT TO ORI OR THE APPROPRIATE SPONSOR NO LATER THAN 120 DAYS FROM THE DATE THE INVESTIGATION BEGAN IF THERE IS A FINDING OF MISCONDUCT. Since the initiation of allegation inquiry, a total of 210 days or approximately 7 months may have elapsed.

    • In addition to the requirements for the inquiry final report detailed above, the investigation final report must also include per allegation whether or not misconduct occurred, and, if it did, whether it was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard. The facts and the analysis which support the conclusion must be summarized, as well as the merits or lack thereof of the respondent’s explanations. Publications or presentations which may need to be withdrawn or corrected, as well as specific grants, contracts, etc. must also addressed.

  6. The Appeal Process
    The Provost may accept the recommendations of the investigating committee or come to a different determination. The respondent will not have a separate opportunity for appeal but may include in the comments submitted to the investigating committee in response to their report the basis for appealing the committee’s decision. The Provost will consider this in his decision. This decision will be final on the part of the University, but subject to review and acceptance by the ORI or other relevant funding agency. Funding agencies may undertake their own review or request further action by the University.

  7. ORI and HHS Hearings and Administrative Actions for Cases of Misconduct in Research or Scholarship Involving PHS Funds, Including Debarment
    Please refer to 42 CFR Part 93, Sections 400 on for a complete description of the ORI and HHS process for resolving allegations of misconduct in research or scholarship.

  8. Illustrative Disciplinary Actions by University in Findings of Misconduct (possible disciplinary actions include but are not limited to the following):

    • Letter of reprimand

    • Special monitoring of future work

    • Probation

    • Removal from a particular project

    • Suspension

    • Rank reduction

    • Termination of employment of faculty/staff

    • Expulsion of a student