Regulation on Responding to Allegations of Research Misconduct

1. Policy & Scope

• 1.1 Policy
  • 1.1.1 East Carolina University is committed to upholding the highest standards in scientific and scholarly research. The University is committed to fostering an environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.
  • 1.1.2 All individuals associated with East Carolina University, including, but not limited to faculty, staff, postdoctoral scholars, and students, have the responsibility to seek honestly and to promulgate ethically the truth in all phases of work. This responsibility governs not only the production and dissemination of research and creative activities, but also all applications for funding, reports to funding agencies, and teaching and publication of teaching materials.
  • 1.1.3 East Carolina University strives to reduce the risk of research misconduct, support all good-faith efforts to report suspected misconduct, and promptly and thoroughly address all allegations of research misconduct, and seeks to rectify the research record and/or restore researchers’ reputations, as appropriate.

• 1.2 Scope

• This Regulation applies to allegations of research misconduct involving individuals associated with East Carolina University, including, but not limited to, faculty, staff, postdoctoral scholars, and students, regardless of funding or funding source. This Regulation does not apply to authorship or collaboration disputes.

2. Definitions

• 2.1 Research & Research Misconduct
  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. For the purposes of this Regulation, research includes all basic, applied, and demonstration research in all academic and scholarly fields. Research fields include, but are not limited to, the arts, the basic sciences, liberal arts, applied sciences, social sciences, clinical sciences, the professions, and research involving human subjects or animals.
  • Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results. Research misconduct does not include honest error or differences of opinion. The utilization of artificial intelligence is also research misconduct where artificial intelligence is used to create an output which falls into any of the three types of research misconduct.
  • Types of Research Misconduct:
  • Fabrication means making up data or results and recording or reporting them.
  • Falsification means manipulating research materials, the Research Record (see 2.4 below), equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  • Plagiarism means the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work that materially misleads the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology.
  • Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project. Self-plagiarism and authorship disputes do not meet the definition of research misconduct.
  • Levels of Intent:
  • Intentionally means to act with the aim of carrying out the act.
  • Knowingly means to act with awareness of the act.
  • Recklessly means to propose, perform, or review research or report research results with indifference to a known risk of fabrication, falsification, or plagiarism.
• 2.2 Research Misconduct Process
  • Allegation means a disclosure of possible research misconduct through any means of communication and brought directly to the attention of the Research Integrity Officer.
  • Assessment means a consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The Assessment only involves the review of readily accessible information relevant to the allegation.
  • Inquiry means preliminary information gathering and preliminary fact-finding to determine if an Investigation is warranted. An Inquiry does not require a full review of all the evidence related to the allegation.
  • Investigation means the formal development of a factual record and the examination of that record, leading to recommended findings of whether research misconduct has been committed, by whom, and to what extent.
• 2.3 Research Misconduct Roles
  • Complainant refers to the individual who in good faith makes an allegation of research misconduct.
  • Deciding Official (DO) refers to the University official who makes the final determination regarding allegations of research misconduct and institutional recommendations and/or corrective actions following Inquiries and Investigations. The Deciding Official may be the Chief Research Officer or another University Official as determined by the Provost, Chancellor, or Chancellor’s designee. The Deciding Official shall not be the same institutional official as the Research Integrity Officer.
  • Research Integrity Officer (RIO) refers to the University official appointed by the Chief Research Officer who is responsible for administering the University’s written policies and procedures for addressing allegations of research misconduct. The same individual will not serve as both the Research Integrity Officer and the Deciding Official. The RIO for ECU is the Director of the Office of Research Integrity and Compliance.
  • Respondent refers to the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.
  • Witness refers to any individual who provides information or records to be used as evidence during any stage of the research misconduct proceeding.
• 2.4 Other Terms
  • Good faith (a), as applied to a Complainant or witness, means having a reasonable belief in the truth of one’s allegation or testimony, based on the information known to the Complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or testimony, or if made without any supporting information or reasonable belief.
  • Good faith (b), as applied to an Inquiry Panel member, Investigation Committee member, and any other applicable University member, means cooperating with the research misconduct proceeding by impartially carrying out the duties assigned for the purpose of helping the University meet its responsibilities in accordance with this Regulation. An Inquiry Panel member, Investigation Committee member, or any other applicable University member does not act in good faith if their acts or omissions during the research misconduct proceeding are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
  • Institutional record is comprised of:
  • the records the University compiled or generated during the research misconduct proceeding, except records the University did not consider or rely on;
  • a single index listing all the research records and evidence that the University compiled during the research misconduct proceeding, except records the University did not consider or rely on; and
  • a general description of the records that were sequestered but not considered or relied on.
  • The institutional record includes, but is not limited to:
    • documentation of the Assessment;
    • if an Inquiry is conducted, the Inquiry Report and all records (other than drafts of the report) considered or relied on during the Inquiry, including, but not limited to, research records, transcripts of any transcribed interviews conducted during the Inquiry, and information the Respondent provided to the University, as well as the documentation of any decision not to investigate; and
    • if an Investigation is conducted, the Investigation Report and all records (other than drafts of the report) considered or relied on during the Investigation, including, but not limited to, research records, transcripts of each interview conducted, and information the Respondent provided to the University, as well as the written decision by the Deciding Official.
  • Preponderance of the evidence means proof by evidence that, compared with evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not.
  • Research record means the record of data or results that embody the facts resulting from scientific and scholarly inquiry. Data or results may be in physical or electronic form. Examples of items, materials, or information that may be considered part of the research record include, but are not limited to: research proposals, raw data, processed data, clinical research records, laboratory records, study records, laboratory notebooks, progress reports, manuscripts, abstracts, theses, records of oral presentations, internal reports, online content, lab meeting reports, books, dissertations, journal articles, and any documents and materials provided to an applicable sponsor or a University official by a Respondent in the course of the research misconduct proceeding. The research record also includes, but is not limited to: grant or contract applications (whether funded or unfunded), grant or contract progress and other reports, laboratory notebooks, notes, correspondence, videos, photographs, X-ray film, slides, biological materials, computer files and printouts, manuscripts and publications, equipment use logs, laboratory procurement records, animal facility records, human and animal subject protocols, consent forms, medical charts, and human subject research files.

3. General Policies and Principles

• 3.1 Responsibility to Report Misconduct
  • 3.1.1 All individuals associated with ECU, including, but not limited to, faculty, staff, postdoctoral scholars, and students, will report observed, suspected, or apparent research misconduct to the RIO. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, they may meet with or contact the RIO to confidentially discuss the suspected research misconduct informally, which may include discussing it hypothetically. If the circumstances described by the individual do not meet the definition of research misconduct, the RIO will refer the individual or allegation to other offices or officials with responsibility for resolving the problem, if any.
• 3.2 Cooperation with Research Misconduct Proceedings
  • 3.2.1 All individuals associated with ECU, including, but not limited to, faculty, staff, postdoctoral scholars, and students, will cooperate with the RIO and other University officials in the review of allegations and the conduct of Inquiries and Investigations. These individuals, including Respondents and Complainants, have an obligation to cooperate with research misconduct proceedings, including, but not limited to, their providing information, research records, and other evidence relevant to research misconduct allegations to the RIO or other University officials. University faculty, staff, and postdoctoral scholars are obligated to cooperate as part of their employment obligations to the University.
  • 3.2.2 Respondents have an obligation as part of their employment duties to provide any and all University Records in their possession or control upon request from an appropriate University official. A Respondent’s intentional or knowing destruction of University Records documenting research implicated by a compliant, with the intent to deprive the University of access to said records is disallowed. Such destruction may be a separate employment infraction, and may be used as evidence by the members of an inquiry or investigation in making their recommendations to the Deciding Official. Additionally, the Respondent’s intentional or knowing failure to provide research records documenting the questioned research when requested may be a separate employment infraction, and as may be used as evidence by the members of an inquiry or investigation in making their recommendations to the Deciding Official.
• 3.3 Confidentiality
  • 3.3.1 To the extent possible, the RIO will limit disclosure of the identity of Respondents, Complainants, and witnesses to those who need to know in order to carry out a thorough, competent, objective, and fair research misconduct proceeding. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions. The RIO will use written confidentiality agreements or other mechanisms to ensure that any individual and/or entity receiving information about the case does not make any further disclosure of Respondents, Complainants, and witnesses.
  • 3.3.2 Research misconduct proceedings are confidential. Except as otherwise prescribed by law, the RIO, DO, inquiry and investigation members, complainants, and witnesses will maintain confidentiality and limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding. The RIO will use written confidentiality agreements or other mechanisms to ensure that any individual and/or entity receiving information about the case does not make any further disclosure of identifying information. Any disclosure of research misconduct proceedings, findings, or evidence must be made in accordance with this Regulation.
• 3.4 Interim Administrative Actions
  • 3.4.1 Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, animal health, sponsor funds, equipment, and/or the integrity of the research process. In the event of such a threat, the RIO will, in consultation with other University officials and any applicable sponsor, take appropriate interim action to protect against any such threat. Interim action might include:
  • – additional monitoring of the research process and the handling of equipment or sponsor funds,
  • – freezing or limiting access to fund accounts,
  • – reassignment of personnel or of the responsibility for the handling of equipment or sponsor funds,
  • – additional review of research data and results, and/or
  • – delaying publication.
  • 3.4.2 The RIO will, at any time during a research misconduct proceeding, notify immediately any applicable sponsor or federal agency with jurisdiction and authority if they have reason to believe that any of the following conditions exist:
  • – Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
  • – Federal resources or interests are threatened.
  • – Research activities should be suspended.
  • – There is a reasonable indication of possible violations of civil or criminal law.
  • – Federal action is required to protect the interests of those involved in the research misconduct proceeding.
  • – The research misconduct proceeding may be made public prematurely and federal agency action may be necessary to safeguard evidence and protect the rights of those involved.
  • – The research community or public should be informed.

4. Procedures Throughout the Research Misconduct Process

• 4.1 Admission of Misconduct
  • 4.1.1 The Respondent should be given the opportunity to admit that research misconduct occurred and that they committed the research misconduct. If admitting to research misconduct, the Respondent will: sign a written statement specifying the affected research records and confirming the misconduct was falsification, fabrication, and/or plagiarism; that the research misconduct was committed intentionally, knowingly, or recklessly; and that the conduct represented a significant departure from accepted practices of the relevant research community.
  • 4.1.2 With the advice of the RIO and/or other University officials, the Deciding Official may terminate the University’s review of an allegation where (1) the Respondent has admitted to the truth of the allegation, (2) the University and the Respondent come to an acceptable proposed settlement, and (3) the University shall provide the signed written confession to the relevant federal agency having authority and jurisdiction. The RIO must not close the case before giving any federal agency with jurisdiction and authority a written statement confirming the Respondent’s culpability and explaining how the University determined that the Respondent’s admission fully addresses the scope of the misconduct.
• 4.2 Interviews
  • 4.2.1 The Inquiry Panel may interview each Respondent and/or Complainant, to the extent Complainants are available or known, during an Inquiry.
  • 4.2.2 The Investigation Committee may interview each Respondent, available or known Complainant, and any other available individual who has been reasonably identified as having information regarding any relevant aspects of the Investigation, including witnesses identified by the Respondent.
  • 4.2.3 All relevant exhibits will be numbered and referred to by that number by the Inquiry Panel or Investigation Committee during interviews.
  • 4.2.4 Interviews that are conducted as part of research misconduct proceedings will be recorded and transcribed. The transcript will be provided to the interviewee for correction.
  • 4.2.5 The RIO will include each transcript with any corrections and exhibits in the Institutional Record of the Inquiry and/or Investigation.
  • 4.2.6 The Respondent must not be present during the witnesses’ interviews, but the University will provide the Respondent with the corrected transcript of each interview, with redactions as appropriate to maintain confidentiality.
• 4.3 Addition of Respondents and/or Allegations
  • 4.3.1 If additional Respondents or allegations are identified during the course of a research misconduct proceeding, the RIO will:
  • – notify the new Respondent(s) in writing of the allegations to be added,
  • – notify all existing Respondents in writing of any new or modified allegations not included in the initial notice of the Investigation, and
  • – sequester any additional relevant evidence pursuant to Section 5.3 of this Regulation.
  • Additional allegations may be uncovered at the inquiry stage or the investigation stage. If additional allegations are uncovered at the investigation stage, the Investigation Committee may be allowed, at the discretion of the DO, to serve as an inquiry panel in order to review the new allegations to determine whether an investigation is warranted, and subsequently also serve as the Investigation Committee. Such review shall only occur after the RIO has notified all new and existing Respondents. In all other respects, the inquiry and investigation process as laid out in this Regulation shall be preserved. When additional allegations are uncovered at the Inquiry stage, the Inquiry Panel who uncovered the allegations may review and assess the allegations upon the prior written confirmation of the DO.
  • 4.3.2 Only allegations specific to a particular Respondent will be included in the notification to that Respondent.
• 4.4 Conflicts of Interest and Expertise Checks
  • 4.4.1 Throughout the research misconduct proceeding, the RIO will take reasonable steps to ensure an impartial and unbiased Inquiry and, as needed, Investigation to the maximum extent practical. The RIO will check for potential unresolved personal, professional, or financial conflicts of interest in relation to key members of the research misconduct process, including the Inquiry Panel and Investigation Committee.
  • 4.4.2 The DO will ensure the Inquiry Panel and Investigation Committee members have the appropriate scientific or other relevant expertise to: (1) carry out a thorough and authoritative evaluation of the evidence and issues related to the allegation, (2) interview the principals and key witnesses, and (3) conduct the Inquiry and, as needed, the Investigation. When necessary to secure the appropriate expertise or to avoid conflicts of interest, the DO may select members from outside the University.
  • 4.4.3 If, after the Inquiry or Investigation has begun, it comes to light that a key individual in the research misconduct process has any unresolved personal, professional, or financial conflicts of interest with the individual(s) involved in the allegation(s), then that person will be recused from participation in the research misconduct proceeding.
• 4.5 Use of Legal Counsel
  • 4.5.1 Respondents may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the personal adviser or legal counsel to interviews or meetings on the case. The role of the Respondent’s legal counsel is restricted to advising the Respondent, and they may not act in a representative capacity or otherwise actively participate in interviews, meetings, or hearings.
  • 4.5.2 The University will provide legal counsel to assist the RIO, DO, Inquiry Panel, and Investigation Committee. The role of counsel is to advise and not to act in a representative capacity or otherwise actively participate in interviews, meetings, or hearings; provided, however, University counsel may be present at such interviews, meetings, or hearings and must be present whenever Respondent’s legal counsel is present.

5. Assessment

• 5.1 Assessment of Allegations
• As soon as practicable upon receiving an allegation of research misconduct, the RIO will assess the allegation to determine (1) whether the allegation falls within the definition of research misconduct and (2) whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The RIO is not obligated to interview the Complainant, Respondent, or witnesses, or gather information or facts beyond what have been submitted in the allegation in order to make their determination. An inquiry must be conducted if these criteria are met pursuant to the other subsections of this Section 5.
• 5.2 Documentation of Assessment
• The RIO will promptly document the Assessment.
• – If the RIO determines that the alleged misconduct does not meet the criteria to proceed to an Inquiry, they will ensure that detailed documentation of the Assessment is retained for seven (7) years after termination of the Assessment so that any federal agency with authority and jurisdiction may assess the reasons why the University decided not to conduct an Inquiry.
• – If the RIO determines that the allegation meets the criteria to proceed to an Inquiry, they will ensure that detailed documentation of the Assessment is retained for seven (7) years after completion of the research misconduct proceedings.
• – This documentation must be provided to any federal agency with authority and jurisdiction upon request.
• 5.3 Sequestration of the Research Records and Other Evidence
  • 5.3.1 Before or at the time in which the Respondent is notified, the RIO must take all reasonable and practical steps to obtain custody of the original, or copies that are substantially equivalent in evidentiary value, of all research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner. The RIO is not obligated to declare an inquiry before all, or substantially all, evidence has been sequestered. This early evidence collection and sequestration is protective and preserves the integrity of the record; it is not determinative and does not imply a finding of research misconduct.
  • 5.3.2 When the research records or evidence encompass scientific instruments shared by a number of users or essential equipment for the Respondent to carry out their normal work duties, custody may be limited to copies of the data or evidence on such instruments or equipment, so long as those copies are substantially equivalent to the evidentiary value of the instruments.
  • 5.3.3 The RIO will provide a receipt of sequestered items to the Respondent or other individuals who have information relating to the Inquiry.
  • 5.3.4 The RIO may consult with any federal agency with jurisdiction and authority for advice and assistance in this regard.

6. Inquiry

• 6.1 Notice to Respondent
• At the time of or before beginning an Inquiry, the RIO must make a good-faith effort to notify the Respondent in writing that an allegation of research misconduct has been raised against them, the relevant research records which have been sequestered, include a copy of or refer to this Regulation, and that an Inquiry will be conducted to decide whether to proceed with an Investigation. If the Inquiry subsequently identifies additional Respondents, they must also be notified in writing pursuant to Section 4.3.
• 6.2 Initiation and Purpose of the Inquiry
• The purpose of the Inquiry is to conduct an initial review of the available evidence to determine whether to conduct an Investigation. An Inquiry does not require a full review of all the evidence related to the allegation. The findings of the Inquiry must be set forth in an Inquiry Report as outlined in Section 6.8.
• 6.3 Appointment of the Inquiry Panel
  • 6.3.1 After checking for conflicts of interest and expertise as outlined in Section 4.4, the DO, in consultation with the RIO and other University officials as appropriate, will appoint an Inquiry Panel of at least three (3) individuals, as soon after the initiation of the Inquiry as is practical. The panel members may be selected from inside or outside the University as warranted.
  • 6.3.2 The RIO will provide the Respondent with written notification of who the proposed Inquiry Panel members are. Upon receiving written notification of who the DO has proposed for the or Panel, the Respondent will have no more than ten (10) calendar days to object to the proposed individual(s) based on a personal, professional, or financial conflict of interest, by submitting written objections to the RIO. The RIO makes the final determination as to whether a conflict exists.
• 6.4 Charge to the Inquiry Panel and First Meeting
  • 6.4.1 The RIO will prepare a charge to the Inquiry Panel that:
  • – sets forth the time for completion of the Inquiry;
  • – confirms that the identities of Respondents, Complainants, witnesses, and evidence are to be kept confidential;
  • – describes the allegation(s) and any related issue(s) identified during the Assessment;
  • – states the purpose of the Inquiry as defined in Section 6.2;
  • – states that, although not required at Inquiry, the Inquiry Panel may elect to conduct interviews at this phase, including seeking additional expert testimony;
  • – states the criteria for determining that an Investigation is warranted as defined in Section 6.7; and
  • – states that the Inquiry Panel is responsible for preparing written report of the Inquiry that meets the requirements of Section 6.8 of this Regulation and applicable law or regulation.
  • 6.4.2 At the first Inquiry meeting with the Panel, the RIO will review the charge; discuss the allegation(s), any related issues, and the appropriate procedures for conducting the Inquiry; assist with organizing plans for the Inquiry; and answer any questions.
  • 6.4.3 The RIO will be available throughout the Inquiry to advise the Inquiry Panel as needed.
• 6.5 Inquiry Process
  • 6.5.1 The Inquiry Panel will conduct a preliminary review of the evidence. In the process of fact-finding, the panel may interview the Respondent and/or Complainant as outlined in Section 4.2.
  • 6.5.2 If a legally sufficient admission of research misconduct is made by the Respondent, misconduct may be determined at the Inquiry stage if all relevant issues are resolved pursuant to Section 4.1.
• 6.6 Time for Completion
• The Inquiry, including preparation of the final Inquiry Report and the decision of the DO on whether an Investigation is warranted, must be completed within ninety (90) calendar days of initiation of the Inquiry, unless the RIO determines that circumstances clearly warrant a longer period. If the RIO and/or any federal agency with jurisdiction and authority approves an extension, the Inquiry record must include documentation of the reasons for the extension, and it must be sufficiently documented in the Inquiry Report. The Respondent will be notified in writing of the extension.
• 6.7 Standard for Determination
• After evaluation of the evidence, the Inquiry Panel will determine whether an Investigation is warranted. An Investigation is warranted if: (1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct in this Regulation, and (2) preliminary information-gathering and fact-finding from the Inquiry indicate that the allegation may have substance.
• 6.8 The Inquiry Report
  • 6.8.1 At the conclusion of the Inquiry, regardless of whether an Investigation is warranted, the Inquiry Panel, with the assistance of the RIO, will prepare a written Inquiry Report that includes the following information:
  • – the names, professional aliases, and positions of the Respondent, and the Complainant where their identity or aliases are known;
  • – a description of the allegation(s) of research misconduct;
  • – the identification of any sponsor support, including, for example, any grant numbers, grant applications, contracts, and publications listing such support;
  • – the names, positions, and subject matter expertise of the Inquiry Panel members and experts who conducted the Inquiry;
  • – a summary of the Inquiry process used, including the Inquiry timeline, procedural history, and any scientific or forensic analyses conducted;
  • – a list of the sequestered research records and other evidence reviewed and a description of how sequestration was conducted, except for evidence that the University did not consider or rely on;
  • – summaries and/or transcripts, if transcribed, of any interviews;
  • – if applicable, documentation of potential evidence of honest error or difference of opinion;
  • – the basis for recommending or not recommending that the allegations warrant an Investigation and whether any other actions should be taken if an Investigation is not recommended;
  • – any institutional actions implemented, including internal communications or external communications with journals or funding agencies permitted by this Regulation; and
  • – any comments on the draft Inquiry Report by the Respondent and/or Complainant.
  • 6.8.2 University Counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the Inquiry Panel.
  • 6.8.3 The Inquiry Report will either be signed by each member of the Inquiry Panel or will include other written evidence of each individual’s concurrence or non-concurrence with the findings and conclusions of the Inquiry.
• 6.9 Opportunity to Comment on the Draft Inquiry Report
  • 6.9.1 The RIO must provide the Respondent with a copy of the draft Inquiry Report. The Respondent will be provided with an opportunity to review and comment on the Inquiry Report. Any comments from the Respondent must be in writing and provided to the RIO within fourteen (14) calendar days of their receipt of the Inquiry Report.
  • 6.9.2 The RIO may provide the Complainant with a copy of the relevant portion(s) of the draft Inquiry Report that address the claimant’s role and opinions in the Inquiry and include a copy of or refer to this Regulation. The Complainant will execute in advance a written confidentiality agreement in a form approved by the Office of University Counsel as a condition for access to the relevant portion(s) of the report. Any comments from the Complainant must be in writing and provided to the RIO within fourteen (14) calendar days of their receipt of the relevant portions of the Inquiry Report.
  • 6.9.3 Any comments that are submitted by the Respondent and the Complainant, respectively, will be attached to the final Inquiry Report. Based on the comments, the Inquiry Panel may revise the draft report as appropriate and prepare it in final form.
  • 6.9.4 The Inquiry Panel will deliver the signed final report to the RIO.
• 6.10 Decision and Notification
  • 6.10.1 Decision by the Deciding Official
  • The RIO will transmit the final Inquiry Report and any written comments to the DO, who will determine in writing whether an Investigation is warranted. The Inquiry is completed when the DO makes this determination. The RIO will also notify those University officials who need to know of the DO’s decision.
  • 6.10.2 Notice to Respondent and Complainant
  • When a final decision has been reached:
  • – The RIO will notify the Respondent in writing of the DO’s determination within thirty (30) calendar days and before beginning an Investigation, if warranted. This notice will include a copy of the final Inquiry Report, a copy of or reference to this Regulation, and a copy of or reference to any applicable federal research misconduct policy/regulation.
  • – The RIO may notify the Complainant of the outcome of the Inquiry specific to that Complainant’s allegation(s). If notification is provided to one Complainant in the case, it must be provided, to the extent possible, to all Complainants in the case for their relevant allegation(s).
  • 6.10.3 Notice to Applicable Sponsor or Federal Agency of Decision to Investigate
  • Within thirty (30) calendar days of the DO’s decision that an Investigation is warranted, as required by applicable law or regulation, the RIO will provide any applicable sponsor, when authorized by this Regulation in order to prevent harm to human subjects, or federal agency with authority and jurisdiction with the DO’s written decision and a copy of the final Inquiry Report. As required by applicable law or regulation, the RIO must provide the following information to such sponsor or federal agency upon request: (1) the University policies and procedures under which the Inquiry was conducted; and (2) the allegations to be considered in the Investigation. Additionally, for government agencies only, the research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents must be provided.
  • 6.10.4 Documentation of Decision Not to Investigate
  • If the DO decides that an Investigation is not warranted, the RIO will secure and maintain for seven (7) years after the termination of the Inquiry sufficiently detailed documentation of the Inquiry to permit a later assessment by any federal agency with authority and jurisdiction of the reasons why an Investigation was not conducted. These documents must be provided to such agencies upon request.

7. Investigation

• 7.1 Initiation and Purpose of the Investigation
• The Investigation must begin within thirty (30) calendar days after the determination by the DO that an Investigation is warranted. The purpose of the Investigation is to develop a factual record by exploring the allegations in detail and examining the evidence in depth, leading to recommended findings on whether research misconduct has been committed, by whom, and to what extent. The Investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged research misconduct involves clinical trials, potential harm to human subjects, the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the Investigation must be set forth in an Investigation Report as outlined in Section 7.8.
• 7.2 Additional Sequestration of Research Records During Investigation
• Throughout the Investigation, the RIO will take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceeding that were not previously sequestered during the Inquiry. The need for additional sequestration of records for the Investigation may occur for any number of reasons, including the University’s decision to investigate additional allegations not considered during the Inquiry stage or the identification of records during the Inquiry process that had not been previously secured. The procedures to be followed for sequestration during the Investigation are the same procedures that apply during the Inquiry as outlined in Section 5.3.
• 7.3 Appointment of the Investigation Committee
  • 7.3.1 After checking for conflicts of interest and expertise as outlined in Section 4.4, the DO, in consultation with the RIO and other University officials as appropriate, will appoint an Investigation Committee of at least five (5) individuals, which includes a committee chair, to conduct the Investigation as soon after the beginning of the investigation as is practical. The majority of the Committee should be faculty without administrative appointment. Individuals appointed to the Investigation Committee may also have served on the Inquiry Panel. When necessary to secure the appropriate expertise or to avoid conflicts of interest, the DO may select Committee members from outside the University.
  • 7.3.2 Upon receiving written notification of the proposed Investigation Committee, the Respondent will have no more than ten (10) calendar days to object to the proposed individuals based on a personal, professional, or financial conflict of interest by submitting written objections to the RIO. The RIO makes the final determination as to whether a conflict exists.
• 7.4 Charge to the Investigation Committee and the First Meeting
  • 7.4.1 The RIO will define the subject matter of the Investigation in a written charge to the Investigation Committee that:
  • – describes the allegation(s) and related issues identified during the Inquiry,
  • – identifies the Respondent(s),
  • – informs the committee that it must conduct the Investigation as set forth in this Regulation,
  • – defines research misconduct,
  • – informs the committee of the purpose of the Investigation as described in Section 7.1, and
  • – Informs the committee that in order to determine that the respondent committed research misconduct it must find that a preponderance of the evidence establishes that: (1) research misconduct, as defined in this Regulation and/or applicable federal agency policy/regulation, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion); (2) the research misconduct is a significant departure from accepted practices of the relevant research community; and (3) the respondent committed the research misconduct intentionally, knowingly, or recklessly; and
  • – informs the committee that it must prepare a written Investigation Report that meets the requirements of Section 7.8 of this Regulation and applicable law or regulation.
  • 7.4.2 At the first Investigation meeting with the Investigation Committee, the RIO will review the charge, the Inquiry Report, and the prescribed procedures and standards for conducting the Investigation, including the necessity for confidentiality and for developing a specific Investigation plan. The Investigation Committee will be provided with a copy of this Regulation and any applicable federal law or regulation governing the Investigation.
  • 7.4.3 The RIO will be present or available throughout the Investigation to advise the Investigation Committee as needed.
• 7.5 Investigation Process
• The Investigation Committee and the RIO must:
• – use diligent efforts to ensure that the Investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of each allegation;
• – take reasonable steps to ensure an impartial and unbiased Investigation to the maximum extent practical;
• – notify the Respondent in writing of any new allegations not included in the initial notice of the Investigation;
• – interview each Respondent, Complainant when possible, and any other available individual who has been reasonably identified as having information regarding any relevant aspects of the Investigation, including witnesses identified by the Respondent, in accordance with Section 4.2; and
• – pursue diligently all significant issues and leads discovered that are determined relevant to the Investigation, including any evidence of additional instances of possible research misconduct, and continue the Investigation to completion.
• 7.6 Time for Completion
• The Investigation is to be completed within one hundred eighty (180) calendar days of beginning it, including conducting the Investigation, preparing the report of findings, providing the draft report for comment, documenting the DO’s final decision, and as required by applicable law or regulation, sending the final report, institutional record, and DO’s decision to any federal agency with jurisdiction and authority. However, if the RIO determines that the Investigation will not be completed within this time period, as required by applicable law or regulation, they will submit to any federal agency with jurisdiction and authority a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with such agency if required, if the agency grants the request for an extension and directs the filing of such reports. If no federal agency is involved, any request for extension of time must be approved in writing by the RIO . The Investigation record must include documentation of the reasons for the extension, and it must be sufficiently documented in the Investigation Report. The Respondent will be notified in writing of the extension.
• 7.7 Standard for Making a Finding of Research Misconduct
• Preponderance of the evidence means proof by evidence that, compared with evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not. In order to make a finding of research misconduct, the Investigation Committee must find that a preponderance of the evidence establishes that:
• – research misconduct, as defined in this Regulation and/or applicable federal agency policy/regulation, occurred;
• – Respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion.
• – the research misconduct is a significant departure from accepted practices of the relevant research community; and
• – the Respondent committed the research misconduct intentionally, knowingly, or recklessly.
• 7.8 The Investigation Report
  • 7.8.1 The Investigation Committee, with the assistance of the RIO, will prepare a written Investigation Report that:
  • – describes the nature of the allegation(s) of research misconduct, including identification of the Respondent;
  • – describes and documents any relevant external sponsor support, including, for example, any grant numbers, grant applications, contracts, and publications listing the sponsor support;
  • – describes the specific allegation(s) of research misconduct considered in the Investigation;
  • – provides the composition of the Investigation Committee, including the names, positions, and subject matter expertise;
  • – provides a description of how sequestration was conducted and identifies and summarizes the research records and evidence considered or relied on during the investigation;
  • – includes the transcripts of all interviews conducted;
  • – identifies the specific published papers, manuscripts submitted but not accepted for publication (including online publication), relevant sponsor funding applications, progress reports, presentations, posters, or other research records that contain the allegedly falsified, fabricated, or plagiarized material;
  • – identifies any institutional actions implemented, including internal communications or external communications with journals or funding agencies;
  • – includes a copy of or references this Regulation and any applicable federal policy/regulation under which the Investigation was conducted; and
  • – includes a statement for each separate allegation of whether the committee recommends a finding of research misconduct as described in Sections 7.8.1.1 and 7.8.1.2.
    • 7.8.1.1 If the Investigation Committee recommends a finding of research misconduct for an allegation, the Investigation Report will include a statement of findings for each allegation that:
    • – identifies whether the research misconduct was falsification, fabrication, or plagiarism and whether it was committed intentionally, knowingly, or recklessly;
    • – summarizes the facts and the analysis that support the conclusion and considers the merits of any reasonable explanation by the Respondent, including any effort by the Respondent to establish by a preponderance of the evidence that they did not engage in research misconduct because of honest error or a difference of opinion;
    • – identifies specific sponsor support;
    • – identifies whether any publications need correction or retraction;
    • – provides recommendations for corrective actions as appropriate, such as monitoring or retraining;
    • – identifies the individual(s) responsible for the misconduct; and
    • – lists any current support or known applications or proposals for support that the Respondent has pending with any federal agencies.
    • 7.8.1.2 If the Investigation Committee does not recommend a finding of research misconduct for an allegation, the Investigation Report will provide a detailed rationale for its conclusion.
  • 7.8.2 If there are multiple Respondents, there will be separate Investigation Reports and separate research misconduct determinations for each Respondent.
  • 7.8.3 University Counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the Investigation Committee.
  • 7.8.4 The Investigation Report will either be signed by each member of the Investigation Committee or will include other written evidence of each member’s concurrence or non-concurrence with the findings and conclusions of the Investigation. No Investigation Report shall be sent until a simple majority of the Investigation Committee agrees on the recommendation.
• 7.9 Comments on the Draft Investigation Report and Access to Evidence
  • 7.9.1 The RIO must provide the Respondent with a copy of the draft Investigation Report for comment and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. In distributing the draft report, or portions thereof, to the Respondent, the RIO will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. Any comments from the Respondent must be in writing and provided to the RIO within thirty (30) calendar days of their receipt of the Investigation Report.
  • 7.9.2 The RIO may provide the Complainant with a copy of the portions of the draft Investigation Report that address the claimant’s role and opinions in the Investigation for comment. The Complainant will execute in advance a written confidentiality agreement in a form approved by the Office of University Counsel as a condition for access to the relevant portion(s) of the report. Any comments from the Complainant must be in writing and provided to the RIO within thirty (30) calendar days of their receipt of the relevant portions of the Investigation Report. Where the Complainant is a federal agency, this obligation to sign a confidentiality agreement may be waived as circumstances permit at the discretion of the University.
  • 7.9.3 Any comments that are submitted by the Respondent and the Complainant, respectively, will be attached to the final Investigation Report. Based on the comments, the Investigation Committee may revise the draft report as appropriate and prepare it in final form.
  • 7.9.4 The Investigation Committee will deliver the signed final report to the RIO.
• 7.10 Decision and Notification
  • 7.10.1 Decision by the Deciding Official
  • The DO will receive the Investigation Report from the RIO and may request all other associated documentation. The DO will make the final determination of the research misconduct findings and document in writing: (1) whether the University accepts the Investigation Report, its findings, and the recommended institutional actions; and (2) the appropriate institutional actions to be taken in response to any accepted findings of research misconduct. If this determination varies from the findings of the Investigation Committee, the DO will, as part of their written determination, explain in detail the basis for rendering a decision different from the findings of the Investigation Committee. Alternatively, the DO may return the report to the Investigation Committee with a request for further fact-finding or analysis.
  • 7.10.2 Notice to Respondent and Complainant
  • When a final decision on the case has been reached, the RIO will notify the Respondent in writing of the DO’s determination. Where the Complainant is a federal agency, this notice may include a copy of the DO’s determination, the final Investigation Report, and a copy of or reference to this Regulation and any applicable federal research misconduct policy/regulation as may be required to comply with federal law and policy. The RIO may also notify the Complainant in writing of the outcome of the Investigation. If notification is provided to one Complainant in the case, it must be provided, to the extent possible, to all Complainants in the case, but such notice will only regard the outcome of allegations leveled by the complainant being notified.
  • 7.10.3 Notice to Applicable Sponsor or Federal Agency
  • In accordance with applicable law or regulation, the RIO will submit the following institutional record to any applicable sponsor or federal agency with jurisdiction and authority:
  • – a copy of the DO’s written determination;
  • – a copy of the final Investigation Report with all attachments; and
  • – if required by the agency, a description of any pending or completed administrative actions involving the Respondent.
  • 7.10.4 Notice to Others
  • The DO, in consultation with the RIO and other University officials as necessary, will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which relevant articles or reports may have been published, collaborators of the Respondent in the work, or other relevant parties should be notified of the outcome of the Investigation.

8. Completion of Cased and Reporting Premature Closures

• Generally, all Inquiries and Investigations will be carried through to completion and all significant issues will be pursued diligently. In accordance with applicable law or regulation, the RIO must notify any federal agency with jurisdiction and authority in advance if there are plans to close a case at the Assessment, Inquiry, or Investigation stage on the basis that the Respondent has admitted to committing research misconduct and a settlement with the Respondent has been reached.

9. Maintaining Records for Review by Federal Agencies

9.1 In accordance with applicable law or regulation, the RIO must maintain and, upon request, provide to any federal agency with jurisdiction and authority records of research misconduct proceedings, including: (1) records secured by the University for Assessment, Inquiry, and Investigation; (2) documentation of records not relied upon in making recommendations; (3) the Inquiry Report and final documents produced in the course of preparing that report, including the documentation of any decision not to investigate; (4) any physical items which have been permanently sequestered and which are shelf-stable without specialized equipment and which are not otherwise needed for conducting routine University business, and (5) the Investigation Report and the records in support of that report, including the recording or transcript of each interview conducted pursuant to this Regulation.
9.2 Unless custody has been transferred to the applicable federal agency or the agency has advised the University in writing that the records no longer need to be retained, these records must be maintained in a secure manner for seven (7) years after completion of the University proceeding or the completion of any federal agency proceeding involving the research misconduct allegation, whichever is later.
9.3 The RIO is responsible for providing any information, documentation, research records, evidence, or clarification requested by the federal agency to carry out its review of an allegation of research misconduct or of the University’s handling of such an allegation.investigation stage, which must be reported to the federal agency, as prescribed in this Regulation.

10. Institutional Administrative Actions

• If the DO determines that research misconduct is substantiated by the findings, they will refer the case to the appropriate Vice Chancellor to decide on the appropriate actions to be taken, after consultation with the RIO and the DO. The administrative actions may include, but are not limited to:
• – retraining;
• – unannounced or announced audits;
• – a letter of reprimand or admonishment to be included in the Respondent’s file;
• – supervision or monitoring of future work, including a requirement for certification by senior personnel that a person’s work met specified conditions;
• – removal from the particular research project;
• – formal notification of findings to sponsoring agencies, funding sources, co-authors, co-investigators, collaborators, and/or journal editors;
• – withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;
• – formal withdrawal of pending applications for research support;
• – public announcements; and/or
• – restitution of funds to the grantor agency, as appropriate.
• Other disciplinary actions appropriate to the research misconduct, may include, but are not limited to:
• – probation or suspension;
• – initiation of steps leading to possible reduction of salary or financial aid;
• – initiation of steps leading to possible rank reduction or revocation of a degree;
• – initiation of steps leading to possible expulsion from the University; and/or
• – initiation of steps leading to possible termination of employment.

11. Other Considerations

• 11.1 Termination or Resignation of Respondent Prior to Completing Inquiry or Investigation
• 11.1.1 The termination of the Respondent’s University employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the University’s responsibilities to investigate the alleged research misconduct.
• 11.1.2 If the Respondent, without admitting to the misconduct, elects to resign their position after the University receives an allegation of research misconduct, the Assessment of the allegation will proceed, as well as the Inquiry and Investigation, as appropriate based on the outcome of the preceding steps. If the Respondent refuses to participate in the research misconduct process after resignation, the RIO and any Inquiry Panel or Investigation Committee will use their best efforts to reach a conclusion concerning the allegations, noting in the Inquiry and/or Investigation Report(s) the Respondent’s failure to cooperate and its effect on the evidence.
• 11.2 Protection and Restoration of Positions and Reputations
• 11.2.1 Respondent
• As appropriate, following a final finding of no research misconduct, including concurrence of any federal agency with jurisdiction and authority, where required by law or regulation, the RIO and other University officials must undertake all reasonable and practical efforts to protect or restore the Respondent’s reputation.
• – Depending on the particular circumstances and the views of the Respondent, the RIO should consider whether to notify those individuals aware of or involved in the research misconduct proceeding of the final outcome, publicize the final outcome in any forum in which the allegation of research misconduct was previously publicized, and/or recommend the expungement of all references to the research misconduct allegation from the Respondent’s personnel file.
• – Any institutional actions to restore the Respondent’s reputation should first be approved by the DO.
• 11.2.2 Complainant, Witnesses, and Official/Panel/Committee
• During the research misconduct proceeding and upon its completion, regardless of whether or not the University or a federal agency determines that research misconduct occurred, the RIO must undertake all reasonable and practical efforts to protect or restore the position and reputation of, or to counter potential or actual retaliation against, any Complainant who made allegations of research misconduct in good faith and any witnesses, Inquiry Panel members, and Investigation Committee members who cooperate in good faith with the research misconduct proceeding.
• – The DO will determine, after consulting with the RIO and with the Complainant, witnesses, Inquiry Panel members, or Investigation Committee members, respectively, what steps, if any, are needed to restore their respective positions or reputations or to counter potential or actual retaliation against them.
• – The RIO is responsible for implementing any steps the DO approves.
• 11.3 Allegations or Actions Not Made in Good Faith
  • 11.3.1 Good faith, as applied to a Complainant or witness, means having a reasonable belief in the truth of one’s allegation or testimony, based on the information known to the Complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or testimony, or if made without any supporting information or reasonable belief.
  • 11.3.2 Good faith, as applied to an Inquiry Panel member, Investigation Committee member, and any other applicable University member, means cooperating with the research misconduct proceeding by impartially carrying out the duties assigned for the purpose of helping the University meet its responsibilities in accordance with this Regulation. An Inquiry Panel member, Investigation Committee member, or any other applicable University member does not act in good faith if their acts or omissions during the research misconduct proceeding are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
  • 11.3.3 If relevant, the DO, in consultation with the RIO and other University officials as appropriate, will determine whether:
  • – the Complainant’s allegations of research misconduct were made in good faith;
  • – a witness’ testimony was made in good faith; or
  • – an Inquiry Panel member, Investigation Committee member, or any other applicable University member acted in good faith.
• If the DO determines that there was an absence of good faith, they will refer the matter to the appropriate Vice Chancellor to determine whether any administrative action should be taken against the individual who failed to act in good faith.