BRIEF

Policy Summary

As an institution engaged in research, Berkeley Lab has a responsibility to investigate allegations of research misconduct fairly, effectively, and expeditiously. This policy sets forth the principles and methods for assessing allegations of research misconduct, conducting inquiries and investigations related to possible research misconduct, and reporting the results to responsible federal and nonfederal funding agencies. Research misconduct is defined as 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), or plagiarism (appropriation of another person's ideas, processes, results, or words without giving appropriate credit) in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include authorship disputes or honest differences of opinion.

Who Should Read This Policy

This policy applies to all employees.

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Contact Information

Research Compliance Office
[email protected]

POLICY

D. Policy Statement
D.1 Introduction
D.2 Scope
D.3 General Policies and Principles
D.4 Conducting the Assessment and Inquiry
D.5 The Inquiry Report
D.6 Laboratory Decision and Notification
D.7 Conducting the Investigation
D.8 The Investigation Report
D.9 Laboratory Decision and Notification
D.10 Completion of Cases: Reporting Premature Closure to the Funding Agency
D.11 Laboratory Actions, Including Employee Corrective (Disciplinary) Actions
D.12 Other Considerations

A. Purpose

As an institution engaged in research, the Laboratory has a responsibility for investigating allegations of research misconduct fairly, effectively, and expeditiously. This policy sets forth the principles and methods for assessing allegations of research misconduct, conducting inquiries and investigations related to possible research misconduct, and reporting the results to responsible federal and non-federal funding agencies.

B. Persons Affected

This policy applies to all employees.

C. Exceptions

This policy does not apply to authorship or collaboration disputes and applies only to allegations of research misconduct that occurred within six years of the date the Laboratory received the allegation, subject to the following exceptions:

1. Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the use of, republication of, or citation to the portion(s) of the research record (e.g., processed data, journal articles, funding proposals, data repositories) alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of the respondent. (See Section D.1.1, Introduction).
   1. When the respondent uses, republishes, or cites to the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized, in submitted or published manuscripts, submitted grant applications, progress reports submitted to funding agencies, posters, presentations, or other research records within six years of when the allegations were received by the Laboratory or the funding agency, this exception applies.
   2. For research misconduct that appears subject to the subsequent use exception, the Research Integrity Officer (RIO) must document their determination that the subsequent use exception does not apply. Such documentation must be retained in accordance with Section D.9.4.
2. Exception for the health or safety of the public. If the funding agency or the Laboratory, following consultation with the funding agency, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public, this exception applies.

D. Policy Statement

D.1 Introduction

1. All persons engaged in research at the Laboratory are responsible for adhering to the highest standards of research integrity. Activities that fall short of the basic ethical principles inherent in the research process undermine the scientific enterprise. As an institution engaged in research, the Laboratory has a responsibility for investigating allegations of research misconduct fairly, effectively, and expeditiously. This policy sets forth the principles and methods for assessing allegations of research misconduct, conducting inquiries and investigations related to possible research misconduct, and reporting the results to responsible federal and non-federal funding agencies.
2. "Research misconduct" means:
   
   1. Fabrication (making up data or results and recording or reporting them)
   2. 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) or
   3. Plagiarism (appropriation of another person's ideas, processes, results, or words without giving appropriate credit)
      in proposing, performing, or reviewing research, or in reporting research results.
      1. 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.
      2. Plagiarism does not include self-plagiarism or authorship disputes, including such 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.
3. Honest error or differences of opinion do not constitute research misconduct.
4. Under this policy, a finding of research misconduct requires that:
   
   1. There has been a significant departure from accepted practices of the relevant research community, involving fabrication, falsification, or plagiarism
   2. The misconduct was committed intentionally, knowingly, or recklessly and
   3. The allegation has been proven by a preponderance of the evidence
5. Evidentiary Standards:
   1. Standard of proof. An institutional or research agency finding of research misconduct must be proved by a preponderance of the evidence.
   2. Burden of proof.
      1. The Laboratory or funding agency has the burden of proof for making a finding of research misconduct. A respondent’s destruction of research records documenting the questioned research is evidence of research misconduct where the Laboratory or research agency establishes by a preponderance of the evidence that the respondent intentionally or knowingly destroyed records after being informed of the research misconduct allegations. A respondent’s failure to provide research records documenting the questioned research is evidence of research misconduct where the respondent claims to possess the records but refuses to provide them upon request.
      2. The respondent has the burden of going forward with and proving, by a preponderance of the evidence, all affirmative defenses raised. In determining whether the Laboratory or the funding agency has carried the burden of proof imposed by this part, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.
   3. The respondent has the burden of going forward with and proving, by a preponderance of the evidence, any mitigating factors relevant to a decision to impose disciplinary or administrative actions after a research misconduct proceeding.
6. The Laboratory Director has delegated authority and responsibility for decisions made under this policy to the Deputy Director (Deciding Official or DO). The head of the Research Integrity Office serves as the Research Integrity Officer (RIO) and is responsible for implementing the procedures described in this policy.

D.2 Scope

1. While this policy fulfills the Laboratory's responsibilities under the rules of several federal agencies, it applies to all research conducted at the Laboratory regardless of funding source.
2. This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results) (See Section D.1.1, Introduction) involving:
   
   1. A person who, at the time of the alleged research misconduct, was employed by, was an agent of, or was affiliated by contract or agreement with the Laboratory; i.e., employees, affiliates, collaborators, students, consultants, and subcontractors (collectively referred to as Laboratory members for purposes of this policy)
   2. Any research proposed, performed, reviewed, or reported, or any research record generated from the research, regardless of whether an application or proposal for funds resulted in a grant, contract, cooperative agreement, or other form of support
   3. With regard to Public Health Service (PHS)–funded research, this policy specifically includes:
      
      1. Applications or proposals for support for biomedical or behavioral extramural or intramural research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information
      2. PHS-supported biomedical or behavioral extramural or intramural research
      3. PHS-supported biomedical or behavioral extramural or intramural research training programs
      4. PHS-supported extramural or intramural biomedical or behavioral activities that are related to biomedical or behavioral research or research training, such as the operation of tissue and data banks and the dissemination of research information and
      5. Plagiarism of research records produced in the course of research, research training, or activities related to that research or research training

D.3 General Policies and Principles

1. Responsibility to Report Misconduct. Laboratory members should report observed, suspected, or apparent research misconduct (See Section D.1.1, Introduction) to the RIO or other appropriate Laboratory official.
   
   1. If the Laboratory member makes their report to a Laboratory official other than the RIO, the report must be forwarded to the RIO.
   2. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, they may meet with or contact the RIO at [email protected] to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or 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.
   3. At any time, a Laboratory member may have confidential discussions and consultations about concerns of possible misconduct with the RIO and will be counseled about appropriate procedures for reporting allegations. The RIO will not be able to agree to a confidential discussion if the subject of the misconduct involves any of the conditions or special circumstances set forth in Section D.3.11, Interim Actions and Notifying the Funding Agency of Special Circumstances.
2. Cooperation with Research Misconduct Proceedings. Laboratory members are required to cooperate with the RIO and other Laboratory officials in the review of allegations and the conduct of inquiries and investigations. Laboratory members, including respondents, have an obligation to provide evidence relevant to research misconduct allegations to the RIO or other Laboratory officials.
3. Confidentiality. The RIO will:
   
   1. Limit disclosure of the identity of respondents, complainants, and witnesses, while conducting the research misconduct proceedings is limited, to the extent possible, to those who need to know, as determined by the Laboratory, in order to carry out a thorough, competent, objective, and fair research misconduct proceeding, and as allowed by law. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions. This limitation on disclosure of the identity of respondents, complainants, and witnesses no longer applies once the Laboratory has made a final determination of research misconduct findings.
   2. Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who need to know to carry out a research misconduct proceeding.
   3. These confidentiality requirements do not prohibit the Laboratory or the research agency from managing published data or acknowledging that data may be unreliable.
4. Protecting Complainants, Witnesses, and Committee Members. Laboratory members may not retaliate in any way against complainants, witnesses, or committee members. Laboratory members should immediately report any alleged or apparent retaliation against complainants, witnesses, or committee members to the RIO, who will review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed.
5. Protecting the Respondent
   
   1. As requested and as appropriate, the RIO and other Laboratory officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.
   2. During the research misconduct proceeding, the RIO is responsible for ensuring that respondents receive all notices and opportunities provided for in this policy. Respondents may consult with personal 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 legal counsel or personal adviser to interviews or meetings on the case. The role of legal counsel in such meetings or interviews is limited to providing advice, not representation, to the respondent.
6. Sequestration of Research Records And Other Evidence. The RIO must promptly take all reasonable and practical steps to obtain all research records and other evidence, which may include copies of the data or other evidence, so long as those copies are substantially equivalent in evidentiary value, needed to conduct the research misconduct proceeding; inventory the research records and other evidence; and sequester them in a secure manner. Where the research records or other evidence are located on or encompass scientific instruments shared by multiple users, the Laboratory may obtain copies of the data or other evidence from such instruments, so long as those copies are substantially equivalent in evidentiary value to the instruments. The RIO may consult with the funding agency for advice and assistance in this regard.
   Whenever possible, the RIO must obtain the research records or other evidence:
   1. Before or at the time the RIO notifies the respondent of the allegation(s); and
   2. Whenever additional items become known or relevant to the inquiry or investigation.
7. Access to research records. Where appropriate, the RIO must give the respondent copies of, or reasonable supervised access to, the research records that are sequestered in accordance with Section D.3.6.
8. Maintenance of sequestered research records and other evidence. The RIO must maintain the sequestered research records and other evidence as required by Section D.9.4.
9. Multiple Respondents. If the Laboratory identifies additional respondents during an inquiry or investigation, the Laboratory is not required to conduct a separate inquiry for each new respondent. However, each additional respondent must be provided notice of and an opportunity to respond to the allegations, consistent with this policy. 
10. Multiple institutions. When allegations involve research conducted at multiple institutions, one institution must be designated as the lead institution if a joint research misconduct proceeding is conducted. In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions. By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.
11. Interim Actions and Notifying the Funding Agency of Special Circumstances. Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal or state funds, and equipment, or the integrity of the funding agency's supported research process. In the event of such a threat, the RIO will, in consultation with other Laboratory officials and the funding agency, take appropriate interim action to protect against any such threat. Such action might include additional monitoring of the research process and the handling of research funds and equipment, reassignment of personnel or of the responsibility for the handling of research funds and equipment, additional review of research data and results, or delaying publication. The RIO will, at any time during a research misconduct proceeding, notify the funding agency immediately if they have reason to believe that any of the following conditions exist:
    1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
    2. Funding agency resources or interests are threatened;
    3. Research activities should be suspended;
    4. There is a reasonable indication of possible violations of civil or criminal law;
    5. Federal or funding agency action is required to protect the interests of those involved in the research misconduct proceeding;
    6. Funding agency action may be necessary to safeguard evidence and protect the rights of those involved.

D.4 Conducting the Assessment and Inquiry

1. Assessment of Allegations. The assessment only involves the review of readily accessible information relevant to the allegation.
   1. Purpose. An assessment’s purpose is to determine whether an allegation warrants an inquiry.
   2. Conducting the assessment. Upon receiving an allegation of research misconduct, the RIO must promptly assess the allegation to determine whether the allegation:
      1. falls within the definition of research misconduct in Section D.1.1, Introduction
      2. whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified, and 
      3. whether it is within the jurisdictional criteria of Section D.2 of this policy.
   3. Assessment results. 
      1. An inquiry must be conducted if the allegation meets the three assessment criteria in paragraph (b) of this section.
      2. If the RIO determines that requirements for an inquiry are met, they must:
         1. Document the assessment; and
         2. Promptly sequester all research records and other evidence, consistent with Section D.3.6, and promptly initiate the inquiry.
         3. If the RIO or another designated institutional official determines that requirements for an inquiry are not met, they must keep sufficiently detailed documentation of the assessment to permit a later review by the funding agency of the reasons why the Laboratory did not conduct an inquiry. Such documentation must be retained in accordance with Section D.9.4.
2. Laboratory Inquiry. 
   1. Criteria warranting an inquiry. An inquiry is warranted if the allegation meets the following three criteria:
      1. falls within the definition of research misconduct in Section D.1.1, Introduction, 
      2. is sufficiently credible and specific so that potential evidence of research misconduct may be identified, and
      3. is within the jurisdictional criteria of Section D.2 of this policy
   2. Purpose. An inquiry’s purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. An inquiry does not require a full review of the evidence related to the allegation.
   3. Notice to the Respondent. At the time of or before beginning an inquiry, the RIO must make a good-faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, the RIO must notify them. Only allegations specific to a particular respondent are to be included in the notification to that respondent. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.
   4. Sequestration of records. The RIO must obtain all research records and other evidence needed to conduct the research misconduct proceeding, consistent with Section D.3.6.
3. Appointment of an Individual (Appointee) or Committee to Conduct an Inquiry.
   1. Multiple institutions. A joint research misconduct proceeding must be conducted consistent with Section D.3.10.
   2. Person conducting the inquiry. The RIO, in consultation with other Laboratory officials as appropriate, may convene committees of experts to conduct reviews at the inquiry stage to determine whether an investigation is warranted. The inquiry review may be done by the RIO or another designated Institutional Appointee in lieu of a committee, with the caveat that if needed, these individuals utilize one or more subject matter experts to assist them in the inquiry. The RIO must consult with the Deciding Official before conducting the inquiry themselves, instead of appointing a different Institutional Appointee or a committee. The Appointee or committee members must not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry. The RIO will ensure that all inquiry committee members or appointees understand their commission, keep the identities of respondents, complainants, and witnesses confidential, and conduct the research misconduct proceedings in compliance with this policy.
4. Inquiry Process. 
   1. Interviews. The RIO, Inquiry Appointee or Committee may interview witnesses or respondents that would provide additional information for the review.
   2. Inquiry Results.
      1. Criteria warranting an investigation. An investigation is warranted if:
         1. there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct in Section D.1.1, Introduction,
         2. is within the jurisdictional criteria of Section D.2 of this policy; and
         3. preliminary information-gathering and fact-finding from the inquiry indicates that the allegation(s) may have substance.
      2. Findings of research misconduct. Findings of research misconduct, including the determination of whether the alleged misconduct is intentional, knowing, or reckless, cannot be made at the inquiry stage.
   3. Time for Completion.
      1. The inquiry, including preparation of the final inquiry report and the decision of the DO (See Section D.5.1) on whether an investigation is warranted, must be completed within 90  days of its initiation of the inquiry, unless the RIO determines that circumstances warrant a longer period.
      2. If the RIO approves an extension, the inquiry report must document the reasons for exceeding the 90-day period.

D.5 The Inquiry Report

1. Elements of the Inquiry Report1.    
   1. A written inquiry report must be prepared that includes the following information:
      1. The names, professional aliases, and positions of the respondent and complainant
      2. Name(s), position(s), and subject matter expertise of the appointee or committee members, if used, who conducted the inquiry
      3. A description of the allegation(s) of research misconduct
      4. The funding agency support, including, for example, grant numbers, grant applications, contracts, and publications listing that support
      5. Inventory of sequestered research records and other evidence and description of how sequestration was conducted
      6. Transcripts of any transcribed interviews. Transcripts may be redacted to protect against retaliation and to maintain confidentiality.
      7. Timeline and procedural history
      8. Any scientific or forensic analyses conductedThe basis for recommending that the allegation(s) warrant an investigation
      9. The basis on which any allegation(s) do not merit an investigation
      10. Any comments on the inquiry report by the respondent or the complainant
      11. Any recommended Laboratory actions implemented, including communications with journals or funding agencies
      12. If there is potential evidence of honest error or difference of opinion, the RIO must note this in the inquiry report.
      13. Laboratory Counsel should review the inquiry report for legal sufficiency. Modifications should be made, as appropriate, in consultation with the RIO and the appointee or committee.
          
2. Notification to the Respondent and Opportunity to Comment
   1. The RIO must provide the respondent an opportunity to review and comment on the inquiry report within 10 calendar days of such notification.
   2. Based on any comments that are timely submitted, the appointee or inquiry committee may revise the draft report as appropriate and prepare it in final form. The appointee or committee will transmit the final report, including any timely submitted comments by the respondent, to the RIO.

D.6 Laboratory Decision and Notification

1. Decision by Deciding Official (DO). The RIO will transmit the final inquiry report to the DO, who will determine in writing whether an investigation is warranted. The inquiry is completed when the DO makes this determination. An investigation is warranted if:
   
   1. There is a reasonable basis for concluding that the allegation falls within the definition of research misconduct under Section D.1.1, Introduction, and
   2. Is within the scope of this policy under Section D.2, Scope and
   3. Preliminary information-gathering and preliminary fact-finding from the inquiry indicates that the allegation(s) may have substance
2. Notification to the Respondent of the Results of the Inquiry. The RIO must notify the respondent whether the inquiry found that an investigation is warranted. The notice must include a copy of the inquiry report and include a copy of the Laboratory's policies and procedures on research misconduct. If the alleged misconduct involves research supported by PHS, the notification must include a copy of, or refer, to 42 CFR Part 93.
3. Notification to the Complainant of the Results of the Inquiry. The RIO shall notify the complainant whether the inquiry found an investigation to be warranted. The RIO may, but is not required to, provide relevant portions of the report to a complainant for comment. If the RIO provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.
4. Notification to the DOE Contracting Officer. If the Contractor determines that there is sufficient evidence to proceed to an investigation, it must notify the Contracting Officer.
5. Notification to the Funding Agency. Within 30 days of the DO's decision that an investigation is warranted, the RIO must provide the funding agency with a copy of the inquiry report and any Laboratory actions implemented, including communications with journals or funding agencies. The RIO will also notify Laboratory or other officials who need to know of the DO's decision. The RIO must provide the following information to the funding agency upon request:
   1. The Laboratory policies and procedures under which the inquiry was conducted
   2. The research records and other evidence reviewed, and copies of all relevant documents
6. Documentation of Decision Not to Investigate. If the DO decides that an investigation is not warranted, the RIO will secure and maintain the institutional record and sequestered evidence in accordance with Section D.9.4.. These documents must be provided to the funding agency upon request.

D.7 Conducting the Investigation

1. Initiation and Purpose. The investigation must begin within 30 days after the DO has decided 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 or potential harm to human subjects or 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 (See Section D.8, The Investigation Report).
2. Notifying the Funding Agency and Respondent: Sequestration of Research Records
   1. On or before the date on which the investigation begins, the RIO must:
      1. Inform the Contracting Officer if an initial inquiry supports a formal investigation and, if requested by the Contracting Officer thereafter, keep the Contracting Officer informed of the results of the investigation and any subsequent adjudication and
      2. Notify the funding agency of the decision to begin the investigation and provide a copy of the inquiry report that meets the requirements of Section D.5 and
      3. Notify the respondent in writing of the allegation(s) to be investigated within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins.
         1. The RIO must give the respondent written notice of any allegation(s) of research misconduct not addressed during the inquiry or in the initial notice of investigation within a reasonable amount of time of deciding to pursue such allegation(s).
         2. If the institution identifies additional respondents during the investigation, the RIO may but is not required to conduct a separate inquiry for each new respondent. If any additional respondent(s) are identified during the investigation, the institution must notify them of the allegation(s) and provide them an opportunity to respond consistent with this policy.
         3. While an investigation into multiple respondents can convene with the same investigation committee members, separate investigation reports and research misconduct determinations are required for each respondent.
   2. The RIO will, prior to notifying respondent of the allegations, 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 and 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 Laboratory'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 (See Section D.3.6)
3. Appointment of the Investigation Committee. The RIO, in consultation with other Laboratory officials as appropriate, will appoint an investigation committee and the committee chair as soon after the beginning of the investigation as is practical. The investigation committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and should include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the respondent and complainant, and conduct the investigation. Individuals who are not Laboratory members but who have specialized expertise germane to the research involved may be appointed to the committee. Individuals appointed to the investigation committee may also have served on the inquiry.
4. Charge to the Committee and the First Meeting
   1. Charge to the Committee. The RIO will define the subject matter of the investigation in a written charge to the committee that:
      1. Describes the allegations and related issues identified during the inquiry
      2. Identifies the respondent
      3. Informs the committee that it must conduct the investigation as prescribed in Section D.7.5, Investigation Process
      4. Defines research misconduct
      5. Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, the type and extent of it and who was responsible
      6. 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 policy occurred (See Section D.1.1, Introduction; 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;
         3. The respondent committed the research misconduct intentionally, knowingly, or recklessly; and
         4. Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy (See Section D.5.1, Elements of the Investigation Report).
   2. First Meeting. The RIO will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of 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 policy. If the research is supported by the PHS, the committee will be provided with a copy of 42 CFR Part 93. The RIO will be present or available throughout the investigation to advise the committee as needed.
5. Investigation Process. The investigation committee and the RIO must:
   1. Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and other evidence relevant to reaching a decision on the merits of the allegation(s);
   2. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical;
   3. Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent.
      1. Interviews during the investigation must be recorded and transcribed.
      2. Any exhibits shown to the interviewee during the interview must be numbered and referred to by that number in the interview.
      3. The transcript of the interview must be made available to the relevant interviewee for correction.
      4. The transcript(s) with any corrections and numbered exhibits must be included in the institutional record of the investigation.
      5. The respondent must not be present during the witnesses’ interviews but must be provided a transcript of the interview.
   4. Consider, consistent with Section D.3.9, the prospect of additional researchers being responsible for the alleged research misconduct.
   5. Conduct research misconduct proceedings involving multiple institutions consistent with Section D.3.10.
   6. bvPursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.
6. Time for Completion.
   1. The RIO must complete all aspects of an investigation within 180 days of beginning it, including conducting the investigation, preparing the draft investigation report for each respondent, providing the draft report to each respondent for comment in accordance with Section D.8.2 and transmitting the institutional record including  the final investigation report and decision by the DO to the funding agency.
   2. If the RIO determines that the investigation will not be completed in 180 days,  the RIO will submit to the funding agency a written request for an extension that includes the circumstances or issues warranting additional time. The RIO will provide periodic progress reports to the funding agency if the funding agency grants the request for an extension and directs the filing of such reports.
   3. If the investigation takes longer than 180 days to complete, the investigation report must include the reasons for exceeding the 180-day period.

D.8 The Investigation Report

1. Elements of the Investigation Report
   1. The investigation committee and the RIO are responsible for preparing a written draft report of the investigation for each respondent that:
      1. Describes the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.
      2. Describes and documents the funding agency support, including, for example, any grants numbers, grant applications, contracts, and publications listing funding agency support.
      3. Describes the specific allegation(s) of research misconduct considered in the investigation of the respondent.
      4. Lists the composition of the investigation committee, including name(s), position(s), and subject matter expertise.
      5. Includes the Laboratory policy and procedures under which the investigation was conducted.
      6. Includes an inventory of sequestered research records and other evidence, except records the institution did not consider or rely on; and a description of how any sequestration was conducted during the investigation. This inventory must include manuscripts and funding proposals that were considered or relied on during the investigation.
      7. Includes transcripts of all interviews conducted, as described in Section D.7.5.3. Transcripts may be redacted to protect against retaliation and to maintain confidentiality.
      8. Identifies the specific published papers, manuscripts submitted but not accepted for publication (including online publication), funding applications, progress reports, presentations, posters, or other research records that allegedly contained the falsified, fabricated, or plagiarized material.
      9. Includes any scientific or forensic analyses conducted.
      10. Includes any comments made by the respondent and complainant on the draft investigation report and the investigation committee’s consideration of those comments.
      11. Includes a statement for each separate allegation of whether the investigation committee recommends a finding of research misconduct.
      12. If the investigation committee recommends a finding of research misconduct for an allegation, the investigation report must, for that allegation:
          1. Identify the individual(s) who committed the research misconduct
          2. Indicate whether the research misconduct was falsification, fabrication, and/or plagiarism
          3. Indicate whether the research misconduct was committed intentionally, knowingly, or recklessly (See Section D.1.1, Introduction)
          4. State whether the other requirements for a finding of research misconduct, as described in Section D.1 have been met
          5. Summarize the facts and the analysis that support the conclusion and consider the merits of any explanation by the respondent
          6. Identify the specific funding agency support
          7. Identify whether any publications need correction or retraction.
      13. If the investigation committee does not recommend a finding of research misconduct for an allegation, the investigation report must provide a detailed rationale.
      14. List any current support or known applications or proposals for support that the respondent has pending with any other funding agencies
   2. Laboratory Counsel should review the investigation report for legal sufficiency. Modifications should be made, as appropriate, in consultation with the RIO and investigative committee.
2. Comments on the Draft Report and Access to Evidence
   1. Respondent. The RIO must give the respondent a copy of the draft investigation report for comment and, concurrently, if requested, a copy of, or supervised access to the evidence on which the report is based. The respondent will be allowed 30 calendar days from the date he/she received the draft report to submit comments to the RIO. The respondent's comments must be included and considered in the final report.
   2. Complainant. At the discretion of the committee, in consultation with the RIO, the complainant may be provided with a copy of the draft investigative report, or relevant portions of it, for comment. Any comments must be submitted within 30 days of the date of receipt of the draft report and any comments received must be included and considered in the final investigation report.
   3. Confidentiality. In distributing the draft report, or portions thereof, to the respondent, or to the complainant, the RIO will inform the recipient of the confidentiality under which the draft report or portion of the report, is made available and may establish reasonable conditions to ensure such confidentiality. For example, the RIO may require that the recipient sign a confidentiality agreement.

D.9 Laboratory Decision and Notification

1. Decision by Deciding Official
   1. The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondent's comments or complainant's comments, if any, are included and considered, and transmit the final investigation report to the DO, who will determine in writing:
      1. Whether they accept the investigation report, its findings, and
      2. Whether the Laboratory found research misconduct and, if so, who committed the misconduct; and
      3. The appropriate Laboratory actions taken or to be taken in response to the findings of research misconduct
   2. 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.
   3. When the DO reaches a decision on the case, generally within 60 days of receipt of the record of investigation, the RIO will normally notify both the respondent and the complainant in writing. The DO's decision represents the final decision of the Laboratory with respect to the issue of research misconduct. There is no right, under Laboratory policy, to appeal this decision. Any disciplinary action which may be imposed as a result of a finding of research misconduct will be handled in accordance with the Corrective Action and Dismissal policy or the applicable collective bargaining agreement. After informing the funding agency of the final decision, the DO will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO is responsible for ensuring compliance with all notification requirements of funding agencies.
2. Notification to the DOE Contracting Officer. When an investigation is complete, the Contractor will forward the institutional record as defined in this policy to the Contracting Officer. The institutional record must be logically organized.
3. Notification to Funding Agency of Laboratory Findings and Actions. After the Institutional Deciding Official has made a final determination of research misconduct findings, the RIO will forward the institutional record as defined in this policy to the funding agency. The institutional record must be logically organized. If not already provided with the inquiry report, the notification includes the institutional policies and procedures under which the investigation was conducted.

1. Maintaining Records for Review by the Funding Agency
   1. Maintenance of institutional record and all sequestered evidence. The RIO must maintain the institutional record and all sequestered evidence including physical objects (regardless of whether the evidence is part of the institutional record) in a secure manner for seven years after completion of the proceeding under this policy, or the completion of any funding agency proceeding involving the research misconduct allegation, or for as long as required by the Laboratory’s records retention schedule, whichever is later, unless custody has been transferred to HHS under paragraph (b) of this section or the funding agency advises otherwise in writing. The RIO is also responsible for providing any information, documentation, research records, evidence, or clarification requested by the funding agency to carry out its review of an allegation of research misconduct or of the Laboratory's handling of such an allegation.
   2. Provision for HHS custody. If the alleged misconduct involves research supported by PHS, on request, the Laboratory must transfer custody, or provide copies, to HHS of the institutional record or any component of the institutional record and any sequestered evidence (regardless of whether the evidence is included in the institutional record) for the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) to conduct its oversight review, develop the administrative record, or present the administrative record in any proceeding under 42 CFR Part 93 subparts D and E.

D.10 Completion of Cases: Reporting Premature Closure to the Funding Agency

1. Generally, all inquiries and investigations will be carried through to completion and all significant issues and credible allegations of research misconduct will be pursued diligently. The RIO must notify the DOE Contracting Officer and the funding agency in advance if there are plans to close a research misconduct proceeding at the assessment, inquiry, investigation, or any other stage on the basis that the respondent has admitted to committing research misconduct or a settlement with the respondent has been reached.
2. A respondent’s admission of research misconduct must be made in writing and signed by the respondent. An admission must specify the falsification, fabrication, and/or plagiarism that occurred and which research records were affected. The admission statement must meet all elements required for a research misconduct finding under Section D.1.4 and must be provided to the DOE Contracting Officer and funding agency before the Laboratory closes its research misconduct proceeding. The RIO must also provide a statement to the DOE Contracting Officer and funding agency describing how it determined that the scope of the misconduct was fully addressed by the admission and confirmed the respondent’s culpability.
3. After consulting with the Laboratory on its basis for closing a case under paragraph (a) of this section, the DOE Contracting Officer or the funding agency may conduct an oversight review of the Laboratory’s handling of the case and take appropriate action including:
   1. Approving or conditionally approving closure of the case;
   2. Directing the Laboratory to complete its process;
   3. Directing the Laboratory to address deficiencies in the institutional record;
   4. Referring the matter for further investigation by DOE or the funding agency; or,
4. Taking a compliance action.

D.11 Laboratory Actions, Including Employee Corrective (Disciplinary) Actions

If the DO determines that research misconduct is substantiated by the findings, they will decide on the appropriate actions to be taken, after consultation with the RIO.

1. Actions may include:
   
   1. Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found
   2. Special monitoring of future work
   3. Restitution of funds to the funding agency as appropriate
   4. In the case of Laboratory members who are not employees, notification of the member’s home institution of the results of the investigation and
   5. Other action appropriate to the research misconduct
2. Employee Corrective (Disciplinary) Actions. The matter will be referred to the respective division director/department head and Human Resources for consideration of possible corrective (disciplinary) action under applicable Laboratory RPM policies and/or collective bargaining agreements.

D.12 Other Considerations

1. Termination or Resignation Prior to Completing Inquiry or Investigation
   
   1. The termination of the respondent's Laboratory employment or a non-employee member's Laboratory association, 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 Laboratory's responsibilities under this policy.
   2. If the respondent, without admitting to the misconduct, elects to resign his or her position after the Laboratory 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 process after resignation, the RIO and any inquiry or investigation committee will use their best efforts to reach a conclusion concerning the allegations, noting in the report the respondent's failure to cooperate and its effect on the evidence.
2. Restoration of the Respondent's Reputation. Following a final decision of no research misconduct, including funding agency concurrence where required by federal regulations or funding agency contracts or grants, the RIO must, at the request of the respondent, undertake all reasonable and practical efforts to restore the respondent's reputation. Depending on the particular circumstances and the views of the respondent, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in any forum in which the allegation of research misconduct was previously publicized, and expunging all reference to the research misconduct allegation from the respondent's personnel file. Any Laboratory actions to restore respondent's reputation should first be approved by the DO.
3. Protection of the Complainant, Witnesses, and Committee Members. During the research misconduct proceeding and upon its completion, regardless of whether the Laboratory or the funding agency determines that research misconduct occurred, the RIO must undertake all reasonable and practical efforts to protect 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 of any witnesses and 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, or 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 approved by the DO.
4. If relevant, the DO, in consultation with the RIO, will determine whether the complainant's allegations of research misconduct were made in good faith, or whether a witness, appointee, or committee member failed to act in good faith. If the DO determines that there was an absence of good faith, they will determine whether any action should be taken against the person who failed to act in good faith and forward any such recommendation for consideration by Human Resources and the appropriate Laboratory official.

E. Roles and Responsibilities

F. Definitions/Acronyms

G. Recordkeeping Requirements

See above

H. Implementing Documents

None

I. Contact Information

Research Compliance Office
[email protected]

J. Revision History

DOCUMENT INFORMATION

Source Requirements Documents

• Contract 31, Clause I.115, DEAR 952.235-71, Research Misconduct (JUL 2005) (prev. 125)
  
• University of California Policy, Responding to Allegations of Research Misconduct
• 10 CFR 733, Allegations of Research Misconduct

Other Driving Requirements

• 42 CFR 93, Public Health Service Policies on Research Misconduct