Procedures for Investigating Allegations of Research Misconduct

Version: March 2022

In accordance with Lewis & Clark College’s Research Misconduct Policy, this document outlines the procedures for the reporting, assessment, inquiry, investigation, and documentation of allegations of Research Misconduct.

I. Reporting Allegations

An initial report of suspected research misconduct should be brought to the attention of the Research Integrity Officer (RIO) or the Deciding Official (DO), either verbally or in writing, including anonymous reports. The RIO or DO shall inform the Dean of the school in which the respondent is employed, unless the allegation involves the Dean. The President will be informed of any allegations involving a Dean or any other member of the Executive Council.

II. Preliminary Assessment

Upon receiving an allegation of research misconduct, the RIO or DO will immediately assess the allegation to determine whether the allegation 1) falls within the definition of research misconduct and 2) is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If these two criteria are met, an Inquiry must be conducted. If the allegation does not meet both of these requirements, the RIO will dismiss the complaint.

Lewis & Clark owns research data generated by institutional employees using the institution’s facilities. The RIO has the authority and obligation to sequester evidence that, in the RIO’s judgment, may be germane to an allegation of misconduct under review.

The preliminary assessment period should be brief, preferably concluded within a week. In conducting the preliminary assessment, it is not necessary to interview the complainant, respondent, or other witnesses, or to gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation meets the aforementioned criteria. The preliminary assessment shall be documented and all records pertaining to the review of allegations will be retained by the RIO for a period of seven (7) years following completion of the assessment.

The DO has the authority to stay any proceeding under the Research Misconduct Policy if the DO or RIO determines that other institutional procedures mandated by law must be completed prior to the institution’s further review of the allegation of misconduct. The order of precedence is: 1) protect public health and safety and the safety and well-being of research subjects; 2) protect evidence necessary to review an allegation of misconduct or alleged violations under other regulated areas of research; and 3) protect the public interest.

At any time during a research misconduct proceeding, the RIO will notify the Office of Research Integrity (ORI) immediately if it has reason to believe that any of the special circumstances outlined in 42 C.F.R. §93.318 exists. Further, the RIO will notify the appropriate compliance committee if the sufficiently credible allegation of research misconduct involves a related regulatory area (e.g. human subjects or vertebrate animals).

III. Inquiry

If the allegation meets both of the above-stated requirements, the RIO or DO shall begin an inquiry in the manner set forth below. 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 RIO must, on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, and whenever additional items become known or relevant, promptly take all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the research misconduct proceeding. The RIO is responsible for inventorying records and evidence, and sequestering them in a secure manner.

The RIO or DO shall appoint an inquiry panel to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. This panel will include at least three but no more than five persons who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the research misconduct proceeding. The inquiry panel must include at least one faculty member from each of the three schools (CAS, Law, GSEC), and at least one subject matter advisor. The RIO or DO will seek recommendations for faculty members to be appointed to this panel from the Dean of each school. The inquiry panel should include individuals with the appropriate subject matter expertise to evaluate the evidence and issues related to the allegation; interview the principals and key witnesses; and conduct the inquiry. Members of the panel must be fair, objective, and impartial and must possess, where required, the competence to understand the research in question. When necessary to secure the necessary expertise or to avoid conflicts of interest, DO may appoint panel members from outside the institution.

At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the respondent in writing of the accusation, the existence of the inquiry, and the names of the inquiry panel members. The respondent(s) shall comply with all requests for information.

The RIO will prepare a charge for the inquiry panel with the purpose of the inquiry, the expected timeframe, the panel’s responsibilities, the allegations, and any related issues identified during the preliminary assessment. The charge also shall inform the panel that an investigation is warranted if the panel determines that: 1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct; and 2) the preliminary information gathering and fact-finding from the inquiry indicates that the allegation may have substance. At the panel’s first meeting, the DO and RIO will review the charge with the panel; discuss the allegations, any related issues, and the procedures for conducting the inquiry; help the panel organize plans for the inquiry; and answer any questions. The identities of the complainant(s), the respondent(s), the inquiry and its findings shall not otherwise be disclosed by the panel, except as necessary to carry out the assignment, or as otherwise provided herein. The RIO will be available throughout the inquiry to advise the panel as needed.

The RIO, DO, and members of the inquiry panel will have all rights necessary to access research records created or maintained by individuals subject to the College’s Research Misconduct Policy. All research data is the property of Lewis & Clark College and may be accessed by the institution without interference. Research records may include digital data relevant to the inquiry for purposes of conducting research misconduct proceedings, including email records. The panel may work with the IT department and will use best practices in sequestering necessary relevant information, including defining records searched in terms of recipients, subjects, and time frames. Efforts will be made to balance the needs of the inquiry panel with privacy interests not related to the inquiry. If the research records or evidence includes scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are equivalent to the evidentiary value. Where appropriate, the RIO shall give the respondent copies of, or reasonable supervised access to, the research records.

The inquiry panel may interview the complainant, respondent, and key witnesses and may examine relevant research records and materials. Interviews will be recorded or transcribed, with recordings or transcripts provided to the interviewee for correction. The inquiry panel will evaluate the evidence, including any testimony obtained during the inquiry and decide whether an investigation is warranted. The scope of an inquiry does not normally include deciding whether misconduct definitely occurred, determining definitively who committed the research misconduct, or conducting exhaustive interviews and analyses. However, if the respondent makes a legally sufficient admission of research misconduct and all relevant issues are resolved, the inquiry panel may determine that misconduct occurred and prepare a report based on that evidence. In that case, if applicable, the RIO shall promptly consult with the relevant sponsoring agency to determine next steps.

The inquiry panel will prepare a written report documenting their process and making a recommendation as to whether or not a formal investigation should be initiated; this report shall be submitted to the RIO. It should include the following information:

1. name and position of the respondent
2. description of the allegations of research misconduct
3. funding support, including, for example, grant numbers, grant applications, contracts and publications listing all support
4. basis for recommending or not recommending that the allegations warrant an investigation

The RIO shall provide a copy of the panel’s preliminary inquiry report and the College’s Research Misconduct Policy and 42 C.F.R. Part 93 (if applicable) to the respondent; the respondent will have 10 business days to respond in writing. Based on the respondent’s comments, the inquiry panel may revise their preliminary report, prepare it in final form, and submit the final report with the respondent’s comments to the DO and RIO.

The DO will review the inquiry panel’s report and make a written determination as to whether an investigation is warranted; the inquiry is completed when the DO makes this determination. The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, should be completed within 60 calendar days of its initiation, unless the DO determines that circumstances clearly warrant a longer period. If an extension is approved, the inquiry record must include documentation of the reasons for exceeding the 60-day period. Alternatively, if the sponsoring agency requires a shorter timeline, the inquiry will follow the agency’s requirements.

If the DO decides that an investigation is not warranted, the RIO shall secure and maintain for seven years sufficiently detailed documentation of the inquiry to permit a later assessment of the reasons why an investigation was not conducted.

IV. Investigation

If the DO determines that a formal investigation is warranted, the investigation should begin shortly after completion of the inquiry; in the case of PHS funding, an investigation must begin within 30 calendar days. 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.

With input from the Deans of each school (CAS, GSEC, Law), the DO will appoint a five-member ad-hoc investigation committee to determine if research misconduct occurred. The committee members appointed must include individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and individuals with the appropriate expertise to evaluate the evidence and issues related to the allegation; conduct interviews; and complete the investigation. The investigation committee must include at least one faculty member from each of the three schools (CAS, Law, GSEC), and at least one subject matter advisor. The DO may appoint external committee members if additional expertise is necessary or to avoid conflicts of interest. Individuals appointed to the investigation committee may have served on the inquiry panel. Prior to the initiation of the investigation, the respondent will be notified of the investigation committee’s membership and shall be given five (5) calendar days to share objections based upon a committee member’s alleged personal, professional, or financial conflict of interest. The DO will make the final determination of whether a conflict exists.

On or before the date on which the respondent is notified, or the investigation begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of and sequester in a secure manner all the research records and evidence needed to conduct the investigation that were not previously sequestered. The need to sequester additional records may occur for any number of reasons, including the institution’s decision to investigate additional allegations not considered during the inquiry stage or 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.

Within a reasonable time of the DO’s decision to proceed with an investigation, but before the investigation begins, the RIO will notify the respondent in writing of the allegations to be investigated. Further, on or before the investigation begins, if applicable, the RIO will notify ORI (Office of Research Integrity) of the decision to begin the investigation and provide ORI with a copy of the inquiry report (or comply with any other notice obligation to a government agency or other funder).

Working with the DO, the RIO will prepare a written charge to the committee that defines the subject matter of the investigation, identifies the respondent, describes the allegations and related issues identified during the inquiry, informs the committee that it must conduct the investigation as prescribed, defines research misconduct, and instructs the investigation committee on the burden of proof. The charge shall state that the committee is to evaluate the evidence and testimony of the respondent, complainant, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. The charge shall also inform the committee that it must prepare a written investigation report as prescribed below. At the committee’s first meeting, the RIO will review the charge, the inquiry panel 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 the College’s Research Misconduct Policy, applicable procedures, and applicable federal regulations. The RIO will be available throughout the investigation to advise the committee as needed.

In conducting the investigation, the committee shall comply with Lewis & Clark processes as well as any procedures that may be required by the regulations of the sponsoring agency. The investigation committee shall diligently pursue all significant issues and leads that are relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. This committee may decide that the investigation should include reviewing all research with which the respondent has been involved. If new allegations are identified during the investigation that will be pursued in the investigation, the RIO will give the respondent written notice of such allegations within a reasonable amount of time. Committee members and staff are prohibited from disclosing committee proceedings at any time, except as otherwise provided by these rules or required by law. The findings of this committee will serve as the factual basis for any subsequent disciplinary proceedings against the respondent. As such, 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;
• Offer 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, the opportunity to be interviewed, record or transcribe each interview, provide the recording or transcript to the interviewee for correction; and include the recording or transcript in the record of the investigation;
• Allow the respondent(s) to appear before the committee and present testimony. The respondent may be accompanied by, and consult with, counsel when appearing before the committee, but only the respondent may address the committee (counsel may not); and
• Pursue 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.

The investigation committee and the RIO are responsible for preparing a written draft report of the investigation that:

• Describes the nature of the research misconduct allegation, including identification of the respondent(s)
• Describes and documents financial support for the research subject to the allegations, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing support;
• Describes the specific allegations of research misconduct considered in the investigation;
• References the institutional policies and procedures under which the investigation was conducted;
• Identifies and summarizes the research records and evidence reviewed and identifies any evidence taken into custody but not reviewed; and
• Includes a statement of findings for each allegation of research misconduct identified during the investigation. The statement of findings for each allegation must 1) identify whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly; 2) summarize the facts and the analysis that support the conclusion and consider the merits of any reasonable explanation by the respondent, including any effort by 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; 3) identify the specific funding support (if any); 4) identify whether any publications need correction or retraction; 5) identify the person(s) responsible for the misconduct; and 6) list any current support or known applications or proposals for support that the respondent has pending with federal agencies or external funders.

If the investigation committee is considering allegations of other professional conduct violations in addition to allegations of research misconduct, the committee and the RIO may separate the findings into two reports: one concerning research misconduct findings that must be reported to federal agencies, and a second report concerning findings that need not be reported to federal agencies, including allegations concerning non-federally funded research or other professional conduct violations. The General Counsel shall be available to advise the investigation committee and the RIO with respect to the reports. Modifications should be made as appropriate in consultation with the RIO and the investigation committee.

The RIO will submit a copy of the investigation committee’s draft report to the respondent for comments. The RIO will remind the respondent of the confidentiality considerations under which the draft report is being made available, and may establish reasonable conditions to ensure such confidentiality. The respondent will be allowed 10 calendar days from receipt of the draft report to submit comments to the RIO; the respondent’s comments will be considered in the final report.

The investigation committee will prepare a final report for submission to the DO, which must include the respondent’s comments. The DO will make a written determination as to 1) whether the institution accepts the investigation report, its findings, and the recommended institutional actions, and 2) the appropriate institutional actions in response to the accepted findings of research misconduct. If this determination varies from the findings of the investigation committee, the DO will explain in detail the basis for rendering a decision different from the findings of the investigation committee; this information will be provided to the committee. Alternatively, the DO may return the report to the investigation committee with a request for further fact-finding or analysis.

When a final decision on the case has been reached, the DO or RIO will notify the respondent in writing. In consultation with institutional officials, 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. Further, in consultation with institutional officials, the DO will determine appropriate sanctions for research misconduct. Sanctions shall be based on the seriousness of the misconduct, including but not limited to, the degree to which the misconduct: a) was intentional, knowing, or reckless; b) was an isolated event or part of a pattern; and c) had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare. The range of administrative actions includes, but is not limited to, the correction of the public record including the withdrawal or correction of all pending or published abstracts and papers emanating from the research where misconduct was found; removal of the responsible person from the particular project, special monitoring of future work, probation, suspension, leave without pay, salary reduction, or initiation of steps leading to rank reduction or termination of employment; restitution of funds as appropriate; suspension or termination of an active award; letters of reprimand; and other action appropriate to the research misconduct. The process for dismissing a faculty member for cause is outlined in Lewis & Clark’s Faculty Handbook and will apply to any effort to terminate a faculty member for research misconduct pursuant to this document. If students are implicated in an inquiry into misconduct, the outcome of fact-finding and the DO’s finding that allegations are substantiated shall be reported to the discipline committee (or its equivalent) of the School in which the student is enrolled. In the case of all other employees implicated in findings of research misconduct, the outcome of fact-finding and the DO’s finding that allegations are substantiated shall be referred to the appropriate Dean or Vice President for action in accordance with applicable procedure.

The entire investigation should be completed within 120 days, including conducting the investigation, preparing the report of findings, providing the draft report for comment, finalizing the report, and making necessary notifications. However, if the DO determines that the investigation cannot be completed within this 120-day period, the rationale for the delay will be documented and the RIO will, if applicable, notify federal agencies as required and in accordance with federal regulations. The RIO is responsible for ensuring compliance with all notification requirements to funding or sponsoring agencies, including periodic progress reporting. The RIO shall notify the individuals and agencies of the decision as required. Lewis & Clark will enforce any federal agency sanctions (e.g. debarment).

V. Other Considerations

Throughout the research misconduct proceedings, the RIO will notify ORI and/or the relevant agency immediately if there is 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 action may be necessary to safeguard evidence and protect the rights of those involved; or
• The research community or public should be informed.

The termination of the respondent’s 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 Lewis & Clark’s responsibilities to pursue allegations. Allegations will be pursued even if the respondent, without admitting to the misconduct, elects to resign the respondent’s position after the institution receives an allegation of research misconduct. 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.

Following a final finding of no research misconduct, including ORI concurrence where required by 42 CFR Part 93 (or, for non-PHS funded research, other applicable federal agency requirements), Lewis & Clark will, at the request of the respondent, undertake all reasonable and practical efforts to restore the respondent’s reputation.

If relevant, the DO will determine whether the complainant’s allegations of research misconduct were made in good faith, or whether a witness or committee member acted in good faith. If the DO determines that there was an absence of good faith, the DO will determine whether any administrative action should be taken against the person who failed to act in good faith.

Unless Lewis & Clark transferred custody of the records of research misconduct proceedings to the funding agency in accordance with applicable law, the RIO shall maintain the records in a secure manner for seven (7) years after completion of the research misconduct proceeding, or completion of any agency oversight proceeding, or as required by any applicable record retention provision, whichever is later. The outcome of the fact-finding shall be reported to the sponsoring organization or government agency given prior notice as required.