Policies & Procedures
Policies & Procedures / Research Misconduct and Research-Related Conflict of Interest Policy

Research Misconduct and Research-Related Conflict of Interest Policy

Purpose:

Willamette University is committed to maintaining high standards of integrity in all research and scholarship. As a recipient of federal research funds, Willamette University has institutional policies and procedures in place to address allegations of research misconduct, conflict of interest, and specifically, research misconduct involving external support from agencies of the United States Public Health Service (PHS).

Individuals at Willamette University are required to conduct research within applicable federal and sponsor guidelines, state law, and University policy. As such, externally funded research is subject to funders' rules, requirements, and processes.

When federal funding is supporting a project that involves research misconduct, the funding agency may impose sanctions on the researcher that are not subject to faculty governance, including withdrawing approval of the Principal Investigator (PI) or other personnel, suspending or terminating an award, rescinding funds, debarment from receipt of future federal funding, or other modification of the terms of an award. The University may impose additional penalties associated exclusively with the individual’s status as a University employee, subject to faculty and staff personnel policies and handbooks.

This policy establishes the requirements for the Responsible Conduct of Research (RCR) and sets forth procedures for addressing allegations of research misconduct and managing Conflicts of Interest (COI). It applies to all individuals affiliated with Willamette University (Investigators, faculty, staff, students, trainees, and visiting scholars) who are proposing, performing, reviewing, or reporting research under the auspices of the University, regardless of the funding source. When the allegation of research misconduct relates to activities funded by the U.S. Public Health Service (PHS), the Policy is intended to meet the requirements of the PHS regulations at 42 C.F.R. Part 93, “Public Health Service Policies on Research Misconduct.”

Definitions related to this Policy:

Appeal means an application to a recognized authority for a review of a research misconduct finding.

Complainant means the person bringing a claim of research misconduct against another person or entity.

Designated Researcher means any undergraduate student, post-baccalaureate fellow, graduate student, postdoctoral fellow, faculty member, senior personnel, or staff member conducting research as part of a Willamette University research endeavor.

Disposition means the final outcome of a research misconduct investigation.

Financial Conflict of Interest (FCOI) means a Significant Financial Interest (see definition below) that the University reasonably determines could directly and significantly affect the design, conduct, or reporting of sponsored research.

Inquiry means a request for information designed to determine whether a full investigation is warranted.

Institutional Deciding Official (IDO), typically the Provost or President, makes the final institutional determinations regarding research misconduct findings, hears appeals, and determines disciplinary actions.

Investigation means a formal examination or inspection designed to determine whether research misconduct has occurred.

Investigator (or Principal Investigator, PI) means any person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or research-related educational activities.

Research Integrity Officer (RIO) is the institutional official appointed by the Provost responsible for the education, implementation, and oversight of this RCR Policy. The RIO receives all allegations of misconduct and manages the initial process, including sequestering evidence.

Research Misconduct means the fabrication, falsification, plagiarism, or other serious deviation from commonly accepted practices in the relevant academic community for proposing, performing or reviewing research, or in reporting research results. It does not include honest error or differences in opinion, interpretations or judgments of data.

  • Fabrication means making up data or results and recording or reporting them.
  • Falsification means 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.
  • Plagiarism means the improper use of another person’s ideas or words without acknowledgement. Examples of plagiarism include: 1) failing to use quotation marks when quoting from a source, 2) failing to document the source of distinctive ideas, or 3) fabricating or inventing sources.

Beyond the basic definition of research misconduct, serious deviation from accepted research practices includes, but is not limited to:

  • Abusing confidentiality, including the improper use of ideas and preliminary data gained from access to privileged information through editorial review of manuscripts or peer review of proposals.
  • Regulatory Violations, namely the violation of any policies held by Willamette’s Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC).
  • Stealing, destroying, or damaging the research property of others with the intent to alter the research record.
  • Directing, encouraging, or knowingly allowing others to engage in fabrication, falsification, or plagiarism.
  • Retaliation of any kind against a person who, in good faith, reported or provided information about possible misconduct.

Research Records means any data, document, or other information, including, but not limited to, laboratory notebooks, clinical records, computer files, research proposals, publications, or oral or written communications, that record the input, conduct, or results of research.

Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.

Responsible Conduct of Research (RCR) means training that is required for all Designated Researchers and Principal Investigators prior to conducting human subjects research, animal subjects research, and/or engaging in NSF- or NIH-funded research. There is an additional research security training requirement for all named grant personnel which must be completed in advance of any grant submissions to NIH and NSF.

Retaliation means any adverse action taken against a person who (a) has made a complaint of research misconduct; (b) has cooperated in an investigation or hearing of alleged research misconduct; or (c) is perceived to be involved in reporting in an investigation or hearing of research misconduct. Retaliation includes confirmed or implied behaviors or actions, including electronic or on-line activity, which intimidate, threaten, harass, or result in other adverse actions threatened or taken. An individual reporting research misconduct is entitled to protection from any form of retaliation following a report that is made in good faith, even if the report is later not substantiated based on the available evidence. Retaliation does not include good faith actions lawfully pursued in response to a report of prohibited conduct.

Significant Financial Interest (SFI) means a financial interest held by the Investigator or their immediate family (spouse/domestic partner and dependent children) that reasonably appears related to the Investigator's institutional responsibilities. This typically includes: (1) Remuneration (salary, fees, etc.) exceeding $5,000 from a single non-University entity over a 12-month period; (2) Any equity interest in a non-publicly traded entity; or (3) Equity exceeding $5,000 in a publicly traded entity.

Note: SFI and FCOI do not include:

  • salary, royalties or other remuneration from the proposing organization;
  • any ownership interests in the organization, if the organization is an applicant under the Small Business Innovation Research Program (SBIR) or Small Business Technology Transfer Program (STTR);
  • income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
  • income from service on advisory committees or review panels for public or nonprofit entities;
  • an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: (i) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value; and (ii) does not represent more than a 5% ownership interest in any single entity; or
  • salary, royalties, or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during the prior twelve-month period.

Policy:

  1. Required Trainings for Researchers - A basic understanding of the RCR can be obtained and documented through Willamette’s affiliation with the Collaborative Institutional Training Institute (CITI) Program (https://www.citiprogram.org). Willamette offers its faculty, staff, and students free access to CITI’s various topic areas and corresponding certifications that hold widely recognized value within the research space. For students, obtaining CITI certification is an indicator to future employers that they have knowledge of research ethics and have been involved in substantive scientific work. Additionally, Willamette offers Research Security Training required by both the NSF and NIH via Workday. Please contact Willamette’s Office of Grants and Strategic Initiatives to obtain access to this training.
    1. Principal Investigator Responsibility - Principal Investigators are responsible for completion of the required RCR training and maintaining training documentation of RCR training for all researchers who work under their direction. Principal Investigators are, themselves, responsible for completing ongoing RCR training appropriate to their own career stage and subject matter and for maintaining documentation of this training. For Principal Investigators conducting externally sponsored research projects, this requires completion of any specific funding agency requirements, as applicable, and may include periodic refresher training.
    2. Training Requirements - RCR training is required for any Designated Researcher before conducting research involving human subjects, regardless of the discipline. This includes secondary data analysis, unless the dataset has been designated by Willamette’s Institutional Review Board (IRB) as not human subjects research due to de-identification. RCR training focused on animal welfare in terms of ethical principles and federal regulations is required for any Designated Researcher before conducting research involving live vertebrate animals or live cephalopods. Training is overseen by Willamette’s Institutional Animal Care and Use Committee (IACUC). RCR training is additionally required for any Designated Researcher conducting research in any discipline paid through NSF grants that are administered by the University. This RCR requirement also applies to anyone paid through grants from other funders that require RCR training per the associated funding announcement and/or funding agency guidelines. Principal Investigators submitting grants to Public Health Service (PHS) (which includes NIH, FDA, CDC, HRSA, AHRQ, and SAMHSA), NSF, or other funding agencies with RCR requirements, must confirm that they have reviewed and will comply with the University’s RCR policy and training plan during the pre-submission Internal Review Process, which must be completed before proposals can be submitted to the funding agency for review. Principal Investigators should note that all Willamette University CITI RCR training courses are valid for four years (with the NSF Research Security training—which must be completed within 12 months of any proposal submission—as the one exception), after which point a refresher course is required.
    3. Documentation - Willamette’s Office of Grants & Strategic Initiatives tracks compliance with the RCR Policy and Training Plan for all Principal Investigators and researchers participating in externally sponsored projects, according to specific funding agency requirements. IRB and IACUC provide RCR oversight for all projects that include human subjects and animals, respectively. All externally sponsored Principal Investigators will work with the Office of Grants & Strategic Initiatives to comply with sponsor-required RCR training during both grant submission and award set-up. Additionally, Principal Investigators will work with the Office of Grants & Strategic Initiatives to comply with sponsor-required RCR training when adding any undergraduates or postdoctoral researchers to their externally sponsored projects.
  2. Conflict of Interest in Research -Willamette University requires all research to be conducted with integrity, ensuring that the design, conduct, and reporting of research are free from bias. This section details the disclosure and management requirements for personal, professional, and financial conflicts of interest that could affect, or reasonably appear to affect, the objectivity of research. Please note that in cases of research compliance, a FCOI, or SFI would be considered in addition to Willamette University’s existing Conflict of Interest Policy.
    1. Mandatory Disclosure - Each Investigator must submit an FCOI disclosure form to the Office of Grants and Strategic Initiatives at the time of proposal submission. This form requires Investigators to disclose all of the Investigator’s SFI (including those of their spouse and dependent children)
      1. that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by the grantor, or
      2. in entities whose financial interests would reasonably appear to be affected by such activities.
    2. Updated Disclosure - Investigators must update their FCOI disclosure within thirty (30) days of acquiring a new SFI that meets the disclosure thresholds.
    3. Committee Review - The IDO - together with the University’s Office of General Counsel - will review all disclosures to determine if an SFI constitutes an FCOI that needs management.
    4. Management of a FCOI - If an FCOI is identified, the IDO will develop and implement a written management plan to reduce, manage, or eliminate the conflict. This plan will be shared with and signed by the Investigator. Management strategies may include:
      1. Public Disclosure: Requiring disclosure of the FCOI in all presentations, publications, and informed consent documents for human subjects research.
      2. Independent Review: Appointing a non-conflicted individual or committee to monitor the research.
      3. Modification of Roles or Research Plan: Modifying the Investigator's role, or limiting their participation in the conflicted portion of the research.
      4. Divestiture: Requiring the Investigator to reduce or eliminate the SFI if the conflict is deemed unmanageable.
      5. Severance: Severance of relationships that create conflicts.
    5. Funder Notification - Willamette University will notify the funder in any instance in which the University is unable to satisfactorily manage an FCOI and/or if the University finds that research will proceed without the imposition of conditions or restrictions when an FCOI exists.
    6. FCOI Record Management - Willamette University will maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the award to which they relate, or until the resolution of any funder action involving those records, whichever is longer.
  3. Research Misconduct - Research Misconduct is a serious deviation from accepted ethical practices and professional standards. Willamette University upholds the federal definition of Research Misconduct as outlined by the Public Health Service (PHS) in 42 CFR Part 93. This policy applies to Research Misconduct involving applications, proposals, research, Research Records, or proposals for support for research.

    The Standard for a Finding of Research Misconduct - will be determined by the process outlined in section 4, must require all of the following three instances;

    1. The Research Misconduct is a significant departure from accepted practices of the relevant research community;
    2. The misconduct is committed intentionally, knowingly, or recklessly; and
    3. The Research Misconduct is established beyond a preponderance of evidence.
  4. Investigating Allegations Research Misconduct -The following process shall apply to all individuals engaged in research conducted under the auspices of Willamette University, regardless of the source of financial support, and is limited to addressing Research Misconduct as defined in this document. Willamette University is responsible for ensuring that these policies and procedures for addressing allegations of Research Misconduct meet the requirements of the PHS Policies on Research Misconduct (42 CFR Part 93). Willamette University is committed to following these policies and procedures when responding to allegations of Research Misconduct.
    1. Reporting Allegations of Research Misconduct - All members of the Willamette University community have an obligation to report observed, suspected, or apparent Research Misconduct—in writing—to the University Provost. The University will make all reasonable and practical steps to protect the confidentiality, position, and reputation of individuals who make allegations or cooperate with a proceeding in good faith.
    2. Interim Administrative Actions - The University Provost may impose Interim Administrative Actions on the Respondent at any time during the proceeding to protect public health and safety, University or sponsor funds, or the integrity of research. These actions may include:
      1. Increased supervision of the Respondent’s research activities or personnel.
      2. Monitoring of communications and expenditures related to the research.
      3. Restricting access to University research resources, facilities, or funds.
      4. Immediate notification to the HHS's Office of Research Integrity (ORI) if the findings or lack of cooperation suggest a significant risk to public health, University resources, or criminal violation.
    3. Assessment - An assessment’s purpose is to determine whether an allegation warrants an Inquiry, and includes a review of readily accessible information relevant to the allegation. Upon receiving an allegation of Research Misconduct, the RIO or another designated University official will promptly determine whether the allegation (a) falls within the definition of Research Misconduct, (b) is within the applicability criteria of 42 CFR Part 93 § 93.102, and (c) is credible and specific enough to identify and sequester potential evidence.

      If it is determined that the allegation meets these three criteria, the RIO or designated official will promptly document the assessment and initiate an Inquiry and sequester all Research Records and other evidence. This documentation must be retained securely for seven years after completion of the misconduct proceedings.

      If it is determined that the alleged misconduct does not meet the criteria to proceed to an Inquiry, the RIO or designated official will write sufficiently detailed documentation to permit a later review by ORI of why Willamette did not proceed to an Inquiry and securely retain this documentation for seven years.
    4. Inquiry - After the formal allegation has been made, the RIO, in consultation with the University Provost, will conduct an initial gathering of facts and determine whether there is a reasonable basis for believing that Research Misconduct may have occurred—this justifying an Investigation. At this stage, they will obtain the original or substantially equivalent copies of all Research Records and other evidence that are pertinent to the proceeding, inventory these materials, and sequester them in a secure manner.

      If additional Respondents are identified, Willamette will provide written notification to the new Respondent(s). All additional Respondents will be given the same rights and opportunities as the initial Respondent. Only allegations specific to a particular Respondent will be included in the notification to that Respondent.

      The RIO will conduct a preliminary review of the evidence. In the process of fact-finding, the RIO may interview the Respondent and/or witnesses, and may also utilize subject matter experts as needed to assist in the Inquiry. An Investigation is warranted if (a) there is a reasonable basis for concluding that the allegation falls within the definition of Research Misconduct under 42 CFR Part 93 and involves PHS supported activities as provided in § 93.102; and (b) preliminary information gathering and fact-finding from the Inquiry indicates that the allegation may have substance. At this stage, the RIO will not determine if Research Misconduct occurred, nor assess whether the alleged misconduct was intentional, knowing, or reckless.

      At the time of or before the beginning of the Inquiry, Willamette will notify the Respondent in writing that an allegation(s) of Research Misconduct has been raised against them, the relevant Research Records have been sequestered, and an Inquiry will be conducted to decide whether to proceed with an Investigation. If additional allegations are raised, Willamette will notify the Respondent(s) in writing; when appropriate, the Respondent will receive copies of—or reasonable supervised access to—the sequestered materials. At the end of the Inquiry, the University will give the Respondent a copy of the draft Inquiry report for review and comment, and will notify them of the Inquiry’s final outcome and provide the Respondent with copies of the final Inquiry report, the PHS regulation, and these policies and procedures.

      At the conclusion of the Inquiry—regardless of outcome—the RIO will prepare a written Inquiry report that includes the following:

      i. The names, professional aliases, and positions of the Respondent and Complainant(s)
      ii. A description of the allegation(s) of Research Misconduct.
      iii. Details about the funding, including any grant numbers, grant applications, contracts, and publications listing grant support.
      iv. The name(s), position(s), and subject matter expertise of individuals involved in the Inquiry.
      v. An inventory of sequestered Research Records and other evidence and description of how sequestration was conducted.
      vi. Transcripts of interviews, if transcribed.
      vii. Inquiry timeline and procedural history.
      viii. Any scientific or forensic analyses conducted.
      ix. The basis for recommending that the allegation(s) warrant an Investigation.
      x. The basis on which any allegation(s) do not merit further Investigation.
      xi. Any comments on the Inquiry report by the Respondent or the Complainant(s).
      xii. Any institutional actions implemented, including internal communications or external communications with journals or funding agencies.
      xiii. Documentation of potential evidence of honest error or difference of opinion

      If it is determined that an Investigation is warranted, Willamette will provide written notice to the Respondent(s) of the decision to conduct an Investigation of the alleged misconduct, including any allegations of Research Misconduct not addressed during the Inquiry. The University will also provide ORI with a copy of the Inquiry report. These notifications will be completed within 30 days of this decision and before the Investigation begins.

    5. Investigation - If an Investigation is warranted, the Provost will convene an Investigation Committee comprising qualified members who are informed of their responsibility to conduct the proceedings in compliance with PHS regulation. The Committee is required to complete all aspects of the Investigation (described below) within 180 days.

      The Committee will conduct interviews, pursue leads, and examine all Research Records and other evidence relevant to reaching a decision on the merits of the allegation(s)—using diligent efforts to ensure that the Investigation is thorough, sufficiently documented, and impartial and unbiased to the maximum extent practicable. The Committee will interview each Respondent, Complainant(s), 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 University will record and transcribe interviews during the Investigation and make the transcripts available to the interviewee for correction, and will include the transcript(s) with any corrections and exhibits in the institutional record of the Investigation.

      Throughout the process, the Respondent will be notified in writing of any additional allegations raised against them during the Investigation. If additional Respondents are identified during the Investigation, Willamette will notify them of the allegation(s) and provide them an opportunity to respond consistent with the PHS regulation. The University may choose to either conduct a separate Inquiry or add the new Respondent(s) to the existing Investigation. The Respondent(s) will have the opportunity to review and correct the interview transcript/recording.

      The Investigation report for each Respondent will include the following:

      i. Description of the nature of the allegation(s) of Research Misconduct, including any additional allegation(s) addressed during the Research Misconduct proceeding.
      ii. Description and documentation of the PHS support, including any grant numbers, grant applications, contracts, and publications listing PHS support. This documentation includes known applications or proposals for support that the Respondent has pending with PHS and non-PHS Federal agencies.
      iii. Description of the specific allegation(s) of Research Misconduct for consideration in the Investigation of the Respondent.
      iv. Composition of the Investigation committee, including name(s), position(s), and subject matter expertise.
      v. Inventory of sequestered Research Records and other evidence, except records the institution did not consider or rely on. This inventory will include manuscripts and funding proposals that were considered or relied on during the Investigation, as well as a description of how any sequestration was conducted during the Investigation.
      vi. Transcripts of all interviews conducted.
      vii. Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other Research Records that contain the allegedly falsified, fabricated, or plagiarized material.
      viii.. Any scientific or forensic analyses conducted.
      ix. A copy of these policies and procedures.
      x. Any comments made by the Respondent and Complainant(s) on the draft Investigation report and the committee’s consideration of those comments.
      xi. A statement for each separate allegation of whether the committee recommends a finding of Research Misconduct.

      If the committee recommends a finding of Research Misconduct for an allegation, the Investigation report will present a finding for each allegation. These findings will (a) identify the individual(s) who committed the Research Misconduct; (b) indicate whether the misconduct was Falsification, Fabrication, and/or Plagiarism; (c) indicate whether the misconduct was committed intentionally, knowingly, or recklessly; (d) identify any significant departure from the accepted practices of the relevant research community and that the allegation was proven by a preponderance of the evidence; (e) summarize the facts and analysis supporting the conclusion and consider the merits of any explanation by the Respondent; (f) identify the specific PHS support; and (g) state whether any publications need correction or retraction.

      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.

      The Committee should also provide a list of any current support or known applications or proposals for support that the Respondent has pending with all Federal agencies.

      The Respondent will receive a copy of the Investigation Committee’s draft report and supporting evidence, and may file a written response to that draft report within 30 days of receipt. This response will be included in the final report.
    6. Determination, Appeal, and Disposition - The IDO will receive the final report, review all materials, and make a final written determination of whether Research Misconduct has occurred and include a description of relevant institutional actions to be taken. This written determination will be added to the Investigation report.

      The Respondent will be sent the report, and will have 10 days to Appeal the final determination to the University President in writing. The President’s decision on the Appeal will be final.

      The University will document the final decision and transmit the institutional record (including the final Investigation report, the IDO’s decision, and any Appeal materials) to ORI. If the Investigation takes more than 180 days to complete, Willamette will ask ORI in writing for an extension and document the reasons for exceeding the 180-day period in the Investigation report. Additionally, the University will inform any sponsoring agencies, collaborators, co-authors, and editors of journals in which the subject research was published, and, where appropriate, criminal authorities of the Disposition and the finding of misconduct.

      If no finding is made, the University must make all reasonable efforts to protect and restore the reputation of the Respondent.
    7. Records Retention - Except as may otherwise be prescribed by applicable law, Willamette will maintain confidentiality for any records or evidence from which research subjects might be identified and will limit disclosure to those who need to know to carry out a Research Misconduct proceeding. Willamette University’s Office of the Provost will 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 the completion of the proceeding or the completion of any HHS proceeding, whichever is later, unless custody has been transferred to HHS.

References:

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1For NSF and NIH applications, Covered Individuals must complete research security training within 12 months prior to submission. For active NIH grantees, Covered Individuals must complete research security training prior to submitting their Research Performance Progress Report (RPPR).

2Existing NIH policy calls for RCR instruction to be undertaken at least once during each career stage, and at a frequency of no less than once every four years. More than 50% of RCR training for PHS-funded investigators must take place in-person; CITI training can be used for some of the hours but not for the majority. Acceptable programs generally involve at least eight contact hours.

Effective Date: October 29, 2025
Responsible Person/Primary Contact: Provost
Responsible University Office: Academic Affairs