PRO-U20.13 Addressing Responsible Conduct of Research

U.S. Public Health Service (PHS): A collection of agencies of the U.S. Department of Health and Human Services that includes: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Services, National Institutes of Health, Substance Abuse and Mental Health Services Administration, Administration for Strategic Preparedness and Response, Advanced Research Projects Agency for Health. 

U.S. Public Health Service Support (PHS support): PHS funding, or applications or proposals for PHS funding, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through funding for PHS intramural research; PHS grants, cooperative agreements, or contracts; subawards, contracts, or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements, or contracts.

Office of Research Integrity (ORI): The Office of Research Integrity in the U.S. Department of Health and Human Services is responsible for the scientific misconduct and research integrity activities of the U.S. Public Health Service (PHS).

U.S. Department of Health and Human Services (DHHS): DHHS is a department of the U.S. federal government that sets guidelines for private healthcare systems and provides funding for medical research.

Witnesses: Witnesses are people whom WWU has reasonably identified as having information regarding any relevant aspects of the investigation. Witnesses provide information for review during research misconduct proceedings. Witnesses will cooperate with the research misconduct proceedings in good faith and have a reasonable belief in the truth of their testimony, based on the information known to them at the time.
 

Action By:

Vice Provost for Research

  1. Appoints or serves as the Research Integrity Officer (RIO).

Research Integrity Officer

  1. Trains all federally funded principal investigators (PI) in responssible conduct of research. Training is offered online and via face-to-face classes offered on campus.

Complainant

  1. Reports the research misconduct allegation orally or in writing to the Dean of the Respondent’s College Dean or to the RIO.
  2. Maintains confidentiality of allegation.

Dean

  1. If contacted by Complainant, notifies RIO of allegation of research misconduct.

RIO

  1. Maintains confidentiality of allegations.
  2. For Public Health Services (PHS) supported projects involving multiple institutions:
    RIO may work closely with the other affected institutions to determine whether a joint research misconduct proceeding will be conducted. If so, the cooperating institutions will choose which institution will serve as the lead institution. In a joint research misconduct proceeding, the lead institution will obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions.
  3. For PHS-supported projects if the Respondent admits to research misconduct at any time: WWU will not close the case until it provides the Office of Research Integrity (ORI) with the respondent’s signed, written admission. The admission must state the specific fabrication, falsification, or plagiarism that occurred, which research records were affected, and that it constituted a significant departure from accepted practices of the relevant research community. The institution must not close the case until giving ORI a written statement confirming the respondent’s culpability and explaining how the institution determined that the respondent’s admission fully addresses the scope of the misconduct.
  4. Special circumstances for PHS supported projects: At any time during the misconduct proceedings, WWU will immediately notify ORI if any of the following circumstances arise:
    • Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
    • U.S. Department of Health and Human Services (DHHS) resources or interests are threatened.
    • Research activities should be suspended.
    • There is 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.
    • HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.
  5. Ensures that all original research records and materials relevant to the allegation are immediately secured,inventoried
    and retained appropriately according to University record retention schedules and/or sponsor requirements. Before or at the time of notifying the Respondent of the allegation(s) and whenever additional items become known or relevant, the RIO will promptly take all reasonable and practical steps to obtain all research records and other evidence and sequester them securely.
  6. Ensure that the institutional record contains all required elements that were compiled and considered during the proceedings including assessment documentation, and inquiry and/or investigation reports. The Office of the Vice Provost for Research will securely retain this documentation according to university policy and or agency policy.
  7. Informs Respondent of misconduct allegation within three (3) business days of receipt of the allegation.
  8. Determines if allegation meets the definition of research misconduct and documents whether to proceed with an inquiry within fourteen (14) calendar days of the initial allegation. If the RIO determines that the alleged misconduct does not meet the criteria to proceed to an inquiry, they will write sufficiently detailed documentation and dismisses the allegation. The documentation of the RIO’s decision will be detailed enough to inform why WWU did not proceed to an inquiry. The RIO will also securely retain this documentation according to university retention schedules and or supporting agency policy. In the event of an allegation involving multiple institutions, 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.
  9. If the allegation meets the definition of research misconduct, communicates the commencement of an inquiry to be completed within ninety (90) calendar days unless circumstances clearly warrant a longer period such as witness unavailability. If the inquiry takes longer than ninety (90) days, the inquiry record must include documentation of the reasons. 

Respondent

  1. Maintains confidentiality and cooperates with the conduct of the inquiry or investigation. The Respondent’s destruction of research records documenting the questioned research is evidence of research misconduct where a preponderance of evidence establishes that the respondent intentionally or knowingly destroyed records after being informed of the research misconduct allegations. 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. If admitting to research misconduct, the Respondent will sign a written statement specifying the affected research records and confirming the misconduct was falsification, fabrication, and/or plagiarism; committed intentionally, knowingly, or recklessly; and a significant departure from accepted practices of the relevant research community.

RIO

  1. Conducts an inquiry into the allegation. The purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the Respondent and witnesses to determine whether there is sufficient evidence to warrant an investigation. The inquiry does not determine whether research misconduct has occurred. For PHS-supported projects: Upon completion of the inquiry, the institution will provide ORI with the complete inquiry report and add it to the institutional record.
  2. Interviews the Respondent, Claimant, and witnesses and examines relevant research records and materials. The institutions will take precautions to ensure that individuals responsible for carrying out any part of the interviews do not have unresolved conflicts with the witness(es), Respondent, or Claimant(s). For PHS-supported projects: During an investigation, Responsible Conduct of Research Panel members may participate in recorded interviews of 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(s).
  3. Completes the inquiry and prepares written inquiry report within sixty (60) calendar days of receipt of the allegation. Written inquiry report listing the name and title of the witnesses and experts, if any; the allegations; the source of external funding, if any; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; and a description of the evidence in sufficient detail to demonstrate whether an investigation is warranted.
  4. Provides a copy of the Inquiry Report to the Respondent and Complainant for comment and rebuttal. For PHS supported projects: The institution is responsible for giving the respondent(s) copies of or supervised access to the sequestered research records used to inform the Inquiry Report.
  5. Provides the witness with the portion of the inquiry report that addresses the witness’s role.
  6. May keep the Complainant apprised of the status of the allegation. For PHS supported projects: If WWU chooses to notify one complainant of the inquiry results in a case, all complainants will be notified by the institution, to the extent possible. 

Respondent

  1. Reviews inquiry report and rebuts allegation if applicable within fourteen (14) calendar days of receiving the report.

Complainant

  1. If inquiry report is provided by RIO, reviews and rebuts allegations in the Inquiry report within fourteen (14) days of receiving the report.

RIO

  1. Attaches Respondent’s and the Claimant’s rebuttals to the report and may revise the inquiry report incorporating and responding to their rebuts.
  2. Establishes reasonable conditions for review to protect the confidentiality of the inquiry report.
  3. Provides a copy of the report with attached records including evidence and any interview transcripts to the Provost.
  4. If the research misconduct was committed on a PHS supported project, the RIO provides a copy of the inquiry report to the Office of Research Integrity (ORI) notifying ORI of inquiry. If the research was funded by another external agency, the RIO provides a copy of the inquiry report to the appropriate agency as required.

Provost

  1. Reviews report and determines whether to proceed with a full investigation. The case warrants full investigation if reasonable basis exists for concluding that the allegation falls within the definition of research misconduct and the preliminary information-gathering from the inquiry indicates that the allegation may have substance. The Provost will not determine if research misconduct occurred, nor assess whether the alleged misconduct was intentional or reckless. Such determination is not made until the case proceeds with an investigation. If a conflict  of interest exists, the President or their appointed delegate will assume the Provost’s responsibilities.  

RIO

  1. At the conclusion of the inquiry, regardless of whether an investigation is warranted, the RIO, or other designated institutional official will prepare a written inquiry report. The contents of a complete inquiry report will include:
    • The names, professional aliases, and positions of the respondent and complainant(s).
    • A description of the allegation(s) of research misconduct.
    • Details about the PHS funding, including any grant numbers, grant applications, contracts, and publications listing PHS support.
    • The composition of the inquiry panel, if used, including name(s), position(s), and subject matter expertise.
    • An inventory of sequestered research records and other evidence and description of how sequestration was conducted.
    • Transcripts of interviews, if transcribed.
    • Inquiry timeline and procedural history.
    • Any scientific or forensic analyses conducted.
    • The basis for recommending that the allegation(s) warrant an investigation.
    • The basis on which any allegation(s) do not merit further investigation.
    • Any comments on the inquiry report by the respondent or the complainant(s).
    • Any institutional actions implemented, including internal communications or external communications with journals or funding agencies. Documentation of potential evidence of honest error or difference of opinion.
    • For PHS-supported projects: Copies of PHS regulations and the University’s Responsible Conduct of Research policy POL-U4520.02 and procedure PRO-U4520.02.
  2. Notify the Respondent of the inquiry’s outcome and provide the respondent with copies of the final inquiry report. The institution may notify the Complainant whether the inquiry found that an investigation is warranted. If the institution provides notice to one Complainant in a case, it must provide notice, to the extent possible, to all Complainants in the case.
  3. For PHS-supported projects: If the RIO or other designated institutional official determines that an investigation is not warranted, The Office of the Vice Provost for Research will keep the inquiry report to permit a later review by ORI of why the institution did not proceed to an investigation, store these records in a secure manner for at least seven years after the termination of the inquiry, and provide them to ORI upon request.
  4. Inform the Respondent if an investigation has been commenced with written notice of any additional allegations raised against them not previously addressed by the inquiry report. If additional Respondents are identified during the investigation, WWU may choose to either conduct a separate inquiry or add the new Respondent(s) to the ongoing investigation.
  5. For PHS-supported projects: Notify ORI of the decision to investigate and begin the investigation within thirty (30) calendar days after deciding an investigation is warranted. If an investigation is warranted all processes will be concluded within one hundred and eighty (180) calendar days. If the investigation takes more than 180 days to complete, the institution will ask ORI in writing for an extension and document the reasons for exceeding the 180-day period in the investigation report.

Respondent

  1. Review and comment on any additional allegations or information added to the institutional record shared by the RIO along with the witness transcripts and the draft investigation report. The institution will give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the Respondent.

RIO

  1. Convene the Responsible Conduct of Research Panel (RCRP). Panel members will be vetted for conflicts of interest and appropriate scientific expertise. The RIO will also ensure that the members understand their responsibility to conduct the research misconduct proceedings in compliance with university policies, state law, and if applicable funding agency policy. For PHS supported projects involving more than one institution: By mutual agreement, the joint research misconduct proceeding may include panel members from the institutions involved.
  2. Informs the Respondent of names of panel members.

Respondent

  1. Reviews names of panel members and if there are objections to composition of panel submits written explanation to RIO of why certain member should be replaced.

RIO

  1. Nominates replacement members to investigation panel to replace any panel members removed following Respondent’s objection if needed.
  2. Prepares charge within fourteen (14) calendar days for RCRP describing the allegations and related issues identified during the inquiry, defines research misconduct, and identifies the name of the Respondent. The charge will state that the panel is to evaluate the evidence and testimony of the Respondent, Complainant, and 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. As part of its investigation, the investigation will pursue significant issues and relevant leads necessary to reach an informed finding.

Responsible Conduct of Research Panel (RCRP)

  1. Begin investigations within thirty (30) calendar days of the completion of the inquiry.
  2. Reviews report prepared by the RIO.
  3. Interview the Respondent, and witnesses. When possible, the interviews should be recorded and transcribed.
  4. Provides transcript of witness testimony to witness for review and revision. Provides transcript of Respondent testimony to Respondent for review and revision.
  5. Convene to review and discuss all evidence including documents, computer files, lab books to determine whether research misconduct has occurred. Experts may be consulted to assist with determination of research misconduct under the circumstances. Panel deliberations may be recorded and transcribed. In order to find research misconduct, the Respondent’s actions must have been a significant departure from accepted practices in the research community.
  6. The Investigation Report must be completed within sixty (60) calendar days of initiation of the investigation process unless extenuating circumstances are documented. Drafts Investigation Report for each Respondent including the following:
    • Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.
    • Description of the specific allegation(s) of research misconduct for consideration in the investigation of the respondent.
    • Composition of investigation panel, including name(s), position(s), and subject matter expertise.
    • 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. The inventory will also include a description of how any sequestration was conducted during the investigation.
    • Transcripts of all interviews conducted. Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication).
    • Any scientific or forensic analyses conducted.
    • A copy of these policies and procedures. Any comments made by the respondent and complainant(s) on the draft investigation report and the panel’s consideration of those comments.
    • A statement for each separate allegation of whether the panel recommends a finding of research misconduct. If the investigation panel does not recommend a finding of research misconduct for an allegation, the investigation report will provide a detailed rationale for its conclusion.
    • For PHS supported projects:
      • Description and documentation of 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.
      • PHS funding applications, progress reports, presentations, posters, or other research records that contain the allegedly falsified, fabricated, or plagiarized material.
  7. Submits the draft investigation report to Respondent and Complainant and, concurrently, a copy of, or supervised access to, the research records and other evidence that the panel considered or relied on. The Respondent will submit any comments on the draft report to the institution within 30 days of receiving the draft investigation report.

Respondent and Complainant

  1. Submit comments and rebuttal to investigation report findings within fourteen (14) calendar days of receiving the report to RIO.

RCRP

  1. Submits investigation panel report including witness testimony transcripts, Complainant’s and Respondent’s comments and rebuttal to the RIO.  

RIO

  1. Submits report and attachments to the Provost, the Respondent, and the Respondent’s dean, department chair, and the appropriate federal agency as required by the terms of project funding.

Provost

  1. Review the investigation report and make a final written determination of whether the institution found research misconduct and, if so, who committed the misconduct. In this statement, the Provost will include a description of relevant institutional actions taken or to be taken.

RIO

  1. Add the Provost’s written decision to the investigation report and organize the institutional record in a logical manner.

Respondent

  1. May appeal determination to President within thirty (30) calendar days of receiving the Provost’s determination. If the respondent filed an appeal, the complete record of any institutional appeal also becomes part of the institutional record. PHS-supported projects: WWU will wait until the appeal period is concluded to transmit the institutional record to ORI.

RIO

  1. Add Respondent’s appeal to the investigation report.

President

  1. Reviews report and Provost’s determination and makes final ruling on disposition of the allegation. PHS Supported projects: After the President has made a final written determination and any institutional appeal is complete, the institution will submit the institutional record to ORI.
  2. Imposes penalty on Respondent.
     

Procedure Information

Approved By:

Vice Provost, RSP

Effective Date:

April 22, 2026

Authority:

  • POL-U4520.02 Addressing Responsible Conduct of Research

Procedure Contact

Research and Sponsored Programs

Phone: (360) 650-3220

Research and Sponsored Programs website