3230 - Research Misconduct

CONTENTS:

• A. Purpose
• B. Scope
• C. Definitions
• D. General Principles
• E. Receipt & Assessment of Allegation
• F. The Inquiry
• G. The Investigation
• H. Institutional Administrative Actions

A. PURPOSE. This policy states the process and establishes the procedures for adjudicating allegations of Research Misconduct at the University of Idaho in a prompt and impartial manner.

B. SCOPE

B-1. This policy applies only to misconduct that meets the definition of both Research and Research Misconduct.

B-2. Not covered. This policy is limited to addressing misconduct related to Research proposals, results, data, or records. It does not apply to misconduct in the research setting that does not affect the integrity of the research record, such as misallocation of funds, sexual harassment, or discrimination.

C. DEFINITIONS

C-1. Accepted Practices of the Relevant Research Community means practices established by federal regulations or the entity funding the research, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive research funds.

C-2. Allegation means a disclosure of possible Research Misconduct through any means of communication and brought directly to the attention of an official of the University or the entity funding the research.

C-3. Assessment means a consideration of whether an allegation of Research Misconduct appears to be within the definition of Research Misconductand is sufficiently credible and specific such that that potential evidence of research misconduct may be identified. The Assessment only reviews information that is readily accessible and relevant to the Allegation.

C-4. Complainant means a person who makes an Allegation of Research Misconduct.

C-5. Conflict of Interest means the real or apparent interference of one person’s interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.

C-6. Day means calendar day unless otherwise specified. If a deadline falls on a Saturday, Sunday, federal holiday, or other day the University is closed to the public, the deadline will be extended to the next day that is not a Saturday, Sunday, federal holiday, or day the University is closed to the public.

C-7. Deciding Official (“DO”) means the UI official who makes the final determination on an allegation of Research Misconduct and any responsive institution actions. The Provost is the University’s Deciding Official. The same individual cannot serve as the DO and the Research Integrity Officer.

C-8. Fabrication means making up data or results and recording or reporting them.

C-9. 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.

C-10. Good Faith

C-11. Inquiry means preliminary information gathering and preliminary fact-finding that meet the requirements of the funding agency.

C-12. Inquiry Board (“Board”) means three individuals selected from the Scientific Misconduct Committee (“SMC”) (see FSH 1640.77) to review a Research Misconduct Allegation(s) to determine if there is sufficient evidence to warrant an Investigation.

C-13. Institutional Record comprises:

C-14. Intentionally means to act with the aim of carrying out the act.

C-15. Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct occurred, and if so, to determine the responsible person and the seriousness of the misconduct.

C-16. Investigation Committee (“Committee”)means the group of people that review an Allegation(s) to determine if Research Misconduct occurred.

C-17. Knowingly means to act with awareness of the act.

C-18. Notice means a written or electronic communication served in person, by mail, or its equivalent to the last known street address, facsimile number, or email address of the addressee.

C-19. Person means any individual, corporation, partnership, institution, association, unit of government, or other legal entity, however organized.

C-20. Plagiarism means the appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit.

C-21. Preponderance of the evidence means proof by evidence that, compared with evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not.

C-22. Research means a systematic experiment, study, evaluation, demonstration, or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) by establishing, discovering, developing, elucidating, or confirming information. This applies to all fields of science, engineering and mathematics, as well as research in economics, education, law, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.

C-23. Research Integrity Officer (“RIO”) means the UI official responsible for administering the University’s written policies and procedures for addressing allegations of research misconduct in compliance with federal regulations. The University’s vice president for research and economic development is the RIO. For PHS policy purposes, the RIO is also the Institutional Certifying Official (see 42 CFR 93 for details).

C-24. Research Misconduct means fabrication, falsification, or plagiarism, in proposing, performing, or reviewing Research, or in reporting Research results. Research Misconduct does not include honest error or difference of opinion.

C-25. Research Misconduct Proceeding (“Proceeding” or “Proceedings”) means any actions related to alleged Research Misconduct taken under this policy, including Allegations, Assessments, Inquiries, Investigations, or federal agency oversight reviews.

C-26. Research Record means the record of data or results that embody the facts resulting from scientific inquiry. Data or results may be in physical or electronic form. Examples of items, materials, or information that may be considered part of the research record include, but are not limited to, research proposals, raw data, processed data, clinical research records, laboratory records, study records, laboratory notebooks, progress reports, manuscripts, abstracts, theses, records of oral presentations, online content, lab meeting reports, and journal articles.

C-27. Respondent means the person against whom an allegation of Research Misconduct is directed or who is the subject of a Research Misconduct Proceeding.

1. Subsequent Use: The six-year limitation is renewed is renewed when Respondent cites to portions of, republishes, or uses a research record for the potential benefit of Respondent and that is the subject of the Research Misconduct Allegation.
2. Health or safety to the public: the alleged misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

1. There was a significant departure from Accepted Practices of the Relevant Research Community;
2. The misconduct was committed intentionally, knowingly, or recklessly; and
3. The Allegation was proven by a Preponderance of the Evidence.

1. Meetings. To maintain confidentiality, all meetings during Proceedings are closed to anyone whose attendance has not been specifically requested by the Board, Committee, or RIO.
2. Identity of Respondents, Complainants, Witnesses. Disclosure of the identity of Respondents, Complainants, or witnesses in a Proceeding is limited to the extent possible to those who need to know, consistent with a thorough, competent, objective, and fair Proceeding, and as allowed by law. This limitation on disclosure of Respondent, Complainant, or witness identities no longer applies once University makes a final determination of Research Misconduct findings. However, the University must disclose the identity of Respondents and Complainants to the appropriate federal agency as required by that agency’s policies.
3. Need to know. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, or collaborating institutions.
4. Records. Subject to applicable law, confidentiality must be maintained for records or evidence from which a research subject’s identity may be discovered. Disclosure of these records is limited to those who have a need to know to carry out Proceedings.
5. Data. This section does not prohibit the University from managing published data or acknowledging that data may be unreliable.

1. Proceedings may be suspended. Proceedings may be suspended and the case forwarded to the DO for a final decision if a Respondent admits guilt during the Proceedings. The RIO and DO must both agree to suspend the Proceedings, and such action must be consistent with this and other University policies.
2. Requirements. An admission of guilt must meet all of the below criteria for Proceedings to be suspended:
   1. The admission is made in writing and signed by the Respondent.
   2. The admission specifies the falsification, fabrication, or plagiarism that occurred and the research records affected.
   3. The admission has all the elements for a Research Misconduct finding as required by this policy or the federal agency’s policies.
   4. The Board or Committee (whichever was undergoing Proceedings when the admission was given) provides a written statement describing how it determined that the scope of the misconduct was fully addressed by the admission and confirming the Respondent’s culpability.
   5. The funding agency is given notice and any required documentation as required by its policies.
3. Funding agency determination. The University shall comply with any direction or -action required by the applicable funding agency after receiving notification of an admission of guilt.

1. Who may receive an Allegation. An Allegation of Research Misconduct may be submitted to the Office of Research Assurances, an appropriate college dean, department chair, or unit head, who then forwards it to the Office of Research Assurances if the Allegation appears to constitute a Research Misconduct Allegation. A prospective Complainant may discuss a concern with ORA or any of the preceding persons before submitting an Allegation.
2. Written Allegations preferred.ORA prefers written allegations because they allow for careful, considered, documented statements of concern and relevant facts. Upon receipt of an Allegation, ORA shall review the matter, including possible Conflicts of Interest, and act according to this policy.

1. Inquiry required. An Inquiry must be conducted if the Allegation meets the three criteria in section E-2. If the RIO or other designated institutional official determines that requirements for an Inquiry are met, they must: (1) Document the Assessment in the Institutional Record; and (2) Promptly sequester all research records and other evidence, consistent with applicable federal regulations and promptly initiate the Inquiry.
2. No Inquiry. If the Assessment determines that the requirements for an Inquiry are not met, the RIO shall document why in the Institutional Record. The documentation must be detailed enough to facilitate and support later review by the funding agency.

1. Is an Investigation Warranted? The Inquiry determines if an Allegation warrants 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, and (2) preliminary information gathering and fact finding from the Inquiry indicate the Allegation may have substance.
2. Initial review of evidence.An Inquiry only conducts an initial review of the evidence. It does not entail a full review of all the evidence or exhaustive interviews or analysis.
3. Not examined at Inquiry. The Inquiry does not determine if Research Misconduct occurred, who was responsible, or if the Allegation was the result of honest error or difference of opinion. However, if any evidence emerges suggesting that the issue may stem from honest error or a difference of opinion, that evidence must be noted in the inquiry report. (See section F-3.j).

1. Start date. An Inquiry begins on the day the Inquiry charge meeting is held (see section F-3.g) and ends when the DO makes a decision (see section F-3.l).
2. Time to complete. The Board must complete its review within 90 days of the charge meeting unless an extension is granted. The Inquiry is complete when the DO makes a decision.
3. Extension Request. The Board must submit an extension request to the RIO if it needs more than 90 days to complete the Inquiry. The extension request must state: (1) the status of the Inquiry, (2) reasons for the delay, (3) a timeline for completing outstanding actions, and (4) the date the Inquiry will be completed. The Respondent shall be notified of any extension granted. The final Inquiry report must include the reason and justification for any extension.
4. Sequestration of Research Records.The RIO must ensure that all original research records and materials relevant to the Allegation are immediately secured if the Assessment determines that an Inquiry is warranted. Research records must be sequestered before notifying the Respondent of the Allegation.
5. Notice to Respondent and Written Response
   1. Written Notice. The Respondent shall be notified in writing of the Inquiry no later than the day the Inquiry begins. The written notice shall have a summary of the Allegation(s) and explain the process for reviewing the Allegation(s).
   2. Additional Respondents or Allegations. If the Inquiry identifies additional Respondents, the University must notify them. Only Allegations specific to a Respondent will be included in the notification. If additional Allegations are raised, the Respondent(s) shall be notified in writing of the additional Allegations.
   3. Respondent’s written response to Allegation.Respondent shall provide a written response to the Allegation(s) within 14 days of receiving the written notice from the RIO. The Respondent’s response should: (1) address the substance of the Allegation in detail, specifically referencing any research records that support the response, and (2) clearly identify all relevant research records and explain how these records were created, their relevance to the Allegation, and their location. Respondent shall provide any records not already given.
   4. Additional time to respond. If Respondent needs more time to give a written response, the Respondent shall send a written request and justification for additional time to the RIO with a new proposed deadline to provide the response. The RIO may approve, modify, or deny the request.
   5. Records. Respondent’s response shall identify and provide the RIO with all records that could reasonably relate to the research that is the subject of the Allegation, regardless of their f3e1.
6. Appointing the Board & qualifications. The RIO shall inform the SMC Chair (see FSH 1640.77) that an Inquiry is being initiated. The SMC Chair shall then appoint three members from the SMC to conduct the Inquiry. A person serving on a Board may not have a real or apparent Conflict of Interest in the case, must be unbiased, and must have expertise to evaluate the allegations, evidence and issues, and conduct interviews as needed. No member of the Board may have a primary appointment in the Respondent’s department.
7. Inquiry Charge. The RIO or delegate will prepare a written charge for the Board that describes the Allegation(s), any related issues identified during the Assessment, and the Inquiry’s purpose.
8. Charge Meeting. The RIO or delegate will meet with the Board to review the charge and discuss the Allegations, any related issues, and the procedures for conducting the Inquiry. The RIO will answer any questions and may assist the Board with organizing plans for conducting the Inquiry. The RIO and institutional counsel will be present or available to advise the Board as needed.
9. Interviews. Interviews are not required during an Inquiry. Witnesses or Respondents may be interviewed if they would provide additional information to help the Board fulfill its charge.
10. The Inquiry report. The Board shall write a report of their findings and recommendations. The Inquiry report must meet the relevant funding agency’s requirements. At a minimum, the Inquiry report must include all of the below:
    1. The names, professional alias, and positions of the Respondent and Complainant.
    2. The Allegation(s) that were considered.
    3. The Board members’ names and titles/positions.
    4. The identity of any federal support for the research at issue.
    5. The basis for recommending that any alleged misconduct warrants an Investigation.
    6. The Respondent or Complainant’s comments on the report.
    7. A list of the research records reviewed.
    8. Potential evidence of honest error or difference of opinion, if any.
11. Comments and the final Inquiry report.
    1. Respondent. The Respondent must be given the opportunity to review and comment on the Board’s draft Inquiry report. The Respondent must provide any comments within 14 days.
    2. Complainant. At the RIO’s discretion, the Complainant may be given relevant portions of the draft Inquiry report for comment. The RIO may set reasonable conditions for the report’s review to maintain confidentiality.
    3. Final Inquiry report. The Board shall finalize the Inquiry report after the comments from the Respondent and Complainant (if applicable) are received. The Board may revise the Inquiry report based on a Respondent or Complainant’s comments. Any comments from the Respondent must be included in the final Inquiry report.
12. Decision by the DO. The RIO will transmit the final Inquiry report to the DO. The DO will review the Inquiry’s findings and decide if an Investigation is warranted. The DO must make this decision within 90 days of the first meeting of the Board or within the period of any granted extension. The Inquiry is complete when the DO renders a decision.
13. Notice of the Inquiry determination.
    1. Respondent. The RIO shall notify the Respondent of the DO’s decision. The notice shall include a copy of the Inquiry report and a copy of or refer to the University and the applicable funding agency policies for Research Misconduct Allegations.
    2. Complainant. The RIO shall decide if the Complainant should be notified of the Inquiry’s findings. If the University provides notice to one Complainant in a case, it must provide notice to all Complainants in the case, to the extent possible.
    3. The Funding Agency.If the DO determines that an Investigation is warranted, the University shall notify the funding agency and provide any additional information required by the agency’s policies.

1. Did Research Misconduct occur? The Investigation determines if Research Misconduct did or did not occur. Research Misconduct occurred if (1) there was a significant departure from Accepted Practices of the Relevant Research Community, (2) the misconduct was committed intentionally, knowingly, or recklessly, and (3) the allegation was proven by a Preponderance of the Evidence.
2. Additional Allegation. The Investigation also explores the extent of the Allegation and if there are additional instances of possible misconduct that justify broadening the scope beyond the initial Allegation(s). This is especially important if the Allegation involves clinical trials, potential harm to human subjects or the public, or if it affects research that forms the basis for public policy, clinical practice, or public health practice.

1. Start date. An Investigation begins on the day the Committee charge meeting is held (see section G-3.f) and ends when the DO makes a final decision (see section G-3.l).
2. Time to Complete. The Investigation must begin within 30 days after the DO determines an Investigation is warranted and be completed within 180 days unless an extension is granted. This includes conducting the Investigation, preparing the Investigation report, making the draft report available to the Respondent for comment, submitting the report to the DO to render a decision, and submitting the report to the funding agency if any.
   1. Extension Request. If an Investigation cannot be finished in 180 days, the Committee shall send an extension request to the RIO. The extension request must state: (1) the status of the Investigation, (2) the reasons for the delay, (3) a timeline for completing outstanding actions, and (4) the date the Investigation will be completed. The Respondent shall be notified of any extensions granted. If the Investigation is not completed by the deadline stated in the status update report to the RIO, the Committee shall send another status update report to the RIO with the information stated above.
   2. Sequestration of the Research Records. The RIO will immediately sequester any pertinent research records not already sequestered. This sequestration should occur before or at the time the Respondent is notified that an Investigation has begun.
3. Notice to federal funding agency.
   1. Initial notice.The RIO shall notify the applicable funding agency, as required by its policies, that an Investigation is underway. This notification must occur before or when the Investigation begins.
   2. Additional notices. The RIO shall apprise the funding agency of any developments during the Investigation that may affect current or potential funding for the Respondent(s) under Investigation or that the funding agency needs to know to ensure appropriate use of federal funds or protect the public interest.
4. The Committee.
   1. Role of the Committee. The Committee shall review records and evidence, conduct interviews, and obtain additional evidence it believes is necessary to make an informed recommendation to the DO on the merits of the Allegation.
   2. Appointment. The DO appoints the Committee. The Committee shall have at least three people who do not have a real or apparent Conflict of Interest in the case; are unbiased; and have expertise to evaluate the allegations, evidence, issues, interview the principal and key witnesses, and conduct the Investigation. At least one member of the Committee cannot be affiliated with UI. A person who served on a Board may not serve on a Committee for the same Allegation.
5. The charge to the Committee. The RIO or delegate shall write a charge to the Committee that: (1) states the subject matter and purpose of the Investigation, (2) describes the Allegation(s) and related issues identified during the Inquiry, (3) defines Research Misconduct, and (4) identifies the Respondent.
6. Charge meeting. The RIO will convene a charge meeting for the Committee to review the written charge, the Inquiry report, and the procedures and standards for conducting the Investigation, including the necessity for confidentiality and developing an Investigation plan. The Committee will be given a copy of these instructions and applicable federal regulations.
7. Interviews. The Committee must interview each Respondent, Complainant, and any available person reasonably identified as having information regarding any relevant aspect of the Investigation, including witnesses identified by the Respondent. All interviews shall be recorded or transcribed and comply with the requirements of the applicable funding agency. The Respondent shall not be present during witness interviews but will be given a transcript of the interviews for review.
8. Additional possible allegations or subject matter. The Committee shall diligently pursue all significant issues and leads relevant to the Investigation, including evidence of additional instances of possible Research Misconduct. The Committee shall notify the RIO if it becomes aware of information during the Investigation that (considering the information’s credibility, specificity, and significance) gives rise to an additional possible allegation of Research Misconduct or substantially changes the subject matter of the Investigation. The RIO shall notify the relevant Respondent(s) in writing of additional Allegation(s).
9. Additional Respondents. The Committee shall notify the RIO of any information that suggests additional Respondent(s). The RIO shall determine if a separate Inquiry is required for the additional Respondent(s) or if they should be incorporated into the current Investigation. Respondent(s) included in the current Investigation have the same notice and other rights as any other Respondent in an Investigation.
10. The Investigation report. The Investigation report must meet the relevant funding agency’s requirements or the requirements in 42 CFR 93.
11. Comments on the draft Investigation report.
    1. Respondent. The RIO shall send the Respondent a copy of the draft Investigation report. Respondent has 30 days to review or comment on the report before it is sent to the DO. The Committee shall consider the comments and address them in the final Investigation report. Respondent’s comments shall be attached to the Investigation report.
    2. Complainant. The RIO may send the Complainant a copy or portions of the draft Investigation report for comment. The Complainant shall have 30 days from the date the draft report was received to submit any comments to the Committee.
    3. Confidentiality. The RIO shall inform the Respondent or Complainant of the confidentiality restrictions associated with the draft Investigation report, or portions thereof, before making it available for comment. The RIO may establish reasonable conditions to ensure the draft report’s confidentiality, such as requiring the recipient to sign a confidentiality statement or to come to the RIO’s office to review the report.
    4. Final Investigation report. The Committee shall finalize the Investigation report after receiving the Respondent or Complainant’s (if applicable) comments. The Committee may revise the Investigation report based on the comments. The Committee shall transmit the final Investigation report to the RIO who will submit it to the DO. The DO’s determination (see section G-3.l) together with the Committee’s report, constitutes the final Investigation report
12. Decision by DO.
    1. Final decision. The DO shall make the final decision as to whether Research Misconduct occurred, based on a Preponderance of the Evidence. The DO’s decision should be consistent with the definition of Research Misconduct, the UI and relevant funding agency policies, and the evidence reviewed and analyzed by the Committee. The DO may return the report to the Committee for further fact-finding or analysis if more information is needed to make a final decision. The DO’s decision is final and is not subject to appeal within UI or to the Regents.
    2. DO’s Decision. The DO’s decision must be in writing and state at a minimum: (1) if Research Misconduct occurred and, if so, who committed the misconduct; and (2) a description of the institutional actions taken or to be taken.
13. Notifying Respondent & Complainant. After the DO makes a final decision, the RIO shall notify the Respondent, relevant funding agency, and Complainant (if necessary) of the final decision in writing.
14. Transmit Institutional Record. After the DO makes a final decision, the RIO will transmit the Institutional Record to the funding agency as required by its policies. The University will comply with any direction received from the applicable funding agency regarding the Institutional Record or Proceedings.

1. Seven years. The RIO will maintain the Institutional Record and all sequestered evidence in a secure manner for seven years after Proceedings end. This includes physical objects and sequestered evidence not part of the Institutional Record.
2. Index. Each Institutional Record must include: (1) a single index listing of all the research records and evidence that the institution compiled during the Proceedings, except records the institution did not consider or rely on, and (2) general description of the records that were sequestered but not considered or relied on.