Policy on Research Misconduct

Preamble

This University of Rochester (“University”) Policy on Allegations of Research Misconduct is intended to meet regulatory requirements, and to provide a fair, transparent, and understandable process for addressing concerns about the conduct of research. The Research Integrity Officer (RIO) and the Office of Research Integrity, Stewardship & Ethics (ORISE) serve as neutral resources for faculty, trainees, and staff, and are available to explain and support the process, answer questions, and help ensure procedural fairness for all parties in implementing this policy.

Confidentiality is a cornerstone of all research misconduct proceedings. To the extent possible, research misconduct proceedings are conducted in a manner intended to minimize disruption to ongoing research. Thus, it is generally anticipated that research activities will continue while a research misconduct proceeding is underway. If, however, serious irregularities are identified during the process- such as non-compliance with regulatory, security or institutional requirements, credible concerns about harassment or unsafe conditions, financial malfeasance, or other serious violations- the University may temporarily modify or pause affected activities to protect and safeguard research participants, personnel, data, and University or sponsor funds and resources.

In sum, this policy and the procedures derived from it are designed to safeguard both the integrity of the research enterprise and the rights of those individuals involved in, or affected by, allegations of research misconduct while ensuring that such allegations are evaluated in a fair, confidential and timely manner.

General Policy Principles

The University is committed to maintaining an active culture of research integrity and upholding the highest standards of scientific rigor in research, where all individuals engaged in research meet the highest ethical and scientific standards, while protecting the academic freedom and reputation of all members of the University’s research community. The University is committed to fostering an environment that promotes research integrity and the responsible and ethical conduct of research. As such, the University, does not tolerate research misconduct, and deals promptly with allegations or evidence of possible research misconduct in accord with this Policy and applicable law. The purpose of this Policy is to ensure that all members of the University community understand their rights and responsibilities, and the University’s standardized method of addressing allegations of conduct that falls short of our ethical and scientific obligations in a clear, transparent manner.

All institutional members are expected to conduct research with honesty, rigor, and transparency. Each institutional member is responsible for contributing to a University culture that establishes, maintains, and promotes research integrity and the responsible and ethical conduct of research and, in accord with the terms of this Policy, a respondent will be found to have engaged in misconduct only by the respondent’s admission or upon a determination by the preponderance of the evidence.

The University strives to reduce the risk of research misconduct, supports all good-faith efforts to report suspected misconduct, promptly and thoroughly address all allegations of research misconduct, and seeks to rectify the research record and/or restore researchers’ reputations, as appropriate.

Research misconduct is contrary to the interests of the University, the health and safety of the public, the integrity of research, and the appropriate use of public and private funds. Both the University and its institutional members have a duty to protect those funds from misuse by ensuring the integrity of all research conducted on behalf of the University.

The University is responsible for ensuring that this policy and the procedures for addressing allegations of research misconduct meet all applicable sponsor requirements and local, state, or federal regulations. These include but are not limited to the PHS Policies on Research Misconduct (42 CFR Parts 50 & 93, “the PHS regulation”), and the NSF Research Misconduct Policy (42 CFR Part 689). ORISE will maintain this policy and its associated procedures, inform all institutional members about them, and make them publicly available.

For definitions of terms used in this section and elsewhere, see the Definitions section.

Scope and Applicability

This policy outlines the steps to be taken in response to an allegation of research misconduct involving any individual reviewing, proposing, performing, or reporting research or scholarly work at the University, regardless of the source of funding. It describes an objective examination of the facts, protection of individual rights, and integration with other relevant review procedures. Further, additional procedures beyond those outlined in this policy may be implemented to comply with the procedural, reporting, and other requirements of external sponsors.

The conduct of proceedings under this policy shall be overseen by the University Research Integrity Officer (“RIO”). Where the alleged matters occurred in part at the University, and in part at another institution, the RIO shall coordinate with the appropriate personnel at the other institution on any review of the allegations, and where the alleged matters are externally funded, the RIO may consult with funding agencies, the Office of Research Project Administration (ORPA) and/or other relevant parties to mutually define a process for a thorough, competent, objective, and fair proceeding, with confidentiality in mind.

To the extent that the subject matter of the allegation(s) falls within the scope of another University policy or falls under the jurisdiction of another University office or committee, such as, but not limited to, the Office for Human Subject Protection (OHSP), University Committee on Animal Resources (UCAR), or the Conflict of Interest Committee (COIC), such matters may be referred at any time to those committees for consultation and/or management.

This policy and its associated procedures apply only to research misconduct occurring within six years of the date the allegation is received, subject to the following exceptions:

• If the respondent continues or renews any incident of alleged research misconduct that occurred before the six-year period through the use of, republication of, or citation to the portion(s) of the research record alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of the respondent, the six-year time limitation does not apply (“subsequent use exception”).
• If after a thorough assessment of relevant materials the RIO or RIO Designee determines that the alleged misconduct is not subject to the exception, the RIO or RIO Designee will document their determination. The University will retain this documentation for seven years after completion of the institutional proceeding or the completion of any pertinent agency proceeding, whichever is later.
• The six-year time limitation also does not apply if a pertinent agency or the University, following consultation with such agency, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

These policies and procedures do not supersede or establish an alternative to applicable laws and regulations for handling research misconduct. In case of any conflict between this document and applicable laws and requirements, the RIO in concert with the University Office of Counsel (OGC), if appropriate, will make a determination as to which laws and regulations will prevail.

Definitions

• Accepted practices of the relevant research community. Accepted practices of the relevant research community refer to the established norms, standards, and procedures recognized and followed by researchers within a specific field of study, including professional codes or norms set forth by external funders, professional societies, or research organizations within that field.
• Administrative record. The administrative record comprises: the institutional record; any information provided by the respondent to a relevant oversight agency related to a research misconduct proceeding, including but not limited to the transcript of any virtual or in-person meetings or correspondence between the respondent and such agency; any additional information provided to such agency while the case is pending; and any analysis or additional information generated or obtained by the oversight agency.
• Allegation. Allegation means disclosure of possible research misconduct through any means of communication when brought directly to the attention of an institutional or pertinent external agency official.
• Assessment. Assessment means a consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct and within the scope of this policy; and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation.
• Complainant. Complainant means an individual who in good faith makes an allegation of research misconduct.
• Evidence. Evidence means anything offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact. Evidence includes documents, whether in hard copy or electronic form, information, tangible items, and testimony.
• Fabrication. Fabrication means making up data or results and recording or reporting them.
• Falsification. 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.
• Good faith. (a) Good faith as applied to a complainant or witness means having a reasonable belief in the truth of one’s allegation or testimony, based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowledge of or reckless disregard for information that would negate the allegation or testimony. (b) Good faith as applied to an institutional or committee member means cooperating with the research misconduct proceeding by impartially carrying out the duties assigned for the purpose of helping the University meet its responsibilities under applicable law. An institutional or committee member will not be deemed to be acting in good faith if their acts or omissions during the research misconduct proceedings are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
• Inquiry. Inquiry means preliminary information gathering and preliminary fact-finding to determine whether the allegation is credible, specific, and may have substance to warrant an investigation. An inquiry does not require a full review of the evidence related to the allegation.
• Institution. Institution means the University of Rochester, including all of its schools, colleges, academic departments, research centers, institutes, and administrative units, as well as any individual or entity acting on its behalf in the conduct of research, research training, or related scholarly activities. This also includes any individual who applies for or receives external support for any research or scholarly activity or program on behalf of the institution.
• Institutional Deciding Official. Institutional Deciding Official (IDO) means the University official who makes final determinations on allegations of research misconduct and memorializes any institutional actions. The same individual cannot serve as the Institutional Deciding Official and the Research Integrity Officer.
• Institutional member. Institutional member and members means an individual (or individuals) who is employed by, is an agent of, or is affiliated by contract or agreement with the University. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, technicians, postdoctoral and other fellows, students, volunteers, subject matter experts, consultants, attorneys, or employees or agents of contractors, subcontractors, or sub-awardees.
• Institutional record. The institutional record comprises: (a) The non-legally privileged records that the University compiled or generated during the research misconduct proceeding, except records the University did not consider or rely on. These records include but are not limited to: (1) documentation of the assessment as required by applicable regulations; (2) if an inquiry is conducted, the inquiry report and all records (other than drafts of the report) considered or relied on during the inquiry, including, but not limited to, research records and the transcripts of any transcribed interviews conducted during the inquiry, information the respondent provided to the University and the documentation of any decision not to investigate as required by applicable regulations; (3) if an investigation is conducted, the investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, research records, the transcripts of each interview conducted pursuant to applicable regulations, and information the respondent provided to the University; (4) decision(s) by the Institutional Deciding Official, such as the written decision from the Institutional Deciding Official; (5) the complete record of any other relevant institutional proceedings; (b) a single index listing all of items (1) through (5) above; (c) a general description of the records that were sequestered but not considered or relied on.
• Intentionally. To act intentionally means to act with the aim of carrying out the act.
• Investigation. Investigation means the formal development of a factual record and the examination of that record that meets the criteria of and follows the documented procedures of this policy.
• Knowingly. To act knowingly means to act with awareness of the act.
• Plagiarism. Plagiarism means the appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit. Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work that materially misleads the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology. Plagiarism does not include self-plagiarism or authorship or authorship credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project. Self-plagiarism and authorship disputes do not meet the definition of research misconduct and will be handled among authors in accordance with applicable publication criteria and University Authorship Guidelines and with assistance of appropriate University offices as needed.
• Preponderance of the evidence. 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.
• Recklessly. To act recklessly means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.
• Research. Research in general 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 or underlying mechanisms.
• Research Integrity Officer. The Research Integrity Officer (RIO) refers to the institutional official responsible for administering the University’s written policy and procedures for addressing allegations of research misconduct.
• Research Integrity Officer Designee (RIO Designee): An impartial individual appointed by the RIO to coordinate specific tasks in a research misconduct proceeding (e.g., intake, assessment, sequestration logistics, record-keeping, communications, timeline tracking) under the RIO’s direction. The designee does not serve as the RIO and does not make material determinations or sign official actions; final authority remains with the RIO.
• Research misconduct. 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 differences of opinion.
• Research misconduct proceeding. Research misconduct proceeding means any actions related to alleged research misconduct addressed under this Policy, and as applicable, federal agency processes.
• Research record. 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.
• Respondent. Respondent means the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.
• Retaliation. Retaliation means an adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to (a) a good faith allegation of research misconduct, or (b) good faith cooperation with a research misconduct proceeding.

Roles, Rights, and Responsibilities

Institution

University of Rochester’s General Responsibilities

The University will, to the extent possible and as allowed by law, limit disclosure of the identity of respondents, complainants, and witnesses while conducting the research misconduct proceedings to those who need to know, inform all institutional members about this policy and procedures, and make this policy and procedures publicly available. After the Institutional Deciding Official’s final determination, the limitation of disclosure to those who “need-to-know” may be reconsidered in light of the outcome of the proceeding. Any disclosure of the identity of respondents, complainants, and witnesses after the proceedings have concluded will be made only as required or permitted by applicable law and University policy. The University will respond to each allegation of research misconduct in a thorough, competent, objective, and fair manner. The University will take all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings, including, but not limited to their providing information, research records, and other evidence.

The University will cooperate with any pertinent agency with ultimate authority over the research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the institutional record if directed by such agency and assist in administering and enforcing any administrative actions imposed on institutional members. The University may also take steps to correct published data as appropriate or acknowledge that data may be unreliable.

University of Rochester’s Responsibilities During and After a Research Misconduct Proceeding

Except as may otherwise be prescribed by applicable law, the University will maintain confidentiality for any records or evidence from which research participants might be identified and will limit disclosure to those who need to know to carry out a research misconduct proceeding. Before or at the time of notifying the respondent of the allegation(s) and whenever additional items become known or relevant, the University will promptly take all reasonable and practical steps to obtain all research records and other evidence and sequester them securely. As appropriate, the University will make reasonable efforts to ensure respondent’s research is minimally impacted throughout the proceeding. The University will ensure that the institutional record contains all required elements, i.e., research records that were compiled and considered during the proceedings, assessment documentation, and inquiry and/or investigation reports. Upon completion of the inquiry, the University will provide any relevant funding or oversight agency with the required documentation and add it to the institutional record. The institution will maintain the institutional record and all sequestered research records and other evidence in a secure manner for seven years after completion of the institutional and/or agency proceedings.

The University will provide information related to the alleged research misconduct and proceedings to relevant funding or oversight agencies upon request and transfer custody or provide copies of the institutional record or any component of it and any sequestered evidence, regardless of whether the evidence is included in the institutional record. Additionally, the University will promptly notify such agency of any special circumstances that may arise.

Disclosure of the identity of respondents, complainants, and witnesses while the University is conducting the research misconduct proceedings is limited to those who need to know, which the University will determine consistently with a thorough, competent, objective, and fair research misconduct proceeding, and as allowed by law. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions.

The University has the responsibility to take reasonable steps to protect any individual involved in conducting or reviewing the proceeding from retaliation.

University of Rochester’s Responsibilities to the Complainant(s)

The University will provide confidentiality consistent with applicable laws for all complainants in a research misconduct proceeding. The University will also take precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the complainant(s). The University will take all reasonable and practical steps to protect the positions and reputations of complainants and to protect these individuals from retaliation by respondents and/or other institutional members. If the University chooses to notify one complainant of the inquiry results in a case, all complainants will be notified by the University, to the extent possible.

University of Rochester’s Responsibilities to the Respondent(s)

As with complainants, the University will provide confidentiality consistent with applicable laws to all respondents in a research misconduct proceeding. The University will make a good-faith effort to notify the respondent(s) in writing of the allegations being made against them. The University will take precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the respondent. Respondents and witnesses may have a support person of their choosing, who is not otherwise a party or a witness, present during any part of their participation in the process. Such persons are permitted to provide support for the Respondent or witness but may not speak on their behalf. Support persons may not intervene or interfere with an interview or any aspect of the proceeding. When appropriate, the University will give the respondent(s) copies of or reasonable supervised access to the sequestered research records. The University will notify the respondent whether the inquiry found that an investigation is warranted, provide the respondent an opportunity to review and comment on the inquiry report, and attach the respondent’s comments to the final inquiry report. If an investigation is commenced, the University will notify the respondent, provide written notice of any additional allegations raised against them not previously addressed by the inquiry report, and will allow the respondent(s) an opportunity to review the witness transcripts with redactions, as appropriate to protect witness identity. The University will give the respondent(s) an opportunity to read and comment on the draft investigation report and any information or allegations added to the institutional record. The University will give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

The University will bear the burden of proof, by a preponderance of the evidence, for making a finding of research misconduct. The University will make all reasonable, practical efforts, if requested and as appropriate, to protect or restore the reputation of respondents against whom no finding of research misconduct is made. The ability of respondents to continue their research, if impacted, may depend on other University policies.

University of Rochester’s Responsibilities to Committee Members

The University will ensure that a committee or person acting on the University’s behalf conducts research misconduct proceedings in compliance with this policy and applicable regulations. The University will take all reasonable and practical steps to protect the positions and reputations of good-faith committee members and to protect these individuals from retaliation.

University of Rochester’s Responsibilities to the Witness[es]

The University will maintain confidentiality to the greatest extent possible for all witnesses. The University will take precautions to ensure that individuals responsible for carrying out any part of the proceedings do not have unresolved personal, professional, or financial conflicts of interest with the witnesses. The University will also take all reasonable and practical steps to protect the positions and reputations of witnesses and to protect these individuals from retaliation.

Research Integrity Officer

The Research Integrity Officer (RIO) is the institutional official responsible for administering this policy and the procedures for addressing allegations of research misconduct in compliance with applicable laws. The same individual will not serve as both the Institutional Deciding Official and the RIO. In certain cases, the RIO may conduct an inquiry in lieu of an inquiry committee, and, if needed, the RIO (or inquiry committee) may utilize one or more subject matter experts to assist them in the inquiry. When subject matter experts are involved, the University will take precautions to ensure that individuals do not have unresolved personal, professional, or financial conflicts and that confidentiality is maintained.

The RIO may, when necessary to ensure continuity and appropriate expertise, appoint another qualified individual to perform one or more RIO responsibilities under the Associate Vice President for Research Integrity’s oversight. If the RIO has an unresolved conflict, the Institutional Deciding Official will appoint a qualified alternative RIO, who is free from unresolved conflicts, for the proceeding.

Upon receiving an allegation of research misconduct, the RIO or RIO Designee will promptly assess the allegation to determine whether the allegation appears to fall within the definition of research misconduct and within the scope of this policy and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation. If the RIO or RIO Designee determines that the requirements for an inquiry are met, they shall document the assessment, promptly sequester all research records and other evidence per relevant regulations, and promptly initiate the inquiry. If the RIO or RIO Designee determines that requirements for an inquiry are not met, they will prepare sufficiently detailed documentation to permit a subsequent review regarding the University’s decision not to conduct an inquiry. The University will keep this documentation and related records in a secure manner for seven years and provide them to relevant oversight agencies upon request. The RIO, in coordination with the Office of Counsel, ensures the University cooperates fully with relevant oversight agencies during any oversight reviews and administrative hearings or appeals.

Complainant

The complainant is the person who in good faith makes an allegation of research misconduct. The complainant brings research misconduct allegations directly to the attention of the University or a relevant agency official through any means of communication.

The complainant will make allegations in good faith, as it is defined in this policy, as having a reasonable belief in the truth of one’s allegation or testimony, based on the information known to the complainant at the time. Complainants should provide and/or identify all relevant information in their possession or knowledge relating to the allegation, even though evidence is not required to make an allegation. Allegations are evaluated in accordance with applicable criteria. An individual found not to have acted in good faith may be referred for action under applicable University policies.

Respondent

The respondent is the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding, and there shall be no finding of misconduct absent the respondent’s written admission or a determination based on the preponderance of the evidence. The respondent may put forth evidence of honest error or difference of opinion and has the burden of going forward with and proving such affirmative defenses by a preponderance of evidence, , and the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent. 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. The respondent’s failure to provide research records documenting the questioned research is evidence of research misconduct where the respondent claims to possess the records but refuses to provide them upon request. Respondents may have a support person of their choosing, who is not otherwise a party or a witness, present during any part of their participation in the process. Such persons are permitted to provide support for the Respondent but may not speak on their behalf. Support persons may not intervene or interfere with an interview or any aspect of the proceeding. Respondents also have the right to identify potential witnesses.

The respondent will not be present during the witnesses’ interviews but will be provided with a transcript of the interview after it takes place, with redactions only as appropriate to protect witness identity to the greatest extent possible. The respondent will have opportunities to (a) view and comment on the inquiry report, (b) view and comment on the investigation report, and (c) submit any comments on the draft investigation report to the University within 30 days of receiving it.

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.

The respondent has the burden of going forward with and proving, by a preponderance of the evidence, any mitigating factors relevant to a decision to impose administrative actions after a research misconduct proceeding.

Committee Members

Committee members are experts who act in good faith to cooperate with the research misconduct proceedings by impartially carrying out their assigned duties for the purpose of helping the University meet its responsibilities under the applicable regulations. Committee members will have relevant scientific expertise and be free of unresolved conflicts of interest with any of the parties involved.

Committee members will conduct research misconduct proceedings consistent with this policy and any applicable regulations. The committee members, engaged in an inquiry, will determine whether an investigation is warranted, documenting the decision in an inquiry report.

During an investigation, committee members 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). The Committee will also determine whether or not the respondent(s) engaged in research misconduct and document their decision in the investigation report.

The University may, but is not required to, provide relevant portions of the report to a complainant for comment. The Committee will consider respondent(s) comments and, if requested by the Committee , complainant(s) comments on the inquiry/investigation report(s) and document their considerations in the pertinent report. An inquiry or investigation into multiple respondents may convene with the same committee members, but there will be separate inquiry or investigation reports and separate research misconduct determinations for each respondent. Committee members may serve for more than one proceeding in cases with multiple respondents. If appropriate, Committee members may also serve for both the inquiry and the investigation. The RIO will assess potential unresolved conflicts before confirming committee membership; respondent(s) will be notified of proposed committee membership and may object to proposed members based upon a demonstrated unresolved conflict. All potential committee members, internal and external to the University, will be required to sign a Conflicts and Confidentiality Statement prior to being proposed to the respondent(s)

Witnesses

Witnesses are those people who have been reasonably identified as having information regarding any relevant aspects of the proceeding. 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.

Institutional Deciding Official

The Vice President for Research shall serve as the University’s Institutional Deciding Official (IDO). If the IDO has an unresolved conflict, the Provost or President of the University will appoint a qualified alternative IDO who is free from unresolved conflicts for the proceeding.

The IDO will make the final determination whether to accept the inquiry and investigation reports, findings, and any recommendations contained therein, including recommendations for administrative or other actions to address the consequences of the research misconduct in accordance with relevant laws and University policies.

The IDO documents their determination in a written decision that includes whether research misconduct occurred, and if so, what kind and who committed it, and a description of the relevant actions the University has taken or will take in accord with this or other University policies, including the Code of Conduct and Policy on Tenure and Promotion. The IDO’s written decision becomes part of the institutional record.

Where appropriate, such as with institutional administrative actions, the IDO will consult with the Provost, the Chief Executive Officer (CEO) of the Medical Center, Office of Counsel (OGC), and other members of University leadership or administration, including the Deans of relevant schools. To the extent other University policies govern specific administrative actions, including the Policy on Tenure and Promotion and Code of Conduct, such other policies shall control any such administrative action or related appeal, and nothing in this Policy grants the IDO any additional authority beyond those described in this Policy to impose any action, sanction, or discipline.

Procedures for Addressing Allegations of Research Misconduct

Reporting Allegations of Research Misconduct

Each member of the University has an ethical duty to report suspected research misconduct in good faith. Allegations of suspected research misconduct can be communicated via oral or written communication to the RIO, the ORISE email address or via the research misconduct reporting line. Information on how to report is available on the ORISE website. Anonymous allegations may be submitted; however, they must include enough information to allow the RIO to conduct an assessment. The University will maintain confidentiality to the greatest extent possible, but full anonymity cannot be guaranteed. The RIO or RIO Designee will respond as soon as possible to allegations to acknowledge their receipt.

Assessment

An assessment’s purpose is to determine whether an allegation warrants an inquiry. An assessment is intended to be a review of readily accessible information relevant to the allegation.

Upon receiving an allegation of research misconduct, the RIO or RIO Designee will promptly determine whether the allegation appears to fall within the definition of research misconduct and within the scope of this policy and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If the RIO or RIO Designee determines that the allegation meets these criteria, they will promptly: (a) document the assessment and (b) initiate an inquiry and sequester all research records and other evidence. The RIO or RIO Designee must document the assessment and retain the assessment documentation securely for seven years after completion of the misconduct proceedings. Where external sponsors are involved, the Director of the Office of Research and Project Administration (ORPA) will be consulted regarding compliance with the reporting requirements of the external sponsor(s) and as appropriate, will ensure that notice is given to such sponsor(s) in accordance with their regulations and guidelines. As appropriate, the RIO or ORPA will consult with the Office of Counsel.

If the RIO or DRIO Designee determines that the alleged misconduct does not meet the criteria to proceed to an inquiry, they will prepare sufficiently detailed documentation to permit a subsequent review regarding the University’s decision not to proceed to an inquiry and securely retain this documentation for seven years. When deemed appropriate by theRIO, the RIO will inform the respondent of the allegation and the outcome of the assessment. In the RIO’s discretion, the RIO may also inform the complainant of the outcome.

Inquiry

An inquiry is warranted if the allegation (a) falls within the definition of research misconduct under PHS regulation 42 CFR Part 93 and this policy, (b) is within the applicability criteria of § 93.102 of the PHS regulations, and (c) is sufficiently credible and specific so that potential evidence of research misconduct may be identified. An inquiry’s purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. An inquiry does not require a full review of all related evidence. The University will complete the inquiry within 90 days of initiating it unless circumstances warrant a longer period, in which case the University will sufficiently document the reasons for exceeding the time limit in the inquiry report.

Sequestering Evidence and Notifying the Respondent

Before or at the time of notifying the respondent(s), the University will obtain the original or substantially equivalent copies of all research records and other evidence that are pertinent to the proceeding, inventory these materials, sequester the materials in a secure manner, and retain them for seven years. The University has a duty to obtain, inventory, and securely sequester evidence that extends to whenever additional items become known or relevant to the inquiry or investigation.

At the time of or before beginning the inquiry, the University will make a good-faith effort to notify the respondent(s), 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, the University will notify the respondent(s) in writing. When appropriate, the University will give the respondent(s) copies of, or reasonably supervised access to, the sequestered materials.

If additional respondents are identified, the University 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 follow the University’s Standard Operating Procedure on Sequestration of Evidence in Research Misconduct Proceedings when collecting evidence, as amended from time to time. This document can be found on the ORISE website.

Initiating the Inquiry and Ensuring Neutrality

The inquiry will be conducted by the RIO, or by a committee of individuals at least one of whom has appropriate subject matter expertise, depending upon the subject matter of the allegation. The committee will be comprised of at least three (3) qualified individuals, typically faculty members. The RIO may identify potential committee members external to the University community as needed to avoid potential conflicts of interest and to allow for adequate subject matter expertise. The University will ensure that the RIO, RIO Designee, or committee members understand their charge, keep the identities of respondents, complainants, and witnesses confidential, and conduct the research misconduct proceedings in compliance with this policy and applicable regulations. The RIO, RIO Designee, or committee may rely on ad hoc subject matter resources as needed to assist in the inquiry. The RIO will assess potential unresolved conflicts before confirming ad hoc subject matter resources; respondents will be notified of committee membership and may object to members for unresolved conflicts. All potential committee members, internal and external to the University, will be required to sign a Conflicts and Confidentiality Statement prior to being proposed to the respondent(s).

Determining Whether an Investigation Is Warranted

The RIO, RIO Designee, or inquiry committee will conduct a preliminary review of the evidence, which may include an interview of the respondent, witnesses, or complainant. An investigation is warranted if (a) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct in this policy; and (b) preliminary information-gathering and fact-finding from the inquiry indicates that the allegation is credible, specific, and may have substance to warrant an investigation.

Unless the respondent has made an acceptable admission, the RIO, or inquiry committee will not determine if research misconduct occurred, nor assess whether the alleged misconduct was intentional, knowing, or reckless; such a determination is not made until the case proceeds to an investigation.

Documenting the Inquiry

At the conclusion of the inquiry, regardless of whether an investigation is warranted, the RIO, RIO Designee, or committee will prepare a written inquiry report. The contents of a complete inquiry report will include:

1. The names, professional aliases, and positions of the respondent and complainant(s).
2. A description of the allegation(s) of research misconduct.
3. Details about the funding source, including any grant numbers, grant applications, contracts, and publications listing federal sources of funding
4. The composition of the inquiry committee, if used, including name(s), position(s), and subject matter expertise.
5. An inventory of sequestered research records and other evidence and description of how sequestration was conducted.
6. Transcripts of interviews. Transcriptions will contain redactions, as appropriate to protect witness identity.
7. Inquiry timeline and procedural history.
8. Any scientific or forensic analyses conducted.
9. The basis for recommending that any allegation(s) warrant an investigation.
10. The basis on which any allegation(s) do not merit further investigation.
11. Any comments on or responses to the inquiry report by the respondent or the complainant(s), including any materials submitted as part of an affirmative defense by the respondent
12. Any institutional actions implemented, including internal communications or external communications with journals or funding agencies.
13. Documentation of potential evidence of honest error or difference of opinion.

Completing the Inquiry

The University will give the respondent a copy of the draft inquiry report for review and comment. Any comments received by the respondent(s) within fourteen calendar days will be attached to the final inquiry report. Extensions may be considered on a case-by-case basis. The University may, but is not required to, provide relevant portions of the report to a complainant for comment.

The RIO or RIO Designee will notify the respondent of the inquiry’s final outcome and provide the respondent with copies of the final inquiry report, the PHS regulation 42 CFR Part 93, when applicable, and this policy and procedures. The University may, but is not required to, notify a complainant whether the inquiry found that an investigation is warranted. If the University chooses to provide notice to one complainant in a case, it will provide notice, to the extent possible, to all complainants in the case.

If an Investigation Is Not Warranted:

If the RIO or RIO Designee, or inquiry committee determines that an investigation is not warranted, the RIO or RIO Designee will prepare sufficiently detailed documentation to permit a subsequent review, upon request by pertinent agencies, regarding the University’s decision not to proceed to an investigation. The records will be securely retained for a period of seven years after the termination of the inquiry.

If an Investigation is Warranted:

If the RIO, or inquiry committee determines that an investigation is warranted, the RIO or RIO Designee will: (a) within a reasonable amount of time and as soon as possible after this decision, 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; and (b) within 30 days of determining that an investigation is warranted, provide pertinent agencies with a copy of the inquiry report.

On a case-by-case basis, the University may choose to notify the complainant that there will be an investigation of the alleged misconduct; the University will take the same notification action for all complainants in cases where there is more than one complainant.

Investigation

The purpose of an investigation is to formally develop a factual record, pursue leads, examine the record, and recommend finding(s) to the IDO, who will make the final decision, based on a preponderance of evidence, on each allegation and any institutional actions. As part of its investigation, the University will pursue diligently all significant issues and relevant leads, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. If the research is federally funded, the University will ensure compliance with federal deadlines and reporting obligations, including notifications to ORI.

Notifying the Respondent and Sequestering Evidence

The RIO or RIO Designee will notify the respondent(s) of the allegation(s) within 30 days of determining that an investigation is warranted and before the investigation begins. If any additional respondent(s) are identified during the investigation, the University will notify them of the allegation(s) and provide them with an opportunity to respond. Only allegations specific to a particular respondent will be included in the notification to that respondent. If the University identifies additional respondents during the investigation, it may choose to either conduct a separate inquiry or add the new respondent(s) to the ongoing investigation. The RIO or RIO Designee will sequester the original or substantially equivalent copies of all research records and other evidence, inventory these materials, store them in a secure manner, and retain them for seven years after its proceeding or any HHS or other external agency proceeding, whichever is later.

Convening an Investigation Committee

The investigation will be conducted by a committee of individuals at least one of whom has appropriate subject matter expertise, depending upon the subject matter of the allegation. The committee will be comprised of at least three (3) qualified individuals, typically faculty members. The RIO may identify potential committee members external to the University community as needed to avoid potential conflicts of interest and to allow for adequate subject matter expertise. After vetting investigation committee members for conflicts and appropriate scientific expertise, the RIO or RIO Designee will convene the committee and ensure that the members understand their responsibility to conduct the research misconduct proceedings in compliance with this policy and applicable regulations. The respondent will be notified of the committee composition and be given an opportunity to report any unresolved conflicts with any of the proposed members. The investigation 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). The RIO or RIO Designee will use diligent efforts to ensure that the investigation is thorough, sufficiently documented, and impartial and unbiased to the maximum extent practicable. The RIO or RIO Designee will notify the respondent in writing of any additional allegations raised against them during the investigation.

Conducting Interviews

The Committee, with support from the RIO, 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. All relevant exhibits will be numbered, and any exhibits shown to the interviewee during the interview will be referred to by that number. The RIO or RIO Designee will record and transcribe interviews during the investigation and make the transcripts available to the interviewee for correction. The RIO or RIO Designee will include the transcript(s) with any corrections and exhibits in the institutional record of the investigation. The respondent will not be present during the witnesses’ interviews, but the institution will provide the respondent with a transcript of each interview, with redactions as appropriate to protect the identity of the witnesses to the greatest extent possible.

Documenting the Investigation

The University will complete all aspects of the investigation within 180 days. The Committee, with support from the RIO, will conduct the investigation, prepare the draft investigation report for each respondent, and provide the opportunity for respondents to comment. The RIO or RIO Designee will document the IDO’s final decision and transmit the institutional record (including the final investigation report and IDO’s decision) to relevant agencies. If the investigation takes more than 180 days to complete, and involves PHS-funded research, the RIO or RIO Designee will ask ORI in writing for an extension. The RIO or RIO Designee will document the reasons for exceeding the 180-day period in the investigation report.

The investigation report for each respondent will include:

1. Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.
2. Description and documentation of funding support, including any grant numbers, grant applications, contracts, and publications listing federal sources of funding support. This documentation includes known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.
3. Description of the specific allegation(s) of research misconduct for consideration in the investigation of the respondent.
4. Composition of investigation committee, including name(s), position(s), and subject matter expertise.
5. Inventory of sequestered research records and other evidence, except records the University 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.
6. Transcripts of all interviews conducted. Transcriptions will contain redactions, as appropriate to protect witness identity to the greatest extent possible
7. Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), federal funding applications, progress reports, presentations, posters, other research records that contain the allegedly falsified, fabricated, or plagiarized material.
8. Any scientific or forensic analyses conducted.
9. A copy of these policies and procedures.
10. Any comments made by the respondent and complainant(s) on the draft investigation report and the committee’s consideration of those comments.
11. 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 Committee’s investigation report will include 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 funding 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.

Completing the Investigation

The University will give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on. The respondent will submit any comments on the draft report to the University within 30 days of receiving the draft investigation report. If the University chooses to share a copy of the draft investigation report or relevant portions of it with the complainant(s) for comment, the complainant’s comments will be submitted within 30 days of the date on which they received the draft report. The University will add any comments received to the final investigation report.

Institutional Deciding Official Review of the Investigation Report

The IDO will review the investigation report and make a final written determination of whether the University found research misconduct and, if so, who committed the misconduct. In this statement, the IDO will also include a description of (i) any relevant institutional actions taken or to be taken; (ii) any disciplinary proceedings or other actions taken pursuant to separate University policies and procedures including the Code of Conduct and Policy on Tenure and Promotion; and (iii) the relevant University officials, leadership or administration and processes that led to such actions. Where appropriate, such as with institutional administrative actions, the IDO will consult with the Provost, the Chief Executive Officer (CEO) of the Medical Center, and other members of University leadership or administration, including the Deans of relevant schools. Nothing in this Policy grants the IDO any additional authority beyond that described in this Policy to impose any action, sanction, or punishment.

Creating and Transmitting the Institutional Record

After the IDO has made a final determination of research misconduct findings, the University will add the IDO’s written decision to the investigation report and organize the institutional record, as defined above, in a logical manner.

After the IDO has made a final written determination, the University will transmit the institutional record to pertinent agencies, including ORI if the misconduct occurred on a project that was federally funded, in compliance with relevant deadlines and reporting obligations.

Other Procedures and Special Circumstances

Multiple Institutions and Multiple Respondents

If the alleged research misconduct involves multiple institutions, the University 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 an institution to 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. By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.

If the alleged research misconduct involves multiple respondents, the University may either conduct a separate inquiry for each new respondent or add them to the ongoing proceedings. The University must give additional respondent(s) notice of and an opportunity to respond to the allegations.

Respondent Admissions

The respondent may at any time during the proceeding prepare a written admission of research misconduct or enter into a written agreement with the University resolving certain issues material to the proceeding. The University will promptly notify relevant agencies in advance if at any point during the proceedings (including the assessment, inquiry, or investigation, or appeal stage) it plans to close a research misconduct case because the respondent has admitted to committing research misconduct , or if the respondent has entered into a written agreement with the University resolving certain issues material to the proceeding If the respondent admits to research misconduct, the University will not close the case until providing the applicable agency 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 the research misconduct constituted a significant departure from accepted practices of the relevant research community. The University will not close the case until giving such agency a written statement confirming the respondent’s culpability and explaining how the University determined that the respondent’s admission fully addresses the scope of the misconduct.

Appeals

Respondents have the right to appeal the Institutional Deciding Official’s final determination and/or the administrative actions resulting from the research misconduct proceeding unless an appeal is separately provided for under another University policy governing the administrative action, including the Code of Conduct and Policy on Tenure and Promotion, in which case appeals should be submitted in accord with such other University policy, and the outcome of the appeal reported to the RIO. Appeals are limited in scope and must follow the procedures below.

1. Who May Appeal
   1. The Respondent(s) may submit an appeal of the final determination or any administrative actions that are not separately governed by another University policy, including the Policy on Tenure and Promotion.
   2. If the RIO determines it is appropriate to notify a complainant of the result, as permitted and appropriate under University policy and federal regulations, the RIO may notify the complainant of outcomes. If notified, the complainants may raise concerns about procedural irregularities to the RIO; however, this is not an appeal.

2. Grounds for Appeal
   1. Appeals must be based on one or more of the following:
      1. A substantial procedural error in adhering to the University’s Research Misconduct Policy that materially affected the outcome; or
      2. New, significant evidence that was not reasonably available during the investigation and that could have materially affected the Inquiry or Investigation Committee’s determinations; or
      3. Administrative actions that are disproportionate to the findings; however, if a separate University policy governs the administrative action, including the Code of Conduct and Policy on Tenure and Promotion, any appeal of the administrative action should be submitted in accord with such other University policy, and the outcome of the appeal reported to the RIO.

3. Timeframe and Contents
   1. Appeals must be submitted in writing via email with attachments within twenty one (21) calendar days of receipt of the IDO’s written decision.
   2. The appeal must identify specific portions of the Inquiry or Investigative Committee report, or IDO’s written determination that are being appealed, with exact references by page and line number. For each item, the appellant must identify the alleged error and explain the nature of the error with specific references or citations to the institutional record. The appeal must be clear and specific and must be limited to providing new information or arguments that were not previously submitted in respondent’s comments on draft inquiry or investigation reports. If the appeal is based on new, significant evidence, respondent shall also provide a detailed explanation regarding why such evidence was not previously provided during the course of the proceeding.

4. To Whom the Appeal is Made
   1. Appeals must be submitted in writing via email with attachments to the RIO.
   2. Appeals must be addressed to the Provost through the Office of the Provost. If the Provost has an unresolved conflict, the University President will designate an alternative senior official to review the appeal.

5. Review of Appeals
   1. The Provost will conduct a thorough review of the appeal and of any relevant portions of the institutional record.
      1. The Provost’s review shall be limited to the contents of the appeal and the institutional record, unless respondent provides sufficient justification for including new, material evidence that was not previously provided during the course of the proceeding.
   2. The Provost will issue a written decision either upholding, modifying, or directing the RIO to obtain further review of the matter which may include performing parts of the proceeding again, such as reconvening or reconstituting the Committee, or supplementing the record with review of additional matters or reconsidering aspects of the determination.
   3. The decision on appeal is final within the University, subject only to obligations for external reporting or review (e.g., by HHS ORI).

Restoration of Reputation

If the University makes no finding of research misconduct, the RIO will, upon request and as appropriate, make all reasonable and practical efforts to protect or restore the respondent’s reputation and ability to continue their academic career. The RIO will collaborate with other University offices and leaders, as necessary.

Other Special Circumstances

At any time during misconduct proceedings, the University will immediately notify ORI when the research is PHS funded, or other relevant agencies and with confidentiality in mind, if any of the following circumstances arise:

1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
2. HHS or other external agency resources or interests are threatened.
3. Research activities should be suspended.
4. There is reasonable indication of possible violations of civil or criminal law.
5. Federal action is required to protect the interests of those involved in the research misconduct proceeding.
6. HHS or other external agency may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

Records Retention

The University 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 or other external agency proceeding, whichever is later, unless custody has been transferred to HHS or another external agency.