Research Misconduct Policy and Proceedings

Op4.01-7 Research Misconduct Policy and Proceedings

Section I. General Research Misconduct Principles

1.1. Commitment to Research Integrity. Missouri State University (“University”) is committed to the highest level of ethical conduct of research and research integrity. The administration, faculty, students, and staff of the University share in the responsibility for fostering, preserving, and maintaining a culture of research integrity and responsible conduct of research. All members of the University community are responsible for promoting the highest ethical principles in each academic discipline.

1.2. Prohibition of Research Misconduct. Research misconduct is contrary to the interests of Missouri State University, the health and safety of the public, the integrity of research, and the conservation of public funds. Both the institution and its institutional members have an affirmative duty to protect those funds from misuse by ensuring the integrity of all research conducted on behalf of the University.

1.3. Research Misconduct Policy and Proceedings. This Policy conforms to the United States Health and Human Services Public Health Service Policies on Research Misconduct, found at 42 Code of Federal Regulations (CFR) Part 93 (“Regulations”). Allegations of research misconduct by University faculty and staff shall be addressed in accordance with this Policy. This Policy is publicly available, members of the University have been informed of this Policy, and the University will continue to maintain the Policy to be consistent with Regulations.

1.4. Institution and Institution Member Cooperation. The Institution will take all reasonable and practical steps to ensure the cooperation of Respondents and other institutional members involved in the research misconduct proceedings defined in this Policy, including but not limited to, providing information, research records, and evidence. Failure to cooperate with a research misconduct proceeding may lead to discipline under the Faculty Handbook.

Section 2. Scope and Applicability of Research Misconduct Policy

2.1 This Policy applies to allegations of research misconduct of University faculty and staff involving:

2.1.1  Applications or proposals for federal Public Health Service (PHS) support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training.

2.1.2  PHS-supported biomedical or behavioral research.

2.1.3  PHS-supported biomedical or behavioral research training programs.

2.1.4  PHS-supported activities that are related to biomedical or behavioral research or research training, such as, but not limited to, the operation of tissue and data banks or the dissemination of research information.

2.1.5 Research records produced during PHS-supported research, research training, or activities related to that research or research training.

2.1.6 Research proposed, performed, reviewed, or reported, as well as any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in an awarded grant, contract, cooperative agreement, subaward, or other form of PHS support.

2.1.7 Allegations of research or other academic misconduct involving scholarly study not connected with PHS support and performed by faculty or staff in their role as a member of the University community.

2.2  Allegations Against Students. Allegations of student academic misconduct involving research related to academic credit will be handled in accordance with the University’s Academic Integrity Policies and Procedures except in cases where allegations against a student are directly related to a student’s participation in an externally funded project from a sponsor, such as PHS, or to research that has been published. Such circumstances will require following the research misconduct proceedings outlined in this Policy.

Section 3. Definitions

3.1 Throughout this Policy the following words have the following meaning:

Accepted practices of the relevant research community. This term means those practices established by the Regulations and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS awards.

Administrative record. The administrative record comprises: the institutional record; any information provided by the respondent to ORI, including but not limited to the transcript of any virtual or in-person meetings between the Respondent and ORI, and correspondence between the Respondent and ORI; any additional information provided to ORI while the case is pending before ORI; and any analysis or additional information generated or obtained by ORI. Any analysis or additional information generated or obtained by ORI will also be made available to the Respondent.

Allegation. This term is a disclosure of possible research misconduct through any means of communication and brought directly to the attention of a University official.

Complainant. Complainant means an individual who in good faith makes an allegation of research misconduct pursuant to this Policy.

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 University meet its responsibilities under this Policy and the Regulations.

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 submitting 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 an institution meet its responsibilities under this Policy and the Regulations. An institutional or committee member does not act 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.

Institution. Institution means the Board of Governors of Missouri State University, doing business as Missouri State University and Missouri State University-West Plains.

Institutional Assessment. Institutional Assessment means a consideration of whether an allegation of research misconduct (i) appears to fall within the definition of research misconduct under this Policy; (ii) appears to fall within the scope of activity of this Policy; and (iii) 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. The purpose of an Assessment is to determine whether an allegation warrants an Inquiry. The University’s Assessment procedures are described in Section 5.

Institutional Deciding Official (DO). Institutional Deciding Official means the institutional official who makes final determinations of allegations of research misconduct and any institutional actions. The University Provost has been designated as the Institutional Deciding Official (DO). The DO, at his/her discretion, may delegate his/her responsibilities outlined in this Policy, to another University official/employee; however, the RIO cannot be designated as the DO. For any misconduct allegations involving the Provost or Vice President for Community and Global Partnerships, the University President will be the DO. If allegations of misconduct involve the President or any staff reporting to the Board of Governors, the Chair of the Board of Governors will be the DO.

Institutional Inquiry. Inquiry means University’s preliminary information gathering and preliminary fact-finding following an Institutional Assessment that seeks to determine whether an Institutional Investigation is warranted. The University’s Institutional Inquiry procedures are described in Section 5.

Institutional Investigation. Institutional Investigation means the formal development of a factual record and the examination of that record for the purpose of determining whether research misconduct occurred. The University’s Institutional Investigation procedures are described in Section 5.

Institutional member. Institutional member and members mean an individual (or individuals) who is employed by, as 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, student volunteers, subject matter experts, consultants, attorneys, or employees or agents of contractors, subcontractors, or sub-awardees.

Institutional record. The institutional record comprises the following: (i) the records that the institution compiled or generated during the research misconduct proceedings, except records the institution did not consider or rely on. These records include but are not limited to (a) documentation of the University’s Assessment; (b) 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 institution, and the documentation of any decision not to investigate as required by Section 5; (c) 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 this Policy (including any provided corrections), and information the respondent provided to the institution; and (d) decision(s) by the Institutional Deciding Official; (ii) a single index listing all research records and evidence that the institution compiled during the research misconduct proceeding, except records the institution did not consider or rely on; and (iii) 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.

Knowingly. To act knowingly means to act with awareness of the act.

Office of Research Integrity (ORI) means the Department of Health and Human Services office that oversees and directs Public Health Service (PHS) research integrity activities.

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 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.

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.

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

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 means academic endeavors in all fields of scholarly study, including but not limited to the fields of science, mathematics, engineering, arts, and humanities.

Research Integrity Officer (RIO). The Research Integrity Officer (RIO) refers to the institutional official responsible for administering the institution’s written policies and procedures for addressing allegations of research misconduct in compliance with this Policy and the Regulations. The RIO at Missouri State University is the Director of Research Compliance, or other University official as appointed by the Institutional Deciding Official. In no event may the RIO and the DO be the same person.

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 difference of opinion or disputes between co-authors.

Research misconduct proceeding. Research misconduct proceeding means any actions related to alleged research misconduct taken pursuant to this Policy, including the Institutional Assessment, Institutional Inquiry, and Institutional Investigation, as described in Section 5.

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, record 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.

Witness(es). Witnesses are individuals who the University has reasonably identified as having information regarding any relevant aspects of a research misconduct proceeding. Witnesses provide information for review during research misconduct proceedings. Witnesses will cooperate with research misconduct proceedings in good faith based on the information known to them at the time.

Section 4. University Responsibilities During Research Misconduct Proceedings

4.1 University’s General Responsibility of Confidentiality. To the extent possible, while conducting research misconduct proceedings, the University will limit disclosure of the identity of Respondents, Complainants, and Witnesses to those who need to know. This limitation on disclosure no longer applies once the University has made a final determination of research misconduct findings. The University will cooperate with ORI during any ORI research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the institutional record if directed by ORI, administering and enforcing any HHS administrative actions imposed on institutional members, and providing information to ORI as indicated in this Policy, including any special circumstances that may arise. Except as may otherwise be prescribed by applicable law, the University will maintain confidentiality for any records or evidence from which research subjects might be identified and will limit disclosure to those who need to know to carry out a research misconduct proceeding. The University will require confidentiality of all participants in research misconduct proceedings as outlined in this Policy.

4.2. University’s Responsibilities to Participants in Research Misconduct Proceedings:

4.2.1 University’s Responsibility to the Complainant(s)/Respondent(s). The University will provide confidentiality consistent with this Policy to all Complainant(s) and Respondent(s) in a research misconduct proceeding. The University will also take reasonable precautions to ensure that individuals responsible for carrying out any part of research misconduct proceedings do not have potential, perceived, or actual personal, professional, or financial conflicts of interest with the Complainant(s) or Respondent(s). The institution agrees to take all reasonable and practical steps to protect the positions and reputations of Complainants and Respondent(s) and to protect these individuals from retaliation by participants in research misconduct proceedings and/or other institutional members. The institution will make reasonable efforts, as appropriate, to protect or restore the reputation of Respondent(s) against whom no finding of research misconduct is made following the conclusion of research misconduct proceedings.

4.2.2 University’s Responsibilities to Committee Members. The University will ensure that committee members acting on the institution’s behalf conduct research misconduct proceedings in compliance with this Policy. The institution 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.

4.2.3 University’s Responsibilities to the Witness[es]. The Institution 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

4.3. University Responsibility to Sequester Records. As identified in research misconduct proceedings below, the University will promptly take all reasonable and practical steps to obtain all research records and other evidence related to the allegations of research misconduct and sequester them securely. The need for additional sequestration of records during research misconduct proceedings may occur for any number of reasons, including the institution’s decision to investigate additional allegations not considered during the institutional inquiry stage or the identification of records during the institutional inquiry process that had not been previously secured. The RIO will be responsible for ensuring that records are appropriately sequestered during research misconduct proceedings.

4.4. Responsibility to Notify ORI of Special Circumstances. In addition to the University’s other obligations to notify ORI, under this Policy, the University is responsible for notifying ORI if the research at issue receives or has received federal funding and, at any point during research misconduct proceedings, the University makes the good faith ascertained that any of following six (6) conditions pertain to the allegations of research misconduct:

4.4.1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;

4.4.2. HHS resources or interests are threatened;

4.4.3. Research activities should be suspended;

4.4.4. There is reasonable indication of possible violations of civil or criminal law;

4.4.5. Federal action is required to protect the interests of those involved in the research misconduct proceeding; or

4.4.6. The University believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.

The University will notify ORI or HHS as soon as possible following the identification of one of the above conditions.

Section 5. Resolution of Research Misconduct Allegations

5.1 Finding of Research Misconduct. A finding of Research Misconduct under this Policy requires that (a) there be a significant departure from accepted practices of the relevant research community; (b) the research misconduct be committed intentionally, knowingly, or recklessly; and (c) the allegation of research misconduct be proven by a preponderance of the evidence. A finding of Research Misconduct can only be made following an Institutional Investigation as outlined under this Section 5. No finding of Research Misconduct can occur in the Institutional Assessment or Institutional Inquiry stage.

5.2 Allegations of Research Misconduct. Members of the University community, including all Principal Investigators involved in University sponsored research, must report suspected research misconduct to the DO and/or RIO as soon as possible. Failure to disclose suspected research misconduct may result in University discipline or loss of research privileges. Additionally, allegations of research misconduct may be presented by HHS officials or other federal agencies.

5.3 Limitation on Allegations of Research Misconduct. This Policy and the research misconduct proceedings process only applies to allegations of research misconduct occurring within six (6) years of the date by which the University receives an allegation of research misconduct, subject to the two (2) exceptions identified below:

5.3.1. Subsequent Use Exception. The six-year time limitation does not apply 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 For alleged research misconduct that appears subject to this subsequent use exception, but is determined by the institution not to be subject to the exception, the institution will document its determination that the subsequent use exception does not apply and will retain this documentation consistent with Section 7.

5.3.2. Health and Safety Exception. The six-year time limitation also does not apply if the ORI or University, following consultation with ORI, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

5.4 Interviews During Research Misconduct Proceedings. All interviews conducted during research misconduct proceedings will be recorded and transcribed. The University will provide the transcript of the interview to the interviewee for correction. The original transcript and any provided corrections will be included in the Institutional Record.

5.5 Admissions of the Respondent. A Respondent may admit to engaging in alleged research misconduct at any point in the research misconduct proceedings. In order for an admission to stop the research misconduct proceedings the admission must be in writing and state the specific misconduct that occurred (fabrication, falsification, and/or plagiarism); which records were affected by the research misconduct; and that the research misconduct constituted a significant departure from the relevant research community. The University will submit a written statement to ORI confirming the Respondent’s culpability and explain how the full scope of the misconduct was addressed by the admission. Once ORI has the University statement and signed and written admission from the Respondent, the research misconduct proceedings will conclude.

5.6 The Research Misconduct Proceeding. The following describes the University procedures to be followed once an allegation of research misconduct is received:

5.6.1. Institutional Assessment. The purpose of the institutional assessment is to determine whether an allegation of research misconduct warrants an institutional inquiry under this Policy.

A. RIO Assessment. Upon receiving an allegation of research misconduct, the RIO will promptly assess the allegation to determine whether the allegation(s) (a) is within the definition of research misconduct under this Policy; (b) is within the applicability criteria set forth in Section 2; and (c) is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

B. Requirements for Assessment Met. If the RIO determines that the above requirements for an Assessment are met, the RIO will promptly proceed to an Inquiry under Section 5.6.2. Prior to beginning the Inquiry, the RIO must: (1) document the Assessment and (2) sequester all research records and other evidence.

C. Requirements for Assessment Not Met. If the RIO determines that the above requirements for an Assessment are not met, the RIO will keep documentation of the letter in sufficient detail to permit later review by ORI of the reasons why the University did not conduct an Inquiry. This documentation will be retained in accordance with Section 7.

D. Federal Granting Agency Assessment. The University may move directly to the Institutional Inquiry stage of the Research Misconduct proceedings if directed to by any federal agency responsible for the underlying research that is the subject of the allegation of research misconduct. In such cases, the notice to the Respondent will include information regarding any federal agency assessment received by the University.

5.6.2. Institutional Inquiry. The purpose of the institutional inquiry is not to reach a final conclusion as to whether misconduct occurred or who was responsible. Instead, the purpose of the institutional inquiry is to conduct an initial review of the evidence of research misconduct to determine whether an allegation warrants an investigation. An institutional inquiry does not require a full review of the evidence related to the allegation of research misconduct. This preliminary phase of information gathering and fact-finding should take no more than ninety (90) calendar days from initiating the inquiry unless circumstances clearly warrant a longer period. If the institutional inquiry phase must be extended beyond ninety (90) days, the reasons for doing so must be documented by the RIO.

A. Initiating the Institutional Inquiry. Upon deciding an allegation of research misconduct meets the Assessment requirements to continue with an Inquiry, the RIO, in consultation with other institutional officials as appropriate, will undertake the following:

B. Sequester Evidence. The RIO, on or before the date on which the Respondent is notified, will take all reasonable and practical steps to obtain custody of all original research records and evidence needed to conduct the institutional inquiry and other research misconduct proceedings, inventorying the records and evidence and sequestering them in a secure manner, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on the instruments, so long as those copies are substantially equivalent to the evidentiary value of the instrument. The RIO will continue to sequester research records or other evidence as they become known through the research misconduct proceedings. Where appropriate, the respondent will be provided copies of, or reasonably supervised access to, the research records.

C. Written Notification to Respondent. The RIO will notify the alleged Respondent in writing of the completed Institutional Assessment and pending Institutional Inquiry. The written notification will include specific allegations relating to the Respondent. If additional allegations are raised during the research misconduct proceedings, the RIO will notify the respondent in writing of the additional allegations raised against them. To the extent practicable, the RIO will provide the names of the institution’s inquiry committee to the Respondent. The Respondent will be given five (5) days to object, in writing, to the members of the institutional inquiry committee, based on any bias or conflict of interest. The RIO will determine whether to replace the challenged person(s) and will provide follow-up to the Respondent prior to beginning the Institutional Inquiry.

D. Appointment of Institutional Inquiry Committee. The RIO will appoint an institutional inquiry committee as soon after the initiation of the inquiry as is practical. The purpose of the committee is to conduct the Institutional Inquiry to determine whether there is sufficient substance to the allegation to warrant a formal investigation. The institutional inquiry committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the institutional inquiry. The institutional inquiry committee will include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry.

E. Notification of Funding and/or Sponsoring Agencies: The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies. Appropriate interim administrative actions will be taken to protect federal funds and ensure the purpose of federal finance assistance is carried out.

F. The Institutional Inquiry. The Institutional Inquiry is conducted as a preliminary review of the evidence available regarding the allegations of research misconduct. The institutional inquiry does not require a full review of the evidence related to the allegation of research misconduct. The Institutional Inquiry may, but need not, involve the review of sequestered evidence, the interviewing of respondent(s), and witnesses.

G. Determination of Institutional Inquiry. The Institutional Inquiry will make the determination whether a research misconduct investigation is warranted. A research misconduct investigation is warranted if the institutional inquiry finds that: (i) there is a reasonable basis for concluding that the allegations of research misconduct fall within the definition of research misconduct under this Policy; (ii) the allegations involve the applicable criteria under Section 2; and (iii) the preliminary information and fact-finding from the institutional inquiry indicates the research misconduct allegations have substance.

H. Draft Institutional Inquiry Report. The University will produce a draft written Institutional Inquiry Report to both Complainant and Respondent for comment. The parties will have five (5) business days to provide comments to the RIO for inclusion in the final Institutional Inquiry Report. The Draft Institutional Inquiry Report will include the following information:

(i). the names, professional aliases, and positions of the respondent(s) and complainant(s);

(ii). a description of the allegation(s) of research misconduct;

(iii). details about the federal support, including, any grant numbers, grant applications, contracts, and publications listing federal support;

(iv). the name(s), positions(s), and subject matter expertise of the inquiry committee;

(v). inventory of sequestered research records and other evidence and description of how sequestration was conducted;

(vi). transcripts of any interviews conducted (including and provided corrections);

(vii). timeline and procedural history of the research misconduct allegation and institutional inquiry;

(viii). any scientific or forensic analyses conducted;

(ix). the basis for recommending that the allegation(s) warrant an investigation;

(x). the basis on which any allegation(s) do not merit further investigation;

(xi). any institutional actions implemented, including internal communications or external communications with journals or funding agencies; and

(xii). documentation of potential evidence of honest error or difference of opinion.

I. Final Institutional Inquiry Report. Following the receipt of any comments from the Complainant and/or Respondent, the University will prepare a Final Institutional Inquiry Report including the information published in the Draft Institutional Inquiry Report along with any comments on the draft institutional inquiry report submitted by the respondent or the complainant(s).The RIO will provide the Final Institutional Inquiry Report to the DO who will review the Report and make the determination as to whether to proceed to an Investigation under this Policy.

J. Investigation Warranted Following Institutional Inquiry. If the DO determines that an investigation is warranted, the RIO will provide written notice to the Respondent(s) of the decision to conduct an investigation of the alleged misconduct. This written notice will include all allegations of research misconduct, including any additional allegations of research misconduct not addressed during the inquiry. Additionally, within thirty (30) days provide ORI with a copy of the final institutional inquiry report, including a written notification that an institutional investigation will commence.

K. Investigation Not Warranted Following Institutional Inquiry. If the DO determines that an investigation is not warranted, the University will retain documentation, consistent with Section 7, to permit later assessment by ORI of the reasons why the University decided not to investigate.

5.6.3. Institutional Investigation. The purpose of the institutional investigation is to formally develop a factual record, pursue leads, examine the record, and recommend finding(s) to the Institutional Deciding Officer, who makes a final decision, based on the preponderance of the evidence, on each allegation as to whether research misconduct occurred.

A. Timeframe for Institutional Investigation. The University will begin the Institutional Investigation within thirty (30) days following the final institutional inquiry report indicating that an investigation is warranted. Unless an extension is approved by ORI in writing, the University must complete all aspects of the institutional investigation within one-hundred eighty (180) days of beginning the investigation.

B. Formation of the Institutional Investigative Committee. The RIO, in consultation with other institutional officials, as appropriate, will appoint an institutional investigative committee. The institutional investigative committee may, but need not be, the same members of the institutional investigative committee. The investigation committee will consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation. The institutional investigative committee will include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the respondent(s), complainant(s) and witness(es), and sufficiently document the investigation. The RIO will provide the names of the institution’s investigative committee to the Respondent. The Respondent will be given five (5) days to object, in writing, to the members of the institutional inquiry committee, based on any bias or conflict of interest. The RIO will determine whether to replace the challenged person(s) and will provide follow-up to the Respondent prior to beginning the investigation.

C. Conduct of the Institutional Investigation committee. During the institutional investigation, the Institutional Investigation Committee must:

(i). Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of each allegation;

(ii). Interview 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); and

(iii). Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion.

D. Institutional Investigation Interviews. Any interview conducted as part of the Institutional Investigation will be recorded and transcribed. Each interviewee will be provided a transcript of the interview for the correction of errors. The Institutional Investigation committee will number all relevant exhibits and refer to any exhibits shown to the interviewee(s) during the interview by number. Respondent(s) will not be allowed to be present during witness interviews; however, the Respondent will be provided a transcript of the interview as soon as reasonably practical thereafter.

E. Draft Institutional Investigation Report. Following its review of the available evidence and interview of all individuals, the Institutional Investigation Committee will prepare a written draft Investigation Report for each respondent under investigation. The University will provide the Complainant(s) and Respondent(s) a copy of the draft investigation report (including access to all research records and evidence that the investigation committee considered or relied on). The Respondent and Complainant may submit comments on the draft institutional investigation report. In order to be considered in the final institutional investigation report, comments must be returned to the University within thirty (30) days of receiving the draft report. The draft institutional investigation report will include:

(i). A description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding;

(ii). A description and documentation of federal support, including any grant numbers, grant applications, contract, and publications listing federal support (this should include known applications or proposals for support that the Respondent has pending with federal agencies (PHS and non-PHS);

(iii). A description of the specific allegation(s) of research misconduct for consideration in the investigation of the Respondent;

(iv). The Composition of investigation committee, including name(s), position(s), and subject matter expertise;

(v). An inventory of sequestered research records and other evidence (including manuscripts and funding proposals that were considered or relied on during the investigation), except records the university did not consider or rely on. The inventory will also include a description of how any sequestration was conducted during the institutional investigation;

(vi). The transcripts of all interviews conducted, including any corrections submitted by interviewees;

(vii). The identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other research records that contain the allegedly falsified, fabricated, or plagiarized material;

(viii). Any scientific or forensic analyses conducted;

(ix). A copy of this Policy; and

(x). A statement for each separate allegation of whether the committee recommends a finding of research misconduct. For each allegation in which the Institutional Investigation committee recommends a finding of research misconduct, the draft investigation report will, for that allegation: (a) identify the individual(s) who committed the research misconduct; (b) indicate whether the research misconduct was falsification, fabrication, and/or plagiarism; (c) indicate whether the research misconduct was committed intentionally, knowingly, or recklessly; (d) indicate whether the requirements for a finding of research misconduct has been met; (e) summarize the facts and the analysis which support the conclusion; (f) identify the specific PHS support; and (g) identify whether any publications need correction or retraction.

F. Final Institutional Investigation Report. Following the receipt of any comments from the Complainant and/or Respondent, the University will prepare a Final Institutional Investigation Report including the information published in the draft Institutional Investigation Report along with any comments on the draft institutional investigation report submitted by the Respondent or the Complainant(s) and considering the Respondent’s comments regarding the Institutional Investigation Committee’s summary of the facts and analysis supporting its conclusion.

G. Review of Final Institutional Investigation Report by Institution Deciding Officer. Following the creation of the Final Institutional Investigation Report, the DO will review the final investigation report and make a final written determination of whether the University found research misconduct. The DO’s final written determination will include the following: (i) whether the University found research misconduct and, if so, who committed the misconduct; and (ii) a description of relevant institutional actions taken or to be taken. The determination of the Institution’s DO is final.

H. Transmittal of the Institutional Record. Once the DO has made a final determination of research misconduct findings, the University will transmit the Institutional Record, as defined herein, to ORI and/or other appropriate federal agency.

Section 6. Special Circumstances in Research Misconduct Proceedings

6.1 Multiple Institutions. With respect to allegations of research misconduct involving research conducted at multiple institutions, the RIO will engage with the institution(s) to determine which institution should be designated as the lead institution if a joint research misconduct proceeding is conducted. The lead institution should obtain research records and evidence, including testimony from other relevant institutions. The committee members may include members from all institutions involved. The institutions should come to an agreement as to which institution’s policy should control the resolution of the allegations.

6.2 Multiple Respondents. If multiple Respondents are named or additional Respondents are identified during research misconduct proceedings, the University does not have to conduct separate inquiries or investigations for each Respondent. However, each Respondent must be provided notice of the proceeding and opportunity to respond to the allegations separately.

Section 7. Research Misconduct Document Retention

7.1 Retention of Research Misconduct Records. Unless otherwise instructed by ORI, the University will maintain all Assessment, Inquiry, and Investigation documentation, including 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 (7) years after the completion of research misconduct proceedings under Section 5, or the completion of any HHS proceeding, whichever is later. The University will have no retention obligation if the custody of documentation has been transferred to HHS pursuant to HHS’ direction.