Research Integrity: Difference between revisions

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== Definitions ==
== Definitions ==
'''''Accepted practices of the relevant research community means''''' those practices established by [https://www.ecfr.gov/current/title-42/part-93 42 CFR part 93] and by PHS funding components or other funding agencies, as applicable, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive federal awards.
'''''Accepted practices of the relevant research community''''' means those practices established by [https://www.ecfr.gov/current/title-42/part-93 42 CFR part 93] and by PHS funding components or other funding agencies, as applicable, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive federal awards.


'''''Allegation''''' means any disclosure of possible research misconduct through any means of communication and brought directly to the attention of a UNMC official.
'''''Allegation''''' means any disclosure of possible research misconduct through any means of communication and brought directly to the attention of a UNMC official.
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'''''Recklessly''''' means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.
'''''Recklessly''''' means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.


'''''Research''''' means a systematic experiment, study, evaluation, demonstration, survey or other process of inquiry designed to generate new knowledge or to confirm, refine, or apply existing knowledge. It encompasses a broad range of disciplines, including but not limited to biomedical, clinical, translational, behavioral, educational, and social sciences, and may comprise many different approaches appropriate to the respective discipline. Research may involve observation, experimentation, analysis, evaluation, or synthesis, and is conducted with the goal of expanding scientific understanding, informing evidence-based practice, improving population-based outcomes, and/or contributing to the public good
'''''Research''''' means a systematic experiment, study, evaluation, demonstration, survey or other process of inquiry designed to generate new knowledge or to confirm, refine, or apply existing knowledge. It encompasses a broad range of disciplines, including but not limited to biomedical, clinical, translational, behavioral, educational, and social sciences, and may comprise many different approaches appropriate to the respective discipline. Research may involve observation, experimentation, analysis, evaluation, or synthesis, and is conducted with the goal of expanding scientific understanding, informing evidence-based practice, improving population-based outcomes, and/or contributing to the public good.


'''''Research Integrity Officer''''' means the institutional official with primary responsibility for implementation of UNMC’s policies and procedures on research misconduct. Among other things, the Research Integrity Officer performs the duties described in this policy.
'''''Research Integrity Officer''''' means the institutional official with primary responsibility for implementation of UNMC’s policies and procedures on research misconduct. Among other things, the Research Integrity Officer performs the duties described in this policy.
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In determining whether an incident falls under this policy, an individual may refer to the definitions under this policy (e.g., authorship disputes and self-plagiarism do not fall under this policy) and review University of Nebraska Executive Memorandum No. 41, Policy on Research Data and Security (e.g., for questions regarding data ownership).  If an individual is unsure whether the suspected incident falls within the definition of research misconduct, they may call the Research Integrity Officer to discuss the suspected misconduct informally, including anonymously or hypothetically. Such discussions shall ordinarily be confidential. If the circumstances do not meet the definition of research misconduct, the Research Integrity Officer or designee will refer the individual or allegation to other offices with responsibility for resolving the problem.
In determining whether an incident falls under this policy, an individual may refer to the definitions under this policy (e.g., authorship disputes and self-plagiarism do not fall under this policy) and review University of Nebraska Executive Memorandum No. 41, Policy on Research Data and Security (e.g., for questions regarding data ownership).  If an individual is unsure whether the suspected incident falls within the definition of research misconduct, they may call the Research Integrity Officer to discuss the suspected misconduct informally, including anonymously or hypothetically. Such discussions shall ordinarily be confidential. If the circumstances do not meet the definition of research misconduct, the Research Integrity Officer or designee will refer the individual or allegation to other offices with responsibility for resolving the problem.


=== '''Allegations Involving Multiple Institutions''' ===
=== Allegations Involving Multiple Institutions ===
When allegations involve research conducted at multiple institutions, the Research Integrity Officer will communicate with the administrator charged with research integrity at the other institution(s). UNMC and the other institution(s) must determine whether a joint research misconduct proceeding will be conducted and, if so, designate one institution to serve as the lead institution. The lead institution will follow its research misconduct policies and procedures to conduct the proceeding as modified by the procedures included- immediately below in this paragraph as agreed to by the participating institutions. In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institution(s). 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.
When allegations involve research conducted at multiple institutions, the Research Integrity Officer will communicate with the administrator charged with research integrity at the other institution(s). UNMC and the other institution(s) must determine whether a joint research misconduct proceeding will be conducted and, if so, designate one institution to serve as the lead institution. The lead institution will follow its research misconduct policies and procedures to conduct the proceeding as modified by the procedures included- immediately below in this paragraph as agreed to by the participating institutions. In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institution(s). 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.


Allegations involving research being conducted at more than one campus of the University of Nebraska will be treated as allegations involving multiple institutions.
Allegations involving research being conducted at more than one campus of the University of Nebraska will be treated as allegations involving multiple institutions.


=== '''Allegations Involving the Research Integrity Officer or Institutional Deciding Official''' ===
=== Allegations Involving the Research Integrity Officer or Institutional Deciding Official ===
In the event an allegation of research misconduct is made against the Research Integrity Officer or Institutional Deciding Official, or the Research Integrity Officer or Institutional Deciding Official has a conflict of interest with the outcome of the assessment, inquiry, or investigation of an allegation, the Vice Chancellor for Research will appoint a substitute for the Research Integrity Officer or Institutional Deciding Official. If such a replacement is not possible, the Vice Chancellor for Research will confer with the Office of General Counsel to determine whether external resources will be engaged to complete the necessary process under this policy.
In the event an allegation of research misconduct is made against the Research Integrity Officer or Institutional Deciding Official, or the Research Integrity Officer or Institutional Deciding Official has a conflict of interest with the outcome of the assessment, inquiry, or investigation of an allegation, the Vice Chancellor for Research will appoint a substitute for the Research Integrity Officer or Institutional Deciding Official. If such a replacement is not possible, the Vice Chancellor for Research will confer with the Office of General Counsel to determine whether external resources will be engaged to complete the necessary process under this policy.


===Preliminary Assessment of Allegations===
===Preliminary Assessment of Allegations===
Upon receiving an allegation of research misconduct, the Research Integrity Officer or designee shall assess the allegation as soon as is feasible (usually within 21 days of receipt of the allegation) to determine whether it falls within the definition of research misconduct, is within the scope of this policy, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If so, the matter must proceed to an inquiry. The Research Integrity Officer or designee will document the assessment, including, in cases where an inquiry is not warranted, with sufficient detail to permit a later review by the ORI of the reasons why an inquiry was not conducted. If the identity of the complainant is known, the Research Integrity Officer or designee will notify the complainant of the outcome of the assessment.
Upon receiving an allegation of research misconduct, the Research Integrity Officer or designee shall assess the allegation as soon as is feasible (usually within 21 days of receipt of the allegation) to determine whether it falls within the definition of research misconduct, is within the scope of this policy, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If so, the matter must proceed to an inquiry. The Research Integrity Officer or designee will document the assessment, including, in cases where an inquiry is not warranted, with sufficient detail to permit a later review by the ORI of the reasons why an inquiry was not conducted. If the identity of the complainant is known, the Research Integrity Officer or designee will notify the complainant of the outcome of the assessment.
Authorship or collaboration disputes and other matters that are not within the definition of research misconduct, as set forth in this policy, are not subject to this policy and shall be addressed through procedures outlined in the UNMC Faculty Handbook [<nowiki/>[[Faculty Handbook|Faculty]]], University of Nebraska Student Code of Conduct [https://catalog.unmc.edu/general-information/student-policies-procedures/code-of-conduct/code-of-conduct.pdf (https://catalog.unmc.edu/general-information/student-policies-procedures/code-of-conduct/code-of-conduct.pdf)] and University of Nebraska Medical Center Code of Conduct (<nowiki>https://catalog.unmc.edu/general-information/student-policies-procedures/unmc-code-of-conduct/</nowiki>), as appropriate.  Authorship guidelines are found at [https://wiki.unmc.edu/index.php/Authorship_Guidelines Authorship Guidelines - University of Nebraska Medical Center]
 
Authorship or collaboration disputes and other matters that are not within the definition of research misconduct, as set forth in this policy, are not subject to this policy and shall be addressed through procedures outlined in the [https://info.unmc.edu/wiki/index.php/Faculty_Handbook UNMC Faculty Handbook] , University of Nebraska Student Code of Conduct [https://catalog.unmc.edu/general-information/student-policies-procedures/code-of-conduct/code-of-conduct.pdf (https://catalog.unmc.edu/general-information/student-policies-procedures/code-of-conduct/code-of-conduct.pdf)] and University of Nebraska Medical Center Code of Conduct (<nowiki>https://catalog.unmc.edu/general-information/student-policies-procedures/unmc-code-of-conduct/</nowiki>), as appropriate.  Authorship guidelines are found at [https://wiki.unmc.edu/index.php/Authorship_Guidelines Authorship Guidelines - University of Nebraska Medical Center]


===Sequestration of Research Records===
===Sequestration of Research Records===
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=== Inquiry===
=== Inquiry===
====Initiation of the Inquiry====
====Initiation of the Inquiry====
At the time of or before beginning an inquiry, the Research Integrity Officer or designee must make a good faith effort to notify the respondent in writing, if the respondent is known. If the inquiry subsequently identifies additional respondents, they must be notified in writing. Only allegations specific to a particular respondent are to be included in the notification to that respondent.  
At the time of or before beginning an inquiry, the Research Integrity Officer or designee must make a good faith effort to notify the respondent in writing, if the respondent is known. If the inquiry subsequently identifies additional respondents, they must be notified in writing. Only allegations specific to a particular respondent are to be included in the notification to that respondent.
====Purpose of the Inquiry====
====Purpose of the Inquiry====
The purpose of the inquiry is to make a preliminary evaluation of the evidence to determine whether to conduct an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible, and an inquiry does not require a full review of all the evidence related to the allegation. An investigation is warranted if the committee determines:  
The purpose of the inquiry is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible, and an inquiry does not require a full review of all the evidence related to the allegation. An investigation is warranted if it is determined:  
:(1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct; and,
:(1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct; and,
:(2) the allegation may have substance, based on the committee’s review during the inquiry.
:(2) the preliminary information-gathering and fact-finding indicate the allegation may have substance.
==== Inquiry Committee====
The Research Integrity Officer, in consultation with other UNMC officials as appropriate, will appoint an inquiry committee and committee chair within ten (10) days after initiation of the inquiry.  The inquiry committee must consist of individuals who do not have real or apparent conflicts of interest with those involved with the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry.<br />
 
The Research Integrity Officer will notify the respondent of the proposed committee membership. If the respondent submits a written objection to a member or members of the inquiry committee based on bias or conflict of interest within five (5) business days, the Deciding Official will determine whether to replace the challenged member with a qualified substitute.
====Inquiry Process====
====Inquiry Process====
The Research Integrity Officer shall deliver a charge to the inquiry committee that sets forth the committee’s responsibilities and timeline. The Research Integrity Officer and other institutional officials and outside consultants may advise the inquiry committee. The inquiry committee may interview the complainant, the respondent, and key witnesses as well as examine relevant research records and materials. The inquiry committee will evaluate the evidence and determine whether an investigation is warranted.
The Research Integrity Officer or designee shall conduct the inquiry. The Research Integrity Officer or designee may obtain assistance from one or more subject matter experts as may be necessary to conduct the inquiry. No person conducting or consulting on the inquiry will have an unresolved personal, professional, or financial conflict of interest with the complainant, respondent, or witnesses. The Research Integrity Officer or designee may interview the complainant, the respondent, and key witnesses as well as examine relevant research records and materials. If additional allegations are raised during the inquiry, the respondent(s) must be notified in writing of the additional allegations raised against them. The Research Integrity Officer or designee will evaluate the evidence and determine whether an investigation is warranted. Findings of research misconduct, including whether the alleged misconduct is intentional, knowing, or reckless, cannot be made through the inquiry process. The Research Integrity Officer or designee may make a determination of honest error as a result of the inquiry, which would not warrant an investigation.  
====Written Report====
====Written Report====
A written report shall be prepared in accordance with applicable legal requirements that includes the following information:  
A written report shall be prepared in accordance with applicable legal requirements that includes the following information:  
:(1) the name and position of the respondent;
 
:(2) a description of the allegations of research misconduct;
# the names, professional aliases, and position of the respondent and the complainant;
:(3) the PHS or other governmental or third-party support;
# a description of the allegations of research misconduct;
:(4) the evidence that was reviewed;
# the PHS or other governmental or third-party support including, for example, grant numbers, grant applications, contracts, and publications listing support;
:(5) the basis for recommending or not recommending that the allegations warrant an investigation; and
# inventory of sequestered research records and other evidence and description of how sequestration was conducted;
:(6) any comments on the draft report by the respondent. The respondent shall be given a copy of the draft inquiry report together with a copy of this policy. <br />
# transcripts of any transcribed interviews;
If the respondent chooses to comment on the report, they must submit a written response to the Research Integrity Officer within fourteen (14) working days after receiving the report in order for it to be made a part of the record. Based on the comments, the Research Integrity Officer may revise the report as appropriate.
# timeline and procedural history;
# any scientific or forensic analyses conducted;
# the basis for recommending or not recommending that the allegations warrant an investigation;
# if there is potential evidence of honest error or difference of opinion;
# any comments on the draft inquiry report by the respondent;
# any institutional actions implemented, including communications with journals or funding agencies; and
# if the inquiry took longer than 90 days to complete, the reasons for exceeding the 90-day period.
 
The respondent shall be given a copy of the draft inquiry report together with a copy of this policy. If the respondent chooses to comment on the report, they must submit a written response to the Research Integrity Officer or designee within fourteen (14) days after receiving the report in order for it to be made a part of the record. Based on the comments, the Research Integrity Officer or designee may revise the report as appropriate.  
 
==== Decision by Deciding Official====
==== Decision by Deciding Official====
The Research Integrity Officer will transmit the final inquiry report and any comments to the Deciding Official, who will make the determination of whether the findings from the inquiry indicate a reasonable basis for concluding that the allegation has sufficient substance to fall within the definition of research misconduct and that the allegation should proceed to an investigation.
The Research Integrity Officer or designee will transmit the final inquiry report and any comments to the Institutional Deciding Official.  The Institutional Deciding Official will make the determination of whether an investigation is warranted after reviewing the inquiry report and recommendation. If the findings from the inquiry indicate a reasonable basis for concluding that the allegation falls within the definition of research misconduct and the preliminary information-gathering and fact-finding from the inquiry indicate the allegation may have substance, then an investigation is warranted.
====Notification of Decision====
====Notification of Decision====
The Research Integrity Officer will notify both the respondent and appropriate UNMC officials in writing of the Deciding Official's decision of whether to proceed with an investigation. This decision may not be appealed internally. If the Deciding Official determines an investigation is needed, the Research Integrity Officer shall notify appropriate funding and oversight agencies (PHS, NSF, etc.) in writing of the decision within thirty days after the Deciding Official’s decision.
The Research Integrity Officer or designee will notify both the respondent and appropriate UNMC officials in writing of the Institutional Deciding Official's decision of whether to proceed with an investigation. The notice to the respondent must include a copy of the inquiry report, a copy of this Policy and, for PHS-funded research, a copy of or reference to 42 CFR Part 93. If the Institutional Deciding Official determines an investigation is warranted, the Research Integrity Officer or designee shall notify appropriate funding and oversight agencies (PHS, NSF, etc.) in writing of the decision and provide a copy of the inquiry report within thirty days after the Institutional Deciding Official’s decision.
====Time for Completion ====
 
The inquiry, including preparation of the final inquiry report and the decision of the Deciding Official, must be completed within 60 calendar days of its initiation, unless the Research Integrity Officer determines that circumstances warrant a longer period.
The Research Integrity Officer or designee is not required to notify a complainant whether the inquiry found that an investigation is warranted. However, if the Research Integrity Officer or designee provides notice to one complainant in a case, they must provide notice, to the extent possible, to all complainants in a case.
 
====Time for Completion of Inquiry ====
The inquiry, including preparation of the final inquiry report and the decision of the Institutional Deciding Official, must be completed within 90 days of its initiation, unless the Research Integrity Officer or designee determines that circumstances warrant a longer period.  
===Investigation===
===Investigation===
====Initiation of the Investigation====
====Initiation of the Investigation====
The investigation must begin within 30 calendar days of the determination by the Deciding Official that the investigation is warranted. On or before the date on which the investigation begins, the Research Integrity Officer must:  
The investigation must begin within 30 days of the decision by the Institutional Deciding Official that the investigation is warranted. On or before the date on which the investigation begins, the Research Integrity Officer or designee must:  
:(1) if applicable, notify ORI of the decision to begin the investigation and provide ORI a copy of the inquiry report (or comply with any other notice obligation to a government agency or other funder);
:(1) if applicable, notify ORI of the decision to begin the investigation and provide ORI a copy of the inquiry report (or comply with any other notice obligation to a government agency or other funder);
:(2) notify the respondent in writing of the allegations to be investigated.
:(2) notify the respondent in writing of the allegations to be investigated.
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The purpose of the investigation is to examine the allegations and evidence in detail and determine specifically whether misconduct has been committed, as defined in accordance with the standards of proof set forth in Section 1, by whom, and to what extent. The investigation committee shall pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. If new allegations are identified, the Research Integrity Officer must also give the respondent written notice of such allegations within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.
The purpose of the investigation is to examine the allegations and evidence in detail and determine specifically whether misconduct has been committed, as defined in accordance with the standards of proof set forth in Section 1, by whom, and to what extent. The investigation committee shall pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. If new allegations are identified, the Research Integrity Officer must also give the respondent written notice of such allegations within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.
====Investigation Committee====
====Investigation Committee====
The Research Integrity Officer, in consultation with other UNMC officials as appropriate, will appoint an investigation committee and the committee chair within ten (10) days after the notification to the respondent of the investigation or as soon thereafter as practicable. The investigation committee shall consist of at least three individuals who do not have real or apparent conflicts of interest in the case, who are unbiased, and who have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. Individuals appointed to the investigation committee may have also participated in the inquiry. The Research Integrity Officer will notify the respondent of the proposed committee membership. If the respondent submits a written objection to the appointed member of the inquiry committee based on bias or conflict of interest within five (5) business days, the Deciding Official will determine whether to replace the challenged member with a qualified substitute.
The Research Integrity Officer or designee, in consultation with other UNMC officials as appropriate, will appoint an investigation committee within ten (10) days after the notification to the respondent of the investigation or as soon thereafter as practicable. The investigation committee shall consist of at least three individuals who do not have unresolved personal, professional, or financial conflicts of interest in the case, who are unbiased, and who have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. Individuals appointed to the investigation committee may have also participated in the inquiry. The Research Integrity Officer or designee will notify the respondent of the proposed committee membership. If the respondent submits a written objection to the appointed member of the inquiry committee based on bias or conflict of interest within five (5) days, the Institutional Deciding Official will determine whether to replace the challenged member with a qualified substitute.
====Investigation Process====
====Investigation Process====
*The Research Integrity Officer will provide a written charge to the committee. Such charge shall describe the allegations and related issues identified during the inquiry; identify the respondent; inform the committee that it must conduct the investigation as prescribed by this policy and in accordance with applicable law; define research misconduct; and instruct the investigation committee on the burden of proof. The charge shall state that the committee is to evaluate the evidence and testimony of the respondent, complainant, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. The committee will review procedures and standards for conduct of the investigation, including this policy and applicable federal regulations. The committee will be instructed that it is advisable to develop an investigation plan and as to the necessity for maintaining confidentiality.
*The Research Integrity Officer or designee will provide a written charge to the committee. Such charge shall describe the allegations and related issues identified during the inquiry; identify the respondent; inform the committee that it must conduct the investigation as prescribed by this policy and in accordance with applicable law; define research misconduct; and instruct the investigation committee on the burden of proof. The charge shall state that the committee is to evaluate the evidence and testimony of the respondent, complainant, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. The committee will review procedures and standards for conduct of the investigation, including this policy and applicable federal regulations. The committee will be instructed that it is advisable to develop an investigation plan and as to the necessity for maintaining confidentiality.
*The investigation committee shall use diligent efforts to ensure that the investigation is impartial, unbiased, objective, thorough and sufficiently documented and shall include examination of all research records and evidence relevant to reaching a decision on the merits of each allegation.
*The investigation committee shall use diligent efforts to ensure that the investigation is impartial, unbiased, objective, thorough and sufficiently documented and shall include examination of all research records and evidence relevant to reaching a decision on the merits of each allegation.
* The investigation committee shall 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, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation.
* The investigation committee shall 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.
*The investigation committee shall determine whether and to what extent research misconduct occurred.
 
# Interviews during the investigation must be recorded and transcribed;
# Any exhibits shown to the interviewee during the interview must be numbered and referred to by that number in the interview;
# The transcript of the interview must be made available to the relevant interviewee for correction;
# The transcript(s) with any corrections and numbered exhibits must be included in the institutional record of the investigation; and
# The respondent must not be present during the witnesses’ interviews but must be provided a transcript of the interviews.
 
* If a respondent, complainant, or witness refuses an interview and or the respondent, complainant, witness or Investigation Committee requests another form of fact gathering, such as a response in writing to written questions, the Research Integrity Officer or designee will confer with the Office of Research Integrity to determine the permissibility of the proposed alternative to interview.
 
* If the investigation committee identifies additional respondents during the investigation, UNMC is not required to conduct a separate inquiry for each new respondent. If any additional respondent(s) are identified during the investigation, the Research Integrity Office must notify them of the allegation(s) and provide them an opportunity to respond consistent with this policy.
* The investigation committee shall determine whether, to what extent, and by whom research misconduct has been committed.
 
====Investigation Report====
====Investigation Report====
Upon completion of the investigation, a written report shall be prepared in accordance with applicable legal requirements. Such report shall, without limitation:  
Upon completion of the investigation, a written report for each respondent shall be prepared in accordance with applicable legal requirements. Such report shall, without limitation:
:(1) describe the nature of the allegation(s) of research misconduct, including identification of the respondent(s);
:(1) describe the nature of the allegation(s) of research misconduct, including identification of the respondent(s);
:(2) describe and document support for the research, including PHS support;
:(2) describe and document support for the research, including PHS or other funding agency support;
:(3) describe the specific allegations of research misconduct considered in the investigation;
:(3) describe the specific allegations of research misconduct considered in the investigation;
:(4) include the institutional policies and procedures under which the investigation was conducted;
:(4) describe composition of the investigation committee, including name(s), position(s), and subject matter expertise; 
:(5) identify and analyze the key research records reviewed;
:(5) include the inventory of sequestered research records and other evidence, except records UNMC did not consider or rely on, with a description of how any sequestration was conducted during the investigation and including manuscripts and funding proposals that were considered or relied on in the investigation; 
:(6) include a statement of findings for each allegation of research misconduct identified during the investigation, summarizing the basis for the investigation committee’s decision and proposed corrective actions (if any).
:(6) include transcripts of all interviews conducted; 
*The Research Integrity Officer shall provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent will be given thirty (30) business days to review and comment on the draft report. The respondent will receive a copy of or have the opportunity to obtain supervised access to the evidence on which the report is based. The respondent shall submit comments to the Research Integrity Officer within 30 days from the date the respondent received the draft report. The respondent's comments will be attached to the final report.
:(7) identify any specific published papers, manuscripts submitted but not accepted for publication (including online publication), funding applications, progress reports, presentations, posters, or other research records that allegedly contain the falsified, fabricated, or plagiarized materials; 
*The investigation committee shall consider and address the respondent(s)’ comments on the draft report in connection with finalizing the report.
:(8) describe any scientific or forensic analyses conducted; 
*The draft investigation report will be transmitted to the University of Nebraska Office of the General Counsel for a review of its legal sufficiency.
:(9) include the institutional policies and procedures under which the investigation was conducted;
:(10) include any comments made by the respondent and complainant on the draft investigation report and the investigation committee’s consideration of those comments;
:(11) include a statement of findings for each allegation of research misconduct identified during the investigation, summarizing the basis for the investigation committee’s decision and proposed corrective actions (if any). The statement shall include the identity of the individual(s) who committed the research misconduct, the type of misconduct (falsification, fabrication, or plagiarism), indicate whether the research misconduct was committed intentionally, knowingly, or recklessly; and state whether the requirements for finding research misconduct have been met. If the committee does not recommend a finding of research misconduct for an allegation, the investigation report must provide a detailed rationale; and 
:(12) If the investigation took longer than 180 days to complete, include the reasons for exceeding the 180-day period.
:* The Research Integrity Officer or designee shall provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent will be given thirty (30) days to review and comment on the draft report. The respondent will receive a copy of or have the opportunity to obtain supervised access to the evidence on which the report is based. The respondent shall submit comments to the Research Integrity Officer or designee within 30 days from the date the respondent received the draft report. The respondent's comments will be attached to the final report.
:* The investigation committee shall consider and address the respondent(s)’ comments on the draft report in connection with finalizing the report.
:* The draft investigation report will be transmitted to the University of Nebraska Office of the General Counsel for a review of its legal sufficiency.
====Decision by Deciding Official====
====Decision by Deciding Official====
Within fifteen (15) calendar days of receiving the investigation report, the Deciding Official will make a final determination whether to accept the final report and the recommended actions (with or without further modifications), or reject the recommendations and instruct the investigation committee to conduct further fact finding. If the Deciding Official's determination varies from that of the investigation committee, the Deciding Official shall explain in writing and in detail the basis for rendering a different decision.
Within fifteen (15) days of receiving the investigation report, the Institutional Deciding Official will make a final determination whether to accept the final report and the recommended actions (with or without further modifications), or reject the recommendations and instruct the investigation committee to conduct further fact finding. If the Institutional Deciding Official's determination varies from that of the investigation committee, the Institutional Deciding Official shall explain in writing and in detail the basis for rendering a different decision.
 
The Institutional Deciding Official’s determination of whether research misconduct occurred is final for UNMC’s purposes and is independent of any finding from ORI or other funding agency regarding research misconduct. The lack of an ORI or other funding agency finding of research misconduct does not overturn UNMC’s determination that the conduct constituted research misconduct warranting remediation under this policy.
 
====Notification of Decision====
====Notification of Decision====
When a final decision is reached, the Research Integrity Officer will normally notify both the respondent and the complainant in writing. After informing ORI, the Deciding Official shall determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which research misconduct may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The Research Integrity Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
When a final decision is reached, the Research Integrity Officer or designee will normally notify both the respondent and the complainant in writing. After informing ORI, the Institutional Deciding Official shall determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which research misconduct may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The Research Integrity Officer or designee is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
====Time for Completion====
====Time for Completion====
All aspects of the investigation shall be complete within 120 days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment in accordance, and sending the final report to ORI or other funding agencies as required. If unable to complete the investigation within 120 days, the Research Integrity Officer shall request an extension in writing from any pertinent funding agencies as required.
All aspects of the investigation shall be complete within 180 days of beginning it, including conducting the investigation, preparing the draft investigation report for each respondent, providing the draft report to each respondent for comment, and transmitting the institutional record including the final investigation report and decision by the Institutional Deciding Official to ORI or other funding agencies as required. If unable to complete the investigation within 180 days, the Research Integrity Officer or designee shall request an extension in writing that includes the circumstances or issues warranting additional time from any pertinent funding agencies as required. If an allegation involves research for which there is no external funding agency, the Research Integrity Officer or designee may extend the time to complete the investigation for a period reasonable under the circumstances in the Research Integrity Officer’s or designee’s discretion.
===Corrective Action===
===Corrective Action===
Corrective action for research misconduct shall be based on the seriousness of the misconduct, including but not limited to, the degree to which the misconduct:  
Corrective action for research misconduct shall be based on the seriousness of the misconduct including, but not limited to, the degree to which the misconduct:  
:a) was intentional, knowing or reckless;
 
:b) was an isolated event or part of a pattern; and
a) was intentional, knowing or reckless;
:c) had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.
 
b) was an isolated event or part of a pattern; and
 
c) had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.
 
The range of corrective actions includes, but is not limited to, withdrawal or correction of all pending or published abstracts and papers emanating from the research where misconduct was found; removal of the responsible person from the particular project; special monitoring of future work; restitution of funds as appropriate; suspension or termination of an active award; termination, expulsion, suspension, leave without pay, and/or letters of reprimand. If the corrective action results in termination or other adverse change in an employee's terms and conditions of employment, the respondent may appeal the decision through the appropriate procedures contained in the Faculty Handbook or UNMC policy for non-faculty members. Students have appeal rights as outlined in the Student or Graduate Student Handbooks.
The range of corrective actions includes, but is not limited to, withdrawal or correction of all pending or published abstracts and papers emanating from the research where misconduct was found; removal of the responsible person from the particular project; special monitoring of future work; restitution of funds as appropriate; suspension or termination of an active award; termination, expulsion, suspension, leave without pay, and/or letters of reprimand. If the corrective action results in termination or other adverse change in an employee's terms and conditions of employment, the respondent may appeal the decision through the appropriate procedures contained in the Faculty Handbook or UNMC policy for non-faculty members. Students have appeal rights as outlined in the Student or Graduate Student Handbooks.
===Reporting to the Funding Agency (including ORI)===
 
The Research Integrity Officer shall notify the funding agency (or agencies in some cases), including the ORI Director if applicable, in writing of the following events, among others:
===Reporting to ORI or the Funding Agency===
The Research Integrity Officer or designee will make any notifications related to research misconduct required by the funding agency.
 
For PHS agencies subject to 42 CFR Part 93: The Research Integrity Officer or designee shall notify the ORI Director, in writing of the following events, among others:
 
* Decision to initiate a research misconduct investigation on or before the date the investigation begins;
* Decision to initiate a research misconduct investigation on or before the date the investigation begins;
* Transmission of the final investigation report;
* Transmission of the final investigation report;
*Decision to terminate an investigation for any reason without completing all regulatory requirements or as otherwise called for by this policy;
* Decision to terminate an investigation for any reason without completing all regulatory requirements or as otherwise called for by this policy;
*Request for extension in the event that UNMC will not be able to complete the investigation within 120 days.
* Request for extension in the event that UNMC will not be able to complete the investigation within 180 days.
The Research Integrity Officer shall provide immediate notice to the funding agency (or agencies in some cases), including the ORI Director if applicable, when:
 
*The health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
The Research Integrity Officer or designee shall provide immediate notice to the ORI Director, when:
*There is an immediate need to protect Federal funds or equipment or interests;
 
*Research activities should be suspended;
* The health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
*Federal action is required to protect the interests of those involved in the research misconduct proceeding;
* There is an immediate need to protect Federal funds or equipment or interests;
*It appears the research misconduct proceeding may be made public prematurely;
* Research activities should be suspended;
*The research community or public should be informed; or
* Federal action is required to protect the interests of those involved in the research misconduct proceeding;
*There is a reasonable indication of possible civil or criminal violation.
* There is a reasonable indication of possible civil or criminal law violation; or
* The Department of Health and Human Services may need to take appropriate steps to safeguard evidence and protect the rights of those involved.
 
UNMC will cooperate with ORI or other government agencies during oversight review or any subsequent administrative hearings or appeals. This includes provision of research records and evidence under the institution's control, custody, or possession and reasonable access to persons within its authority necessary to develop a complete record of relevant evidence.
UNMC will cooperate with ORI or other government agencies during oversight review or any subsequent administrative hearings or appeals. This includes provision of research records and evidence under the institution's control, custody, or possession and reasonable access to persons within its authority necessary to develop a complete record of relevant evidence.
===Other Considerations===
===Other Considerations===
==== Respondent Admissions ====
==== Respondent Admissions ====
Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. The Research Integrity Officer must notify ORI in advance if there are plans to close a case at the inquiry, investigation, or appeal stage on the basis that respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except:
Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. For PHS-funded research, the Research Integrity Officer or designee must notify ORI in advance if there are plans to close a research misconduct proceeding at the assessment, inquiry, investigation, or appeal stage on the basis that respondent has admitted to committing research misconduct or a settlement with the respondent has been reached.
:(1) closing of a case at the inquiry stage on the basis that an investigation is not warranted; or
 
:(2) a finding of no misconduct at the investigation stage, which must be reported to ORI, as prescribed in this policy and 42 CFR § 93.315.
* A respondent’s admission must be made in writing and signed by the respondent and specify the falsification, fabrication, and/or plagiarism that occurred and which records were affected. The admission statement must meet all elements required for a finding of research misconduct and must be provided to ORI before the institution closes its research misconduct proceeding. UNMC must also provide a statement to ORI describing how it determined that the scope of misconduct was fully addressed by the admission and confirmed the respondent’s culpability.
:
==== Respondent Resignation/Withdrawal====
==== Respondent Resignation/Withdrawal====
If the respondent terminates UNMC employment, resigns, or withdraws from school (in the case of a student) prior to completion of the inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the proceedings, the investigation committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent’s failure to cooperate and its effect on the committee's review of all the evidence.
If the respondent terminates UNMC employment, resigns, or withdraws from school (in the case of a student) prior to completion of the inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the proceedings, the investigation committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent’s failure to cooperate and its effect on the committee's review of all the evidence. If a finding of research misconduct is made after a respondent terminates, resigns, or withdraws, UNMC will implement such corrective actions as may be applicable and possible given the termination, resignation, or withdrawal including, but not limited to, correcting the research record.
==== Restoration of Respondent's Reputation ====
==== Restoration of Respondent's Reputation ====
If UNMC finds no research misconduct, and the funding agency concurs when required, the Research Integrity Officer will undertake reasonable efforts to restore the respondent's reputation after consulting with the respondent and receiving approval from the Deciding Official. Such actions could include, for example only, notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in any forum in which the allegation of research misconduct was previously publicized, and expunging all reference to the research misconduct allegation from the respondent's personnel file.
If UNMC finds no research misconduct, and the funding agency concurs when required, the Research Integrity Officer will undertake reasonable efforts to restore the respondent's reputation after consulting with the respondent and receiving approval from the Institutional Deciding Official. Such actions could include, for example only, notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in any forum in which the allegation of research misconduct was previously publicized, and expunging all reference to the research misconduct allegation from the respondent's personnel file.
====Allegations Not Made in Good Faith====
====Allegations Not Made in Good Faith====
If relevant, the Deciding Official will determine whether the Complainant’s allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Deciding Official will determine if any administrative action should be taken against the Complainant.
If relevant, the Institutional Deciding Official will determine whether the complainant’s allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Institutional Deciding Official will determine if any administrative action should be taken against the complainant.
====Interim Administrative Actions====
====Interim Administrative Actions====
UNMC officials shall take interim administrative actions, as appropriate, to protect Federal funds and ensure that the purposes of the Federal financial assistance are carried out.
UNMC officials shall take interim administrative actions, as appropriate, to protect Federal funds and ensure that the purposes of the Federal financial assistance are carried out.
===Record Retention===
===Record Retention===
The Research Integrity Officer is delegated responsibility for preparing and maintaining all documentation gathered or generated during an inquiry and investigation. All records shall be maintained in a secure manner for at least seven years after completion of the UNMC case. Federal funding and oversight agencies will be given access to the records upon request.
The Research Integrity Officer or designee is delegated responsibility for preparing and maintaining all documentation gathered or generated during an inquiry and investigation including the institutional record and all sequestered evidence including physical objects (regardless of whether the evidence is part of the institutional record). All records shall be maintained in a secure manner for seven years after completion of the UNMC case or the completion of any federal proceeding involving the research misconduct allegation, whichever is later, unless custody has been transferred to the federal agency or the ORI or other federal agency advises otherwise in writing. If a person involved in a research misconduct proceeding for research that does not involve PHS or other federal funds whose data, documents, physical objects, or other materials were sequestered for purposes of the proceeding requests a return of such data, documents, physical objects, or other materials at the end of the proceeding, the Research Integrity Officer or designee will determine whether there are funding entity record retention requirements and whether substantially equivalent copies can be created and retained such that return is permissible.  Federal funding and oversight agencies will be given access to the records upon request.
 
=== No Appeals ===
The decisions made by UNMC at assessment, inquiry, or investigation regarding an allegation of research misconduct are not subject to appeal by any complainant, respondent, or other individual.
 
==Additional information==
==Additional information==
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]<br />
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]<br />