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Research Integrity: Difference between revisions
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== Definitions == | == Definitions == | ||
'''''Accepted practices of the relevant research community | '''''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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===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 | |||
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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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. | 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 ==== | ====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. | 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=== | ||
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====Investigation Report==== | ====Investigation Report==== | ||
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: | 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); (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; (4) describe composition of the investigation committee, including name(s), position(s), and subject matter expertise; (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 transcripts of all interviews conducted; (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; (8) describe any scientific or forensic analyses conducted; (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. | :(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 or other funding agency support; | |||
:(3) describe the specific allegations of research misconduct considered in the investigation; | |||
:(4) describe composition of the investigation committee, including name(s), position(s), and subject matter expertise; | |||
:(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 transcripts of all interviews conducted; | |||
:(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; | |||
:(8) describe any scientific or forensic analyses conducted; | |||
:(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 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 investigation committee shall consider and address the respondent(s)’ comments on the draft report in connection with finalizing the report. | ||
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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. | 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. | 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. | ||