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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[International | [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]] | [[Electronic Digital Signatures and Records]]<br /> | ||
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Policy No.: '''8003'''<br /> | Policy No.: '''8003'''<br /> | ||
Effective Date: '''02/11/05'''<br /> | Effective Date: '''02/11/05'''<br /> | ||
Revised Date: ''' | Revised Date: '''08/18/21'''<br /> | ||
Reviewed Date:''' | Reviewed Date: '''07/09/24'''<br /> <br /> | ||
<br /> | <big>'''Research Integrity Policy'''</big> | ||
<big>Research Integrity Policy</big> | |||
== Basis for Policy == | == Basis for Policy == | ||
The University of Nebraska Medical Center (UNMC) is committed to maintaining an academic environment based on honesty, integrity and ethical conduct. UNMC promotes an environment of productivity, creativity, and academic freedom, while establishing firm expectations that individuals will not commit research misconduct.<br /> | The University of Nebraska Medical Center (UNMC) is committed to maintaining an academic environment based on honesty, integrity and ethical conduct. UNMC promotes an environment of productivity, creativity, and academic freedom, while establishing firm expectations that individuals will not commit research misconduct.<br /> | ||
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This policy applies to all individuals at UNMC engaged in research, including non-funded projects, projects supported by the Public Health Service (PHS), the National Science Foundation (NSF), other governmental entities and private funding sources. This policy applies to any person paid by, under the control of, or affiliated with UNMC, such as scientists, trainees, technicians, and other staff members, students, fellows, guest researchers and collaborators. | This policy applies to all individuals at UNMC engaged in research, including non-funded projects, projects supported by the Public Health Service (PHS), the National Science Foundation (NSF), other governmental entities and private funding sources. This policy applies to any person paid by, under the control of, or affiliated with UNMC, such as scientists, trainees, technicians, and other staff members, students, fellows, guest researchers and collaborators. | ||
== Applicability == | == Applicability == | ||
This policy applies only to alleged research misconduct that occurred within six years of the date UNMC received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR § 93.105(b). 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 [[https://info.unmc.edu/wiki/index.php/Faculty_Handbook Faculty]], Graduate Student, and [[ | This policy applies only to alleged research misconduct that occurred within six years of the date UNMC received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR § 93.105(b). 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 [[https://info.unmc.edu/wiki/index.php/Faculty_Handbook Faculty]], Graduate Student, and [[http://catalog.unmc.edu/ Student]] Handbooks, as appropriate. | ||
== Definitions == | == Definitions == | ||
'''''Allegation''''' means any disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication.<br /> | '''''Allegation''''' means any disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication.<br /> | ||
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'''''Falsification''''' means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.<br /> | '''''Falsification''''' means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.<br /> | ||
'''''Good faith''''' as applied to a complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have 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 knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping UNMC meet its responsibilities under this part. A committee member does not act in good faith if | '''''Good faith''''' as applied to a complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have 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 knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping UNMC meet its responsibilities under this part. A committee member does not act in good faith if their acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding. | ||
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*UNMC bears the burden of proof for making a finding of research misconduct. The destruction, absence of, or respondent’s failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the respondent’s conduct constitutes a significant departure from accepted practices of the relevant research community. A respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised (such as honest error). | *UNMC bears the burden of proof for making a finding of research misconduct. The destruction, absence of, or respondent’s failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the respondent’s conduct constitutes a significant departure from accepted practices of the relevant research community. A respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised (such as honest error). | ||
===Duty to Report Research Misconduct=== | ===Duty to Report Research Misconduct=== | ||
All individuals subject to this policy, including, without limitation, all employees, students or other individuals associated with UNMC | All individuals subject to this policy, including, without limitation, all employees, students or other individuals associated with UNMC shall report observed, suspected, or apparent research misconduct in accordance with the procedures outlined in this policy. | ||
===Duty to Cooperate with Inquiries and Investigations=== | ===Duty to Cooperate with Inquiries and Investigations=== | ||
All individuals subject to this policy shall cooperate with the Research Integrity Officer and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Institutional members, including respondents, have an obligation to provide all requested evidence and information related to such inquiries or investigations. Cooperation includes, without limitation, maintaining confidentiality and deferring to the process outlined in this policy, which is designed both to hold researchers accountable and to prevent unjust harm to a career as a result of an allegation that does not ultimately result in a finding of research misconduct. | All individuals subject to this policy shall cooperate with the Research Integrity Officer and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Institutional members, including respondents, have an obligation to provide all requested evidence and information related to such inquiries or investigations. Cooperation includes, without limitation, maintaining confidentiality and deferring to the process outlined in this policy, which is designed both to hold researchers accountable and to prevent unjust harm to a career as a result of an allegation that does not ultimately result in a finding of research misconduct. | ||
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The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation. The complainant may be interviewed at the inquiry phase and shall be interviewed at the investigation phase as described below. The role of a complainant is not to act as special prosecutor; once a complainant makes an allegation of research misconduct, the complainant is responsible for providing evidence and information in connection with the response to the allegation but otherwise shall defer to, and cooperate with, UNMC’s review, adjudication and response to research misconduct as provided in this policy. A complainant shall not discuss the allegations of research misconduct outside the process. | The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation. The complainant may be interviewed at the inquiry phase and shall be interviewed at the investigation phase as described below. The role of a complainant is not to act as special prosecutor; once a complainant makes an allegation of research misconduct, the complainant is responsible for providing evidence and information in connection with the response to the allegation but otherwise shall defer to, and cooperate with, UNMC’s review, adjudication and response to research misconduct as provided in this policy. A complainant shall not discuss the allegations of research misconduct outside the process. | ||
===Rights and Responsibilities of Respondent=== | ===Rights and Responsibilities of Respondent=== | ||
The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry and investigation. The respondent shall ordinarily receive the procedural rights and protections set forth in this policy. A respondent may be accompanied by legal counsel of | The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry and investigation. The respondent shall ordinarily receive the procedural rights and protections set forth in this policy. A respondent may be accompanied by legal counsel of their own choosing and at their own expense during an interview conducted under this policy. Legal counsel may advise the respondent, but may not question witnesses or otherwise take part in the proceedings. | ||
===Retaliation Prohibited=== | ===Retaliation Prohibited=== | ||
Retaliation against complainants, witnesses, or committee members in any way is prohibited. Any individual covered by this policy should immediately report any alleged or apparent retaliation against complainants, witnesses or committee members to the Research Integrity Officer. The Research Integrity Officer shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed. | Retaliation against complainants, witnesses, or committee members in any way is prohibited. Any individual covered by this policy should immediately report any alleged or apparent retaliation against complainants, witnesses or committee members to the Research Integrity Officer. The Research Integrity Officer shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed. | ||
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==Procedures== | ==Procedures== | ||
===Reporting Misconduct=== | ===Reporting Misconduct=== | ||
All individuals subject to this policy shall report observed, suspected, or apparent research misconduct to the Research Integrity Officer at 402-559-5130 or to the UNMC Compliance Hotline at 1-844-348-9584 or www.nebraska.ethicspoint.com. If an individual is unsure whether the suspected incident falls within the definition of research misconduct, | All individuals subject to this policy shall report observed, suspected, or apparent research misconduct to the Research Integrity Officer at 402-559-5130 or to the UNMC Compliance Hotline at 1-844-348-9584 or www.nebraska.ethicspoint.com. 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 will refer the individual or allegation to other offices with responsibility for resolving the problem. | ||
===Preliminary Assessment of Allegations=== | ===Preliminary Assessment of Allegations=== | ||
Upon receiving an allegation of research misconduct, the Research Integrity Officer shall assess the allegation as soon as is feasible (usually within 21 days of receipt of the allegation) to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If so, the matter must proceed to an inquiry. | Upon receiving an allegation of research misconduct, the Research Integrity Officer shall assess the allegation as soon as is feasible (usually within 21 days of receipt of the allegation) to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If so, the matter must proceed to an inquiry. | ||
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:(2) the allegation may have substance, based on the committee’s review during the inquiry. | :(2) the allegation may have substance, based on the committee’s review during the inquiry. | ||
====Inquiry Committee==== | ====Inquiry Committee==== | ||
The Research Integrity Officer, in consultation with other UNMC officials as appropriate, will appoint an inquiry committee and committee chair within | 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. | 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. | ||
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:(5) the basis for recommending or not recommending that the allegations warrant an investigation; and | :(5) the basis for recommending or not recommending that the allegations warrant an investigation; and | ||
:(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 /> | :(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 /> | ||
If the respondent chooses to comment on the report, | 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. | ||
====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 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. | ||
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:b) was an isolated event or part of a pattern; and | :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. | :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 | 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)=== | ===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: | 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: | ||
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==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 /> | ||
*Contact the [mailto: | *Contact the [mailto:jmeza@unmc.edu Research Integrity Officer]<br /> | ||
This page maintained by [mailto: | This page maintained by [mailto:mhurlocker@unmc.edu mh]. |