Research Integrity

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.

UNMC is responsible for the inquiry, investigation and adjudication of alleged research misconduct, and, in appropriate cases, taking corrective action. As a recipient of federal research funds, UNMC must comply with federal policies and regulations on responding to allegations of research misconduct including, without limitation:

“Public Health Service Policies on Research Misconduct”, 42 CFR Part 93, Subpart A, Public Health Service regulations
"Federal Policy on Research Misconduct", Executive Office of the President, 65 Fed. Reg. No. 235, December 6, 2000, Office of Science and Technology Policy
"Research Misconduct", 45 CFR Part. 689, National Science Foundation regulations

Scope

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

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 [Faculty], Graduate Student, and [Student] Handbooks, as appropriate.

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.

Complainant is the person(s) who make(s) an allegation of research misconduct.

Conflict of Interest means an unresolved personal, professional, or financial conflict of interest involving the complainant or respondent or in the underlying research.

Deciding Official is the UNMC official who makes final determinations on allegations of research misconduct and any institutional administrative actions. The Deciding Official will not be the same individual as the Research Integrity Officer and should have no direct prior involvement in the institution’s inquiry, investigation, or allegation assessment. The Deciding Official’s appointment of an individual to assess allegations of research misconduct, or to serve on an inquiry or investigation committee, is not considered to be direct prior involvement. The UNMC Deciding Official is ordinarily the Senior Vice Chancellor for Academic Affairs.

Fabrication means making up data or results and recording or reporting them.

Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Good faith 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.

Inquiry means preliminary information-gathering and preliminary fact-finding in accordance with applicable law to determine whether an allegation of research misconduct warrants investigation.

Investigation means the formal development of a factual record and the examination of that record leading to a decision to recommend or not a finding of research misconduct and may include a recommendation for other appropriate actions, including administrative action.

ORI means the Office of Research Integrity in the U.S. Department of Health and Human Services (DHHS). ORI is responsible for the scientific misconduct and research integrity activities of the U.S. Public Health Service (PHS).

Plagiarism means the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

Research means a systematic experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) relating broadly to establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanism relating to matters to be studied.

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 Misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.

Research Record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals (funded or unfunded), laboratory records (both physical and electronic), progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to an outside funder or an institutional official by a respondent in the course of the research misconduct proceeding. A research record includes, but is not limited to, any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct.

Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding. There can be more than one respondent in any inquiry or investigation.

Retaliation means any adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to—(a) a good faith allegation of research misconduct; or (b) good faith cooperation with a research misconduct proceeding.

Responsibility for Implementation

The Senior Vice Chancellor for Academic Affairs is responsible for assuring compliance with federal, state, and university policies and procedures governing the responsible and ethical conduct of research. The Senior Vice Chancellor for Academic Affairs delegates responsibility for responding to allegations of research misconduct to the Research Integrity Officer, who shall be responsible for ensuring that inquiries and investigations thoroughly evaluate the facts while protecting the rights of the parties involved in the alleged misconduct.

General Policies

Research Misconduct Prohibited; Standard of Proof

UNMC prohibits research misconduct. Individuals subject to this policy found to have committed research misconduct shall be subject to sanctions up to and including termination.
A finding of research misconduct requires that:

(a) there be a significant departure from accepted practices of the relevant research community; and

(b) the respondent committed the research misconduct intentionally, knowingly, or recklessly; and

(c) the allegation be proven by preponderance of the evidence.

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

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

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.

Duty to Maintain Confidentiality

Allegations of research misconduct (even when ultimately disproven) can have serious career consequences for a researcher. Therefore, to the maximum extent permitted by applicable law, all individuals subject to this policy shall maintain the strict confidentiality of any information relating to allegations of research misconduct or a research misconduct proceeding and shall disclose such information only to those with a legitimate need to know. The Research Integrity Officer shall limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding, and, except as otherwise prescribed by law, limit the disclosure of records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding. The Research Integrity Officer may use written confidentiality agreements or other mechanisms to implement this section. Inappropriate dissemination of information can result in sanctions up to and including termination.

Rights and Responsibilities of Complainant

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

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 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.

Research Integrity Officer Responsibilities

The Research integrity Officer shall serve as the primary point of contact for implementation of this policy and shall perform the functions set forth below.

Procedures

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, 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

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.

Sequestration of Research Records

On or before the date the respondent is notified of any allegation of research misconduct or the inquiry begins, the Research Integrity Officer must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding. This will include the inventory of records and evidence and sequestration of them in a secure manner. Where the research records or evidence encompasses scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence of such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.
The Research Integrity Officer shall sequester any additional research records that become pertinent to an inquiry or investigation after the initial sequestration.
The Research Integrity Officer may consult with UNMC legal counsel and/or ORI for advice and assistance in this regard. Where appropriate, UNMC shall give the respondent copies of, or reasonable supervised access to the research records. Where the allegation is determined to be sufficiently credible and specific from the assessment the matter must proceed to an inquiry.

Inquiry

Initiation of the Inquiry

At the time of or before beginning an inquiry, the Research Integrity Officer 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.

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:

(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.

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.

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

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.

Written Report

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;

(3) the PHS or other governmental or third-party support;

(4) the evidence that was reviewed;

(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.

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

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.

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.

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.

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:

(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.

Purpose 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

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.

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 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 determine whether and to what extent research misconduct occurred.

Investigation Report

Upon completion of the investigation, a written report 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 support;

(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;

(5) identify and analyze the key research records reviewed;

(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).

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.
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

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.

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.

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.

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:

a) was intentional, knowing or reckless;

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.

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:

Decision to initiate a research misconduct investigation on or before the date the investigation begins;
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;
Request for extension in the event that UNMC will not be able to complete the investigation within 120 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;
There is an immediate need to protect Federal funds or equipment or interests;
Research activities should be suspended;
Federal action is required to protect the interests of those involved in the research misconduct proceeding;
It appears the research misconduct proceeding may be made public prematurely;
The research community or public should be informed; or
There is a reasonable indication of possible civil or criminal violation.

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

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:

(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.

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.

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.

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.

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.

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.

Additional information

Contact the Chief Compliance Officer
Contact the Research Integrity Officer

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