Research Integrity

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POLICY NO : 8003
EFFECTIVE DATE: 02/11/05
REVISED DATE:
REVIEWED DATE:

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 knowingly, intentionally or recklessly commit misconduct.

UNMC is responsible for the inquiry, investigation and adjudication of alleged research misconduct. As a recipient of federal research funds, UNMC must comply with federal policies and regulations on responding to allegations of research misconduct including:

• "Federal Policy on Research Misconduct", Executive Office of the President, 65 FR No. 235, December 6, 2000, Office of Science and Technology Policy
• "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science", 42 CFR Part 50, Subpart A, Public Health Service regulations
• "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 misconduct involving research. Non-research related misconduct that involves fraud, plagiarism, fabrication or other types of misconduct shall be addressed through procedures outlined in the UNMC Faculty, Graduate Student, and Student handbooks.

Definitions

Allegation means any written or oral statement or other indication of possible research misconduct made to an institutional official.

Complainant is the person who makes an allegation of research misconduct.

Conflict of Interest means the real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.

Deciding Official is the UNMC official that issues final determinations on allegations of research misconduct and any related responsive institutional actions. The Deciding Official will not be the same person as the Research Integrity Officer and should have no direct prior involvement in the inquiry or investigation of scientific misconduct allegations. The UNMC Deciding Official is the Vice Chancellor for Academic Affairs.

Fabrication means making up research 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 Allegation means an allegation made with an honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation.

Inquiry means gathering information and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation. Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred, and if so, to determine the responsible person and the seriousness of the misconduct.

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 research ideas, processes, results or words without giving appropriate credit.

Research means all basic, applied and demonstration research in any field of science, engineering and mathematics. This includes, but is not limited to, research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human or animal subjects.

Research Integrity Officer means the institutional official responsible for assessing allegations of scientific misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations.

Research Record means any data, document, computer file, computer diskette, or 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. A research record includes, but is not limited to, research proposals, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; abstracts, theses, dissertations, oral presentations, internal reports, journal articles, manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

Respondent means the person against whom an allegation of scientific misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.

Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has in good faith, made an allegation of research misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation.

Research Misconduct or Misconduct in Science means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, performing or reviewing research, or in reporting research results. It does not include honest error or honest differences in interpretations or judgments of data.

Whistleblower means a person who makes an allegation of research misconduct.

Responsibility for Implementation

The 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 Vice Chancellor for Academic Affairs delegates responsibility for responding to allegations of research misconduct to the Research Integrity Officer, who shall be responsible for carrying out inquiries and investigations that thoroughly evaluate the facts while protecting the rights of the parties involved in the alleged misconduct.

Procedures

1. Reporting Misconduct
   • Initial Report. All employees, students or other individuals associated with UNMC should report observed, suspected, or apparent research misconduct to the Research Integrity Officer at 559-6767 or to the UNMC Compliance Hotline at 1-866-568-5430.

If an individual is unsure whether the suspected incident falls within the definition of research misconduct, s/he may call the Research Integrity Officer to discuss the suspected misconduct informally. Such discussions shall 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.

1. • Protecting the Whistleblower/Complainant. UNMC representatives who receive or learn of an allegation of research misconduct will treat the whistleblower or complainant with fairness and respect. UNMC will protect the privacy of those who report misconduct in good faith to the maximum extent possible. If the whistleblower/complainant requests anonymity, UNMC will make an effort to honor the request during the allegation assessment or inquiry to the extent permitted by policies and regulations. If the matter is referred to an investigation committee, and the whistleblower's testimony is required, s/he will be notified that anonymity may no longer be guaranteed. UNMC will also take reasonable steps to protect the position and reputation of the individual who reports, and other individuals who cooperate with the inquiry and any subsequent investigation, against retaliation. UNMC employees will immediately report any alleged or apparent retaliation to the Research Integrity Officer.
   • Protecting the Respondent. UNMC representatives who receive or learn of an allegation of research misconduct will treat the respondent with fairness and respect. The respondent's identity and circumstances of the investigation shall remain confidential to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.
   • Cooperation with Inquiries and Investigations. UNMC employees and students will cooperate in the review of allegations and the conduct of inquiries and investigations, and have an obligation to provide relevant evidence to the Research Integrity Officer or other institutional officials on misconduct allegations.
   • Preliminary Assessment of Allegations. Upon receiving an allegation of research misconduct, the Research Integrity Officer will immediately assess the allegation to determine whether there is sufficient evidence to warrant an inquiry, whether PHS or NSF funds are involved, and whether the allegation falls under the definition of research misconduct.
   • Sequestration of Research Records. After determining that an allegation falls within the definition of research misconduct, the Research Integrity Officer must ensure that all original research records and materials relevant to the allegation are immediately secured. The Research Integrity Officer may consult with UNMC legal counsel and/or ORI for advice and assistance in this regard.
2. Inquiry Process

• • Initiation and Purpose of the Inquiry. Following the preliminary assessment, if the Research Integrity Officer determines that the allegation constitutes suspected research misconduct, s/he will initiate the inquiry process. The respondent will be notified within five (5) business days after the inquiry has begun. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible.
  • 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 of initiation of the inquiry. The inquiry committee should consist of individuals who do not have real or apparent conflicts of interest in 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 the appointed member of the inquiry committee based on bias or conflict of interest within five (5) business days, the Research Integrity Officer will determine whether to replace the challenged member with a qualified substitute.

The inquiry committee will normally interview the whistleblower, the respondent, and key witnesses as well as examine relevant research records and materials. The respondent may be accompanied by legal counsel of his or her own choosing during an interview. Legal counsel may advise the respondent, but may not question witnesses or otherwise take part in the proceedings. The inquiry committee will evaluate the evidence and testimony obtained during the inquiry. The committee will decide whether there is sufficient evidence of possible research misconduct to recommend further investigation. The scope of the inquiry does not include deciding whether misconduct occurred or conducting exhaustive interviews and analysis.

• • Written Report. The Research Integrity Officer or designee shall prepare a written report stating what evidence was reviewed, summarizing relevant interviews, and including any conclusions reached as a result of the inquiry. The respondent shall be given a copy of the inquiry report. The whistleblower (if s/he is identifiable) shall be given portions of the draft inquiry report that address the whistleblower's role and opinions of the investigation for comment. If the respondent and/or whistleblower choose to comment on the report, s/he 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 provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed when the Deciding Official makes this determination, which will be made within 60 days of the first meeting of the inquiry committee. Any extension of this period will be based on good cause and recorded in the inquiry file.
  • Notification of Decision. The Research Integrity Officer will notify both the respondent and the whistleblower, and all 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.

1. Investigation

• • Purpose. The purpose of the investigation is to examine the allegations and evidence in detail and determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations.
  • Appointment of 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 of the notification to the respondent that an investigation is planned or as soon thereafter as practicable. The investigation committee should 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.
  • Investigation Committee Proceedings. The Research Integrity Officer will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, defines research misconduct, and identifies the name of the respondent. The charge will state that the committee is to evaluate the evidence and testimony of the respondent, whistleblower, 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 to develop a specific investigation plan, including the necessity for maintaining confidentiality.

The investigation committee may interview individuals to gather facts. Interviews should be tape recorded, transcribed, and summarized. Summaries or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory files. The respondent may be accompanied by legal counsel of his or her own choosing during an interview. Legal counsel may advise the respondent, but may not question witnesses or otherwise take part in the proceedings.

• • Investigation Report. Upon completion of the investigation, the Research Integrity Officer or designee shall prepare a written report describing the policies and procedures under which the investigation was conducted, how and from whom information relevant to the investigation was obtained, the findings, and the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct as well as a description of any sanctions imposed and administrative actions taken by UNMC.
    • Respondent's Comments. The Research Integrity Officer will provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent will be given ten (10) business days to review and comment on the draft report. The respondent's comments will be attached to the final report.
    • Whistleblower's Comments. The Research Integrity Officer will provide the whistleblower, if s/he is identifiable, with those portions of the draft investigation report that address the whistleblower's role and opinions in the investigation. The whistleblower will be given ten (10) business days to review and comment on the report. The report may be modified based on the whistleblower's comments.
    • Legal Counsel. The draft investigation report will be transmitted to the University of Nebraska Office of the General Counsel for a review of its legal sufficiency.
    • Confidentiality. The Research Integrity Officer will inform each recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality, such as requesting that the recipient sign a confidentiality statement, or coming to his/her office to review the report.
  • Deciding Official's Review and Final Determination. 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 will explain in detail the basis for rendering a different decision in a transmittal letter accompanying the final report to the Federal funding agency (including ORI).

1. 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.

In the case of civil or criminal fraud violations, the Deciding Official shall ensure that the matter is promptly reported to the Department of Justice, the Inspector General for the funding agency, or other appropriate body.

1. Reporting to the Funding Agency (including ORI)

The Research Integrity Officer will notify the funding agency (or agencies in some cases), including the ORI Director if applicable, in writing of the following events:

• • 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 inquiry or investigation for any reason without completing all regulatory requirements;
  • Request for extension in the event that UNMC will not be able to complete the investigation within 120 days;
  • Notification at any stage of the inquiry or investigation if:
    • there is an immediate health hazard involved;
    • there is an immediate need to protect Federal funds or equipment;
    • there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any;
    • it is probable that the alleged incident is going to be reported publicly;
    • the allegation involves a public health sensitive issue, e.g., a clinical trial; or
    • there is a reasonable indication of possible criminal violation. In this case, the funding agency, including ORI, must be informed within 24 hours of UNMC obtaining that information.

1. Other Considerations

• • 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 misconduct, and the funding agency concurs, 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.
  • Allegations Not Made in Good Faith. If relevant, the Deciding Official will determine whether the whistleblower'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 whistleblower.
  • 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.

1. 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.
For additional information, please contact the Compliance Officer.

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