Research Misconduct Policy at University: Reporting, Investigation, and Sanctions, Schemes and Mind Maps of Public Health

Download Research Misconduct Policy at University: Reporting, Investigation, and Sanctions and more Schemes and Mind Maps Public Health in PDF only on Docsity! Page 1 of 19 Research Misconduct # 2370.070 INITIAL EFFECTIVE DATE: January 27, 2006 LAST REVISION DATE: November 24, 2020 RESPONSIBLE UNIVERSITY DIVISION/DEPARTMENT Office of Research and Economic Development POLICY STATEMENT It is the policy of the University that all persons involved in University research, including without limitation, University faculty, staff, and students and non-University personnel collaborating on University research, maintain high ethical standards in the conduct and reporting of their research. Allegations of research misconduct are to be reported to, and shall be investigated and, if the allegations are substantiated, sanctioned by, the University as set forth in this policy. This policy applies to students and all individuals who are employed by or are agents of, the University, or who are affiliated with the University by contract or agreement and who are engaged in any University research project whether or not the research is supported by external funding. SCOPE All persons involved in University research. REASON FOR POLICY The University bears the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of alleged research misconduct. The University must take action necessary to ensure the integrity of research, the rights and interests of research subjects and the public, the protection of sponsor funds from misuse by ensuring the integrity of the research work, the observance of legal requirements or responsibilities and to provide appropriate safeguards for subjects of allegations, as well as complainants. This policy sets forth procedures for addressing allegations of research misconduct in compliance with applicable laws and regulations and in a manner which is thorough, competent, objective and fair. This policy seeks to: a) Foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, Page 2 of 19 discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct; b) Set forth reasonable and practical steps to protect the positions and reputations of good faith complainants, witnesses and committee members and protect them from retaliation by respondents and other University members; c) Provide confidentiality to the extent required by applicable laws and regulations to all respondents, complainants, and research subjects identifiable from Research Records or evidence; d) Take reasonable and practical steps to ensure the cooperation of respondents and other University members with research misconduct proceedings, including, but not limited to, their providing information, Research Records, and evidence; e) Set forth the manner in which the University will cooperate with federal agencies during any research misconduct proceeding or compliance review; f) Assist in administering and enforcing any federal agency administrative actions imposed on the University. DEFINITIONS TERM DEFINITIONS Allegation A disclosure of possible research misconduct through any means of communication. The disclosure may be by written or verbal statement or other communication. Complainant A person who in good faith makes an allegation of research misconduct. Conflict of Interest When a person’s professional judgment or adherence to widely recognized professional norms may be, or may appear to be, compromised by the person’s or a Related Person’s interests, commitments, obligations or loyalties outside the University. A conflict of interest may exist by virtue of financial or other personal considerations that have the potential to compromise or bias professional judgment and objectivity. Conflict of interest includes, but is not limited to, the provisions of federal regulations which provide that a conflict of interest exists if an individual has a significant financial interest that could affect the design, conduct or reporting of the research or educational activities funded or proposed for funding. Days Refers to business days unless otherwise stated. Evidence Any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact. Fabrication Making up data or results and recording or reporting them. Page 5 of 19 2. income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities; 3. income from service on advisory committees or review panels for public or nonprofit entities; 4. an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or 5. salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $5,000 during the twelve-month period. University Florida International University VPR Vice President for Research ROLES AND RESPONSIBILITIES The University community is responsible for following the requirements of this policy and the associated procedures. RELATED RESOURCES 42 CFR Part 93 Public Health Service, “Public health service policies on research misconduct.” 45 CFR Part 689 National Science Foundation, “Research Misconduct.” Office of Research Integrity, Office of Science and Technology Policy responses to questions regarding the Federal Research Misconduct policy found at https://ori.hhs.gov/federal- research-misconduct-policy, which includes the following: “Section II: Findings of Research Misconduct Issue: Several comments stressed the need for greater precision in the phrase “significant departure from accepted practices of the scientific community.” Response: This phrase is intended to make it clear that behavior alleged to involve research misconduct should be assessed in the context of community practices, meaning practices that Page 6 of 19 are generally understood by the community but that may not be in a written form. For clarification purposes and in order to be more comprehensive, the term “scientific community” has been modified to read “relevant research community.”' The policy is not intended to ratify those “accepted practices” but rather to indicate that these may vary among different communities. Office of Economic Development and Commercialization policy #2370.005 – Conflict of Interest in Research University-Wide Governance and Guidance policy #140.110 – Fraud Prevention and Mitigation Policy CONTACTS Office of Research Integrity Modesto A. Maidique Campus, MARC 430 11200 S.W. Eighth Street Miami, Florida 33199 Telephone: (305) 348-2494 HISTORY Initial Effective Date: January 27, 2006 Review Dates (review performed, no updates): N/A Revision Dates (updates made to document): June 10, 2011, June 15, 2018, June 17, 2019, November 24, 2020 Page 7 of 19 Research Misconduct # 2370.070a INITIAL EFFECTIVE DATE: January 27, 2006 LAST REVISION DATE: November 24, 2020 RESPONSIBLE UNIVERSITY DIVISION/DEPARTMENT Office of Research and Economic Development PROCEDURE STATEMENT I. Research Misconduct Finding A finding of research misconduct requires that with respect to the research misconduct alleged (i.e., the fabrication, falsification or plagiarism): a) there is a significant departure from accepted practices of the relevant research community (i.e., the behavior is to be viewed in the context of community research practices); b) the misconduct be committed intentionally, knowingly, or recklessly; and c) the allegation be proven by a preponderance of the evidence. Any allegation of misconduct must be resolved promptly and equitably using procedures that safeguard the rights of all administrators, faculty, staff, and students and other concerned parties. The University has the responsibility of conducting all inquiry and investigations in a manner that will ensure fair treatment and confidentiality of the Respondent, the Complainant and others involved in the process. Findings pursuant to this policy must be made using the following evidentiary standards: a) Standard of proof. The University finding of research misconduct must be proved by a preponderance of the evidence. b) Burden of proof. The University has 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 University 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. c) The Respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses he/she raises. In determining whether the University has carried the burden of proof imposed by this part, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the Respondent. Page 10 of 19 Within 10 days of the appointment of the inquiry committee, the VPR will notify the Respondent in writing of the proposed membership of the inquiry committee. If the Respondent objects to the proposed membership, the Respondent must submit a written objection to the VPR within 5 days of the date of the VPR’s notice to the Respondent of the composition of the committee. The VPR will then determine whether to replace the challenged member(s) of the inquiry committee. If the inquiry subsequently identifies additional respondents, the VPR shall notify them and provide the same notifications and rights to the additional respondents as to the original Respondent described above. D. Inquiry Committee First Meeting The VPR shall convene the first meeting of the inquiry committee no later than fifteen (15) days from the appointment of the inquiry committee. At the inquiry committee's first meeting, the VPR will give a copy to the inquiry committee of the formal written allegation given to the Provost. The VPR will review with the inquiry committee the allegations and the appropriate procedures as stated in this policy, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee for conducting the inquiry. E. Inquiry Process and Draft Inquiry Report The inquiry committee will interview the Respondent, Complainant (if the Complainant’s identity is known), and key witnesses and prepare a summary of those interviews. They will examine relevant Research Records and evaluate the evidence and testimony obtained during the inquiry. The inquiry committee will then consult with the VPR and other University officials to determine whether there is sufficient evidence of misconduct to recommend further investigation. The inquiry committee shall prepare a draft inquiry report in the format of the final inquiry report described below and provide a copy of that draft report to the Respondent and the Complainant for comment. The Complainant and Respondent shall have 10 days from the receipt of the draft report to respond to the inquiry committee with any comments on the draft inquiry report. F. Final Inquiry Report The inquiry committee shall prepare the final inquiry report which shall include: a) The name and position of the Respondent; b) A description of the allegations of research misconduct; c) Information regarding externally sponsored research project, including, for example, grant numbers, grant applications, contracts, and publications; d) The basis for recommending or not recommending that the alleged actions warrant an investigation. An investigation is warranted if there is--(1) A reasonable basis for concluding that the allegation falls within the definition of research misconduct Page 11 of 19 under this policy; and (2) Preliminary information-gathering and preliminary fact- finding from the inquiry indicates that the allegation may have substance. e) Comments received from the Respondent and/or the Complainant in response to the draft report. If no comments were received, a statement that a copy of the draft inquiry report was provided to the Respondent and the Complainant and that either or both did not provide any comments to the inquiry committee in response to that draft report. f) Sufficient detail to permit a later assessment of the determination of whether or not a full investigation is warranted. g) A description of the information reviewed. h) A list of the interviews conducted. i) Statements of conclusions reached and the findings and facts supporting them. j) A recommendation to the VPR whether an investigation is warranted. G. Notice of Results of the Inquiry The VPR shall notify the Respondent whether the inquiry found that an investigation is warranted. The notice shall include a copy of the final inquiry report and include a copy of or refer to this part and the policy. H. Time Limit for the Inquiry The VPR will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed once the VPR makes this determination. The inquiry must be completed within 60 calendar days of the initiation of the inquiry, which shall be deemed to be the date of the first meeting of the inquiry committee, unless circumstances clearly warrant a longer period. If the inquiry requires longer than 60 calendar days to complete, the inquiry record must include documentation of the reasons for exceeding the 60 calendar day period. IV. The Investigation A. Purpose of Investigation The purpose of an investigation is to examine in-depth the evidence presented and determine whether research misconduct has occurred, by whom, and to what extent and the consequences to be imposed for such misconduct. The investigation shall be commenced within 30 calendar days after the VPR determines that an investigation is warranted after the inquiry. B. Appointment of Investigation Committee Page 12 of 19 The Investigation Committee, appointed by the VPR, should be constituted within 10 days after the Respondent has been notified that an investigation is planned. The committee should consist of at least 3 individuals, who have sufficient expertise to evaluate the evidence related to the allegations. The University may use the services of a consortium or person(s) that the University reasonably determines to be qualified by practice and experience to conduct the research misconduct investigation. A consortium or person acting on behalf of the University must follow the requirements of this policy in conducting the research misconduct proceedings. C. Notice to Respondent of Commencement of Investigation The VPR shall notify the Respondent in writing of the allegations within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins. The VPR should notify the Respondent of the proposed committee within 5 days of appointing the Investigation Committee. If the Respondent objects to any of the proposed committee members; the Respondent must submit a written objection to the VPR within 5 days, who will determine whether to replace the challenged member. The VPR shall give the Respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of investigation. D. Investigation Committee First Meeting The VPR shall convene the first meeting of the Investigation Committee no later than 30 calendar days after completion of the inquiry. At the first meeting, the VPR shall provide the Investigation Committee with the allegation of research misconduct and a copy of the final inquiry report. The VPR will review with the committee the appropriate procedures as stated in this policy, assist the committee with organizing plans for the investigation and answer any questions raised by the committee for conducting the investigation. E. Investigation Process and Draft Investigation Report The investigation process includes examination of all documents, including but not necessarily limited to, Research Records, computer files, proposals, manuscripts, publications, correspondence, memoranda and notes of telephone calls. The Investigation Committee shall interview each Respondent, Complainant (if the Complainant’s identity is known),, 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 if the allegation relates to a PHS-funded project, or as required by law, or if deemed necessary by the University, 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 pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances Page 15 of 19 If an allegation of research misconduct relates to a sponsored research project, the VPR shall provide notifications to the sponsoring agency as required by the sponsor’s regulations, guidelines and/or the sponsor award document for the project. (a) PHS Funded Projects Research allegations related to any sponsored project that has support from the Public Health Service (PHS) require that the University inform the PHS Office of Research Integrity (ORI) as follows: (i) Within thirty (30) calendar days of finding that an investigation is warranted, and no later than on the date the investigation begins, the VPR must notify the ORI Director of the decision to begin an investigation and provide the inquiry report as noted below. (ii) Provide ORI with the written finding and a copy of the inquiry report which includes the information: a. The name and position of the Respondent; b. A description of the allegations of research misconduct; c. The PHS support, including for example, grant numbers, grant applications, contracts, and publications listing PHS support; d. The basis for recommending that the alleged actions warrant an investigation; and e. Any comments on the report, by the Respondent or the Complainant. (iii) The University must notify ORI in advance if the University plans to close a case at the inquiry or investigation stage on the basis that the Respondent has admitted guilt, a settlement with the Respondent has been reached or for any other reasons, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of no misconduct at the investigation stage, which must be reported to ORI per subsection V.(B)(a)(iv) below. (iv) The University provide to ORI the following: a. Investigation report, including all attachments; b. Final University action, stating whether the University found research misconduct and if so, who committed the misconduct. c. Findings, stating whether the University accepts the investigation’s findings; d. Institutional administrative actions, describing any pending or completed administrative actions against the Respondent. (v) The University must provide the following information to ORI on request: Page 16 of 19 a. The University policies and procedures under which the inquiry was conducted; b. The research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and c. The charges for the investigation to consider. (vi) At any time during a research misconduct proceeding, the University must notify ORI immediately if it has reason to believe that any of the following conditions exist, including any facts that may be relevant to protect public health, Federal funds and equipment, and the integrity of the PHS supported research process: a. Health and safety of the public is at risk, including an immediate need to protect human or animal subjects; b. Resources or interests of the U.S. Department of Health and Human Service (HHS) are threatened; c. Research activities should be suspended; d. There is reasonable indication of possible violations of civil or criminal law; e. Federal action is required to protect the interests of those involved in the research misconduct proceeding; f. The University believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved; g. The research community or public should be informed. The University shall also notify the National Institutes of Health (NIH) at any time during the research misconduct proceeding as required by applicable NIH policy or regulations. (b) NSF Funded Projects Research allegations related to any sponsored project that has support from the National Science Foundation (NSF) require that the University inform the NSF Office of Inspector General (OIG) as follows: (i) If the completion of the inquiry is delayed beyond 90 calendar days, but the University wishes NSF to defer the research misconduct inquiry or investigation to the University, NSF may require submission of period status reports; (ii) Immediately if an initial inquiry supports an investigation; (iii) Keep NSF informed during the investigation; (iv) If the completion of the investigation is delayed beyond 180 calendar days, but the University wishes NSF to defer the research misconduct investigation to the University, NSF may require submission of period status reports; (v) Provide OIG with the final report from the investigation; Page 17 of 19 (vi) Promptly notify the OIG if the University becomes aware during the inquiry or investigation that: a. Public health or safety is at risk; b. NSF’s resources, reputation, or other interests need protecting; c. There is reasonable indication of possible violations of civil or criminal law; d. Research activities should be suspended; e. Federal action may be needed to protect the interests of a subject of the investigation or of others potentially affected; or f. The scientific community or the public should be informed. VI. Confidentiality Disclosure of the identity of Respondents and Complainants in research misconduct proceedings and of any records or evidence related thereto shall be limited, to the extent possible, to those who need to know, consistent with a thorough, competent, objective and fair research misconduct proceeding, and as allowed by law. Although reasonable efforts to maintain confidentiality will be made, anonymity cannot be guaranteed. As pertains to public records requests under Florida law, while an investigation into research misconduct is ongoing, records regarding the investigation, whether at the allegation, inquiry or investigation stage, are exempt from disclosure as public records. However, once the investigation is concluded, the records are public and generally would be subject to disclosure pursuant to a Florida public records request unless the records requested are otherwise exempt from disclosure pursuant to Florida law. VII. Other Considerations • Termination of Institutional Employment or Resignation Prior to Completing Inquiry or Investigation: In accordance with federal regulations, termination of the Respondent's University employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the misconduct procedures. • Restoration of Reputation: The University shall undertake reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct but against whom no finding of research misconduct is made, and of any Complainant, witness, or committee member and to counter potential or actual retaliation against these Complainants, witnesses, and committee members. Accordingly, if misconduct is not found, the VPR must consult with the Respondent, Complainant, witness or committee member, as applicable, and find alternatives to restore the affected person’s reputation. Any University actions to restore the person’s reputation must be done in consultation with the Provost and shall be determined by the Provost in consultation with the VPR. • University Employees not Acting in Good Faith, Including Allegations Not Made in Good Faith: Any University employee engaging in research misconduct proceedings in a