Policies and Procedures on Ethical Practices in Research

1. Introduction

The Icahn School of Medicine at Mount Sinai (the “School”) hereby affirms its commitment to the highest ethical standards in the conduct of scientific research, the promotion of original research of high quality, and the importance of academic freedom. It also acknowledges that unethical conduct in research is extremely serious and threatens these principles. As the primary steward of academic activities within the Mount Sinai Health System (the “Health System”), the School is responsible for the oversight and adjudication of allegations of Research Misconduct.[1] The School is committed to preventing unethical conduct in research from occurring and, should it occur, to dealing with it swiftly, fairly and thoroughly.

The School expects every person involved in research (“Researcher”)[2] to do his or her part to maintain and further standards of ethical practices in research. As part of the commitment to intellectual honesty and integrity, each Researcher within the Health System is responsible for promoting an environment that emphasizes open publication and discussion, high quality research, appropriate supervision, accurate and complete research records and appropriate attribution of credit and responsibility. Faculty must ensure that everyone involved in their research adheres to federal and institutional policies governing the conduct of research. Further, if Researchers observe Unethical Practices in Research, it is their obligation to report this information to the Research Integrity Officer (“RIO”) as provided for below.

The identity of individuals who bring concerns of Unethical Practices in Research to the RIO, i.e., Complainants, will be protected to the extent consistent with the needs of an inquiry or investigation. Anonymous reporting is available through the School’s Reporting Hotline, 24 hours per day, seven days per week at: 1.800.853.9212. Complainants who provide information in good faith about questionable conduct will be protected against reprisals.

The policy provides a framework to ensure that Unethical Practices in Research are reviewed and corrected as appropriate. It is further intended to satisfy the requirements of the Public Health Service (PHS), Office of Research Integrity (ORI)[3] for allegations of Research Misconduct as that term is specifically defined.

2. Definitions

1. 1. Research for purposes of this policy, “research” is defined as anything that is or purports to be "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." (45 CFR § 690.102(d))
      
      
   2. Researcher, for purposes of this policy, is defined as anyone who participates in research under the auspices of the School of Medicine, regardless of position. This includes faculty members, regardless of employment or worksite, staff members, employees, students, trainees, guests and/or volunteers.
      
      
   3. Research Misconduct is based on the ORI definition and encompasses: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and/or recording or reporting them. Falsification is 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. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Research Misconduct does not include honest error or differences of opinion.
      
      
   4. Unethical Practices in Research as it is used in these guidelines, refers to the intentional, knowing or reckless disregard for ethical practices in the conduct of research. The definition is broader than the definition of Research Misconduct used by the PHS/ORI and encompasses, but is not limited to: Activities that compromise the integrity of the research results such as fabrication (see Sec. B.2 above), falsification (see Sec. B.2); plagiarism (see Sec. B.2); failure to comply with these guidelines for handling misconduct in research; a material violation of the School of Medicine's policies concerning human or animal research; or other practices that are a material violation of those that are commonly accepted within the scientific community for proposing, conducting or reporting research. The guidelines apply to all research conducted under the auspices of the School of Medicine and to any Researcher who participates in such research, regardless of position.
      
      Unethical Practices in Research as used in these guidelines does not encompass disagreements between authors and/or collaborators, i.e., authorship disputes, regarding manuscript submission, e.g. relative contributions of involved parties and order of authorship. The School’s Authorship and Data Retention policies provide relevant information. Authorship disputes should be resolved at the department level unless the case involves Unethical Practices in Research, as defined in this policy.
      
      
   5. Deciding Official (D.O.) means the institutional official who makes final determinations on allegations of Research Misconduct and any institutional administrative actions. The Dean of the Icahn School of Medicine at Mount Sinai, and/or his/her designee will serve as the Deciding Official.
      
      
   6. Research Integrity Officer (RIO) is responsible for receipt of allegations of Research Misconduct and then: (1) conducting an Assessment of the allegations; (2) overseeing inquiries and investigations; and (3) the other responsibilities described in this policy.
      
      
   7. Research Integrity Committee (RIC) is responsible for review of the Assessment of allegations of Unethical Practices in Research to determine if they fall within the definition of Research Misconduct and/or are covered by 42 CFR Part 93, and/or warrant further action by existing institutional committees. The RIC, in coordination with the RIO, may engage one of the three methods of review as detailed in this policy.
      
      
   8. Good Faith Allegation is an allegation made with the honest belief that Research Misconduct may have occurred. Individuals reporting in Good Faith will be provided with all institutional protections as appropriate. 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.
      
      
   9. Bad Faith Allegation is an allegation based upon false or fabricated information, retaliatory motives, and/or reckless disregard for the truth. Individuals bringing Bad Faith allegations may be subject to institutional disciplinary actions up to and including termination.
      
      
   10. Retaliation encompasses actions taken to suppress reporting under these policies or any actions toward individuals or the institution as a result of reporting concerns of Research Misconduct or other Unethical Practices in Research. Mount Sinai has a “zero tolerance” policy regarding retaliation. Relevant policies include: (1) The Mount Sinai Code of Conduct (Intranet only); and (2) Mount Sinai’s Policies and Procedures on Protecting Whistleblowers.
       
       
   11. Complainantmeans a person who in Good Faith makes an allegation of Research Misconduct; or other Unethical Practices in Research.
       
       
   12. Respondent means the person against whom an allegation of Research Misconduct, or other Unethical Practices in Research, is directed, or who is the subject of a Research Misconduct proceeding.

3. Responsibilities of Research Integrity Officer (RIO) and Research Integrity Committee (RIC)

1. Research Integrity Officer (RIO) -- The Dean[4] will appoint the Senior RIO who will have primary responsibility for implementation of the institution’s policies and procedures on Unethical Practices in Research. The RIO has general responsibility for overseeing the investigation of all allegations of Unethical Practices in Research and shall be available to:

• • Consult confidentially with persons uncertain about whether to submit an allegation of unethical research practices, and if the allegations do not involve Unethical Practices in Research, refer the individual to other offices with responsibility for resolving the issue.
  • Receive allegations of suspected Unethical Practices in Research and work with the RIC to determine and pursue the appropriate method for investigating and resolving these allegations.

For Research Misconduct proceedings, the RIO also has specific responsibilities including but not limited to:

• • Consulting confidentially with persons uncertain about whether to submit an allegation of Research Misconduct;
  • Receiving allegations of suspected Research Misconduct;
  • As necessary, taking interim action and notifying the ORI of special circumstances, in accordance with this policy;
  • Directing and organizing the sequestration of research data and evidence pertinent to the allegation of Research Misconduct in accordance with this policy;
  • Providing confidentiality to those involved in the Research Misconduct proceeding as required by 42 CFR § 93.108, other applicable law, and institutional policy;
  • Overseeing the processes for notifying the Respondent and providing opportunities for him/her to review/comment/respond to allegations, evidence, and committee reports;
  • Overseeing the processes for informing Respondents, Complainants, and witnesses of the procedural steps in the Research Misconduct proceeding;
  • In cooperation with other institutional officials, taking all reasonable and practical steps to protect or restore the positions and reputations of good faith Complainants, witnesses, and committee members and counter potential or actual Retaliation against them by Respondents or other institutional members;
  • Keeping the RIC and D.O. and others who need to know apprised of the progress of the review of the allegation(s) of Research Misconduct;
  • Acting as the primary institutional representative to ORI and ensures prompt notifications and reports as required by 42 CFR Part 93;
  • Taking appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards of those actions; and
  • Overseeing the maintenance of records of the Research Misconduct proceeding and making them available to ORI.

2.   Responsibilities of the RIC 

The RIC will be appointed by the Dean. The committee will consist of at least five members and will include: (1) At least one tenured faculty member with expertise in basic science research; (2) at least one tenured faculty member with expertise in translational science research, (3) at least one tenured faculty member with expertise in clinical research, and (4) a representative from the Compliance Office. The committee will be co-chaired by two of the aforementioned tenured faculty members. An attorney from the Office of the General Counsel will serve as counsel to the Committee.

The Committee will have the following duties:

• • • Receive and review reports from the RIO and other committee members regarding alleged Unethical Practices in Research. The RIC retains the option of requesting additional information or pursuing additional courses of action with regard to the status of any actions brought before the committee.

D. Inquiries and Investigations Based on the nature of the allegations and the review by the RIO, in consultation with Legal and the D.O., alleged Unethical Practices in Research will be classified as either:

1. Allegations of Substantive Noncompliance with Regulations and Institutional Policies
2. Allegations of Financial Misappropriation
3. Research Misconduct as defined by 42 CFR Part 93

Each of the above categories has its own review process as described below. The Institution may pursue one of the following methods of review detailed below.

1. 1. Allegations of Substantive Noncompliance with Regulations and Institutional Policies

Often, Unethical Practices in Research involve noncompliance with regulatory policies including but not limited to human subject research, animal research or biosafety. These allegations should be reviewed with the RIO for confirmation that the alleged failure to comply with federal, state or institutional regulations may be assessed and managed by the primary regulatory entity within the School (Program for the Protection of Human Subjects (PPHS), the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC) or the HIPAA Oversight Committee according to the respective standard policies and procedures. The RIC and RIO are available for consultation regarding proper management and resolution of specific cases.

Findings that fall within grounds for disciplinary action as defined in the Faculty Handbook will be reported to the D.O.

   2. Allegation of Financial Misappropriation

Unethical Practices in Research may involve misuse of research funds. At the discretion of the Chief Financial Officer of the School, failure to comply with federal, state or institutional financial controls may be assessed and managed by the Chief Financial Officer with the assistance of the Compliance, Grants and Contracts and Legal offices as appropriate.

Findings that fall within grounds for disciplinary action as defined in the Faculty Handbook will be reported to the D.O.

   3. Research Misconduct as Defined by 42 CFR Part 93

Allegations of Research Misconduct that are reported to the RIO or referred to the RIC within the School will be managed by the process set forth below. This process is intended to comply with the regulatory requirements set forth in 42 CFR Part 93.

1.      Assessment of Allegations

1.1. An allegation of Research Misconduct should be reported promptly to the relevant Hospital Official, Department Chairperson, Institute Director, or Center Director, or to the RIO. Upon receipt, all allegations shall be forwarded to the RIO immediately, without further local review. This low threshold for referral is to ensure that the initial review is swift and that all allegations requiring further review are appropriately handled by the RIO's Office.

1.2. In the event the Department Chairperson is the subject of the allegation the matter should be reported directly to the RIO.

1.3. Upon receipt, the RIO shall commence an Assessment of the Allegations to determine whether the allegation of Research Misconduct (1) appears to fall within the definition of Research Misconduct, (2) appears to involve PHS- supported biomedical or behavior research, Research training or activities related to that research or research training, as provided in 42 CFR § 93.102, and (3) is sufficiently specific so that potential evidence may be identified and sufficiently substantive to warrant an inquiry. (42 CFR § 93.402(b)) Once identified, the RIO must move promptly to sequester such evidence.

1.4 The Assessment has no specific timeframe. However, the goal should be completion within seven (7) calendar days. An Assessment Report should be presented to the RIC. An explanation should be included in the report for exceeding this time limit.

1.5. If the RIO concludes that the allegation is specific such that potential evidence of Research Misconduct may be identified, the RIO shall refer the matter immediately to the RIC.

2. The Inquiry

2.1. Upon determination that a matter requires further review pursuant to this process, members of the RIC, shall act as a standing panel to conduct an inquiry (“Inquiry Panel” or the "Panel"). A representative from the Office of General Counsel shall serve as counsel to the Panel. The RIC shall use its discretion to appoint additional members with appropriate scientific expertise to evaluate the allegations. The Panel shall consist of no fewer than three faculty members and shall be staffed by the Dean's Office. Any committee member who has any involvement in the alleged wrongdoing must be excluded from the Panel. The Respondent must receive written notice of the composition of the Panel and may object in writing to the RIO regarding the composition, based upon any personal, professional or financial conflict of interest. The decision of the RIC to change or not change the composition of the Panel is final.

As part of this inquiry, and before or at the same time that the Respondent is informed of the specific allegations, the RIO shall secure the relevant research records and evidence (also known as “Sequestration”). The RIO will provide the Respondent access to the records unless such access would impede the investigation or be otherwise inappropriate.

2.2. The Panel will promptly conduct an inquiry into the alleged wrongdoing for the purpose of determining whether a formal investigation should be initiated.

2.3. The Panel must complete its inquiry within 60 calendar days of initiation of the inquiry, unless circumstances clearly warrant a longer period, in which case the record of the Panel shall include documentation of the reasons for extending the 60 day period.

2.4. At the conclusion of its inquiry, the Panel must issue a written report to the D.O. with recommendations as to whether to pursue an investigation or close the inquiry. The report must include the name and position of the subject of the inquiry; a description of the allegations of Research Misconduct; any PHS support that triggers ORI oversight; a summary of the evidence reviewed, and the basis for the recommendations of the Panel.

2.5. If the Respondent admits to the allegations of Research Misconduct during the inquiry stage, then the Inquiry Panel may recommend a finding of Research Misconduct without the need to continue to the investigation stage; however, decisions to close an inquiry in cases involving PHS funds, based upon an admission, require prior consultation with ORI.

2.6. The RIO shall provide a draft of the Panel’s inquiry report to any individual who has been a subject, i.e., Respondent, of the inquiry. Such subjects will be given an opportunity to comment on the allegations and conclusions of the Panel and any written comments shall be made part of the final report.

2.7. After the subject(s) have submitted their responses, the final report with appended comments shall be provided to the D.O. The D.O. will make a written determination whether to accept the Panel’s recommendations regarding whether an investigation is warranted or not. The inquiry shall be deemed complete when the D.O. makes this determination. If the D.O. has further questions regarding the Panel’s recommendations, the D.O. may send the inquiry back to the Panel for further consideration.

2.8. If the D.O. decides that an investigation is warranted and if the research involved PHS funds, he/she shall instruct the RIO to notify ORI within 30 days of the issuance of this decision and provide ORI with a copy of his written decision and the Final Inquiry Panel Report.

2.9. If the D.O. decides to close the inquiry, the RIO shall ensure that the documentation of the inquiry is retained for seven years. These documents will be provided to ORI upon request.

3. The Investigation

3.1. In the event the D.O. determines that the allegation may have substance, the RIO, in consultation with the D.O., shall appoint an ad hoc Investigation Committee (“Committee”) for the purpose of conducting a formal investigation. To ensure appropriate peer review, the Committee will be composed of a sufficient number of research scientists, at least two of whom shall have expertise in the subject matter of the investigation. The RIO may also appoint others, such as subject matter experts from outside of the institution, to serve on the Committee. The Committee will be advised by the General Counsel's office. The Dean’s Office will supply such staff and other resources to the Committee as may be necessary. In no event may any individual who is selected to serve on the Committee have any prior involvement in the research project that is the subject of the inquiry.

3.2. The RIO shall notify the Respondent, in writing, of the allegations against him/her and provide Respondent with notice of any new allegations of Research Misconduct that were not addressed in the inquiry or arose as part of the investigation.

3.3 The RIO shall ensure that any additional research records or evidence not previously secured during the inquiry are properly sequestered for the duration of the investigation.

3.4 Respondent shall be apprised of the composition of the Committee and may object to any member of the Committee based upon personal, professional or financial conflict(s) of interest. The objection should be made in writing to the RIO and must state the reasons for the objection. The decision of the RIO to change or not change the composition of the Committee is final.

3.5. The Investigation Committee will commence its investigation within 30 days of a determination by the D.O. that an investigation should be conducted. The Committee shall make diligent efforts to complete the investigation, including a written report within 120 days. The Final Investigation Committee Report shall be submitted to the RIC for review, then forwarded to the D.O. for approval prior to submission to external agencies (ORI, etc). If the Committee is unable to complete the investigation and written report within 120 days, the Committee Chairperson must inform the RIO and D.O. and provide the reasons for the needed extension. The RIO shall submit a written request for an extension to ORI.

3.6. The Committee review shall encompass the significant issues it identified during the course of the investigation and, in the event that the evidence indicates pervasive issues, it shall expand its review to encompass other implicated research performed by Respondent. The Committee shall review relevant documents and interview those persons it reasonably determines  having relevant information, including the Respondent. Transcriptions of all interviews must be provided to the interviewee for correction/comment and then made part of the record.

3.7. The Committee shall issue a written report to the D.O. The content of the report must include at a minimum the elements set forth in 42 CFR § 93.313, including but not limited to: 1) A description of the allegations of Research Misconduct; 2) a summary of the research records and evidence reviewed; and 3) any findings of misconduct separately delineated and the supporting basis for each of these findings. Furthermore, for every finding of misconduct, the Report shall identify the following: 1) the form of misconduct, 2) whether it was committed intentionally, knowingly, or recklessly, 3) the specific PHS support if any, 4) whether any publications need correction or retraction and 5) whether there is any non-PHS current or pending support. The Committee shall use the preponderance of the evidence standard for reaching these conclusions. Before it is finalized, a draft of the report, or relevant portions of it, shall be sent to each Respondent.

3.8. The D.O. may accept the Committee's report as final or may require that the Committee reopen its investigation to address any additional issues and revise its report accordingly. The D.O. must issue an approval of the report in writing.  This written approval will be included in the Final Investigation Committee Report. 

4. Implementation of the Report Findings

4.1. RIO Duties

1. 1. 1. If the Final Report substantiates a finding of misconduct in research the RIO shall be responsible for working with Respondents to achieve the following:

1. 1. withdrawing any pending abstracts or papers containing false information and notifying the co-authors;
   2. if there are published papers or abstracts containing false information, notifying the editors of the journals in which abstracts and papers appeared and notifying all co–authors and giving them the opportunity to retract their names from the publication; and
   3. if there is reason to question the validity of previous research, notifying any institution or sponsoring agency with which the individual is or has been affiliated, and any other co-authors.

4.2. D.O. Duties

If the Final Report substantiates a finding of misconduct in research, the D.O. shall be responsible for taking other appropriate action including disciplinary action against those individuals who engaged in misconduct in research.

4.3. If the alleged misconduct in research is not substantiated, the RIO shall be responsible for overseeing that:

                        a.    reasonable and practicable efforts are made by the institution, as appropriate, to restore the reputation of the researcher and any others whose reputation may have been injured. Specifically, any agency or individual which has been informed of the investigation will be notified that the allegations have been reviewed and not substantiated;

                        b.    appropriate action is taken against any Complainant, or witness who did not act in good faith when making unfounded allegations of scientific misconduct and/or refused to cooperate with the investigation.

5. Notification to the Office of Research Integrity (ORI) for all Inquiries and Investigations of Research Misconduct involving PHS funds.

5.1. The RIO shall ensure compliance with the ORI reporting requirements set forth in 42 CFR § 93.315, including but not limited to the following:

                              a.      Notification to ORI on or before the date on which an investigation is commenced and providing ORI with a copy of the Committee's report within 30 days of the D.O. decision.

                              b.      Notification of the outcome of any Committee investigation, including a copy of the Committee's Final Report;

                              c.      Immediate notification if the School has reason to believe that any of the following conditions exist:

• •                 if there is an immediate health hazard;
  •                 if there is an immediate need to protect federal funds or equipment;
  •                 if there is an immediate need to protect the individual making the allegation, i.e., Complainant, the individual who is accused of the allegation, i.e., Respondent, or his or her investigators; or
  •                 if it is probable that there will be a public report of the allegations;
  •                 if the Respondent admits to the Research Misconduct;
  •                 if there has been possible criminal or civil violation of the law.
  •                 Prior to beginning any discussion on a negotiated settlement with the Respondent.

 6. Record Retention

All documents relating to each Research Misconduct proceeding must be maintained for at least seven years after the final conclusion of the proceeding or the completion of any PHS proceeding involving the Research Misconduct allegation, whichever is later. The documents shall be made available upon request to authorized ORI personnel.

Updated April 2019