Policies and Procedures on Ethical Practices in Research

  1. Introduction

The Icahn School of Medicine at Mount Sinai (the “School” or “ISMMS”) 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 suspect or observe Unethical Practices in Research, it is their obligation to report this concern to the Research Integrity Officer (“RIO”) as provided for below. Researchers should NOT attempt to review concerns of Research Misconduct themselves as this may compromise a full and complete review of the matter and risk violating the Institutional Assurance with the Public Health Service (PHS)/Office of Research Integrity (ORI).

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 pursuant to the School’s anti-retaliation policies.

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

These policies and procedures are intended to implement the PHS regulations set forth in 42 CFR Part 93 for alleged Research Misconduct as defined in Section B herein. In the event of any conflict between these policies and the PHS regulations, the federal regulations shall govern.

 

B. Definitions

    1. 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.
    2. Complainant means a person who makes an allegation of Research Misconduct; or other Unethical Practices in Research.
    3. Good Faith Allegationis 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.
    4. Institutional Certifying Official means the institutional official responsible for assuring on behalf of an institution that the institution has written policies and procedures for addressing allegations of Research Misconduct, in compliance with 42 CFR Part 93; and complies with its own policies and procedures and the requirements of 42 CFR Part 93. The Institutional Certifying Official is responsible for certifying the content of the institution’s annual report, which contains information specified by ORI on the institution’s compliance with 42 CFR Part 93, and ensuring the report is submitted to ORI, as required.
    5. Institutional 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. Intentionally means to act with the aim of carrying out the act. Intentionality is an element of a finding of Research Misconduct.
    7. Knowingly means to act with awareness of the act. Intentionality is an element of a finding of Research Misconduct.
    8. Recklessly means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism. Intentionality is an element of a finding of Research Misconduct.
    9. 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))
    10. 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. The RIO is also the Institutional Certifying Official.
    11. Research Integrity Committee (RIC) The RIC acts as a "standing committee" which receives the findings of the Assessment and makes the final determination to proceed or not to proceed to an Inquiry. If the decision is to proceed, a subcommittee of the RIC (i.e., 2-3 members) conducts the Inquiry ("Inquiry Panel).
    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.
    13. Research Misconductis based on the ORI definition and encompasses: Fabrication, Falsification, or Plagiarism (FFP) 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[4] is the appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit.[5] Research Misconduct does not include honest error or differences of opinion.[6] This statement of policy and procedures applies only to allegations of Research Misconduct that occurred within six years of the date the institution or HHS received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR § 93.104(b).
    14. 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.
    15. Retaliation encompasses adverse actions taken to suppress reporting under these policies or any adverse actions toward individuals or the institution as a result of reporting concerns of Research Misconduct or other Unethical Practices in Research or participating in any such review. Mount Sinai has a “zero tolerance” policy regarding retaliation. Relevant policies include: (1) The Mount Sinai Health System Code of Conduct (Intranet only); and (2) Mount Sinai’s Policies and Procedures on Protecting Whistleblowers.
    16. Unethical Practices in Researchas 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 detrimental or questionable research practices (DRP or QRP)[7]; 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 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.

 

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

    1. Responsibilities of the RIO

The RIO is responsible for overseeing the Research Misconduct review and proceedings consistent with the requirements set forth in 42 CFR §§ 93.106, 93.233, 93.300, and 93.304.

    1. 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 faculty member with expertise in basic science research; (2) at least one faculty member with expertise in translational science research, (3) and at least one faculty member with expertise in clinical research. The committee will be co-chaired by two of the aforementioned faculty members such that Basic Science and Clinical Research are represented. 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 InvestigationsBased on the nature of the allegations and the Assessment of Allegations by the RIO, 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:

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. for further action as warranted.

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 RIO 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. Upon receipt, the RIO shall commence an Assessment of the allegations (i.e., an initial screening) to determine whether the allegation of Research Misconduct (1)  falls within the definition of Research Misconduct, (2)  involves PHS-supported biomedical or behavioral research, biomedical or behavioral research training or activities related to that research or research training, as provided in 42 CFR § 93.102, and (3) is sufficiently credible and specific so that potential evidence of Research Misconduct may be identified to warrant an Inquiry. (42 CFR § 93.306)

1.3. If the RIO concludes that the allegation is credible and specific such that potential evidence of Research Misconduct may be identified, the RIO shall (1) document the Assessment, and (2)  promptly sequester any evidence that is identified, consistent with 42 CFR § 93.305(a) prior to notification of the Respondent. (42 CFR § 93.306) The RIO shall then refer the matter immediately to the RIC.

1.4. If the RIO determines that requirements for an Inquiry are not met, the RIO shall retain sufficiently detailed documentation of the Assessment to permit a later review by ORI of the reasons why the institution did not conduct an Inquiry in accordance with § 93.318. (42 CFR § 93.306)

1.5. If the Respondent makes an admission of Research Misconduct consistent with the requirements of 42 C.F.R.93.317(b) during the Assessment or Inquiry stage, then the RIC/Panel may recommend a finding of Research Misconduct without proceeding through the Inquiry and Investigation stages, but it shall notify and obtain ORI’s approval before closing the case.[8]

  1. 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"). The RIO shall use his/her discretion to appoint additional members with appropriate scientific expertise to evaluate the allegations. Any RIC member who has any involvement in the alleged wrongdoing or a conflict of interest (personal, professional, or financial) with the Respondent or Complainant shall self-disclose such conflict and recuse themselves from the Panel.

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. The bar to proceeding is intentionally low, so this phase of the review should be limited in scope to determine whether an allegation may have substance.

2.3. The Panel must complete its Inquiry and prepare an Inquiry Report within 90 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 90-day period. The report shall include all the necessary elements as required pursuant to 42 CFR § 93.307(g)(2)). If there is potential evidence of honest error or difference of opinion, the Panel must note this in its Inquiry report.

2.4. The RIO must notify the Respondent whether the Inquiry found that an Investigation is warranted. The RIO must provide the Inquiry Panel report to the Respondent and include a copy of (or refer to) 42 CFR Part 93, as well as Mount Sinai’s Policies and Procedures on Ethical Practices in Research, which were adopted under Mount Sinai’s assurance with HHS/ORI. (42 CFR §93.308(a)). The Respondent will be given an opportunity, not to exceed 30 days, to comment on the allegations and conclusions of the Inquiry, and any written comments shall be appended to the Inquiry report. The RIO, in consultation with the RIC, may, but is not required to, provide relevant portions of the report to all the Complainant(s) for comment and shall append any comments to the Report.

2.5. If the Inquiry Panel decides that an Investigation is warranted and if the research involved PHS funds, the RIO will notify ORI within 30 days of the issuance of this decision and provide ORI with a copy of the Final Inquiry Panel Report.

2.6. If the Inquiry Panel decides that an Investigation is not warranted and 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.

 

  1. The Investigation

3.1. In the event the RIC determines that the allegation(s) should proceed to an Investigation, the RIO, in consultation with the D.O., shall appoint an ad hoc Investigation Committee (the “Committee”). 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 Investigation.

3.2. The RIO shall notify the Respondent, in writing, of the decision to proceed to an Investigation, 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. If the institution identifies additional Respondents during the Investigation, the institution may but is not required to conduct a separate Inquiry for each new Respondent. If any additional Respondent(s) are identified during the Investigation, the institution must notify them of the allegation(s) and provide them an opportunity to respond consistent with 42 CFR Part 93, Subpart C. While an investigation into multiple Respondents can convene with the same Investigation Committee members, the Committee shall complete separate Investigation reports and make discrete Research Misconduct determinations for each Respondent.

3.4 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.

3.5 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 must 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 shall be final.

3.6. The Investigation is a peer review process. The Respondent and all other interviewees may be represented by an attorney or other person of his or her choice. The role of this representative shall be limited to providing advice and counsel to the interviewee. The Committee may at its discretion further define, expand or limit the role of any such representative. 

3.7. The Investigation Committee will commence its Investigation within 30 days of a determination by the Deciding Official that an Investigation should be conducted. The Committee shall make diligent efforts to complete the Investigation, including a written report within 180 days. The Draft Investigation Committee Report must be forwarded to each Respondent together with access to the relevant research record/evidence relied upon by the Committee for review and comment. The Respondent must submit any comments within 30 days. The Committee shall consider the Respondent’s submitted comments when finalizing the Report and append the comments to the written Report. The Report may also be forwarded to the Complainant for review and comment and any comments shall be appended to the Report. If the Committee is unable to complete the Investigation and written report within 180 days, the Committee must inform the RIO and provide the reasons for the needed extension. The RIO shall submit a written request for an extension to ORI.

3.8. The Committee review shall encompass the significant issues identified during the course of the Investigation and must be broad in scope such that any other instances of Research Misconduct may be identified. The Committee shall review relevant documents, 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. All such interviews shall be recorded and transcribed and provided to the witness for review and correction.

3.9. The Committee shall issue a written report to the D.O. (i.e., the “Final Investigation Committee Report”). The content of the report shall include at a minimum the elements set forth in 42 CFR § 93.313. The Committee shall use the preponderance of the evidence standard for reaching its conclusions (e.g., more likely than not). If the Investigation Committee does not recommend a finding of Research Misconduct for an allegation, it shall provide a detailed rationale.

3.10. The D.O. may accept the Committee's report as final or may require that the Committee continue the Investigation to address any additional issues and revise the report accordingly. The D.O. must issue an approval of the report in writing (see “D.O. Duties” below). The D.O.’s decision is final and there shall be no appeal.

  1. Implementation of the Report Findings

4.1. RIO Duties

a. 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. 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.

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

        1. reasonable and practicable efforts are made by the institution, as appropriate, to restore the reputation of persons cleared of all allegations per 42 CFR §304(c). Specifically, any agency or individual which has been informed of the Investigation will be notified that the allegations have been reviewed and not substantiated;
        2. 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.
  1.  

 

4.2. D.O. Duties

    1. If the Final Report substantiates a finding of misconduct in research, the D.O. shall be responsible for taking other appropriate action including recommending disciplinary action against those individuals who engaged in misconduct in research.
    2. The Institutional Deciding Official is responsible for making a final determination of Research Misconduct findings. (42 CFR § 93.314) This determination must be provided in a written decision that includes:
      1. Whether the institution found Research Misconduct and, if so, who committed the misconduct; and
      2. A description of relevant institutional actions taken or to be taken.

 

  1. 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 §§ 93.310, 93.314, 93.315, 93.316, including but not limited to the following:

    1. Notification to ORI on or before the date on which an Investigation is commenced and providing ORI with a copy of the committee's Final Inquiry Panel Report, that meets the requirements of § 93.307 and § 93.309, as well a copy of the institutional policies and procedures under which the investigation was conducted (if not already provided to ORI with the Inquiry Report), within 30 days of the D.O. decision.
    2. Notification of the outcome of any Committee Investigation, including a copy of the Committee's Final Investigation Report and a written decision by the D.O. (see “D.O. Duties” above);
    3. Transmittal of the institutional record to ORI. The institutional record must be consistent with § 93.220 and logically organized.
    4. 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.

 

  1. 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.

 

_______________________________________________________________________________________

[1] This term and others that are capitalized in this Introduction are defined below in Sec. B.

[2] For purposes of this policy, a “Researcher” 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] As the recipient of PHS funds, through the National Institutes of Health (NIH), the ISMMS has signed an “Assurance” to develop policies and procedures to address allegations of Research Misconduct. Failure to adhere to this assurance may result in the loss of NIH funding to the institution.

[4] Plagiarism – While the ORI may decline to pursue allegations of plagiarism there is an expectation that institutions will develop policies and procedures for review of concerns.

[5] Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project (42 CFR § 93.227).

[6] If there is evidence of honest error, regardless of who provides it, institutions must consider that evidence when determining whether a Respondent’s actions meet the definition of Research Misconduct.

[7] Detrimental or Questionable Research Practices lead to a loss of confidence in the reported research results.  E.g., “P” hacking or poor statistical design.

[8] Per 42 CFR §93.317(b), “A respondent’s admission of research misconduct must be made in writing and signed by the respondent. An admission must specify the falsification, fabrication, and/or plagiarism that occurred and which research records were affected. The admission statement must meet all elements required for a research misconduct finding under § 93.103 and must be provided to ORI before the institution closes its research misconduct proceeding. The institution must also provide a statement to ORI describing how it determined that the scope of the misconduct was fully addressed by the admission and confirmed the respondent’s culpability.”