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OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

 

RESEARCH INTEGRITY AND COMPLIANCE

Review of Alleged Scientific Misconduct Policy

I. Policy Statement
 
Scientific research must be carried out in accordance with the highest ethical standards. Impropriety of any type in the conduct of research is abhorrent to the inherent purpose of all scientific inquiry: the discovery and dissemination of truth. The academic community cannot condone plagiarism, fraud, lying or other types of wrong-doing in the conduct of scientific research. Such activities seriously undermine the moral foundations of our institutions, the idea of scientific research, and the public's trust in the personal integrity of scientists engaged in health related research. The SUNY Health Science Center at Brooklyn is committed to sustaining and encouraging an environment of creativity commensurate with the highest ethical standards of scientific research and regards the imparting of principles of integrity and honesty to students as an integral part of the education process and a responsibility of the faculty and administration. The Health Science Center is also committed to undertake diligent efforts to protect the position and reputation of the individual(s) who makes, in good faith, an allegation of scientific misconduct. To this end, the Health Science Center at Brooklyn has established and implemented the following Guidelines for the Review of Alleged Scientific Misconduct.
 
This policy and the associated procedures apply to all individuals at the Health Science Center at Brooklyn engaged in research regardless of the sponsor of the research. Consistent with the Public Health Service regulations (42 CFR Part 93, PHS Policies on Research Misconduct), the Health Science Center recognizes its reporting and procedural obligations to the PHS, during each phase of the review process, when an allegation of possible misconduct in science involves any research, research-training or research-related grant or cooperative agreement with the PHS.
 
This policy and associated procedures will normally be followed when an allegation of possible misconduct in science is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interest of the Health Science Center at Brooklyn and the Public Health Service. Any change from normal procedures also must ensure fair treatment to the subject of the inquiry or investigation. Any significant variation should be approved in advance by the Senior Vice President for Biomedical Education and Research of the Health Science Center.

II. Definitions

  1. Allegation means any written or oral statement or other indication of possible scientific misconduct made, in good faith, to an institutional official.

  2. Inquiry means information gathering and initial fact finding to determine whether an allegation or apparent instance of misconduct warrants an investigation.

  3. Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has taken place. If misconduct has already been confirmed, an investigation may, nevertheless, be conducted to determine the extent of any adverse effects resulting from the misconduct.

  4. Misconduct in the context of research means fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted for proposing, carrying out or reporting results from research (for example, but not limited to, material failure to comply with Federal requirements affecting specific aspects of the conduct of research such as the protection of human subjects and the welfare of laboratory animals, or the failure to meet other material legal requirements governing research). It does not include honest error or honest differences in interpretations or judgments of data.

III. Responsibilities of and Protection of Those Involved

  1. The individual making the allegation is responsible for making allegations in good faith, maintaining confidentiality and cooperating with the inquiry and/or investigation. He/she will have the opportunity to testify before the inquiry and investigation committees, to review portions of the inquiry and investigation reports pertinent to his/her allegations or testimony and to be informed of the results of the inquiry and investigation.

    The Health Science Center will ensure that this individual will not be retaliated against in the terms and conditions of his/her employment or other status at the Center and will review instances of alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the Senior Vice President.

    In addition, the Health Science Center will, to the maximum extent possible, protect the privacy of those who report scientific misconduct in good faith. For example, if the individual requests anonymity, the Health Science Center will make an effort to honor the request during the allegation assessment or inquiry within applicable policies, procedures and laws. The individual will be advised that if the matter is referred to an investigation committee and their testimony is required, anonymity may no longer be guaranteed.

  2. The individual against whom the allegation is made is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. He/she will be informed of the allegations when an inquiry is opened and notified in writing of the final determinations and resulting actions. This individual will also have the opportunity to be interviewed by and present evidence to the inquiry and investigation committees and to review the draft inquiry and investigation reports.

    If the inquiry and/or investigation process finds no misconduct, the Health Science Center, after consulting with the individual, will undertake diligent efforts to restore the reputation of the individual against whom the allegation was made. A letter from the President will be sent to the individual and a copy kept on file indicating that a thorough inquiry and/or investigation into the allegations had been conducted and the findings of the President. Other actions (e.g., public notification, expunging all references to the scientific misconduct allegation from the individual's personnel file) as might be appropriate may also be taken. Any institutional actions to restore the individual's reputation must first be approved by the President.

IV. The Conduct of Inquiry and Investigation

  1. Initiation of an Allegation
    1. The initial allegation(s) pertaining to an impropriety by an individual (faculty, staff or student) in the conduct of research shall be directed to the Chair of the Department of that individual and/or to the appropriate Dean of either the College of Medicine, School of Graduate Studies, College of Health Related Professions or College of Nursing.
    2. The Chair and/or Dean will require that the allegations or charges be filed in writing and signed.
    3. A Chair and/or Dean receiving an allegation(s) pertaining to research misconduct must immediately notify the Senior Vice President of such allegations and his/her plan of inquiry. Upon receiving an allegation of scientific misconduct, the Senior Vice President (in consultation with the Assistant Vice President for Scientific Affairs) shall assess the allegation to determine whether there is sufficient evidence to warrant an inquiry, whether PHS support or PHS applications for funding are involved and whether the allegation falls under the PHS definition of scientific misconduct.
    4. After determining that an allegation falls within the definition of misconduct, the Assistant Vice President for Scientific Affairs will ensure that all original research records and materials (e.g., copies or originals of relevant correspondence, laboratory notebooks, publications, etc.) relevant to the allegation are immediately secured and submitted to the Senior Vice President along with the final inquiry report.
    5. During the inquiry/investigation process, Health Science Center officials will take interim administrative actions, as may be appropriate and required, to protect sponsor funding and to ensure that the purposes of the sponsor financial assistance are carried out.

  2. Protection of Those Involved
    1. Every effort shall be made to protect the privacy and interests of the individuals involved. Any inquiry and/or investigation will be as discreet as possible in an attempt to protect all involved until such time as it shall be determined by the President of the Health Science Center that further action must be taken.

  3. Inquiry
    1. The Chair and/or Dean with whom the allegation(s) or charges are filed will conduct a discreet and informal inquiry making every effort to protect the individual reputations and the integrity of the research. An ad hoc inquiry committee shall be appointed to assist the Chair and/or Dean which will 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 purpose of the inquiry is to make a preliminary evaluation of the available evidence and to determine whether there is sufficient evidence of possible scientific misconduct to warrant an investigation.
    2. The individual who is the subject of the allegation shall be notified that an allegation has been lodged, the nature of the allegation and the procedures to be followed.
    3. The inquiry shall be conducted in confidence with the purpose of separating unfounded allegation(s) from those of a substantive nature and shall be completed within 60 days of the initial receipt of the allegation(s). If the inquiry cannot be completed within 60 days, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period. The individual(s) against whom the allegation was made shall be given a copy of the report of the inquiry. If the individual(s) comment on that report, his (their) comments may be made a part of the record.

      At the completion of the inquiry, a written report shall be submitted to the Senior Vice President with an assessment regarding whether or not the allegation(s) warrant a formal investigation and the reasons attendant thereto. The written report will include a description of the evidence reviewed, summaries of relevant interviews and the conclusions of the inquiry.

  4. Response by the Senior Vice President
    1. The Senior Vice President will determine on the basis of the written report of the inquiry, the response from the subject of the allegation, if any, and any other informal consultation deemed necessary whether the accusations require a formal investigation. In either case, the basis for the decision will be recorded. Every effort will be taken at all levels of an investigation to avoid possible conflicts of interest.
    2. If it is determined, as a result of the informal inquiry, that the charges are without merit, the Senior Vice President shall accordingly notify in writing the individual(s) who were respondents to the allegation(s), the President of the Health Science Center and all other parties involved.
    3. If the Senior Vice President finds that the allegations cannot be dismissed at this juncture, a formal investigation shall be initiated within 30 days following such a finding by the Senior Vice President.

  5. Investigation
    1. If the decision is that a formal investigation is necessary, the Senior Vice President shall:
      1. Inform the individual in question of the allegations and that a formal investigation will be conducted and invite the individual to make a written response to the allegations.
      2. Consult, as the need arises, on an ad hoc basis with impartial faculty members of his choice during the formal investigation. (The involvement of faculty and staff in inquiries or investigations pursuant to these Guidelines is considered part of their employment duties and responsibilities within the meaning of s17 of the Public Officers Law.)
      3. Inform collaborator(s) in the research project under investigation and give him (them) the opportunity to comment.
      4. After administrative and legal consultation, inform the Research Foundation, the granting agency and any other parties potentially impacted by the investigation. Notification to granting agencies for those sponsored programs administered through The Research Foundation of State University of New York shall be made in accordance with applicable regulatory requirements after consultation with the appropriate Research Foundation legal and administrative staff.
    2. The Assistant Vice President for Scientific Affairs will immediately ensure that any additional pertinent research records not previously secured during the inquiry are secured. This will occur before or at the time the individual who is the subject of the allegation is notified that an investigation has begun.
    3. During the course of the investigation, the Senior Vice President and/or his/her designee(s) shall:
      1. Receive and review relevant documents.
      2. Interview involved faculty, staff and students. (A faculty/staff member who is the subject of an inquiry or investigation has, as a matter of course, the right to consultation with legal counsel if he/she chooses. However, the faculty member has the right to representation by counsel in institutional proceedings only after formal disciplinary charges have been filed in accordance with Section 19.8 of the Agreement between the State of New York and the United University Professions.)
      3. Seek additional information as deemed necessary.
      4. Consult, when appropriate, with expert(s) from outside the institution.
      5. Record and document all relevant information obtained in the course of the investigation.
      6. Analyze and summarize results of the investigation.
      7. Submit a written report to the President. Included in this report shall be:
        1. A statement of the facts.
        2. An indication of the evidence or lack of evidence of misconduct.
        3. An evaluation of the seriousness of any misconduct found.
        4. Recommendations for further action.
      8. Submit a copy of the report to the subject of the investigation for response.
      9. Submit the response by the subject of the investigation to the President.

  6. If an investigation is to be undertaken, the institution shall take no more than 120 days for its completion including the preparation of a final report. The receipt of comments from the subject(s) of the investigation shall be allowed up to 14 days.

  7. The President, upon receiving the report of the Senior Vice President and any statement of rebuttal by the subject of the investigation, shall make a final determination regarding what action shall be taken in accordance with Article 19 of the Agreement between the State of New York and United University Professions, and formally notify all parties, including the sponsoring agency and the Research Foundation of that decision. Such actions may include but not be limited to withdrawal or correction of all pending or published papers, letter of reprimand, monitoring of future research activity, restitution of funds if appropriate, termination, etc.

  8. If the alleged misconduct is not substantiated, diligent efforts will be undertaken if needed to restore the reputation of those under investigation. See Section III.B. above.

V. Reporting Requirements to the Public Health Service

When it is determined that an allegation of scientific misconduct involves PHS support or PHS application for funding and that the allegation falls under the PHS definition of scientific misconduct, the Assistant Vice President for Scientific Affairs will report to the PHS Office of Research Integrity (ORI) the following:

  1. The decision to initiate an investigation must be reported in writing to the PHS/ORI on or before the date the investigation begins. At a minimum, the notification will include the name of the individual(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of scientific misconduct and the PHS application or grant number(s) involved.

    The PHS/ORI will also be notified of the final outcome of the investigation and will be provided with a copy of the investigation report within 120 calendar days of the initiation of the investigation. This final report, to substantiate the findings of the investigation, will include:

    1. a description of the policies and procedures under which the investigation was conducted;
    2. how and from whom information was obtained relevant to the investigation;
    3. the findings of the investigation and the basis for those findings;
    4. the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct; and
    5. a description of any sanctions taken by the Health Science Center.
  2. If it is determined that the investigation will not be completed within 120 days, a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report and describes other necessary steps to be taken will be submitted to the PHS/ORI. If the request is granted, periodic progress reports will be submitted to the PHS/ORI.
  3. If it is decided to terminate an inquiry or investigation for any reason without completing all relevant requirements of the PHS regulations, a report including a description of the reasons for the proposed termination will be submitted to the PHS/ORI.
  4. The PHS/ORI will be kept apprised of any developments during the course of the inquiry or investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.
  5. The PHS/ORI will be notified at any stage of the inquiry or investigation if any of the following conditions exist:
    1. there is an immediate health hazard involved;
    2. there is an immediate need to protect Federal funds or equipment;
    3. 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;
    4. it is probable that the alleged incident is going to be reported publicly;
    5. the allegation involves a public health sensitive issue (e.g., a clinical trial);
    6. there is a reasonable indication of possible criminal violation; in this instance, the PHS/ORI will be notified within 24 hours of obtaining this information.
  6. Reporting to sponsors other than the PHS will be done in accordance with individual sponsor requirements.

VI. Records Retention

After completion of the case and all ensuing related actions, the Assistant Vice President for Scientific Affairs will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Chair/Dean, the Senior Vice President and the inquiry and investigation committees. The Assistant Vice President for Scientific Affairs will keep the file for three years after completion of the case to permit later assessment of the case to substantiate the investigation's findings or the reasons for determining that an investigation was not warranted.

The PHS/ORI or other authorized DHHS personnel will be given access to the records upon request.

Approved December 1990 by President Scherl
Revisions Approved June 1998 by Interim President Feigelson
Revisions Approved October 2013 by Dean Ian Taylor