Life Sciences Research for Lifelong Health

Research Misconduct Policy

The Babraham Institute (BI) is committed to maintaining high standards in all areas of our research; to that end, we will strive to ensure that all funding is used appropriately (and in accordance with all regulations and requirements) to produce reproducible, well planned and executed excellent science. This policy and Code of Practice does not replace the BBSRC Code of Conduct Policy currently used by BI (and which should be read in conjunction with this policy and procedure) but is supplementary to it and specific to the area of research misconduct.

In order to comply with UK legislation and sponsor regulations and reassure the public and ourselves that our standards are being upheld, we need to reaffirm our policies, to specify procedures and appropriate safeguards for handling investigations, and to foster an environment that discourages misconduct in all research. The following procedures are based on and guided by the US Public Health Service (Department of Health and Human Services) Final Rule 42 Code of Regulations (CFR) Part 93, which is exemplar.

The Institute's 'Statement on Dealing with Allegations of Research Misconduct Under United States Public Health Service Research-Related Activities for Foreign Institutions' can be found here:

Statement on Dealing with Allegations of Research Misconduct Under United States Public Health Service Research-Related Activities for Foreign Institutions (pdf)


INVESTIGATION OF ALLEGED RESEARCH MISCONDUCT

DEFINITION OF RESEARCH MISCONDUCT

Research misconduct means fabrication, falsification or plagiarism, in proposing, performing or reviewing research, or in reporting research results.
  • Fabrication is making up data or results and 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 adoption of another person's ideas, processes, results or words without giving appropriate credit.
  • Research misconduct does not include honest error or differences of opinion.
REQUIREMENTS FOR A CLAIM OF RESEARCH MISCONDUCT

A finding of research misconduct requires that:
  • There is a significant departure from the accepted practices of the relevant research community
  • The misconduct is committed intentionally, knowingly, negligently or recklessly
  • The allegation is confirmed by the majority of the evidence
DELEGATION OF AUTHORITY AND RESPONSIBILITY

The BI Director may delegate to the BI Deputy Director for Research Support (DDRS) responsibility for:
  • Coordination of all procedures related to allegations of research misconduct by anyone carrying out research under the aegis of the BI.
  • Fostering a research environment that discourages misconduct in all areas of research.
  • Dissemination of policy and maintenance of records relating to misconduct in research.
  • Appointment of an individual or a committee to conduct inquiries and investigations into allegations of research misconduct. If funding from external organisations is involved the BI Director or DDRS determines whether the law, BI regulations or the terms or conditions of the award:
    • Require that the sponsor is notified;
    • Specify the time limits specified throughout the various procedures;
    • Require other actions to assure compliance.
  • Coordinating with all relevant members of staff, the BI Director, BI Human Resources (HR), the BI Grants Office, and other concerned parties to ensure the following:
  • Assurance of appropriate confidentiality or anonymity, fairness and objectivity of proceedings.
  • Assurance of a full and complete inquiry, investigation, and resolution process in line with the relevant (BI or BBSRC) disciplinary procedure.
  • Assurance that no real or apparent conflicts of interest arise in those appointed to pursue this process; that they have the appropriate disciplinary expertise; that due regard is given to the prevailing standards of the field.
  • Maintenance of confidentiality of records, in accord with established BI policy, relating to the investigation and resolution of incidents of misconduct in research.
  • If appropriate or required, notifying concerned parties such as sponsors, co-authors, collaborators, editors, licensing boards, professional societies, and criminal authorities of the outcome of investigations, taking care to clear the name of anyone falsely charged.
  • Protecting, to the maximum extent possible, the positions and reputations of those persons who, in good faith, make allegations of research misconduct, and those against whom allegations of misconduct are not confirmed.
  • Efforts to restore the reputation of persons alleged to have engaged in misconduct when allegations are not confirmed.
The BI Director or DDRS may designate one or more Research Conduct Investigator (RCI) and delegate to them any or all of the tasks/responsibilities as detailed above.
RCI will need to be a member of senior management or a senior group leader with an understanding of the areas of research or support relevant to the inquiry and/or investigation.
Alternatively, the BI Director or DDRS can, at his or her discretion, serve as the RCI.

INQUIRIES AND INVESTIGATIONS INTO ALLEGATIONS OF MISCONDUCT IN RESEARCH

The BI adopted BBSRC document “BBSRC_good_scientific_practice” sets out the responsibility of those in authority (especially the Director and Research Group Leaders) in maintaining ethical standards. It also emphasises that the (BI adopted) BBSRC Staff Code, which forms part of individual’s terms and conditions of employment, states that: “employees maintain the highest standards of honesty and integrity in presentation of scientific work, data and results. Fabrication of data or results is gross misconduct”.

All individuals associated with BI should report observed or suspected research misconduct to the BI Director and/or DDRS.

An allegation should, in addition to stating the nature of the suspected misconduct, present corroborative evidence of research misconduct.

The BI Director or DDRS will immediately respond, as outlined below, to each allegation or other evidence of possible misconduct.

If an individual is unsure whether a suspected incident falls within the definition of research misconduct he or she should first contact the BI Director or DDRS to discuss the suspected misconduct informally. If the circumstances described do not meet the definition or research misconduct, the BI Director or DDRS will refer the individual or allegation to the appropriate offices or officials with responsibility for resolving the problem.

The informal discussion of potential research misconduct, as well as all subsequent stages in this procedure will be, as far as is feasible, treated as strictly confidential.

The following describes procedures to be followed once an allegation or other evidence of misconduct is received:

1. PRELIMINARY ASSESSMENT

The BI Director or DDRS promptly assesses the reported incident to determine if it constitutes a bona fide allegation of research misconduct—i.e., does the alleged incident fit the definition of research misconduct and is the evidence sufficiently credible and specific to identify a case of research misconduct?
If it is concluded that a bona fide allegation of research misconduct has been made, the misconduct procedure enters an inquiry phase.

2. INQUIRY
  1. Following receipt of an allegation of research misconduct, the BI Director or DDRS appoints one or more persons to conduct an inquiry to determine whether there is sufficient substance to the allegation to warrant a formal investigation. The purpose of the inquiry is not to reach a final conclusion as to whether misconduct occurred or who was responsible. This preliminary phase of information gathering and fact-finding should take no more than sixty calendar days from the receipt of the allegation unless circumstances clearly warrant a longer period. If the inquiry phase must be extended beyond sixty days, the reasons for doing so should be documented.
  2. The RCI notifies the person(s) accused (against whom misconduct allegations have been made) that an inquiry is being undertaken plus the:
    • Procedure that will be followed
    • Membership of the inquiry committee
    • Nature of the misconduct allegation(s).
    • The person(s) accused has five days to challenge, in writing, the committee's membership based on bias or conflict of interest. The RCI and/or the DDRS will determine whether to replace the challenged member with a qualified substitute.
  3. At the time of notification, and in the course of the inquiry, or of any subsequent investigation, the Office of the BI Director or DDRS will sequester such information as is necessary to protect the integrity of the investigation.
    • Where appropriate, the person(s) accused will be provided with copies of, or reasonably supervised access to, the research records.
    • All records of the BI misconduct proceeding will be retained for ten years after the inquiry's conclusion is published.
  4. If the research at issue receives or has received external funding, and if, at any point during an inquiry or subsequent investigation, it is ascertained that any of following conditions apply, BI will notify the appropriate authorities and/or the sponsoring agency.
    • Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
    • BI resources or interests are threatened.
    • Research activities should be suspended.
    • There is reasonable indication of possible violations of civil or criminal law.
    • Action is required to protect the interests of those involved in the research misconduct proceeding.
    • It is believed that the research misconduct proceeding may be made public prematurely so BI may take appropriate steps to safeguard evidence and protect the rights of those involved.
    • The research community or public should be informed.
  5. In the case of externally funded research, BI will take appropriate administrative actions in the interim to protect the relevant external funds and ensure that the purpose of the funding is carried out.
  6. Matters related to the Inquiry will be treated confidentially, as far as it is possible, allowing for fact finding and the reporting required to funding bodies.
  7. A written report of the Inquiry shall be prepared that describes the evidence that was reviewed, summarizes any interviews that were conducted, and includes the conclusions of the Inquiry.
  8. The individual(s) against whom the allegation was made shall be given a copy of the Inquiry report and will be invited to comment in writing. When comments are provided they will be included in the record.
  9. Upon receipt of the Inquiry report, the BI Director or DDRS will provide a written justification of whether a full (formal) investigation is warranted or not. Records of the Inquiry, including all documentary evidence, interview notes, the Inquiry report, and the DDRS's or RCI's written justification shall be maintained in a secure manner for at least ten years.
    • If an Inquiry is closed before its completion a report, including the reasons for such an action, should be made to those funding bodies that require it.
    • The Inquiry report and supporting documentation will be provided to relevant external funding bodies upon request.
  10. If, following completion of the inquiry report and/or within 30 calendar days, it is determined that there is sufficient evidence to warrant a formal investigation, the BI Director or DDRS shall initiate the following process:
3. FULL INVESTIGATION
  1. An Investigative Committee is appointed to determine whether research misconduct has occurred, and, if so, to make recommendations for disciplinary measures. The investigation phase should be completed within 120 days from the appointment of the investigative committee, unless circumstances warrant a longer period. If the investigation stage is extended beyond 120 days the reasons for doing so should be documented. If the person(s) accused is:
    • Head of Laboratory (Institute Strategic Programme) or Group Leader, the investigative committee is appointed by the DDRS. It will be constituted from members of the Babraham Executive Committee (BEC), and contain two or more members (larger committees may be appointed if in the opinion of the DDRS it would facilitate the investigation).
    • An academic researcher (visiting scholar, post-doctoral fellow, etc.), the BI Director or DDRS appoints an investigative committee that, typically, will include a member of the researcher's relevant peer group plus one or two members of BEC.
    • A student, the DDRS appoints an investigative committee of at least two members from BEC.
  2. When external funding is involved, the relevant organisation shall be informed that a full investigation will be started within 30 days of the BI Director or DDRS's decision on whether there is sufficient evidence to warrant an investigation of research misconduct.
  3. If a funding organisation requires an extension to the length of the investigation beyond 120 days they must send BI a request. The extension request should include an explanation for the delay, an interim report on the progress to date, an outline of what remains to be done, and an estimated date of completion.
  4. The RCI will notify the person(s) accused(s) in writing that a full investigation is being undertaken, will inform him/her of the allegations that are under investigation, as well as of the composition of the investigative committee and the procedures that will be followed in the course of the investigation. In the event that new allegations arise in the course of the investigation, the person(s) accused will be notified in writing.
  5. The person(s) accused has five days to challenge, in writing, the committee's membership based on bias or conflict of interest. The RCI will determine whether to replace the challenged member with a qualified substitute.
  6. The investigation will normally include examination of relevant documents including (but not necessarily limited to) all electronic and hard copy versions of relevant research data and proposals, publications, correspondence, and memoranda. Typically, the investigative committee will conduct interviews as part of its fact-finding process, including interviews with those making allegations of research misconduct (accuser) and with the individual(s) against whom the allegations are made (person(s) accused). Whenever it is feasible, investigators shall create and maintain records of their interviews.
  7. All individuals affected by the investigation will be accorded confidential treatment, as far as is reasonably practicable, allowing for fact finding and the reporting required to funding bodies.
  8. If an investigation is closed before its completion, a report including the reasons for such an action, should be made to those funding bodies that require it. The BI will notify relevant funding bodies if, during the course of the investigation, facts are disclosed that may affect current or potential funding for the individual(s) under investigation or that the funding body needs to know to ensure appropriate use of its funds.
  9. When the investigation is completed, the Chair of the investigative committee shall prepare, and submit to the BI Director or DDRS, a written report of the results, reviewing the facts, and stating the committee's findings. The DDRS shall make the report available to the person(s) accused for comment. In a separate communication to the BI Director or DDRS, the investigative committee shall offer its recommendations with respect to disciplinary measures, if any.
  10. The person(s) accused (s) shall have twenty-one calendar days to submit to the BI Director or DDRS comments on the investigative report.
  11. When the investigative committee's report, and the accused person’s(s’) comments, have been received, the BI Director or DDRS will:
  12. If appropriate and/or required, communicate the committee's report and findings to relevant external bodies. Based upon a reading of the Investigative Report and any comments thereon, the BI Director or DDRS will determine whether or not research misconduct has been committed. The BI Director or DDRS will issue a Final Report to any funding body that requires it. The final report must describe the policies and procedures under which the investigation was conducted, how and from whom information was obtained, the findings, and the basis for the findings, and include an accurate summary of the views of any individual(s) found to have engaged in misconduct, as well as a description of any sanctions taken by the campus. Documentation to substantiate an investigation's findings will also be made available if required.
  13. The DDRS decides whether or not to recommend the imposition of disciplinary measures to the BI Director.
4. DISCIPLINARY PROCEDURE
  1. If the BI Director or DDRS intends to initiate disciplinary measures, the BI or BBSRC Disciplinary Procedure (whichever is appropriate) will be activated.
  2. The BI Director or DDRS shall report any disciplinary measures taken by BI to any funding body that requires it.