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Statement on the handling of allegations of research misconduct1

November 2005

(This is an updated version. The first version of this statement was published in January 2002.)

It is a condition of Wellcome Trust grants that host institutions in the UK and the Republic of Ireland have in place formal written procedures for the handling of allegations of research misconduct. Host institutions outside the UK and the Republic of Ireland will be expected to adhere to the spirit of the Trust's Guidelines on Good Research Practice.

This statement sets out the minimum criteria that a host institution's procedures for handling such allegations should satisfy. It should be read in conjunction with the Trust's Guidelines on Good Research Practice.

The Trust identifies integrity, openness and partnership as key values: this statement has been produced, and is intended to be applied, in line with those values. The expectation is that the necessity to invoke these procedures will be a rare event but that by following these general principles the process of investigating allegations of research misconduct will be a fair process that protects the interests of all the parties involved.

Useful models for procedures for handling allegations of research misconduct may be found in the Medical Research Council's Policy and Procedure for Inquiring into Allegations of Research Misconduct (December 1997) and the General Medical Council's report Good Practice in Medical Research (December 1999).

Throughout this statement:

• 'Trust contact’ means the Trust's Head of Grants Management, or any person notified to a host institution, from time to time

• 'host institution' means any institution in receipt of Trust funds

• 'the Trust' means the Wellcome Trust, a registered charity (number 210183)

• 'Trust-funded researcher' means all Trust-salaried researchers and non-Trust-salaried researchers in receipt of funds in any form from the Trust in order to advance their research.

1 Definition of research misconduct

1.1 'Research misconduct' is defined by the Trust as:

The fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting results of research or deliberate, dangerous or negligent deviations from accepted practices in carrying out research. It includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans, other vertebrates or the environment and facilitating of misconduct in research by collusion in, or concealment of, such actions by others. It also includes intentional, unauthorised use, disclosure or removal of, or damage to, research-related property of another, including apparatus, materials, writings, data, hardware or software or any other substances or devices used in or produced by the conduct of research.

It does not include honest error or honest differences in the design, execution, interpretation or judgement in evaluating research methods or results or misconduct unrelated to the research process. Similarly it does not include poor research unless this encompasses the intention to deceive.2

2 Responsibilities of the host institution

2.1 The Trust considers that it is the responsibility of the host institution to investigate all allegations of research misconduct made against its staff and students. Findings of research misconduct may be matters for consideration under the host institution's disciplinary procedures.

2.2 Host institutions will need to give consideration to the procedures that will apply to visiting researchers while based in the host institution and the host institution's staff while based in another institution.

2.3 It is the responsibility of the host institution to inform the Trust Contact, in confidence, at the earliest opportunity, about allegations of serious research misconduct that concern Trust-funded researchers where it seems that there are reasonable grounds to believe that the allegation may be substantiated on investigation. It is at the discretion of the host institution to determine what constitutes 'serious misconduct'.

2.4 The host institution is also responsible for keeping the Trust Contact informed during the process of the investigation of allegations of research misconduct involving Trust-funded researchers.

2.5 It is the responsibility of the host institution to inform the Trust Contact, in confidence, of all instances of research misconduct involving Trust-funded researchers that have resulted in the allegations being substantiated, and to ensure that the outcome of such misconduct investigations are formally reported to the Trust Contact on behalf of the Trust.

2.6 The host institution should have in place a policy statement relating to the treatment of whistleblowers under the Public Interest Disclosure Act 1998, including a clear statement that research misconduct is taken seriously in the institution and that any member of staff raising bona fide concerns can do so confidentially, and without fear of suffering any detriment. The statement should include a clear indication of the procedures in which such bona fide concerns by staff may be brought to the attention of a designated individual within the institution.

3 Principles for investigation by host institutions of allegations of research misconduct

3.1 Each host institution must have in place formal written procedures3 for dealing with allegations of research misconduct against its staff and students. Host institutions should, where appropriate, take legal advice on implementing these procedures to ensure that the procedures comply with all legal obligations for the conduct of such investigations from time to time in force.

3.2 Host institutions should endorse the following principles when implementing these procedures:

• the responsibilities of those dealing with the allegation should be clear and understood by all interested parties

• measures should be in place to ensure an impartial and independent investigation and to ensure that line management obligations or other interests of those dealing with the allegation do not conflict with these procedures

• those undertaking research at the host institution should be contractually obliged to participate in and comply with the procedure

• the host institution should consider the confidential nature of the investigation and how to safeguard the rights to confidentiality of the interested parties

• anyone accused of misconduct should have the right to respond

• in line with the Public Interest Disclosure Act 1998, a policy should be in place to ensure that no employee shall suffer a detriment who makes an allegation in good faith against another employee, but equally that disciplinary procedures are in place to deal with malicious allegations

• all interested parties should be informed of the allegation at an appropriate stage in the proceedings

• the allegation should be dealt with in a fair and timely manner

• proper records of the proceedings should be kept

• the outcome should be made known as quickly as possible to all interested parties

• anyone found guilty of misconduct should have the right to an appeal

• appropriate sanctions should be in place for cases when the allegation is upheld

• if appropriate, efforts should be made to restore the reputation of the accused party if the allegation is dismissed.

4 Involvement of the Wellcome Trust

4.1 Receipt of allegations
The Trust recognises that there may be instances where an allegation of research misconduct is made directly to the Trust Contact, a member of the Trust's staff or a Governor rather than to an individual within the host institution. In such instances, the Trust Contact will get in touch with an appropriate individual at the host institution and the host institution will then be responsible for taking suitable action in line with its formal written procedures for handling allegations of research misconduct.

4.2 Investigations by the Trust
As stated above, it is the host institution's responsibility to investigate allegations of research misconduct made against its staff and students and this would be the Trust's preferred course of action in most cases. In exceptional cases, however, the Trust may wish to undertake its own investigation into alleged cases of research misconduct that concern Trust-funded researchers (for example where the Trust's reputation is at risk or where the Trust is dissatisfied with the investigation undertaken by the host institution). Any investigations by the Trust would only be undertaken following consultation between the Trust Contact and the appropriate representative(s) of the host institution.

In such cases the procedure described in Annexe A will apply.

5 Sanctions

5.1 If the host institution or the Trust determines that the allegation of scientific misconduct is substantiated, the Trust may consider appropriate sanctions. These may include, but are not restricted to:

• letter of reprimand

• withdrawal of funding

• requiring the withdrawal or correction of pending or published abstracts and papers emanating from the research in question

• changes to the staffing of the particular project

• special monitoring of future work

• barring of the Trust-funded researcher from applying for Trust funds for a given period

• repayment of grant plus interest at the Trust's discretion

• discussion with the host institution on the implementation of appropriate disciplinary procedures.

5.2 At all times, in line with its Grant Conditions, the Trust reserves the right to withdraw funding with immediate effect.

Annexe A: Procedures for investigation of research misconduct by the Wellcome Trust

1 Instigation of proceedings

1.1 Where the Trust has decided to carry out its own investigation of an allegation of research misconduct, the Trust Contact shall inform the host institution, the subject of the allegation ('the respondent') and the person(s) making the allegation ('the complainant') of his/her decision to instigate a formal investigation. The Trust's investigation will follow the principles that the Trust expects host institutions to follow in the investigations of allegations of research misconduct.

2 Appointment of investigation committee

The Director of the Trust (or his/her nominee) will appoint an investigation committee, which will consist of five people, including three representatives of the Trust, one of whom may be a member of Trust staff nominated by the respondent. The fourth and fifth representatives will be independent of the Trust4 and, prior to appointment, will be required to declare any conflicts of interest and to agree to a duty of confidence. In the event that any representative declares a conflict of interest, or in the opinion of the Director of the Trust (or his/her nominee) any conflict of interest is or becomes apparent in respect of any representative, the Director of the Trust (or his/her nominee) shall in his/her discretion have the power to remove that representative from the investigation committee. The investigation committee will elect one of the two independent representatives as chair. The host institution, the respondent and the complainant will be notified of the proposed investigation committee membership.

2.2 The Trust Contact will define the scope of the investigation in written terms of reference to the investigation committee. The Trust will provide the secretariat to the investigation and will keep a fair and accurate record of the proceedings.

3 Investigation

3.1 Where possible, the investigation will include examination of all relevant documentation, including, but not limited to: relevant research data; laboratory notebooks; computer files; other materials; proposals; publications; correspondence; memoranda; and notes of telephone calls. Interviews will be conducted with the complainant and the respondent, and any other individuals involved in making the allegation and other individuals who might have information regarding key aspects of the allegations.

3.2 Details of the allegation and the investigation will be made available by the Trust only to the investigation committee and to such members of Trust staff as are necessary to conduct the investigation. All individuals interviewed during the investigation will be asked to respect the confidential nature of the investigation.

4 Investigation report

4.1 The investigation committee will produce a report stating: the procedures under which the formal investigation was conducted; how and, where appropriate, from whom, information was obtained; the findings of the committee and the basis for these; a summary of the views of the respondent; and a description of any sanctions recommended by the committee.

4.2 The host institution and the respondent will receive a copy of the investigation report and have an opportunity to comment on it. Comments may be submitted to the investigation committee and will be attached as an addendum to the investigation report.

5 Right of appeal

5.1 The respondent has a right of appeal, against the decision and/or sanctions made by the investigation committee. The complainant has no right of appeal.

5.2 The respondent may appeal within 14 days of receiving notification of the final outcome of the investigation. The appeal must be made in writing and should state the basis for the appeal. The Deputy Chairman of the Wellcome Trust will appoint an appeal board consisting of three or more persons, at least one of whom will be independent of the Trust. The Deputy Chairman of the Wellcome Trust will notify the respondent of the proposed appeal board membership.

6 Appeal process

The appeal will normally include examination of all evidence called into question by the respondent. The respondent will also be invited to attend to give oral evidence. The respondent may submit any relevant supplementary evidence in support of his/her appeal.

An appeal should normally be completed, with the report submitted to the Deputy Chairman of the Wellcome Trust, within 90 days of its initiation, with the initiation being defined as the appointment of the appeal board.

7 Appeal report

The appeal report must state how the appeal was conducted; describe how and, where appropriate, from whom, further information was obtained relevant to the appeal; state the findings of the appeal board; and explain the basis for those findings.

8 Final decision

8.1 The Deputy Chairman of the Wellcome Trust will decide, on the basis of the appeal report, whether to endorse, amend or overturn the conclusions of the investigation committee and/or resultant sanctions imposed on the respondent.

8.2 The Deputy Chairman of the Wellcome Trust will notify the respondent and the host institution in writing of the outcome of the appeal board and will provide a copy of the appeal report and evidence considered by the appeal board.

8.3 The Deputy Chairman of the Wellcome Trust will give consideration to informing other interested parties, including journals in which the research was published, of the outcome of the investigation.

8.4 The decision of the Deputy Chairman of the Wellcome Trust is final.

Notes

1In formulating these guidelines, the Trust has drawn on the Medical Research Council's Ethics Series, in particular 'Good Research Practice' (December 2000) and 'Policy and Procedure for Inquiring into Allegations of Scientific Misconduct' (December 1997) and the General Medical Council's 'Good Practice in Medical Research' (2002). It has also been informed by the 'Joint Consensus Conference on Misconduct in Biomedical Research', Royal College of Physicians of Edinburgh (January 2000) and the Biotechnology and Biological Sciences Research Council's 'Statement on Safeguarding Good Scientific Practice'.

2Based on the definitions given in the MRC's 'Policy and Procedure for Inquiring into Allegations of Scientific Misconduct' (December 1997) and the GMC's report 'Good Practice in Medical Research' (2002).

3Useful models of such procedures may be found in the MRC's 'Policy and Procedure for Inquiring into Allegations of Scientific Misconduct' (December 1997) and the GMC's 'Good Practice in Medical Research' (2002).

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