POLICY AND PROCEDURE

POLICY AND PROCEDURE TRUST REQUIREMENTS FOR RESEARCH PRACTICE (INCORPORATING MANAGING RESEARCH MISCONDUCT) Reference Number: 133 2006 Author/Manager Responsible: Dr Alistair Taylor Research & Development Manager First Reviewed: October 2005 Next Review Date April 2009 Ratified by: TCNC, Management Board & Clinical Risk Committee Date Ratified: October 2005 Related Policies Managing Conduct Managing Performance Code of Expectations for Employees Whistle blowing Policy Page 1 of 15

CONSULTATION AND RATIFICATION SCHEDULE Royal United Hospital Bath NHS Trust Name and Title of Individual R&D Committee Clinical Risk Committee Date Consulted Ongoing Ongoing Name of Committee Date of Committee TCNC Policy Sub-group 15/12/04 TCNC Policy Sub-group 23/3/05 TCNC 1/4/05 Ratified Management Board 27/4/05 Page 2 of 15

DISTRIBUTION LIST Internal Name Appointment / Function E-Mail Distribution Divisional Chairs & Specialty Leads Clinical Managers Divisional Managers HR Managers Trade Union representatives Page 3 of 15

INDEX Section Page POLICY - - - - - - - - 5 1. Introduction - - - - - - - 5 2. Context - - - - - - - 5 3. Definitions - - - - - - - 6 4. Principles - - - - - - - 6 Related Documents - - - - - - 8 PROCEDURE - - - - - - - 9 6. Operational Framework for Research & Development - 9 7. Reporting - - - - - - - 10 8. Documentation - - - - - - 10 9. Disciplinary Action - - - - - - 10 10. Procedure for Handling Complaints of Potential Research Fraud / Misconduct - - - - - - - 11 10.1 Informal Stage: - - - - - - 11 10.2 Formal Stages - - - - - - 11 11. Further guidance and advice - - - - 14 CONSULTATION CHECKLIST - - - - 15 Page 4 of 15

POLICY 1. Introduction 1.1 This policy has been written on the understanding that the Trust recognises first and foremost that staff engaging in medical and non-medical research should and do so with integrity and with the best of motives in order to improve patient care and treatment and the Trust working environment. 1.2 Research and development is essential for the NHS to achieve its aim of continual quality improvement. However whilst pursuing research, NHS Trusts must ensure that there are proper systems and processes to protect and safeguard the well-being of both participants and researchers. 1.3 This policy sets out the required principles and standards expected to be carried out by all RUH researchers in order to ensure good clinical practice in research and to prevent and deal with research misconduct and fraud. Education and training of both supervisors and researchers will therefore play a major part in helping to prevent incidence of misconduct and fraud. 1.4 This policy applies to all Trust employees and to individuals appointed on honorary contracts with the Trust. It should be noted that all individuals appointed to an honorary contract will be required to give their agreement to abide by the terms of this policy as part of the contract. 1.5 The policy and accompanying procedures form part of the wider management arrangements for governance within the Trust. The documents make clear the arrangements in place for personnel to raise concerns over the conduct of research within the Trust. 1.6 The Policy will be reviewed and updated on a two-year basis. The review will be undertaken by the R&D Committee and ratified through normal RUH Trust processes 2. Context 2.1 In keeping within the main precepts in NHS R&D development, the policy and procedure emphasises the view that patients and consumers are not simply passive subjects on whom research is carried out but should be seen as active participants in the research process. Page 5 of 15

2.2 The Research Governance Framework sets in place systems and processes which ensure that all research is safe, is of a high quality and contributes to improving the treatment and care of patients. All research active organisations are required to have implemented a plan for research governance. Part of the requirement contained in this document refers to systems to detect and deal with research misconduct and fraud. 2.3 Additionally, sponsors and funders (notably the research charities) who provide major grants for NHS related research might make specific requirements for host institutions. 3. Definitions 3.1 'Research misconduct and fraud' is defined 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 (e.g. consent), including those of the Local Research Ethics Committee and Tissue Bank Committee, 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 substance or devices used in or by the conduct of research. 3.2 Research misconduct and fraud 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. 4. Principles The Policy and Procedure for Proper Research Practice (incorporating how Misconduct and Fraud is based on the following principles of good practice: Awareness of the existence of this Policy & Procedure will form an important first step in proper research practice. All staff involved in research will be made aware of the policy and procedure and their responsibilities under it. The Trust lays considerable emphasis on prevention of misconduct and fraud. Page 6 of 15

The Medical Director will have responsibility for informing the Research and Development Committee of any matters raised under this policy which require their consideration and/or action. In turn, the Research and Development Committee has a responsibility to report to the Clinical Governance Committee where appropriate. The Trust will seek to ensure that all concerns raised are dealt with in the timescale set out in the procedure. The Trust will seek to ensure that due consideration is given to safeguarding the confidentiality and professional reputation of members of staff about whom concerns are raised. The Principal Investigator (PI) must inform the Trust R&D Office of all Trust related research i.e. human research that makes a call on, patients, patient samples (blood, tissue etc.) and patient data and Trust infrastructure (e.g. research equipment). This is achieved via the Trust R&D research registration and approval process. All research must undergo peer review and patient based research must be submitted to the Local Research Ethics Committee for approval. All commercially led research must comply with the same conditions applied to non-commercial research. Under the research governance framework, the PI is responsible for the conduct of his or her research team. If a PI is unsure of due process in relation to any of the above points then he/she should contact the Trust R&D Manager for advice. Any actions potentially coming under the definition of Research Misconduct & Fraud will be investigated in a timely manner and where there is evidence of Research Misconduct / Fraud will be handled in line with the employer s Managing Conduct or Disciplinary Policy & Procedure. Where the issue relates to a doctor or dentist this may require using the organisation s policy for managing performance and conduct in doctors & dentists. Page 7 of 15

Related Documents 1. Research Governance Framework, Department of Health, Leeds 1998 2. Research Governance Implementation Plan, Department of Health, Leeds 2000 3. The Wellcome Trust Guidelines for Good Research Practice January 2002 London 4. Medical Research Council Policy and Procedure for inquiring into allegations of scientific misconduct London MRC 1997 5. The Wellcome Trust Statement on the handling of allegations of research misconduct January 2002 London 6. General Medical Council Good Practice in Medical Research January 2002 London Page 8 of 15

PROCEDURE 6. Operational Framework for Research & Development 6.1 In view of the strong interdependence and positive working relationships of clinical departments/units and academic departments (University), individuals who wish to make a complaint about research & development may use one of the following channels: The appropriate Division Chair or Specialty Lead, The Head of Academic Department (University) The R&D Director or Manager The Medical Director Issues may also come through the Trust Procedure for Raising Concerns in relation to the Provision of Healthcare Services ( whistleblowing Policy) 6.2 The Trust and its research partners wish to ensure that a culture of openness is fostered and that there exists a research environment that supports the raising of legitimate concerns. However, where it is found that the complaint is made on malicious or vexatious grounds, the matter will investigated in line with the employer s Disciplinary or Managing Conduct Policy and if evidence is found, disciplinary action will be considered in line with that Policy. 6.3 The documentation arising from this Policy and Procedure will comply with the guidance of the Data Protection Act 1998. 6.4 There are a number of distinct stages to investigating any complaint of an alleged case of research misconduct and fraud can be dealt with. These stages are set out in Section 10 below (Procedure for Handling Complaints of Potential Research Fraud / Misconduct). 6.5 Where appropriate, the overall aim of the procedure is to try and solve concerns at an informal level; however there may be occasions when a formal investigation may be required. 6.6 Anonymity and confidentiality of both the complainant and the researcher are vital to the proper conclusion of all cases. Anonymity and confidentiality should be maintained as long as possible. Where matters have to be referred to the employer s Disciplinary or Managing Conduct Policy & Procedure it may become necessary for witnesses to complete statements etc in line with that policy. Page 9 of 15

6.7 Information will be exchanged for the proper conduct and conclusion of any case and disclosure of any information will only be to those individuals who need to know. 6.8 The Trust may on occasion consider seeking the involvement of an external adviser to investigate particular complaints. 7. Reporting The levels of reporting will be governed by four main criteria: i) The outcome of the particular stage of the review process, ii) The main employer status, iii) The conditions set by funding body, iv) The regulations set by professional body. 8. Documentation 8.1 Comprehensive and careful notes should be taken at each of the stage of the review process. All notes should be stored in a safe and secure environment during the process and filed in the Medical Director s Office once the matter is concluded. 8.2 All documentation should be handled in accordance with the provisions of the Data Protection Act 1998. 8.3 Any one of the following may grant access rights to these notes: R&D Director, Medical Director Chief Executive. 9. Disciplinary Action 9.1 If during the investigation set out below it becomes clear that there is evidence of potential research fraud / misconduct then the matter will be investigated in line with employer s Disciplinary or Managing Conduct Policy or any separate policy for managing the conduct of Doctors & Dentists. This would normally occur at stage 3 or 4 in the process set out in section 10.2 below. Where the issue relates to a doctor or dentist this may require using the organisation s policy for managing performance and conduct in doctors & dentists. Page 10 of 15

9.2 Where misconduct is found through investigation under the employer s Disciplinary or Managing Conduct Policy or any separate policy for managing the conduct of Doctors & Dentists then disciplinary action up to and including summary dismissal (immediate dismissal without notice) may be issued. 10. Procedure for Handling Complaints of Potential Research Fraud / Misconduct A complaint or concern is raised by an individual to either the Divisional Chair, Head of Department, R&D Director or Manager, Medical Director or any appropriate person identified through a local policy for raising concerns (whistleblowing). 10.1 Informal Stage: If this complaint or concern is of a minor nature and may be resolved informally it can be dealt with on an informal basis without a need for referral to the formal stages, if appropriate. Whilst the process is informal, written records of the issues raised and how they were resolved must be made and retained. If there is any doubt as to the seriousness of the matter, then the Medical Director or the Director of Research & Development (R&D) must be consulted. 10.2 Formal Stages The table below sets out the formal stages to be followed in the investigation of complaints of about research practice: Page 11 of 15

10.2 Formal Stages of the Procedure for Handling Complaints of Potential Research Fraud / Misconduct Stage Process Action Timescale 1. Raising complaint/ concern R&D Director or Medical Director receives communication of complaint i) Complainant to provide a detailed written statement in support of the allegation ii) Researcher to be informed by the Medical Director that an anonomised complaint / concern has been made and that an assessment panel will be set up to review the complaint / concern Normally within 2 weeks 2. Assessment An Assessment Panel should be set up consisting of 2 members as a minimum i) R&D Director, Divisional Chair or Specialty Lead or a nominee of the Medical Director ii) a representative of the lead employer (e.g. Trust, University or other) 3. Formal Investigation Panel to inform the Medical Director of their findings within 7 days of receipt of the complaint, under the following headings: i) No case to answer ii) No case, but malicious intent iii) Minor concern iv) Major Concern Investigation Team to be appointed consisting of : 2 members as a minimum i) R&D Director, Clinical Director or a nominee of the Medical Director ii) a representative of the lead employer (E.g. Trust, University or other.) The following actions should then be taken: i) No case the researcher and complainant to be informed ii) No case, but malicious intent the researcher to be informed. The relevant HR Departments to be informed and for relevant action to be taken in respect of the complainant. iii) Minor concern the panel to recommend actions for resolution of the concern for the Medical Director to consider and authorise if appropriate. Medical Director to then communicate with necessary parties. iv) Major Concern to proceed to Stage 3 of the process. The Assessment Panel may decide that the issues are so potentially serious that it is necessary to suspend the research carried out by the researcher including informing other sites if related research is being carried out there by the researcher in question. v) Major Concern Conduct Investigation - The Assessment Panel may also decide with advice from the employing organisation s HR department that the issues are so serious that they need to be investigated immediately under the Trust Disciplinary / Managing Conduct policy or any separate policy for managing the conduct of Doctors & Dentists. i) Researcher to be advised of the detail of the complaint in order to prepare and will be informed of the membership of the Investigation Team. ii) Researcher to be given written notice of requirement to assist fully in the formal investigation process. iii) v) Researcher will be interviewed by the Investigating Team as part of their investigation. vi) A written report of the findings to be prepared by the Investigation Team and presented to the Normally within a month This will be completed as quickly as possible but will vary depending on the complexity of the research and the complaint raised. Page 12 of 15

4. Outcomes of investigation 5. Appeal Process Medical Director to receive a report of the findings and recommendations of the Investigation Team. Medical Director Medical Director to recommend 1 or more of the following and to communicate recommendation(s) to the relevant parties: i) Implementation of all or some of the Investigation Team s recommendations. ii) Referral to Lead Employer recommending action under Disciplinary Procedures iii) Report to the Research Governance Committee iv) Report to an external regulatory body There is no right of appeal in respect of recommendations 4 i. iii. and iv above. Where disciplinary action has been invoked then the researcher would have access to a right of appeal through their Lead Employers Disciplinary / Managing Conduct Policy & Procedure. If no disciplinary action has been invoked and the researcher wishes to appeal against the process of the investigation, then an appeal should be submitted under the Lead Employers appropriate Appeals or Grievance Procedure. Normally within 2 weeks of receiving the report from the investigating team Within the timescales of the employing organisations appeal process. Page 13 of 15

11. Further guidance and advice 11.1 For further information and advice on the application of this policy please contact the following or your HR Manager or: R&D Manager, Dr Alistair Taylor Tel: 01225 824160 E-mail: alistair.taylor@ruh-bath.swest.nhs.uk R&D Director Prof John Osborne Tel: 01225 824215 E-mail: john.osborne@ruh-bath.swest.nhs.uk Page 14 of 15

CONSULTATION CHECKLIST Author; please attach this to each copy of the policy being sent to a meeting for comments. Dear Chairman, please would you review this policy at your committee and return any amendments / comments to by / / Title of meeting Date of meeting Name of policy Name of author Are there any elements of this policy which present operational issues that require further discussion? If yes, please provide a contact name for the author. Yes No N/A Is the policy referenced? Does the policy include a training plan? If you are the appropriate forum, have the necessary resources been agreed to implement this policy? Is there a plan for policy implementation? Does your meeting recommend further consultation with groups or staff other than listed at the front of the policy? Other comments from meeting. Policy accepted without further comment. (Please circle) Policy needs further amendment. (Please circle) Yes / No Yes / No Name of Chair Signature Date / / For Human Resources Policies only Name of Staff Side Signature Date / / Page 15 of 15