RESEARCH MISCONDUCT AND FRAUD POLICY AND PROCEDURES

Transcription

1 RESEARCH MISCONDUCT AND FRAUD POLICY AND PROCEDURES Reference GG/CG/004 Date approved October 2009 Approving Body Trust Board Implementation date Supersedes NUH Version (Identification and Management of Research Misconduct and Fraud) July 2006 Consultation undertaken Directors Group Date of Completion of Equality Impact Assessment Target audience Supporting Procedure(s) - 3 August 200 All Staff Review Date October 202 Lead Executive Author/Lead Manager Medical Director Director Of R&D Further Guidance/Information R&D Department, QMC Campus: Extension 622

2 CONTENTS Paragraph Title Page. Purpose 3 2. Policy Statement 3 3. Scope of policy 3 4. Definitions 4 5. Staff Obligations 5 6. Assignment of Responsibilities 5 7. Reporting Arrangements 6 8. Process of Investigation 6 9. Outcomes of Investigation 8 0. Equality and Diversity 9. References 9 Appendix Equality Impact Assessment 0 Appendix 2 We are Here for You Assessment 4 Appendix 2 Employee Record of Having Read the Policy 7

3 . Purpose RESEARCH FRAUD AND MISCONDUCT POLICY The aim of this policy is to set out clearly what constitutes research misconduct and fraud and the processes to be followed when failure to comply with the relevant legislative and regulatory frameworks is suspected and identified. 2. Policy Statement The Trust Policy is to encourage, promote and facilitate employees to participate in research. The policy adheres to principles and process described in the NUH Disciplinary Policy, and is intended to be read in conjunction with the NUH Disciplinary Investigation Procedure and Disciplinary Hearing Procedure. 3. Scope of Policy This policy applies to the following categories of staff:- a) All full time or part time staff whose substantive employer is the Trust whether holding permanent, temporary or fixed term Contracts of Employment with Nottingham University Hospitals NHS Trust b) All full time or part time staff engaged in Trust activities who do not necessarily hold Contracts of Employment with the Trust themselves but who are employed for purposes of carrying out Trust functions and/or activities. This category applies to staff recruited via employment agencies, c) Staff who hold Trust Contracts of Employment but have additional duties and/or obligations to another Employer(s) and/or who are self-employed or undertake additional duties on a consultantled basis.

4 d) Staff holding Trust contracts of employment whose payroll costs are met either partially or wholly by another party (e.g. a university, medical charity, a government department or commercial sponsor). e) All Trust employees who hold honorary contracts with other organisations (e.g. a university) which recognises the research status of an employee. f) Trainee professionals hosted by the Trust who conduct research during the course of their training. 4. Definitions According to the MRC Policy and Procedure for Inquiring into Allegations of Scientific Misconduct (997), research fraud and misconduct are 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 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, unauthorized use, disclosure or removal, or damage to, research related property of another, including apparatus, materials, writings 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 judgment in evaluating research methods or results or misconduct unrelated to the research process. Similarly, it does not include poor research unless it encompasses the intention to deceive. Examples of research misconduct/fraud include but are not limited to:

5 failure to obtain all necessary permissions (e.g. Ethics, MHRA, ARSAC, Trust approval) to undertake a research project failure to document consent appropriately fabrication of research participants, results or analysis. abuse of research funds or equipment. 5. Staff Obligations All staff should conduct research according to The Medicines for Human Use (clinical trials) regulations 2004 The Human Tissue Act 2004 The Mental Capacity Act 2004 The Data Protection Act Assignment of Responsibilities The Trust Director of R&D will be responsible for the initial assessment of the allegation of research fraud and/or misconduct and will decide the likely complexity of the investigation. Where the researcher involved is not an NUH employee but holds an honorary contract or a letter of access with the Trust, the researcher s substantial employer will be informed. Where the study is hosted but not sponsored by NUH, then the research Sponsor will be informed. Under the Research Governance

6 Framework, it is the Sponsor s responsibility to ensure that adequate arrangements are in place for the detection, investigation and management of research fraud and misconduct. It is therefore essential that research partnership agreements specify arrangements for the detection, reporting and investigation of research misconduct. 7. Reporting Arrangements All allegations of misconduct in research will be treated seriously and fairly and their merit investigated with integrity and sensitivity, in order to observe the principle of no-detriment, such that neither the Complainant nor the Respondent should suffer solely as a consequence of the fact that a good faith allegation has been made. Suspected research fraud and misconduct should be reported to the Director of R&D. Where necessary the R&D Director will seek more senior, expert or independent advice and make an early decision whether or not to suspend temporarily Trust approval of the research project concerned. Care will be taken to balance the risks to the safety and benefit to research participants. The Medicines and Healthcare Regulatory Agency (MHRA) has the power of inspection of sites involved in the conduct of clinical trials of investigational medicinal products, and may identify research fraud or misconduct. 8. Process of investigation The process of investigation will follow the procedure outlined in the NUH Disciplinary Investigation Procedure, with minor modification:

7 The Director of R&D Director will identify a suitable Case Investigator with responsibility for conducting the investigation. In view of the limited number of individuals in the Trust qualified to investigate cases of alleged research misconduct or fraud, the Case Investigator may also be the Director of R&D, or nominated deputy. If a minor issue is raised, a more informal approach will be adopted and the R&D director will call a meeting to discuss the case with all involved. For those cases which the Director of R&D considers may lead to serious outcome, as defined in 6. v) vii), and NUH retains responsibility, either as the employing organisation, or by mutual agreement with the researches employers, a full investigation will be conducted by a panel constituted for the purpose. The panel will be selected at the discretion of the Director of R&D, but will include representatives of HR from the organisation employing the researcher and may include a senior Disciplinary Manager, i.e the Medical Director, and expertise in the field under investigation. Rarely the investigation will be chaired by an independent party. Members should have no direct involvement in the activity under investigation. Any Hearing which takes place will be conducted in accordance with the Trust Disciplinary Hearing Procedure (2009). The Trust undertakes to conduct such investigation in a timely manner, bearing in mind the MRC Guidelines (997), but cannot commit to specific deadlines in any individual case. Comprehensive notes will be taken at each stage of the review and investigative process. All notes should be stored in a safe

8 and secure environment during the process and filed within the R&D Office once the matter is concluded. All documentation will be handled in accordance with the provisions of the Data Protection Act Outcomes of an Investigation If the investigation concludes that research misconduct or fraud has taken place one or more sanctions may be appropriate at the discretion of the Director of R&D or, in event of full investigation, the Disciplinary Manager with the support of R&D and HR: i) withdrawal of NUH R&D approval for the specific research project ii) withdrawal of Trust or other funding iii) withdrawal or correction of pending or published abstracts and papers emanating form the research project in question iv) increase of the Risk Index for the research project in question, resulting in frequent auditing/monitoring and closer attention to future work originating from the researcher. v) barring of the researcher from applying for future research funding or conducting any research within NUH. vi) revoking an honorary contract/letter of access vii) report researchers to ethics committees and professional bodies.

9 0. Equality and Diversity All patients, employees and members of the public should be treated fairly and with respect, regardless of age, disability, gender, marital status, membership or non-membership of a trade union, race, religion, domestic circumstances, sexual orientation, ethnic or national origin, social & employment status, HIV status, or gender reassignment. Equality Impact Assessment NUH is committed to ensuring that none of its policies, procedures, services, projects or functions discriminate unlawfully. In order to ensure this commitment all policies, procedures, services, projects or functions will undergo an Equality Impact Assessment. Reviews of Equality Impact Assessments will be conducted in line with the review of the policy, procedure, service, project or function. References Research Governance Framework for Health and Social Care, 2 nd ed, April NUH Disciplinary Policy, Disciplinary Investigation Procedure and Disciplinary Hearing Procedure Code of practice for Research, UK Research Integrity office, September 2009

10 Appendix EQUALITY IMPACT ASSESSMENT TEMPLATES / FORMS. Name of Policy or Service Research Fraud and Misconduct Policy 2. Name of Responsible Manager Maria Koufali 3. Name of person completing assessment Helen Jones 4. Date EIA Completed 03 August Description and Aims of Policy/Service (including relevance to equalities) The aim of this policy is to set out clearly what constitutes research misconduct and fraud and the processes to be followed when failure to comply with the relevant legislative and regulatory frameworks is suspected and identified 6. Results of Initial Screening or Full Equality Impact Assessment: Equality Group Age Gender Assessment of Impact

11 Race Sexual Orientation Religion or belief Disability Dignity and Human Rights Working Patterns Social Deprivation 7. Decisions and/or Recommendations (including supporting rationale) None Equality Area Gender Key Equalities Legislation / Policy (See summary sheet) Sex Discriminati on Act 975 Equal Pay Act 970 Equalities Act 2006 Gender Recognition Act 2004 Is this policy or service RELEVA NT to this equality area? YES / Assessment of Potential Impact: HIGH MEDIUM LOW T KWN positiv e (+) negative (-) Reasons for Assessme nt Race Race Relations Act 976

12 Disability Age Sexual orientation Religion and beliefs Social Deprivatio n Dignity and Human Rights Race Relations (Amendmen t) Act 2000 Disability Discriminati on Act 995 and 2005 Age Regulations 2006 Equalities Act 2006 Relevant employment legislation Equalities Act 2006 Relevant employment legislation Neighbourh ood Renewal Strategy Tackling Health Inequalities Local Area Agreement Human Rights Act 998 (relevant

13 Working Patterns articles) The Parttime Workers (Prevention of Less Favourable Treatment) Regulations Monitoring and Review Arrangements Review to be carried out October 202

14 Appendix 2 WE ARE HERE FOR YOU ASSESSMENT To what extent is your Policy or Trust-wide Procedure affected by the following We Are Here For You values? Please rate each value from 3 ( being not at all, 2 being affected and 3 being very affected). Polite and Respectful Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people s individuality, privacy and dignity. 2. Communicate and Listen We take the time to listen, asking open questions, to hear what people say; and keep people informed of what s happening; providing smooth handovers. 3. Helpful and Kind All of us keep our eyes open for (and don t avoid ) people who need help; we take ownership of delivering the help and can be relied on. 4. Vigilant (patients are safe) Every one of us is vigilant across all aspects of safety, practices hand hygiene and demonstrates attention to detail for a clean and tidy environment everywhere. 5. On Stage (patients feel safe) We imagine anywhere that patients could see or hear us as a stage. Whenever we are on stage we look and behave professionally, acting as an ambassador for the Trust, so patients, families and carers feel safe, and are

15 never unduly worried. 6. Speak Up (patients stay safe) We are confident to speak up if colleagues don t meet these standards, we are appreciative when they do, and are open to positive challenge by colleagues. 7. Informative We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues. 8. Timely We appreciate that other people s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital. 9. Compassionate We understand the important role that patients and family s feelings play in helping them feel better. We are considerate of patients pain, and compassionate, gentle and reassuring with patients and colleagues. 0. Accountable Take responsibility for our own actions and results. Best Use of Time and Resources Simplify processes and eliminate waste, while improving quality

16 2. Improve Our best gets better. Working in teams to innovate and to solve patient frustrations TOTAL 2

17 Appendix 3 EMPLOYEE RECORD OF HAVING READ THE POLICY RESEARCH MISCONDUCT AND FRAUD POLICY AND PROCEDURES I have read and understand the principles contained in the named policy. PRINT FULL NAME SIGNATURE DATE