STANDARD OPERATING PROCEDURE SOP 220 Investigation of allegations of Research Fraud and Misconduct Version 1.4 Version date 27.02.2018 Effective date 2.03.2018 Number of pages 8 Review date February 2020 Author Role Approved by Role NNUH UEA Joint Research Office Julie Dawson Acting Research Services Manager Signature Date 2.03.2018 Authorised for NNUH & UEA by Role Professor Alastair Forbes Chief of Research and Innovation Signature Date 2/3/18 Page 1 of 8
It is the responsibility of all users of this SOP to ensure that the correct version is being used. All staff should regularly check the NNUH R&D website for information relating to the implementation of new or revised versions of SOPs. Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use. The definitive versions of all Joint NNUH/UEA health care research SOPs appear online. If you are reading this in printed form please check that the version number and effective date is the most recent one as shown on the NNUH R&D website: http://www.nnuh.nhs.uk/dept.asp?id=681 TABLE OF CONTENTS 1 ABBREVIATIONS 3 2 INTRODUCTION 3 3 SCOPE 3 4 PRINICIPLES 4 5 RESPONSIBILITIES AT NNUH 5 6 RESPONSIBILITIES AT UEA 6 7 REFERENCES 6 8 RELATED DOCUMENTS 7 9 LIST OF APPENDICES 7 Appendix 1: Change Control, Revision and Review Sheet 8 Page 2 of 8
1 ABBREVIATIONS GCP Good Clinical Practice ICH International Conference for Harmonisation NNUH Norfolk and Norwich University Hospital R&D Research & Development RCUK Research Councils UK RIN Research and Innovation Services at UEA SOP Standard Operating Procedure UEA University of East Anglia UK RIO UK Research Integrity Office 2 INTRODUCTION NNUH and UEA are committed to maintaining the highest standards of integrity and probity in the conduct of research. The aim of this SOP is to describe the principles, responsibilities and procedures to be followed when there has been an allegation made related to misconduct or fraud in conducting research within NNUH and UEA. It is established in accordance with ICH GCP, the Medicines for Human Use (Clinical Trials Regulations (2004), the UK Policy Framework for Health and Social Care Research (2017). It outlines the process to be followed locally for the reporting and investigation of allegations of fraud and misconduct. 3 SCOPE This SOP applies to all research sponsored by or conducted at NNUH or UEA which falls within the scope of the UK Policy Framework for Health and Social Care Research (2017). Where additional legislation applies for example the Medicines for Human Use (Clinical Trials) Regulations 2004 (and amendments) or the Medical Devices Regulations 2002, required procedures will be indicated. While external sponsors may also require the use of their own SOPs and this will be specified in site agreements, this SOP covers all research conducted by NNUH and UEA staff and all research conducted at NNUH and UEA (even if not conducted by NNUH or UEA staff). It is the responsibility of the local PI to ensure that study specific SOPs can be operated without conflict to this SOP and in accordance with all organisational polices related to research. For the purposes of this SOP the definition of scientific misconduct is taken from the Medical Research Council Misconduct Policy and Procedure (December 2014). Scientific misconduct means the fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting results of research and deliberate, dangerous or negligent deviations from accepted practice 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 misconduct in research by collusion in, concealment or such actions by others. Page 3 of 8
It does not include honest error or honest differences in the design, execution, interpretation or judgement in evaluating research methods or results or misconduct (including gross misconduct) unrelated to the research process. 4 PRINCIPLES 4.1 The NNUH and UEA expect all research to be carried out to the highest standards, irrespective of the nature of the research or its Sponsor. It is the responsibility of all those participating in or conducting research involving NNUH and/or UEA staff, patients and premises to be aware of the principles of GCP, the UK Policy Framework for Health and Social Care Research, UK RIO Code of Practice for Research, Standard Operating Procedures (SOPs) for research and applicable regulations and to avail themselves of any relevant training provided to support good practice in research. 4.2 Allegations of Fraud or misconduct are serious for the person against whom the allegations are being made and for the organization. It is, therefore, the responsibility of anyone making an allegation of fraud or misconduct to put their name to a written statement outlining the allegation. There may be circumstances where the information source may have to be disclosed to individuals during the investigation in order for it to progress. 4.3 Individuals who are named in an allegation will be informed of the allegations made against them, with the supporting evidence, in writing, taking confidentiality into consideration. The point at which this notification occurs will depend on the circumstances of the case and the processes of the organization receiving the notification. The named individual will be given an opportunity to respond and if they wish can be accompanied by a colleague or staff representative. 4.4 Investigations will be made as quickly as possible, dependent on the circumstances of the allegation. 4.5 A report of the outcomes of the investigations will be made known to the persons involved, including the person/s accused and the person/s making the allegation. This report will be treated in a confidential manner. 4.6 Where an allegation involves external funding then the Funding body will be made aware of the relevant aspects of a substantiated allegation at the earliest opportunity. 4.7 Where allegations of misconduct or fraud are upheld and disciplinary or other action is to be taken the individual will have the opportunity to put their case forward and respond to allegations in accordance with the principles of natural justice i.e. the right to a fair hearing and the rule against bias and in accordance with NNUH or UEA procedures. 4.8 Where the substantiated allegation has implications for Clinical conduct and governance then the Medical Director and Clinical Director of the relevant Trust will be informed. Where nursing misconduct is involved then the Director of Nursing of the relevant Trust will be informed. Page 4 of 8
4.9 Where allegations of research fraud or misconduct are upheld, depending on the circumstances, further actions may need to be taken to inform relevant organisations, individuals and to correct the scientific record. These could include:- funders, collaborators, publishers, patent office, licensees etc and potentially research subjects. 4.10 If an allegation is made which is subsequently found to be malicious and/or vexatious then the individual making this claim may be subject to disciplinary or other appropriate action. Suspicious activity reported in confidence and in good faith which are not confirmed by investigation will not lead to any action against that person being taken. 4.11 Where a clinical incident occurs which affects research then the relevant NNUH Clinical Director will work with the NNUH Chief of Research and Innovation. 4.12 This procedure will operate in conjunction with existing Trust, NHS and UEA policies and processes as relevant. 5 RESPONSIBILITIES AT NNUH 5.1 All NNUH staff, including those with honorary contracts have a duty to report any incident of misconduct, whether witnessed or suspected. Allegations should be made either directly to the Chief of Research and Innovation or to the Research Services Manager. Anyone who feels unable to speak to either of these individuals, should tell their line-manager who should report as outlined above. If notified, the Research Services Manager will ensure that the Chief of R&I is notified as soon as possible. Where the notification involves staff having a contract of employment with UEA or UEA Registered Student, the Research Services Manager shall notify the RIN Research Integrity Manager. In the event that the Chief of R&I is involved in the allegation then the allegation should be made to the Medical Director or to the Research Services Manager who will in turn notify the Medical Director. 5.2 The Chief of R&I will ensure that a formal investigation into allegations of fraud and misconduct is undertaken by a suitably independent and qualified group of individuals. As the persons conducting the investigation should not be the persons making decisions on the findings, in the interests of fairness, the Chief of R & I will not conduct the investigation personally. The Chief of R&I will: Decide how an investigation will take place Select who will conduct the investigation, and delegate responsibilities as appropriate including appropriate inclusion of UEA staff where relevant Decide on further actions required including any actions pertaining to the safety of subjects and the security and integrity of evidence. Page 5 of 8
Inform relevant senior officers including the Director of Resources if there are financial implications, the Head of Legal if there may be contractual or legal repercussions. Report to the NHS Counter Fraud Service if there is a substantiated serious allegation of fraud and follow their advice. Involve Human Resources if appropriate Notify the Joint Research Governance Committee, subject to issues of confidentiality. Inform employers of those individuals holding honorary contracts if allegations are substantiated. It will be the responsibility of the substantive employer of these staff to undertake any further disciplinary action. The Chief of R&I should document their analysis of the investigation report and their conclusions. This should include their decision on the allegations and the next steps with respect to the person against whom the allegations were made, the person who made the allegations and, if relevant in terms of correcting the research record. Ensure that the report of the investigation and the conclusions of the Chief of R&I are recorded on the R&D Database and a note placed in the Trial Master File pertaining to the study involved in the investigation. Decide on who should be notified formally and any relevant procedures that should be changed as a result of the findings of the investigation. Report to the Medical Director and Director of Nursing if further disciplinary action for clinical staff is required. Consult with the Trust legal team where there may be legal implications of the allegation 6 RESPONSIBILITIES AT UEA 6.1 All UEA staff, including those with honorary contracts, have a duty to report any incident of misconduct, whether witnessed or suspected. The process of reporting and investigating alleged incidents of misconduct is specified in the UEA Procedures for Dealing with Allegations of Misconduct in Research (October 2017). 6.2 Additionally, where the incident involves any member of staff employed by an NHS Trust then the Registrar and RIN Research Integrity Manager shall notify the R&D Office of the relevant Trust of the existence of the allegation and of the process that will be followed to investigate it. 7 REFERENCES EU Directive 2001/20/EC ICH GCP E6 Guideline for Good Clinical Practice Medical Research Council: Policy and Procedure for Investigating Allegations of Research Misconduct: November 2014 Research Governance Framework for Health and Social Care (DH 2005) Page 6 of 8
RESEARCH MISCONDUCT AND FRAUD: NHS R&D Forum: Good Practice Guidance July 2004 The Concordat to support research integrity: Universities UK (July 2012) RCUK Policy and Guidance on Governance of Good Research Conduct (February 2013) UEA Guidelines on Good Practice in Research (November 2017) UEA Procedures for Dealing with Allegations of Misconduct in Research (October 2017) 8 RELATED DOCUMENTS SOP 710 Audit and inspection SOP 330 Monitoring Clinical Trials SOP 210 Protocol Violations 9 LIST OF APPENDICES Appendix 1: Change Control, Revision and Review Sheet Page 7 of 8
Appendix 1: Change Control, Revision and Review Sheet Change Control, Revision and Review Sheet: SOP 220 Version No Change Date Reason for Change 1.1 31/01/2011 SOP updated to reflect UEA/NNUH joint working arrangements. 1.2 01/01/2014 Extension of review date to 31.01.2014 1.4 27/02/2018 SOP updated to clarify the process and to reflect new reference documents and versions and role titles and combining change control and revision sheets. Reviewer: Designation: Signature and Date: Reviewer: Designation: Signature and Date: Reviewer: Designation: Signature and Date: Page 8 of 8