SEN17D016. Issue. Recommendation

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1 SEN7D6 Title: UEA Annual Research Integrity Report 26/7 Author: Dr Helen Brownlee (RIN) Date: 23 rd October 27 Circulation: Senate 8 November 27 Agenda: SEN7A Version: Final Status: Open Issue The Concordat to Support Research Integrity recommends that employers of researchers present a short annual statement to their governing body concerning research integrity. The Concordat also recommends that this statement is made publically available to improve accountability, and provide assurances that measures being taken continue to support consistently high standards of research integrity. Recommendation Recipients are invited to receive and accept the attached report summarising activities undertaken to support and strengthen understanding and application of research integrity issues in the period st August 26 to 3 st July 27, which was reviewed and approved by the University Research Ethics Committee on 8 th October 27 and by the University Research Executive on 9 th October 27. That assurances be given to Council on the activities undertaken to support and strengthen understanding and application of research integrity issues across the University; that the processes in place for dealing with allegations of misconduct in research are transparent, robust and fair and are appropriate for the University s needs; and that the very small number of formal investigations of research misconduct undertaken mean that it is not possible to identify any trends and further analysis is not warranted. Resource Implications Support for research integrity is provided by RIN and by the Schools which are responsible for the management of researchers and for the University s Research Ethics Subcommittees (S-RECs). Personnel are already in post within RIN and the Schools to provide training sessions on research integrity. The two-page summary of the report would be made available on the University s Research Integrity webpage: and on the RIN portal page for Research Integrity: The University s Procedures for Dealing with Allegations of Misconduct in Research are currently under review and have been presented to Senate for approval (SEN7XXXX).

2 Risk Implications Failure to accept this report would compromise the University s Annual Accountability Return for 27 to the Higher Education Funding Council for England (HEFCE), which requires a statement of compliance with the Concordat to Support Research Integrity as part of its ongoing financial support. Equality and Diversity No equality and diversity issues are associated with this report. Timing of decisions Acceptance by Senate and recommendation of assurance to the Council will support the University s Annual Accountability Return for 27 to HEFCE which is currently being compiled. Further Information For further information contact: Dr Helen Brownlee, Research Integrity Manager, Research and Innovation Services on or h.brownlee@uea.ac.uk. Background The Concordat to Support Research Integrity encourages research active institutions to make an annual report to their governing bodies which: provides a summary of actions and activities that have been undertaken to support and strengthen understanding and application of research integrity issues; provides assurance that the processes that they have in place for dealing with allegations of misconduct in research are transparent, robust and fair and that they continue to be appropriate to the needs of the organisation; and provides a high-level statement on any formal investigations of research misconduct that have been undertaken. This report summarises UEA s activities and issues relating to Research Integrity in the period st August 26 to 3 st July 27 in alignment with the university s academic and financial years. There were two cases of misconduct in research in the reporting period; both have had the allegation of research misconduct upheld. With such small numbers of cases it is not possible to identify any trends and further analysis is not warranted. In addition, the Concordat recommends: to improve accountability, and provide assurances that measures being taken continue to support consistently high standards of research integrity, this statement should be made publically available. The University s Annual Research Integrity Report has not been made publically available before. Discussion No discussion is anticipated. Attachments The annual report including a breakdown by S REC (Annex ) is attached. 2

3 Annual Research Integrity Report 26/7 Summary This short statement is produced annually for the University Research Executive to consider and is presented thereafter to the University s Senate and Council to approve. The report provides a summary of activities and issues relating to the support and implementation of research integrity, and processes relating to allegations of misconduct in research in the period st August 26 to 3 st July 27. This Summary will be made available to the public on the University s Research Integrity website. The University is fully committed to ensuring that all research undertaken by staff and students is carried out to the highest professional standards of research integrity, and that all researchers uphold the principles set out in the Universities UK Concordat to Support Research Integrity. The term Research Integrity has been adopted internationally to describe the core principles and responsibilities that should be common to all good research. Responsibility for maintaining the highest standards of research integrity at the University rests with the Pro Vice Chancellor for Research and Innovation (PVC R&I). The University s Research and Innovation Services (RIN) support the PVC R&I in this area, and have a Research Integrity Manager who is also the first point of contact for any queries on the relevant policies or process to follow. RIN also has formal nominated representatives who act as legal representatives (under the Health Research Authority s (HRA) Sponsor requirements) for all NHS related studies in accordance with the HRA s UK Policy Framework for Health and Social Care Research (HRA Framework). RIN further advises on legal and regulatory requirements. In addition, the University has an overarching committee, the University Research Ethics Committee (U REC), to define the University's Research Ethics Policy and operational principles. It also has oversight of the University s Research Ethics Subcommittees (S RECs). U REC is led by a Chair appointed by the PVC R&I, and is constituted from the S REC Chairs, lay members and co opted experts. The S RECs provide ethics reviews of student and staff research projects and teaching modules. In 26/7, they also undertook ethics reviews of internally funded impact projects in support of the University s stance that ethics issues should be considered throughout the lifecycle of a project. Occasionally, ethics reviews have been undertaken by the S RECs for academics in the Norwich Biosciences Institutes to facilitate efficient operations across the Norwich Research Park. During the reporting period, a total of 783 proposals were reviewed within the University of which 735 were given ethical clearance. Governance arrangements in support of research at the University include a number of research integrity policies and guidelines. The University is also required to comply with UK legislation relating to research, as well as Concordats and codes of practice issued by funding bodies and collaborating organisations. In 26/7, the University became one of the 735 organisations which support the AllTrials Campaign, which calls for all past and present clinical trials to be registered and their full methods and summary results reported regardless of the research outcome. The Concordat to Support Research Integrity. 3

4 The University has a rolling programme of reviews for its research integrity policies and guidelines. During 26/7, reviews of the following policies and guidelines were initiated: Guidelines for Good Practice in Research (last reviewed and approved by Senate in November 25) Procedures for Dealing with Allegations of Misconduct in Research (last reviewed and approved by Senate in February 23) Open Access Policy (last reviewed and approved by Senate in June 25) Research Data Management Policy (last reviewed and approved by Senate in November 25) The University s Research Ethics Policy was reviewed in 25/6 and approved by Senate in November 26. To help researchers comply with institutional procedures relating to research ethics, and research integrity standards expected by the University, specific Ethics Guidance Notes covering a range of topics were issued by U REC in 26/7. These are available on the University s Research Integrity intranet. To further promote best practice within the University, it was agreed to include additional guidelines on ethical considerations for academics in the University s Module Online Guidance when seeking Module approval. A new Policy for Approving the Integrity of UEA Research and Enterprise Related Activities and Funding was approved by Senate and Council in March 27 to ensure that any proposed research and innovation activity and acceptance of any associated external funding is consistent with the University s stated principles and standards of integrity and ethical practice. The University has Procedures for Dealing with Allegations of Misconduct in Research, which outline the actions to be taken when any allegation of misconduct in research is brought against any present or past member of staff of the University in respect of research undertaken while employed by the University and / or while registered as a student at the University. During 26/7, there was one formal investigation concerning a member of staff and one concerning a student Good data management is a fundamental aspect of the research process, and in light of the recent Concordat on Open Research Data, the University is now making research data gathered and generated by its academic staff openly available for use by others in the UK research community wherever possible. Alongside U REC, the University with the NNUH Trust operates a Joint Research Governance Policy (revised with effect from January 27) together with joint UEA and NNUH Standard Operating Procedures (revised according to an agreed schedule), which apply to all healthcare research within the NNUH Trust and the UEA, under the HRA Framework. These documents are available on the NNUH website. Professor Fiona Lettice Pro Vice Chancellor for Research and Innovation October 27 4

5 Report Further details supporting the above Summary are presented below and will not be made available to the public. The information is provided under three main sections a summary of UEA activities relating to research integrity, development of UEA s research integrity framework, and arising issues or areas for further development and consideration. Summary of UEA Activities Relating to Research Integrity Activity Number ( ) Number ( ) Number ( ) Comments on 26/7 Activity Research Ethics Subcommittees (S RECs):. Proposals reviewed 2. Proposals approved 3. Alleged misconduct cases 4. Incident reports for adverse events 5. Incidents of non compliance A breakdown by S REC is provided in Annex. S RECs have this year also reviewed internally funded impact projects. University Research Ethics Committee (U REC):. Proposals reviewed 2. Proposals approved U REC has reviewed surveys by Central Services, and two nonstandard ethics requests. New alleged cases of research misconduct:. Staff 2. Staff/Student 3. Student Number of Serious Adverse Events for UEA sponsored healthcare studies Number of breaches of Good Clinical Practice for UEA sponsored healthcare studies * ** ** 5 *Allegation substantiated and further actions being considered. **Referred to SSDC allegation of research misconduct upheld and action taken Across two studies. None of the SAEs were assessed as being related to the study. SAEs reported to NNUH / UEA Joint Research Governance Committee. Freedom of Information requests

6 Development of UEA s Research Integrity Framework During the reporting period the framework in support of Research Integrity has been developed as follows:. The University s research integrity guidelines / policies are subject to periodic (normally three year) reviews. This year the U REC has been given responsibility to comment on those under review before being considered by the University Research Executive. During the year, the following reviews have been approved by the University Research Executive with a version date of June 27: Guidelines for Good Practice in Research (last reviewed and approved by Senate in November 25) Open Access Policy (last reviewed and approved by Senate in June 25) Research Data Management Policy (last reviewed and approved by Senate in November 25) These documents will be submitted for approval by Senate on 8 th November 27. In addition, the review of the University s Procedures for Dealing with Allegations of Misconduct in Research (last reviewed and approved by Senate in February 23) has been initiated. 2. The University s Research Ethics Policy and Principles document was reviewed in 25/6 and approved by Senate on 9 th November 26. To support the revised Research Ethics Policy, 9 specific Ethics Guidance Notes were written in 26/7 and are now available for researchers on the University s Research Integrity intranet. The latter has undergone a major redevelopment this year to provide concise research ethics information for researchers. 3. A new Policy for Approving the Integrity of UEA Research and Enterprise Related Activities and Funding was approved by Senate and Council in March 27. This policy outlines the principles within the University for considering proposed research and innovation activities and any associated external funding to ensure that they are consistent with the University s stated goals and standards of integrity and ethical practice. 4. In July 27, it was agreed that occasional research projects within the Norwich BioScience Institutes (NBI) could be submitted to the University s Animal Welfare and Ethical Review Body (AWERB) for ethics approval. This supplements the agreement in July 26 that occasional research projects within the NBI could be submitted to the University s FMH REC for ethics approval on the understanding that: i.) the NBI researcher will accept the FMH REC decision, and ii.) the FMH REC may suggest that a project is submitted to the Health Research Authority (HRA). 5. The Concordat on Open Research Data was published in July 26 to help to ensure that the research data gathered and generated by members of the UK research community is made openly available for use by others wherever possible in a manner consistent with relevant legal, ethical, disciplinary and regulatory frameworks and norms, and with due regard to the costs involved. Metadata for datasets arising from RCUK funded research is now being captured in Pure, and will be extended to other funders. 6

7 6. In 26/7, the University agreed to become a signatory to the Concordat on Openness in Animal Research, which commits its signatories to supporting clear, transparent and open communication and proactive public engagement on this subject. It also became one of the 735 organisations that support the AllTrials Campaign: supporting the registration of all trials prior to the research happening and reporting of all research regardless of outcome. 7. It was agreed following discussions between RIN and LTS, to include additional guidelines in the University s Module Online Guidance on ethical considerations for academics when seeking Module approval. 8. The University s Procedures for Dealing with Allegations of Misconduct in Research have been required for one staff case and one postgraduate student case since August 26. The staff/student investigation in progress since 25/6 was referred to the Senate Student Disciplinary Committee in 26/7 and the allegation of research misconduct was upheld and action taken. 9. Revised Terms of Reference of the NNUH / UEA Joint Research Governance Committee were discussed during 26 and a revised policy was approved with effect from January 27, which is available on the NNUH website.. The Joint Research Governance Committee has a newly appointed Chair, Professor Ann Marie Swart, with newly appointed members to represent the different areas of research. This Committee now additionally reviews recruitment onto major UEA studies.. The Research Governance Operations Group have been reviewing the NNUH / UEA Standard Operating Procedures (SOPs) as part of an organised programme, and have established a sub group to finalise those that are outstanding. 2. Training and workshop activities have been undertaken with staff, students and Research Ethics Committee members on research integrity, research ethics and governance. Issues and Future Development Issues arising for further development and consideration are:. Compliance with the Concordat to Support Research Integrity is a status that needs to be maintained, and this requires training and development of staff, students and members of Research Ethics Committees. The University has a subscription to the UK Research Integrity Office (UKRIO) and among other benefits it has produced a Concordat Self Assessment Tool, which enables universities to approach compliance in a structured way. 2. Raising the awareness of research ethics issues has been identified as a priority by the PVC R&I, the Head of Research Services, the Research Integrity Manager and the U REC Chair. The latter will take this forward initially through attending the autumn meetings of the Faculty Research Execs. It is essential that the information percolates to all staff and students to be aware of the University s requirements for ethics review. 7

8 3. In 27/8, RIN will offer training in research integrity through a combination of scheduled CSED courses, and bespoke training as required by Faculties / Schools / Committees / Individuals etc. Online training in research ethics, similar to that implemented in August 27 for Data Protection, would be beneficial to students and staff. RIN are currently exploring externally provided online research ethics training modules. 4. The new General Data Protection Regulation (GDPR) comes into force In May 28 replacing the Data Protection Act. The University will need to consider the impact of this on research studies and data when more details are released in due course. 5. Discussions with primary care on a joint policy for the research governance of health related projects continued during 26/7 and will be finalised during 27/8, including discussion with the relevant Faculties prior to approval. 6. Work will continue in 27/8 with the Quadrum Institute Biosciences to ensure efficient and simple to use research governance processes wherever possible across the member organisations. 7. The application of the forthcoming EU Clinical Trials Regulation (EU no 536/24) is linked to the full functionality of the EU portal and database under development by the European Medicines Agency (EMA). It is anticipated that this will come into application in 29. The implications for the UK following Brexit will also need to be followed carefully. 8. The Joint Research Operations Group will be reviewing the format and usability of the joint NNUH / UEA SOPs, and will be making a recommendation to the Joint Research Governance Committee on how these should be developed going forwards. Dr Helen Brownlee Research Integrity Manager, RIN 23 rd October 27 8

9 Annex Research Ethics Subcommittee Number of Proposals Reviewed Number of Proposals Approved Number of Alleged Misconduct Cases Number of Incident Reports for Adverse Events Number of Incidents of Non- Compliance Comments AWERB Project Licence proposals for Home Office, 3 small projects (mainly observational, not requiring HO approval). CMP-REC proposals were returned for revision. DEV-REC 29 ECO-REC EDU-REC FMH-REC 3 99 A masters student had been misadvised by their supervisor and so failed to obtain ethical clearance for fieldwork. It was a reasonably quiet year. Some proposals were sent back for changes before being approved. proposal was withdrawn. The misconduct allegation resulted in a warning letter being sent to the UG student concerned. proposal was deemed not to be within the remit of the FMH-REC. GENERAL-REC (G-REC) non-standard proposals were referred to U-REC so not included here. 4 proposals were received in 25/6 but reviewed in 26/7 so included here. G-REC reviewed 22% more proposals in 26/7 than in 25/6. ENV UG student proposals are now reviewed by G-REC rather than within ENV. NBS-REC 9 8 PSY-REC 4 3 SWK-REC 4 4 proposal was referred for approval to the FMH-REC. Proposals were rejected if ethical issues could not be practically resolved within the time frame, and/or if they were beyond the scope of PSY-REC (e.g. requiring NHS ethics). TOTAL Note that the above figures include a small number of retrospective ethics approvals which is being trialled within UEA. 9