Annual Statement on Research Integrity 2023/24

New Developments in Research Governance, Ethics and Integrity

a) A project is underway to develop the University’s Framework for Responsible Research and Innovation aimed at strengthening the partnerships between the different agendas that support responsible research and innovation (RRI) within the University and build on University initiatives to advance and pilot RRI in order to develop effective and integrated support mechanisms to assist researchers to conduct their research responsibly.

b) In June 2022 Universities UK published “Managing risks in international research and innovation: an overview of higher education sector guidance”.  In response to this paper and to the National Protective Security Authority (NPSA) Trusted Research guidelines, the University has developed a Quality Management System of policies, processes, documented procedures and records intended to provide assurance to RCC that the risks inherent in international research are being appropriately managed.   

Priorities for 2023/2024

a) To address the risks related to international research by:

• Implementing and embedding the newly developed Quality Management System with effective reporting through to RCC.
• Ratifying and effectively communicating the University’s Policy on the Governance of International Research Activities and Collaboration.

b) Given that it has been over 10 years since the MHRA, and 4 years since EPIC Auditors, audited the University’s quality systems for regulatory responsibilities linked to clinical trials, and that new quality systems have been developed for medical device trials, another independent external audit will be arranged for summer 2023.

c) In an effort to improve the overall functionality, ease of use and engagement with the University’s research ethics process, the application form of the Ethical Review Manager system will be upgraded. Extensive consultation will take place across the Faculties in order to gain the viewpoints of a variety of stakeholders and further support the University’s EDI objectives. It is intended that the upgraded version of the form will be released in August 2023 and will contain refined and tailored versions of the application form for different types of research activities such as social media research and collaborations with third party panel providers, thus improving the experience for both users and committee members.

 Investigations into Allegations of Research Misconduct and complaints received between June 2022 and April 2023

New Developments in Research Governance, Ethics and Integrity

a)       In line with our priority for 2021/22, we have drafted a Research Integrity Promotion Plan for the University and established a Research Integrity Promotion Group to take the agenda forwards.

b)      The University’s Code of Good Research Conduct and Code of Practice for Investigating Concerns about the Conduct of Research have been revised in line with their review dates, following consultation across the Faculties and have been approved and published.

c)       The Policy for Use of Animals in Research and Teaching has been revised as part of a periodic review and to include teaching activities. 

d)      The University launched its SafePod, which is part of the SafePod Network (SPN), a major research innovation to provide and manage a network of standardised safe settings (SafePods) across the UK for data that requires secure access for research. Based in the main library, it is a small standardised safe setting which includes a door control access system, CCTV, a researcher area for the analysis of datasets and a separate secure storage area for IT equipment. The SafePod is also wheelchair accessible and includes a height adjustable desk.

 Investigations into Allegations of Research Misconduct and complaints received between June 2021 and June 2022

New Developments in Research Governance, Ethics and Integrity

1. In accordance with our priority for 2020/21, we have reviewed our current structures and governance arrangements in order to meet the need to make financial savings whilst assuring regulatory compliance. As a consequence the RGT, based in FBMH has been incorporated into the Research Governance, Ethics and Integrity Team.
2. In order to meet our 2020/21 priority to continue work on mitigating governance risks in international research collaborations, The University has established a new governance group, the Research Relationship Oversight Group (RROG), to review and assess the suitability of our research relationships with external organisations.A revised Policy on the Involvement of Human Participants in Research has been approved.
3. A revised Policy on the use of Animals in Research and Teaching Activities has been approved.
4. We have developed and published a Standard Operating Procedure for suspending/prematurely closing a research project to ensure that The University has adequate oversight when a research project has to be suspended or prematurely closed. 
5. We have approved a Policy on Compliance with the Nagoya Protocol which covers the utilisation of non-human genetic material from outside the UK for the purposes of research.
6. CRUK MI now holds its own Establishment Licence for its ASPA activities in the Incubator building.
7. The radiochemistry production facility at the WMIC closed down in Dec 2020. The request to cancel the University of Manchester manufacturing licences has been approved by the MHRA. The University is now no longer authorised to manufacture, assemble of import medicinal products for human use.

 Investigations into Allegations of Research Misconduct and complaints received between June 2020 and May 2021

New Developments in Research Governance, Ethics and Integrity

1. We have appointed an Academic Director for Research Governance, Ethics and Integrity who, working closing with the Research Governance, Ethics and Integrity Team, is responsible for setting the standards of research governance, ethics and integrity and ensuring that processes and procedures are in place to enable compliance with those standards. This new role reports to the Vice President for Social Responsibility.
2. We have published a revised Code of Good Research Conduct and Code of Practice for Investigating Concerns about the Conduct of Research.  The changes take account of lessons learnt from cases investigated; updates to the UUK Concordat to Support Research Integrity; and changes to funder terms and conditions.  The changes underwent consultation via University Research Group and were approved by Senate. 
3. In accordance with our priorities for 2019/20, we have implemented on-line research ethics training for supervisors in the Faculty of Biology, Medicine and Health.
4. An HRA Oversight Committee has been established and HRA approvals are now reported as a separate area of compliance to RCC.

Investigations into Allegations of Research Misconduct and complaints received between June 2019 to May 2020

New Developments in Research Governance, Ethics and Integrity

1. We have implemented mandatory research integrity training for all PGR students and staff whose role involves research.  The training is delivered online by an external company called Epigium.  PGR students are required to undertake a five hour extensive course, while staff are required to undertake a one hour comprehensive course, although encouraged to look through the longer course.  There is an expectation that training should be repeated every three years. 
2. We have developed an online research ethics training course for supervisors in the Faculty of Humanities which aims to improve their understanding of research ethics.  This training will enable supervisors to provide the correct guidance and support to their students.  A similar training package is currently under development for the Faculty of Biology, Medicine and Health Sciences and a package for the Faculty of Science and Engineering is planned.
3. The Manchester Clinical Trials Unit (MCTU) transferred successfully to The University of Manchester on 1^st August 2018.  Research Compliance Committee is now overseeing regulatory compliance for this new area of responsibility.

Investigations into Allegations of Research Misconduct and complaints received between June 2018 to May 2019

New Developments in Research Governance, Ethics and Integrity

1. Since the fire at the Paterson Building housing the CRUK MI animal facility (BRU), the facility has successfully relocated to Alderley Park.  The facility is owned and managed by AstraZeneca.  During 2018, a new small facility is being developed in the Kay Kendall laboratory at the Christie Hospital.  This is for the transplantation of time-critical tumour samples to form patient-derived xenograft and circulating tumour cell derived xenograft models.  The facility is currently undergoing temperature and humidity testing ahead of it being added to the CRUK MI Establishment Licence.  The Home Office Inspector has toured the facility and is comfortable with the plans.  Relatively few mice will be housed there and, following a period of recovery, will be transferred to the facility at Alderley Park.
2. Research Compliance Committee has taken responsibility for oversight of export controls in order to comply with the UN requirements to have a system of controls on exports of certain goods and technologies that, in addition to legitimate civilian applications, may also be misused for severe human rights violations, terrorist acts or the development of weapons of mass destruction.  Appropriate processes are being put in place by the University to ensure that individual academics who need an export licence from the Export Control Organisation (ECO) in order to carry out an activity related to their research have the appropriate licence in place.
3. In 2015/16 we implemented an on-line ethical review process for the University’s ethics committees which provided a more efficient and user-friendly experience for applicants.  In May 2017 we introduced ‘proportionate review’ for low-risk projects in order to make further efficiencies.  Since proportionate review was introduced 155 applications have gone through this process.  As these applications are initially reviewed within 10 working days of receipt, it has reduced the average turnaround time for UREC approval from 27 working days to 16 working days.  This has saved the Committees 212 hours of work (including 19 meetings).
4. The University’s strong commitment to the Concordat on Openness on Animal Research is reflected in its ground-breaking animal research website developed over the past two years which publishes anonymised non-technical license summaries and ethics committee minutes, welfare policies, case studies, governance information, and infographics on the species and numbers of animals we use every year.  It was given an openness award in 2016 by “Understanding Animal Research”, a respected not-for-profit organisation which aims to achieve a broad understanding of the humane use of animals in research.  The website forms the core of an animal research communications and engagement strategy which the University published in April 2018 as a UK first.  It will also shortly be the only UK University website to host a virtual tour of its animal facility, which enables viewers to navigate their way around 12 different rooms, clicking on icons to open video content.
5. The introduction of the chemical inventory, LabCup, is showing a positive impact on the quality and safety of research being carried out.  The implementation of the inventory is identifying many out-of-date chemicals and their disposal ensures that better quality research is undertaken using only chemicals within their expiry date and increased safety, as the storage of hazardous substances in the labs is being reduced.

Investigations into Allegations of Research Misconduct and complaints received between June 2017 to June 2018 

New Developments in Research Governance, Ethics and Integrity

1. In 2015/16 we implemented an on-line ethical review process for the University’s ethics committees.  The Ethical Review Manager (ERM) provides a more efficient and user friendly experience for staff and students at the University of Manchester.  Since the implementation of the system the average time for processing a UREC application has been reduced from 51.5 days (2015/16) to 20 days (2016/17).  Further reductions are anticipated with the implementation in May 2017 of proportionate review for low-risk staff or student projects.
2. We are supporting the transfer of the Manchester Academic Health Science Centre (MAHSC) Clinical Trials Unit from the Christie Hospital NHS Foundation Trust into the University of Manchester.  Professor Thakkar has chaired a Research Governance Working Group responsible for creating an assurance and compliance framework for the CTU including defining clear roles and responsibilities.  He is now chairing a Transition Strategy Group which will ensure these are implemented.
3. In order to support the University’s growing clinical trials portfolio, the University has entered into contractual arrangements with partner NHS Trusts to provide Sponsor Pharmacy support and support for monitoring clinical trials.
4. The University purchased a Chemical Inventory System in February 2017 to provide a single, consolidated management system for records of chemicals and other harmful substances, lasers and X-ray machines as well as radiochemicals and those regulated materials which require reporting.  The inventory will also facilitate compliance reporting which currently is done entirely manually.  The implementation across the University is ongoing after a successful pilot phase, which identified over 120 litres/Kg of legacy hazardous substances (mostly corrosive and flammables) to be disposed of in one building, thereby reducing the ongoing risk to the organisation.  Further reductions of legacy stocks would be expected in the rest of the buildings as the inventory rolls out.

Investigations into Allegations of Research Misconduct and complaints received between September 2016 to May 2017