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1.1. Introduction

This statement has been prepared as a summary of activities carried out by the Research Governance section in support of good research conduct and research integrity during the period 1 January to 31 December 2020.

1.2. General policies and processes

The University’s Code of Practice for Professional Integrity in the Conduct of Research was reviewed, updated and republished during the summer of 2019 in time for the beginning of the 2019/20 academic year and, in particular, the annual intake of new PhD students. This document reflects the Universities UK Concordat and addresses, in a style appropriate to Ulster, the required precepts and commitments.  The next review will take place during the summer of 2021.

1.3. Oversight

Research Governance Steering Committee (RGSC) was scheduled to meet twice during the period to address operational and strategic matters and to review reports and minutes from subordinate committees. Due to COVID-19 restrictions the meeting scheduled for April 2020 was replaced with an email update to members. The meeting scheduled for November 2020 took place online.

In turn, the minutes from RGSC were considered by Research & Impact Committee (RIC) and Senate.

The Committee will meet twice during 2021.

1.4. General communication with staff and students

Communication of policy requirements and procedural matters is via e-mail to all staff and students, reminding people of the Code of Practice for Professional Integrity in the Conduct of Research and to ensure that all are aware of the need for ethical review where appropriate. This will be scheduled on a quarterly basis for 2021.

1.5. Research misconduct

The University’s procedures for investigating allegations of research misconduct are reviewed regularly and are compliant with the format recommended by Universities UK and the UK Research Integrity Office.

One new allegation of research misconduct was received during the period. This was investigated in accordance with the Procedure. The outcome was that while some concerns had been identified, these were due to inexperience on the part of the researcher concerned and should be addressed through appropriate training and mentoring.

1.6. Research ethics – human participants

The University’s Research Ethics Committee (UREC) was scheduled to meet on 10 occasions during the period but alternative arrangements were put in place due to COVID 19 restrictions.  UREC reviewed 32 applications.

The accompanying detailed report (part 2) provides further information on the arrangements and activities of UREC and associated filter committees.

1.7. Regulation – animals

The University Animal Welfare and Ethical Review Body (or AWERB) met three times during the period and reviewed (i) updates to membership, policies and procedural documentation necessitated by revisions to reporting procedures under the Animal Scientific Procedures Act and (ii) individual personal and project licence renewals and applications. There are currently no outstanding matters of significance to be addressed. AWERB will meet three times in 2021.

In addition, the Biomedical and Behavioural Research Unit (BBRU) Management Committee, whose remit is to oversee general compliance and the efficient running of the animal research facility, met on two occasions during the period to review operational matters, advise on resources and ensure that staffing needs were addressed.

The formal annual inspection of the BBRU and meeting with the Establishment Licence Holder took place in January 2020.

1.8. Regulation – Human Tissue Act

The Human Tissue Act Working Group (HTAWG) was scheduled to meet twice during the period to review and resolve matters associated with the University’s licence from the Human Tissue Authority, including revisions to standard operating procedures, issues relating to facilities at Coleraine, Jordanstown, Clinical Translational Research & Innovation Centre (C-TRIC) and the NI Clinical Research Facility (NICRF), and freezer management, audits and personnel. Due to COVID-19 restrictions the meetings scheduled for April and November 2020 were replaced with an email update to members.

Since March 2019 the role of Designated Individual under the University’s HTA licence has been fulfilled by Dr P Allsopp.

There are no significant issues but storage management at Coleraine and support personnel on the C-TRIC are being kept under review. The Group will meet twice in 2021.

1.9. Regulation – use of radiation (dual energy x-ray absorptiometry, or DXA)

The DXA Sub Committee was re-established in late 2018 as a sub-committee of Research Governance Steering Committee and the Faculty of LHS Health & Safety Committee, and is chaired by Dr J Cathcart. Its remit is to review practice, procedures and associated documentation on an ongoing basis to ensure viability, currency, compatibility/harmonisation across campuses/schools/RIs and the clarity of the roles and responsibilities of all involved in the process.

The Sub-committee met twice during 2020 to review membership, terms of reference, training requirements and implications for the University following an update to national regulations covering the clinical and/or research use of radiation. One of these was a virtual meeting due to COVID-19 restrictions. A third scheduled meeting was replaced with an email update to all members.

It will meet three times in 2021.

1.10. Research Integrity

a. Research Integrity Contacts - In keeping with the requirement of the Concordat to ensure that research integrity is embedded within the research community and is not viewed exclusively as a centralised or top-down consideration, a network of Research Integrity Contacts (RICs) is in place.  Their role is to deal with local queries and concerns with reference to Research Governance and appropriate resources. They are not expected to act in any investigative capacity.

b. Research Integrity Course – This mandatory course for all research active staff and students involved in research at all levels is now monitored against set targets and the completion rates for staff are regularly reported to Associate Deans and Research Directors. 275 staff either completed or revisited the course during 2020. Completion illustrates a pro-active attitude towards research integrity and has been included as a component of the REF2021 return on Ulster’s research environment. There is full completion in some areas, particularly those where access to human participants is required, while in other areas, although improving, the completion rate remains lower. The overall completion rate is 98% based on REF SRR staff. Monitoring will continue for 2021.

1.11 Training

  1. Research Integrity – this Ulster online course was successfully completed by 241 PhD researchers (it is mandatory for this group) during 2020. The course is also available to all undergraduate and taught postgraduate students whose courses include a research module or dissertation. See also 1.10 above for information on staff completions.
  2. Research Ethics – 99 PhD researchers attended a new course called An Introduction to Research Governance and Ethics (23 face to face at Coleraine, Magee and Jordanstown campuses in February 2020 and 76 online in October 2020. This is an increase from 84 in 2019. These sessions will be repeated twice during 2021.

c. Human Tissue Act: research and consent – Research Governance, in collaboration with staff from Biomedical Sciences, provided training to 80 staff and students (63 pre-COVID-19 restrictions at Coleraine, Jordanstown, Magee and C-TRIC and 17 online during the period). The course and supporting materials were recorded and uploaded to an online platform and are now available at any time, although a return to face-to-face instruction will be considered when circumstances permit.

d. Research staff and students – staff in Research Governance were invited to speak at a number of RI and faculty “away days”, filter committee meetings and general events. This will continue in 2021.

1.12  Audits undertaken by Research Governance section

No audits were carried out during the period due to COVID-19 restrictions as it was not possible to review participant consent forms (normally hard copy) and human samples.

All HTA studies are audited once in their lifetime; other studies are selected for audit randomly but in proportion to the number of active studies in any given discipline area. Audits will resume when appropriate.