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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 2018.

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 2017 in time for the beginning of the 2017/18 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.  A review will take place during the summer of 2019.

1.3. Oversight

Research Governance Steering Committee (RGSC) met twice during the period to address operational and strategic matters and to review reports and minutes from subordinate committees.

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

The Committee will meet twice during 2019.

1.4. General communication with staff and students

Communication of policy requirements and procedural matters is via quarterly 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.

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.

No new allegations of research misconduct were received during the period.

1.6. Research ethics – human participants

The University’s Research Ethics Committee (UREC) met on ten occasions during the period and reviewed 60 applications (an increase from 42 in 2017).

Please refer to the accompanying detailed report for information on the activities of UREC and associated filter committees.

1.7. Regulation – animals

The University Animal Welfare and Ethical Review Body (or AWERB, formerly ERC or Ethical Review Committee) 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 2019.

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.

1.8. Regulation – Human Tissue Act

The Human Tissue Act Working Group (HTAWG) met 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.

After a significant period in the substantial role of Designated Individual under the University HTA licence, Prof K Burnett has indicated that this is no longer sustainable due to other duties. At the time of writing, a replacement is being sought.

There are currently no other outstanding matters of significance to be addressed. The Group will meet twice in 2019.

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

The DXA Monitoring Group was re-established in late 2018 as a sub-committee of Research Governance Steering Committee and the Faculty of LHS Health & Safety Committee, 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 once during 2018 and reviewed membership, terms of reference and implications for the University following an update to national regulations covering the clinical and/or research use of radiation.

The Group will meet three times in 2019.

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 and they will not be 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. A further 297 staff completed the course during 2018 (with an additional 43 in progress). Completion illustrates a pro-active attitude towards research integrity and will be a valuable component of the REF2021 return on Ulster’s research environment. Completions in some areas are high, particularly those where access to human participants is required while in other areas, although improving, the completion rate remains low. Monitoring will continue for 2019.

1.11 Inductions

During the period, Research Governance participated in PhD researcher inductions at Jordanstown and Coleraine and provided information on governance, ethics and integrity requirements and resources to over 100 new PhD researchers based at all four of the University’s campuses.

1.12. Training

  1. Research Integrity – this Ulster-only online course was successfully completed by 283 PhD researchers (it is mandatory for this group) during 2018. This is an increase from 213 in 2017. The course is also available to all undergraduate and taught postgraduate students whose courses include a research module or dissertation.
  2. Research Ethics – 32 PhD researchers attended a new course called An Introduction to Research Governance and Ethics at the Coleraine, Magee and Jordanstown campuses and were also invited to stay for a follow-on drop-in session for one-to-one guidance. These sessions will be repeated twice during 2019.

c. Human Tissue Act: research and consent – Research Governance, in collaboration with staff from Biomedical Sciences, provided training to 207 staff and students at Coleraine, Jordanstown, Magee and C-TRIC during the period. This is an increase from 153 in 2017.

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 2019.

1.13 Audits undertaken by Research Governance section

Audits were carried out during the period as follows:

a. Studies regulated under the Human Tissue Act or involving human material – 7

During August to October 2018, audits of four category D and three category C human tissue projects were undertaken by the Research Governance section in collaboration with the University’s Designated Individual (Dr K Burnett, School of Pharmacy) for its Human Tissue Authority licence. This collaborative approach avoids the need for separate Research Governance and HTA reviews.

b. Other studies involving human participants – 3

During 2018 audits of two category B and one non-human tissue category C projects were undertaken by the Research Governance section.

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.

All audits were routinely scheduled; none was carried out on a specific or “for cause” basis.  These focused on adherence to the approved protocol, consent, retention of documentation, data and (where appropriate) sample storage and progress of individual projects.

Overall, the findings of the audits were positive. No significant issues were found but in some cases recommendations were made in relation to data retention and security.  This will be emphasized again in 2019 to reflect General Data Protection Regulations and the University’s new Data Management Policy.

A definition of each research governance category is provided in Appendix III to Part 2 of this report.