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Annual Report to Senate and Council

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 2016.

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 2016 in time for the beginning of the 2016/17 academic year and, in particular, the annual intake of new PhD students. This document reflects the UUK Concordat and addresses, in a style appropriate to Ulster, the required precepts and commitments.

1.3.      Oversight

Research Governance Steering Committee 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 & Innovation Committee (RIC) and Senate.

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. Two e-mails are routinely sent, one reminding people of the CoP for Professional Integrity in the Conduct of Research and the other 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 UKRIO.

Two allegations of research misconduct were received during the period.

The first, received in February 2016 was investigated and has been satisfactorily concluded. While there was evidence of misrepresentation in documentation, this was considered to be relatively minor and it was recommended that this should be addressed through training rather than disciplinary action.

The second was a complaint consisting of several allegations made against a former member of staff. For the most part, these were referred to the individual’s current employer for action. However, two of the allegations related to a specific publication and to a patent and were being considered by Ulster.

1.6.      Research ethics – human participants

The University’s Research Ethics Committee (UREC) met on ten occasions during the period and reviewed 59 applications.

1.7.      Regulation – animals

The University Animal Welfare and Ethical Review Body (or AWERB, formerly ERC or Ethical Review Committee) met twice during the period and reviewed (i) updates to membership, policies and procedural documentation necessitated by revisions to 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. The Board will meet three times in 2017.

In addition, the 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, C-TRIC and the NICRF, and freezer management, audits and personnel. There are currently no outstanding matters of significance to be addressed. The Group will meet twice in 2017.

1.9       Regulation – use of radiation (DXA)

The DXA Monitoring Group’s 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.

All required activity and correspondence during the year was conducted by email. The Group will meet in 2017 with a revised membership and a replacement chair (following the departure from the University of the current chair).

1.10     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, it was agreed that a network of Research Integrity Contacts (RICs) should be put 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.  RICs are now in place across the University. Contact details are available in the Research Governance area of the University portal.

1.11     Inductions

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

1.12.    Training

a.         Research Integrity – this Ulster-only online course was successfully completed by 231 PhD students during 2016 (it is mandatory for this group) and to date 158 members of staff have completed the course (with a further 76 in progress). The course is also available to all undergraduate and taught postgraduate students whose courses include a research module or dissertation.

b.         Human Tissue Act: research and consent – Research Governance, in collaboration with staff from Biomedical Sciences, provided training to 170 staff and students at Coleraine, Jordanstown and C-TRIC during the period.

c.         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.

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 – 13

During July to September 2016, audits of six category D and seven category C human tissue projects were undertaken by the Research Governance section in collaboration with the University’s Designated Individual for its Human Tissue Authority licence, and the Clinical Trials Manager, School of Biomedical Sciences. This collaborative approach avoids the need for separate Research Governance and HTA reviews.

b.         Other studies involving human participants – 2

During January 2016 audits of one category B and one non-human tissue category C projects were undertaken by the Research Governance section (see also 1.14 below).

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 were 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. However, there were lapses, some of which required a further review of documentation and, in some cases, the renewal of consent and a review of tissue sample holdings.

1.14     Audits undertaken by KPMG

An internal audit was undertaken by KPMG in February 2016 to assess the quality assurance of research governance structures and processes.

As part of this process, 13 face-to-face and 7 desk-based project-specific audits were carried out. The scope of these audits was compared with those undertaken by the research governance section and it was decided that, as the number of intended audits (i.e 12) had been exceeded, no further non-HTA audits were required for the period.

The outcome of the audit was that the quality assurance of structures and processes are satisfactory. All recommendations have been implemented including ensuring that all members of a research team have completed the research Integrity online training course before ethical approval or sponsorship is granted.