University Research Integrity and Ethics Committee Minutes 8 October 2019

Minutes of the Meeting of the University Research Integrity and Ethics Committee held on 8 October 2019 in the Council Chamber, Main Building at 10:30

Present: Professor Kim Graham (Chair), Professor Gary Baxter, Professor Gillian Bristow, Dr Rhian Deslandes, Professor William Evans, Dr Dawn Knight, Dr Michael Lewis, Judge Ray Singh, Dr Jessica Steventon and Professor Andrew Westwell.

In attendance: Dr Carina Fraser, Emma Gore, Chris Shaw and Alison Tobin.

Apologies for absence were received from: Oro Asby, Professor Debbie Foster, Professor Kerry Hood, Catrin Morgan, Professor Oliver Ottmann, Professor Phil Stephens and Professor Roger Whitaker.

111 Welcome and Introductions

The Chair welcomed Dr Rhian Deslandes (School of Pharmacy) and welcomed back Dr Michael Lewis (School of Psychology), both as a representatives of the College of Biomedical and Life Sciences (BLS).

112 Declaration of Interests

No declaration of interests were made during the meeting.

113     Minutes

The Minutes (18/650) of the last meeting of the Committee were approved.

114    Matters Arising

Received and noted paper 19/55B, ‘Matters Arising’ subject to the following additional matters:

114.1  Online Ethics submission and review system [Minute 102.3]

The Research Governance Team (Research and Innovation Services) has been notified of external software packages for managing the electronic submission of ethics applications. The Research Governance Team shall explore the utility of these packages and report back to URIEC accordingly.

114.2 URIEC Terms of Reference [Minute 103.5 and 103.6]

The following individuals have left the Committee and the Committee would like to thank them for their respective contributions to URIEC: Dr Richard Clarkson, Dr Juliet Davis, Professor Rick Delbridge and Dr Kathy Pittard Davies.

Resolved

114.3  That the Chair of URIEC liaise with Professor Roger Whitaker to identify an additional representative for the College of Physical Sciences and Engineering.

114.4 Security Sensitive Research at Cardiff University[Minute 109.9 to 109.12]

There are two areas of work that the University needs to address relating to Security Sensitive Research (SSR). The first requires immediate action and concerns the submission of particularly sensitive impact case studies to REF.  It is imperative that a system is in place which allows the University to review these case studies prior to submission.  The Chair of URIEC has discussed this matter with the University’s REF Manager who is working towards establishing a process to review impact case studies for research which requires security clearance.

In respect of the second area of work concerning the ethical review of projects requiring security clearance, a paper will be brought to the January URIEC meeting to address this in further detail.

115 Terms of Reference

Received and considered paper 19/56, ‘Amendments to the University Research Integrity and Ethics Committee Constitution and Membership’.

Noted

115.1  that it has been proposed that URIEC changes its name to the ‘Open Research, Integrity and Ethics Committee’ and that this was one of the recommendations made by the Open Research Task and Finish Group to emphasise the University’s commitment to Open Research;

115.2  that the Committee membership has been updated to confirm the re-appointments of Judge Ray Singh, Professor Wil Evans (both lay members), and Professor Deborah Foster (College of Arts, Humanities and Social Science representative) and the new appointments of Professor Kerry Hood (co-opted) and Dr Rhian Deslandes (BLS representative);

115.3  that the Committee will ensure that the University meets the requirements of Open Research and the San Francisco Declaration on Research Assessment (DORA);

Resolved

115.4  that the Committee should be renamed the ‘Open Research Integrity and Ethics Committee;

115.5  that an additional commitment (Commitment #6) be added at 2.1 to set out the University’s commitment to Open Research

116 University Research Ethics Procedures

Received and considered paper 19/57, ‘Cardiff University Research Ethics Procedures’.

Noted

116.1 that, at the meeting with Chairs of School Research Ethics Committees (SRECs) 08 July 2019, it was requested that the phrase ‘common methodologies’ be reviewed. The suggested alternative, as set out in the ESRC guidance, is: ‘commonly occurring situations’;

116.2 that the Research Governance Team has received queries from SRECs regarding section 1.3 of the template procedures for School Research Ethics Committees, namely the requirement that SRECs obtain evidence of ethical review where the review has been conducted by another university or institution (for projects involving Cardiff University researchers). Clarity is sought on the scope of this requirement;

116. 3 that the Research Governance Team already retains a copy of NHS ethics approval for projects Sponsored by the University;

116.4 that the University should be assured that all researchers, whether the lead researcher or not, are undertaking research with the appropriate ethical approval;

116.5 that Universities in the UK will normally adhere to the standards set by the ESRC framework for research ethics and therefore it would not normally be necessary to obtain evidence of the ethical review policy from those organisations;

116.6 that ethical frameworks in low-middle income countries, and countries that are the subject of Global Challenges research, may not necessarily have ethical review procedures akin to those in the UK;

116.7 that the Research Governance Team had been made aware of a project where there was ongoing discussion as to the appropriate SREC to review the project in light of a lack of expertise within the SREC where the Principal Investigator is based;

116,8 that concerns had been raised about ongoing accountability and monitoring requirements should the project noted above be reviewed by a SREC other than the one in which the Principal Investigator is based;

116.9 that research projects should be reviewed by individuals with appropriate expertise;

116.10 that the Research Governance Team has received queries from, and provided responses to, SRECs on the implementation of the new procedures.  These will be shared across SRECs as an FAQ document;

116.11 that the Research Governance Team has undertaken, and continues to undertake, a lot of work to support SRECs through implementation of the new procedures and that the Committee thanks them for this work;

116.12 that CARBS has submitted a proposal to URIEC, via the Secretary to URIEC, to delay implementation of the new ethics procedures for a particular cohort of students due to a programme review taking place within the School (details below).  CARBS requests URIEC’s approval of this proposal;

116.13 CARBS has implemented the updated SREC procedures for both staff and PhD research projects.  CARBS has approximately 2000 taught postgraduate students.  The taught postgraduate programmes are currently being reviewed with implementation of the new modules taking place from the start of the 2020/21 Academic Year.  Certain new PGR programmes (for example, within Economics, Accounting and Finance) will not be implemented until the 2012/22 Academic Year.  Research projects on these programmes typically do not involve human participants.  The CARBS proposal is to integrate research integrity and ethics into the new programmes and modules (this would include training on the ethics application procedures).  CARBS are committed to implementing the updated ethics procedures.  CARBS have requested that the postgraduate taught students be transitioned to the use of the new procedures from the start of the 2020/21 Academic Year.

Resolved

116.14          that the new ethics procedures (and associated template application form) retain reference to ‘common methodologies’ and that the use of this term be reviewed at a later date following full implementation of the procedures;

116.15 that the Research Governance Team meet with the Chairs of the SRECs to discuss progress with implementation of the new ethics procedures, how SRECs have approached the use of ‘common methodologies’ and to share best practice across SRECs;

116.16 that the Research Governance Team is responsible for retaining evidence of NHS Research Ethics Committee approval for studies that are Sponsored by Cardiff University.  SRECs do not need to obtain evidence of ethical approval for these projects;

116.17 that, where another university or institution has conducted ethical review of a research project that involves any Cardiff University Researchers, the SREC should obtain evidence of that ethical review and make a record of the project and the ethical review obtained;

116.18 that in all cases where another university or institution has conducted ethical review, the SREC should obtain the outcome letter as evidence of ethical review.  The Chair of the SREC should also decide, depending on the nature of the project and the university or institution that has conducted ethical review, whether additional evidence of ethical review is required, such as the ethical review policy of the reviewing organisation;

116.19 that the onus will be on Researchers to disclose projects involving human participants, data or tissue that have been reviewed by another university or institution to their SREC;

116.20 That section 1.3 of the template procedures for School Research Ethics Committees by amended to read:

“….the SREC must obtain evidence of the review (namely the outcome letter/communication and, if deemed necessary, the relevant review policy)…”

116.21 that guidance be provided to SRECs on circumstances where evidence may be required of ethical approval from another university or research institution.  This guidance shall include confirmation that the Chair of a SREC may escalate a matter to URIEC if they have concerns about the ethical approval obtained for a particular project.  This guidance shall be incorporated into an FAQ document to be shared with SRECs;

116.22 that, in situations where an SREC does not have the appropriate expertise to review a project, the SREC should co-opt individual(s) with appropriate expertise on to the SREC but that SREC should retain responsibility for the overall ethical review process and monitoring;

116.23 that a central record of SREC membership and the expertise of members should be centrally maintained and made available to Chairs of SRECs;

116.24 that CARBS proposal be approved on the basis that it is an exceptional case and that the request to delay implementation of the new ethics procedures for the relevant cohort is reasonable in light of the substantial review of its postgraduate taught programme.  It is recognised that the introduction of the new procedures at this stage would cause significant disruption.

117     Research Integrity Annual Statement

Received and considered paper 19/58, ‘2018/2019 Annual Statement on Research Integrity’.

Noted

117.1  that this is the third Cardiff University Annual Statement on Research Integrity, and has been prepared in accordance with the Universities UK ‘Concordat to Support Research Integrity’ (Concordat) and URIECs Terms of Reference;

117.2  that the Annual Statement will be submitted to UEB, Governance Committee and to Senate for information, before proceeding to Council for approval.  Following Council approval, it will be made publicly available on the internet as required by the Concordat.

Resolved

117.3  that section 7.3 be amended to read:

“…completion of the training will be mandatory for all academic staff. …”;

117.4  that, subject to the change set out at 117.3, the annual statement be approved for submission to Council;

117.5  that the Research Governance Team ensures that references to the mandatory training groups be updated on the University’s Intranet pages, and within the Research Integrity Online Training Programme, to reflect URIECs resolution at 117.3

118     Open Research Task and Finish Group

Received and considered paper 19/59, ‘Open Research Task and Finish Group (ORTFG)’.

Noted

118.1  that an Action Plan to Support Open Research at Cardiff University has been developed by the ORTFG.  The Action Plan adopts the format of the DORA action plan. The action plan will be submitted to UEB, Governance Committee, Senate and Council for approval;

118.2  that a Cardiff University Open Research Position Statement has been developed by the ORTFG;

118.3  that the Action Plan and Position Statement will be submitted to UEB, Governance Committee, Senate and Council and will then be made publicly available on the internet;

118.4  that the role description for the University’s Research Integrity Leads has been updated to include responsibilities for open research and the responsible use of metrics;

118.5  that it is proposed that the University’s Research Integrity Lead role be renamed ‘Open Research and Integrity Leads’ (ORI Leads);

118.6  that the Research Governance Team has had initial discussions with the workload modelling team to explore incorporating the ORI Lead roles into the University’s workload model;

118.7  that the role of School ORI Lead should be advertised so that individuals can apply for the role;

118.8  that the individuals currently in the School Research Integrity Lead role (largely SREC Chairs/School Ethics Officers) will be invited to apply for the School ORI Lead should they wish to retain the role;

118.9  that the College Research Integrity Leads are currently the Deans of Research, unless they opted to appoint a nominee to carry out the role, and consideration will be needed as to whether this should remain the position moving forwards.

Resolved

118.10          that the Open Research Action Plan and Position Statement be approved;

118.11          that the Statement of Purpose within the ORI Lead Role Description by amended to read:

“…This will involve taking part in University consultations and sharing best practice on matters relating to RI and OR”;

118.12          that, subject to the change set out in section 118.11, the ORI Lead Role Description be approved;

118.13          that the Research Governance Team submits the ORI Role Description to the workload modelling team to allow them to liaise with Schools regarding the role, advertisement and the likely FTE range;

118.14          that the role of School ORI Lead should be held by a member of Academic Staff, who should also be a member of the School SREC;

118.15          that the Chair of URIEC discusses the role of College ORI Lead with the College Research Deans to consider whether the role should continue to be undertaken by the College Research Deans (or their nominee).  Any decision made by the Chair and College Research Deans must be reported to URIEC.

119     Research Integrity Activity Update

Received and considered paper 19/60, ‘Research Integrity Activity Update’.

Noted

119.1  that approximately 1000 staff and students have completed the RI training modules during the 2018/19 Academic Year.  This is similar to the overall number of staff and students that completed the modules in the 2017/18 Academic Year;

119.2  that the content of the 2019/20 modules has been updated to incorporate open research and responsible use of research metrics;

119.3 that the revised Concordat to Support Research Integrity is scheduled to be released in October 2019.  The Research Governance Team understands that the commitments within the Concordat will remain the same though the expectations on individuals and organisations will be more explicit;

119.4 that the Research Governance Team intends to prepare a paper for a future meeting of URIEC, outlining any substantive changes to the Concordat, once the new version is published;

119.5 that the Research Governance Team responded to a Wellcome Trust survey on the implementation of its Bullying and Harassment Policy and how universities were complying with it;

119.6 that there is increasing attention, and email traffic, on the topic of Bullying and Harassment cases involving researchers and to what extent these cases should be reported to funders in the same way as Academic Research Misconduct cases;

119.7 that in light of the complexities around where a process for reporting Bullying and Harassment cases to funders (and/or otherwise complying with funder policies in this area) sits within the University, RIS will establish a working group with Human Resources and Strategic Planning and Governance to identify appropriate actions for the University in this area;

119.8 that since the last meeting of URIEC there has been an improvement in the percentage of Cardiff University’s Clinical Trials that have reported results on the EU Trials Register; 80% of Cardiff University’s Clinical Trials that were ‘due to’ report (as defined by the EU trials tracker) have now reported results on the EU trials register.  This is compared to a figure of 40% in January 2019).

Resolved

119.9  that URIEC be provided with a more detailed breakdown of the RI training completion rates by School, specifically the number of staff and students that have completed the RI training modules;

119.10  that the Chair of URIEC liaise with HR regarding integration of RI training with CORE.

120     Reports Received by the Committee

Received and noted papers 19/62B ‘DORA Working Group Meeting (minutes of 18 September 2019 meeting)’, 19/63B ‘ Biological Standards Committee (minutes of 16 May 2019)’ and 19/64B ‘Human Tissue Stnadrds Committee (minutes of 16 May 2019 meeting)’.

Noted

DORA Working Group

120.1  that the University will sign the San Francisco Declaration on Research Assessment (DORA) in November 2019;

120.2  that internal and external communications have been devleoped regarding the University’s commitment to DORA;

120.3  that the DORA Working Group will have a stand as part of the University’s Open Access week;

120.4  that RIS has recruited a ‘Responsible Metrics Officer’ who will be in post from 28 October 2019;

Biological Standards Committee (BSC)

120.5  that the Redwood facilty has been closed, meaning the University has one less animal facility.  This reduces institutional risk of non-compliance and does not impact on capacity;

120.6  that the BSC is undertaking a review of research involving animals which fall outside of the Animal (Scentific Procedures) Act, 1986 (ASPA) with a view to identifying the range of work taking place at Cardiff University to enable further consideration of what systems may need to be put in place to ensure this research is subject to appropriate ethical scrutiny. This review is likely to take some time to complete and a non-ASPA Working Group has been established to report to BSC.  The Home Officer Inspector is very pleased that the University is reviewing its position in relation to research involving non-protected species;

120.7  that Freedom of Information (FOI) Requests on the use of animals in research, from a variety of individuals and groups, continue to present a resource challenge for the Biological Standards Officer and wider team.  The information requested is often already in the public domain or is about to be made publicly available;

Human Tissue Standards Committee (HTSC)

120.8  that the College of Biomedical and Life Sciences would soon be contacting the Human Tissue Authority for notification and advice following extensive investigations into the use of samples from completed clinical trials through research tissue banks where the donor opted out of the future use of their samples or the decision could not be evidenced;

120.9 that investigations carried out over the summer by the HTA Manager and staff working in the Cardiff University Biobank and the Centre for Trials Research had identified a small number of individuals whose samples had been released through one of the research tissue banks hosted by Cardiff University and who had either declined to give consent for biobanking or had withdrawn their consent for the trial and the scope of the withdrawal could not be ascertained (hereinafter collectively referred to as ‘non-consented’), further samples from non-consented donors were still held in the research tissue bank;

120.10          that the investigations also identified a larger number of donors whose samples had been released or stored from the same research tissue bank where consent for biobanking was inconclusive, i.e. there was nothing in the patient notes suggesting consent had been declined yet the signed biobanking consent form could not be located;

120.11          that other research tissue banks within the University were subsequently scrutinised and the issue was not unique to one bank, similar issues had been identified in two further research tissue banks hosted by the University;