Open Research Integrity and Ethics Committee Minutes 28 January 2020

Minutes of the meeting of the Open Research Integrity and Ethics Committee held on 28 January 2020 in the Council Chamber, Main Building at 12:00

Present: Professor Kim Graham (Chair), Professor Gillian Bristow, Dr Rhian Deslandes, Professor William Evans, Professor Kerry Hood, Dr Michael Lewis, Judge Ray Singh, Professor Phil Stephens and Professor Andrew Westwell.

In attendance: Oro Asby, Karen Desborough, Dr Carina Fraser, Emma Gore, Andrew Lane, Chris Shaw and Alison Tobin.

Apologies for absence were received from: Professor Gary Baxter, Professor Debbie Foster, Dr Dawn Knight, Catrin Morgan, Professor Oliver Ottmann, Dr Jessica Steventon and Professor Roger Whitaker.

121 Welcome and Introductions

The Chair welcomed Professor Kerry Hood (co-opted member), Karen Desborough (Officer), and Andrew Lane (deputising for Catrin Morgan).

122 Declaration of Interests

No declaration of interests were made during the meeting.

123 Minutes

The Minutes (19/61) of the last meeting of the Committee were approved.

124 Matters Arising

Received and noted paper 19/311, ‘Matters Arising’ subject to the following additional matters:

124.1  Online Ethics submission and review system [Minute 114.4]

Resolved

that the Research Integrity, Governance and Ethics (RIGE) team (Research and Innovation Services) shall develop a briefing document identifying the main options for an online ethics submission form. Consideration should be given to linking this work with the Transforming Services programme.

124.2 Open Research Integrity (ORI) Lead Update [Minutes 118.11-118.15]

The Open Research Operational Group will review the ORI Lead role description to ensure the College and School roles are accurately described.  The School ORI lead roles shall be advertised once that review is complete.

Resolved

that the amended ORI Lead role description be approved through Chair’s action if the amendments are considered non-substantial, or through ORIEC if the amendments are substantial.

124.3  Bullying and Harassment Reporting [Minute 119.7]

Resolved

that any proposed solution and/or actions identified by the working group be reported to ORIEC.

125 Revised Concordat to Support Research Integrity

Received and considered paper 19/312, ‘Revised Concordat to Support Research Integrity’.

Noted

125.1  that a summary of the main revisions to the Concordat to Support Research Integrity was presented to the Committee;

125.2  that individual and organisational accountability is a key element of the revised Concordat;

125.3  that funding bodies will be expected to link compliance with the Concordat to the award of funding;

125.4 that Research Organisations (ROs) are expected to implement the revised Concordat within 12 months. In practice, Universities UK (UUK) has advised that ROs will be expected to supply the Concordat’s Secretariat with a link to an annual research integrity statement towards the end of 2020;

125.5  that UUK is preparing a checklist of requirements to support ROs with implementation of the revised Concordat.  The UK Research Integrity Office (UKRIO) is also updating its Self-Assessment Tool to address the requirements of the revised Concordat;

125.6  that the University does not have a standard system for reporting, recording or investigating ‘questionable research practices’ – i.e. those practices which fall below best practice but do not meet the definition of academic research misconduct;

125.7 that the University requires a system to identify lessons learnt from any formal investigations of research misconduct to prevent the same type of incident re-occurring;

125.8  that the University is required to have mechanisms in place that periodically review research practice and culture to ensure that practice remains fit for purpose.  ORIEC currently receives an annual report on the number of academic research misconduct cases and regular reports on completion of the University’s RI training, and the activity of its sub-committees.

Resolved

125.9  that the proposed actions set out in paper 19/312 Appendix 1 be approved;

125.10  that the Academic Research Misconduct (ARM) Working Group consider:

• the University’s compliance with the requirements contained in Concordat Commitment 4;
• how to embed systems within the research environment that identify potential concerns at an early stage;
• processes for individuals to raise concerns about research integrity - to include consideration of an appropriate pathway for reporting and reviewing ‘questionable research practice’ and research misconduct;
• Ensure that the University can identify lessons learnt from any formal investigations of research misconduct to prevent the same type of incident re-occurring;
• the provision of guidance and mandatory training for researchers on research misconduct and questionable research practice (to include consideration of discipline-specific case studies);
• how to communicate research misconduct and questionable research practice procedures to researchers;

125.11 that RIGE co-ordinate a more detailed analysis of the University’s compliance with the Concordat once the UUK checklist and UKRIO self-assessment tool are available;

125.12 that further consideration be given to the remit of ‘research culture and practice’ in the context of the Concordat requirement set out at 125.8 above.  This activity should be informed by the UUK checklist, UKRIO self-assessment tool, and existing work taking place on research culture at the University.

126 Research Ethics Procedures

Received and considered paper 19/313, ‘Research Ethics Procedures’.

Noted

126.1 that a workshop, chaired by Professor Kim Graham and representatives of RIGE, was held for Chairs of School Research Ethics Committees (SRECs) on 12 December 2019;

126.2 that the workshop highlighted the need for continued interaction with, and between, SRECs;

126.3 that the workshop identified several areas where SRECs require further assistance or advice and that specific queries were raised in relation to: sanctions for not obtaining ethical review; definition of publicly available data; escalation of issues from SRECs to ORIEC; and the role of Supervisor in ethical review;

126.4 all Cardiff University supervisors on Research only, Teaching and Research or Teaching and Scholarship career pathways (and their clinical equivalents) are now required to undertake mandatory Research Integrity training.

Resolved

126.5  that potential sanctions for not obtaining ethical review be considered by the ARM Working Group;

126.6 that a working group be established to explore and recommend an appropriate definition of ‘publicly available data’ and the requirements for ethical review of human research projects involving publicly available data.  The working group should include the College Deans of Research, academic representatives from across the three Colleges (ideally a SREC Chair from each College), the University’s Senior Assurance Advisor – Data and Information and the Director of Population Health, Centre for Trials Research;

126.7 that the working group should seek to ‘map’ the use of secondary or publicly available data across the University and consider the relevance of anonymisation in the definition of publicly available data and the requirements for ethical review of projects using anonymised data only;

126.8 that the template application for ethical review (section 2.5) be updated to read:

“… information that is publicly and lawfully available e.g. census data and population statistics published by government departments. Note: research projects involving the use of Human Data obtained from social media (or similar internet forums) do not fall within this category.

If yes, please seek advice from the Committee, providing details of the information and source of information.  The Committee will determine whether you are required to proceed with the application.”;

126.9 that RIGE engage with Committee Support to confirm ORIEC’s authority to address matters raised by SRECs (or otherwise) outside of scheduled ORIEC meetings;

126.10 that consideration be given to updating the Research Integrity training to provide detailed expectations for Supervisors in relation to ethical review;

126.11 that the proposed actions set out in paper 19/313 Appendix 1 be approved;

126.12 that the Frequently Asked Questions document be updated following ORIEC discussions and distributed to SRECs.

127 Template Annual Report for School Research Ethics Committees

Received and considered paper 19/314, ‘Template Annual Report for School Research Ethics Committees’.

Resolved

127.1  that Section C be amended to ensure that any School that has indicated it does not require research ethics procedures is required to provide a justification for this decision;

127.2  that implementation of the template Participant Information Sheet and Consent Form should be included at Section B, question 3;

127.3  that clarification is added to Section B, question 4 that a copy of School approved common methodologies should be attached to the report;

127.4  that Section B, question 9 be amended to read:

“In respect of the period covered by this report, please confirm whether the School has been made aware of any Human Research project (requiring ethical review) which commenced prior to obtaining ethical review?”

127.5  that, subject to the changes listed above, the annual report be disseminated to Schools;

127.6  that the College Deans of Research and RIGE will have joint responsibility for reviewing the Annual Reports and identifying any specific actions required but the College Deans of Research will remain responsible for ensuring any identified action is taken by Schools.

128 Research Integrity Activity Update

Received and considered paper 19/315, ‘Research Integrity Activity Update’.

Noted

128.1  that approximately 2791 staff and students have completed the RI training since it was launched;

128.2  that only 26% of new academic staff have completed the RI training so far in the 2019/20 academic year and that this figure was at 5% prior to an email reminder being issued by RIGE (suggesting that more action is required locally to raise awareness of the mandatory training);

128.3 that monitoring completion of the RI Training and reporting on completion rates continues to require a significant amount of RIGE resource due to the absence of an IT solution;

128.4 that RIGE is working with HR to confirm the total number of academic staff (new and existing) that have completed the RI training;

128.5 that clinical trial transparency and reporting continues to be a topic of interest to the Research Integrity Inquiry and that the University’s clinical trial reporting figures have improved significantly to 78.1%;

128.6 that Export Control compliance by universities is a topic of interest to the UK Government and discussion on this topic is taking place across the Russell Group;

128.7 that RIS has prepared a memo to the Vice-Chancellor on this topic and an RIS Export Controls Working Group is being established to identify the actions required by the University in this area;

128.8 That RIS will report to ORIEC on what action is identified or undertaken by the RIS Export Controls Working Group;

128.9 That the Director of RIS has been named as the University’s point of contact for the ‘Trusted Research’ initiative;

Resolved

128.10 that RIGE continues to engage with HR to identify the number of academic staff that have completed the RI training in each School;

128.11 that, instead of a Blas article, a memo be prepared to each Head of School confirming overall completion statistics and reiterating the importance of RI training completion;

128.12 that the Chair of ORIEC, when visiting Heads of School, discuss completion rates and re-iterate that completion of the RI training is mandatory for all staff on Research only, Teaching and Research, and Teaching and Scholarship career pathways (and their clinical equivalents).

129 Assurance Services Activity Update

Received and considered paper 19/316, ‘Assurance Services Activity Update’.

Noted

129.1  that the ARM Working Group is scheduled to meet in February and March 2020, and will report to ORIEC in May 2020;

129.2  that a third meeting of the ARM Working Group is likely to be required in April 2020 given the additional matters to be considered by the group.  This should still allow the ARM Working Group to report to ORIEC in May 2020;

129.3  that the Assurance Services team is working with RIS and Human Resources to identify requirements to report ARM, Bullying and harassment and other relevant issues to funding bodies.  This will involve a review of the University policies, guidance and training;

129.4 that the University is developing a policy and procedure for the use of drones which has been approved by the University’s Governance, Risk and Assurance Group, subject to legal advice on airspace;

129.5 that members or officers of ORIEC are invited to contact Assurance Services if they wish to input into the development of the drone policy and procedure

130 Reports Received by the Committee

Received and noted papers 19/317 ‘Report from the Open Research Operational Group’, 19/318 ‘Report from the DORA Working Group’, 19/319B ‘Report from Biological Standards Committee’, 19/320 ‘Human Tissue Stnadrds Committee (minutes of 10 October 2019 meeting)’ 19/326 ‘Clinical Trials and Biobanking Report to the Human Tissue Authority and response letter’, 19/327 ‘Amendments to the Human Tissue Standards Committee Terms of Reference’, and 19/321 ‘Report from the Clinical Trials of an Investigational Medicinal Product Governance Group’.

Noted

Open Research Operational Group (OROG)

130.1  that the College Deans of Research (or their nominee) shall continue to undertake the role of College ORI lead;

130.2  that Professor Chris Chambers has been nominated as the ORI lead for the College of Biomedical and Life Sciences;

130.3  that OROG supports the University becoming a member of the UK Reproducibility Network and that Professor Gillian Bristow, as College (AHSS) Lead for Research Integrity and Chair of OROG, would be an appropriate institutional lead;

DORA Working Group

130.4  that the University signed the San Francisco Declaration on Research Assessment (DORA) in November 2019;

130.5  that a ‘Responsible Metrics Officer’ was appointed October 2019;

130.6  that work is underway to ensure that the university’s central HR processes align to DORA;

130.7  that the Responsible Metrics Officer is engaging with researchers to gather information about culture and practice;

Biological Standards Committee (BSC)

130.8  that the non-ASPA Ethical Review Working Group held its inaugural meeting in December 2019.  The Working Group will report to BSC;

130.9  that two project licence amendment requests were not supported.  Whilst this is unusual, it demonstrates that appropriate scrutiny is being given to amendment requests;

130.10 that discussion is taking place about increasing transparency around the work of the Animal Welfare and Ethical Review Body (AWERB) and the extent to which it is appropriate to make information about the work of AWERB open (at least across BLS)

Human Tissue Standards Committee (HTSC)

130.11  that a HTA Compliance and Audit Officer has been appointed;

130.12 that the Human Tissue Authority undertook an inspection of the Wales Cancer Bank in January 2020;

130.13  that the Human Tissue Authority is required to notify the Medicines and Healthcare products Regulatory Agency (MHRA) of findings related to samples being held without participant consent (or being held without conclusive evidence of appropriate consent);

130.14  that the Human Tissue Authority position is that tissue samples must be destroyed if evidence of appropriate consent is not available;

Clinical Trial of an Investigational Medicinal Product Governance Group (CTIMP-GG)

130.15  that the next CTIMP-GG meeting is scheduled for 12 February 2020.  The group will be focussing on preparedness for any potential MHRA inspection.

Resolved

130.16 that the amendments to the Human Tissue Standards Committee Terms of Reference be approved.

131 Any Other Business

Noted

131.1  that the University’ Template Procedures for SRECs requires that Human Research proposals must be subject to appropriate scientific review prior to SREC review. The template ethics application form instructs researchers to obtain appropriate scientific review prior to submitting to the SREC.  SRECs are seeking advice on the definition of ‘appropriate’ scientific review;