Open Research Integrity and Ethics Committee Minutes 19 May 2020

Minutes of the meeting of the Open Research Integrity and Ethics Committee held on 19 May 2020 via videoconference at 9:30.

Present: Professor Kim Graham (Chair), Professor Gary Baxter, Professor Gillian Bristow, Dr Rhian Deslandes, Professor William Evans, Professor Debbie Foster, Professor Kerry Hood, Dr Dawn Knight, Dr Michael Lewis, Professor Phil Stephens, Dr Jessica Steventon, Professor Andrew Westwell and Professor Roger Whitaker

In attendance: Orosia Asby, Dr Carina Fraser, Emma Gore, Kim Mears, Catrin Morgan, Chris Shaw and Alison Tobin.

Apologies for absence were received from: Judge Ray Singh, Professor Oliver Ottmann and Professor Adrian Porch.

132 Welcome and introductions

The Chair welcomed everyone to the meeting.

133 Declaration of interests

No declaration of interests were made during the meeting.

134 Minutes

The Minutes (19/408) of the last meeting of the Committee were approved.

135 Matters arising

Received and noted paper 19/600, ‘Matters Arising’ subject to the following additional matter:

135.1 JOMEC re practical journalism [Minute 131.5]

Noted

that this item will be addressed in further detail as part of agenda item 6 [Minute 136.29].

136 Annual report for School Research Ethics Committees

Received and considered paper 19/601, ‘Annual Report for School Research Ethics Committees’.

Noted

136.1 that, in addition to the information set out in paper 19/601, five further school Annual Reports have been received (two Annual Reports remain outstanding). A preliminary review has indicted that no additional major themes or concerns have been raised within the five new reports;

136.2 that a number of Schools in the College of Physical Sciences and Engineering (PSE) receive very few applications for review;

136.3 that the University’s Data Protection Officer is planning to discuss Data Protection Impact Assessments (DPIAs) with School Research Ethics Committees (SRECs).  Incorporating DPIA’s in the ethical review process, where necessary, will reduce the burden placed on SRECs to review data protection aspects of such applications;

136.4 A Microsoft Teams page will be established to share information with SRECs and to facilitate discussion between SRECs;

136.5 that the Secretary to ORIEC/RIGE and the Director of the Centre for Trials Research are due to discuss potential updates required to the University’s Safeguarding Policy in light of concerns being raised about whether the Policy provides accurate advice in respect of research activity;

136.6 that deviation request 11 (entitled ‘Matter 11 in 19/601) has already been resolved by CARBS prior to the meeting of ORIEC.

Resolved

136.7 that, once the University has returned to a more normal state of working,  the Chair of ORIEC engages with the PSE College Pro Vice Chancellor and the PSE College Dean of Research to consider whether there is scope to combine PSE SRECs and/or whether there could be workload saving if a cross school ethics committee were to be established;

136.8 that, in order to facilitate the discussions noted in 136.4, the Research Integrity, Governance and Ethics (RIGE) team provide a summary of the number of projects reviewed by SRECs within the College of PSE;

136.9  that RIGE and the Director of the Centre for Trials Research advise Catrin Morgan (Head of Assurance Services) on any changes required to the University’s Safeguarding policy, as a result of the discussion noted at 136.5 above;

136.10 that RIGE identify relevant training courses already provided by the University which could be mandated for individuals sitting on an SREC (this would be in addition to training courses that are already mandatory for all staff);

136.11 that RIGE obtain further information from the Schools that have reported cases of research projects commencing prior to ethical review, in particular RIGE should seek to understand why such cases have arisen (in the SRECs opinion).  ORIEC is keen ensure a consistent approach across Schools;

136.12 that, in respect of the specific deviation requests contained in paper 19/601 and the subsequent ORIEC exhibit book:

Matter 1 – Implementation date

136.13 that, in light of current COVID-19 working conditions, Schools be granted a one year extension to implement the new Ethics Procedures and templates, meaning that SRECs can opt to delay implementation until the start of the 2021/22 Academic Year if this is preferable;

Matter 2 – ‘Common Methodology’ terminology and process

136.14 that the proposed amendment to the ‘common methodology’ terminology, together with the proposed related changes to the template SREC procedures and SREC Application Form, are approved;

Matter 3 – Proportionate review

136.15 that the Proportionate Review (PR) model in the template SREC Procedures (namely that projects suitable for PR[1] are reviewed by at least two SREC Members) be amended to allow review by at least ‘one SREC Member and a ‘second reviewer’’ (option 4 of the Matter 3 proposal contained in paper 19/601).  The School should agree an approved list of Second Reviewers and the list should be maintained by the SREC and training requirements for the second reviewer should be considered as part of the action in minute 136.7;

136.16 that ORIEC does not support any proposal that PR be conducted by solely the SREC Chair or by only one SREC Member (even if this was just to apply to student projects). ORIEC considers that two reviewers are necessary for every Human Research project from a safeguarding perspective (preventing one member of staff taking sole responsibility for ethical decision making) and to ensure sufficient ethical oversight;

Matter 4 – Template application form

136.17 that, in order to reduce administrative burden for SRECs, changes to the template SREC Application Form should only be made once a year (if required), following review of the SREC Annual Reports;

136.18 that the term ‘gate keeper’ be further defined in the FAQ document being prepared by RIGE;

136.19 that the proposed amendments to the template SREC Application Form are approved;

Matter 5 – Research Integrity Online Training Programme (RI Training)

136.20 that, as previously resolved by ORIEC, the RI Training should be completed by Academic Staff on R/T&R/T&S Pathways every 3 years;

136.21 that completion of the RI Training be a mandatory requirement for SREC applicants, namely that all Cardiff University applicants and co-applicants (this will include supervisors, for student applications) named on the SREC Application Form must confirm completion of the RI training prior to review of the application by the SREC;

136.22 that, in respect of concerns raised by the School of Welsh regarding the RI Training only being available in the English language, that RIGE engages with Assurance Services to explore whether the RI Training needs to be provided in Welsh (translated);

Matter 6 – ARCHI (Proportionate review (PR))

136.23 that the deviation request be rejected.  ARCHI should be advised of the resolution contained at minute 136.11;

Matters 7 and 8 – GEOPL (short application form) and OPTOM (PR and short application form)

136.24 that the deviation requests be rejected.  ORIEC recognises the challenges SRECs are facing but considers that the template SREC Application Form must be adopted for all projects and that only one form should be operational to avoid confusion;

136.25 that SRECs be reminded of the  12-month extension for implementation of the new SREC procedures and templates and notified that  an online SREC Application Form will be considered in the future which could filter out certain questions if not relevant to a particular project;

Matter 9 – ENCAP (Module-wide ethical approval)

136.26 that RIGE liaise with ENCAP to obtain more information about how ENCAP is proposing that its proposal would work in practice, for example: What would be submitted to the SREC for review? Who would submit the application? Who would have overall responsibility?  ORIEC would prefer ENCAP to utilise the ‘common methodologies’ approach and to consider individual applications using such ‘common methodology’;

Matter 10 – ENCAP (PR)

136.27 that ENCAP’s PR deviation request is acceptable in light of the matter resolved by ORIEC at 136.11;

Matter 12 – SOCSI (response timetable)

136.28 that the deviation request be approved;

Matter 13 – SOCSI (UG/MA/MSC/PGT review)

136.29 that the deviation request be rejected but that SOCSI be advised of the eased PR requirement resolved at 136.11 (which would allow a triage reviewer to act as the ‘second reviewer’ for student projects, albeit a SREC member would also be required to review applications in their entirety) and the extended period for implementation of the new SREC Procedures and templates. The extra time being provided to all SRECs to implement the new procedures (resolved at 136.13) will provide support for SOCSI in addressing this request;

136.30 that RIGE considers the extent to which CARBS (and specifically the CARBS SREC Chair) may be able to assist SOCSI by sharing its own approach and proposed solutions for managing a high volume of student projects requiring ethical review;

Matter 14 – SOCSI (full review criteria)

136.31 that the deviation request be rejected but that SOCSI be advised of the extended period for implementation of the new SREC Procedures and templates and reminded of its ability to develop ethics protocols/standard operating procedures (previously ‘common methodologies’) for any of the full review criteria which would enable projects usually falling under such criteria to proceed via proportionate review;

Matter 15 – SOCSI (documents reviewed)

136.32 that the deviation request be rejected as ORIEC considers that the supporting documentation is key to the SREC making an informed ethical decision;

Matter 16 – JOMEC practical journalism (‘non-academic’ research)

136.33 that RIGE obtains further information from JOMEC which shall be considered by ORIEC either at its next meeting or via correspondence if a more urgent determination is desired.

137 Research Integrity Activity update

Received and considered paper 19/602b, ‘Research Integrity Activity Update’.

Noted

137.1 that the paper had been classified as ‘confidential’ due to the contents of Appendix 1;

137.2 that some of the actions resolved at the last meeting of ORIEC, in respect of the revised Concordat to Support Research Integrity, are still in progress and some are on hold pending the release of external frameworks;

137.3 that Assurance Services will provide an update on the matters resolved by ORIEC to be considered by the ARM Working Group (agenda item 8);

137.4 that further work is required to improve Academic Staff uptake of the RI Training.  A memo is being prepared for issue to Heads of School requesting further action to help improve completion rates;

137.5 that the forthcoming establishment of a national Research Integrity Committee reinforces the importance of ensuring that our procedures for handling research misconduct cases are fit for purpose and implemented correctly;

137.6 that a review of the University’s Security Sensitive Research policy has commenced but that engagement with the University’s Crime and Security Research Institute is key to taking the review forward. RIGE is awaiting a meeting with the Institute to progress the review;

137.7 that the first meeting of the Publicly Available Data Task and Finish group has not yet taken place but that RIGE intends to facilitate the work of the group over the summer with a view to providing its recommendations to ORIEC  at the first meeting in the 2020/2021 Academic Year;

137.8 that RIGE is represented on the new University Research Culture Working Group (RCWG), chaired by Professor Claire Gorrara, and that the Chair of ORIEC and Chair of the RCWG will need to discuss how the two groups will interact;

137.9 that, following two meetings of the RIS Export Controls Working Group, RIGE intends to draft an Export Controls policy. Pending the development of the policy, an intranet page has been created to provide basic information and to signpost researchers to relevant contacts and resources.

138 Assurance Services Activity update

Received and considered paper 19/603, ‘Assurance Services Activity Update’.

Noted

138.1 that two allegations of research misconduct were received prior to the COVID-19 lockdown. One was able to be progressed and one was unable to be taken forward before the alternative working arrangements were in place;

138.2 that progress with the review of the Academic Research Misconduct Policy has been delayed.  Work will re-commence on reviewing the policy over the summer months, however the review will focus on bringing the policy and procedure in line with the revised Concordat to Support Research Integrity;

138.3 that, in respect of the wider matters resolved by ORIEC to be considered by the ARM Working Group, which included issues around promoting good practice and responding to practice falling short of ‘research misconduct’, these will be considered at a later date;

138.4 that Assurance Services can provide further guidance on the use of Drones whilst the drone policy is being finalised.

139 Reports received by the Committee

Received and noted papers 19/604 ‘OROG report to ORIEC’, 19/605 ‘DWG report to ORIEC’, 19/606B ‘BSC Chair’s report to ORIEC’, 19/607 ‘HTSC report to ORIEC’’ and 19/608 CTIMPGG report to ORIEC’.

Noted

Open Research Operational Group (OROG)

139.1 that OROG has reviewed the Open Research and Integrity (ORI) Lead role description and proposed amendments for ORIEC approval;

139.2 that feedback is expected from the workload modelling team.  Initial advice is to delay implementation of the new role past Autumn 2020 given current staff workload issues;

139.3 that the School ORI leads will need to be in place in order to undertake the actions in the Open Research Action plan;

DORA Working Group (DWG)

139.4  that discussions are ongoing to rationalise the work of the DWG, OROG and the Research Culture Working Group;

Biological Standards Committee (BSC)

139.5  that the Chair thanked the BSC team for their support of researchers during the COVID-19 lockdown;

Human Tissue Standards Committee (HTSC)

139.6 that the Wales Cancer Bank has requested authority to sign template MTAs, which have been designed and approved by the RIS Contracts team;

Resolved

139.7 that the proposed changes to the ORI Lead role description were approved by the Committee;

139.8 that ORIEC supports the Wales Cancer Bank request for the authority to sign template MTAs.  Governance Committee shall be notified of ORIEC’s support for this request.

140 Any other business

Noted

140.1 that the UK Research Integrity Office, in collaboration with the Association of Research Managers and Administrators, had published guidance on research ethics support and review in research organisations. A summary presentation was included in the ORIEC meeting book for information;

140.2 that there is a risk that research integrity and ethics standards may be compromised due to current COVID-19 remote working conditions;

140.3 that SRECs have been receiving requests for very rapid decisions on certain projects and that it is important that projects are still subject to appropriate review processes;

140.4 that SRECs and researchers would benefit from advice regarding adaptations to research required in the current COVID-19 lockdown environment;

140.5 that CARBS have ceased all primary data gathering for student projects apart from PhD and social science research methods students.

Resolved

140.6 that a piece of work is undertaken, co-ordinated by RIGE, to review potential risks and associated mitigation strategies related to human participant research in the current COVID-19 lockdown environment. This work should feed into the Task and Finish Group reviewing the return to research arrangements.

Date of next meeting October 2020, details TBC.