Open Research Integrity and Ethics Committee minutes 9 February 2021

Minutes of the meeting of the Open Research Integrity and Ethics Committee held on 9 February 2021 via videoconference at 10:00.

Present: Professor Andrew Westwell (Chair), Dr Rhian Deslandes, Professor William Evans, Professor Debbie Foster, Professor Kerry Hood, Dr Dawn Knight, Dr Michael Lewis, Professor Stephen Lynch, Judge Ray Singh and Dr Chris Whitman.

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

Apologies for absence were received from: Professor Gillian Bristow, Professor Claire Gorrara, Professor Kim Graham, Professor Oliver Ottmann, Professor Adrian Porch, Professor Phil Stephens, Dr Jessica Steventon and Professor Roger Whitaker.

153 Welcome and Introductions

The Chair welcomed everyone to the meeting.

153.1  The Chair welcomed Professor Stephen Lynch to his first meeting, as the incoming Dean of Research for the College of PSE;

153.2  The Committee noted that Professor Claire Gorrara will be joining the Committee in her new capacity as Dean of Research and Innovation for AHSS;

153.3  The Committee would like to thank the following for their valuable contributions to the Committee: Professor Gillian Bristow, Professor Roger Whitaker (both leaving their roles as College Dean of Research for AHSS and PSE respectively), Professor Debbie Foster and Professor Adrian Porch (stepping down from their roles as Academic Representatives for AHSS and PSE respectively).

154 Declaration of Interests

No declaration of interests were made during the meeting.

155 Minutes

The Minutes (20/414) of the last meeting of the Committee were approved.

156 Matters arising

Received and noted paper 20/415, ‘Matters Arising’ subject to the following:

Noted

156.1  That the JOMEC Annual SREC Report for the 2019 reporting period has now been received and will be reviewed by RIGE alongside the 2020 Annual SREC Reports (given that the 2020 Annual SREC Reports will be issued during February 2021 and are expected to be returned by 31 March 2021);

156.2  That the Chair and Secretary of ORIEC considered a request from an external researcher to conduct a study involving interviews and focus groups with Cardiff University staff and students from multiple Schools.  The project had received ethical approval from the University of Lancaster.  The Chair and Secretary of ORIEC confirmed that the University has no objection to the commencement of recruitment;

156.3  That the BIOSI SREC has received an application for an undergraduate student project that consists of using a questionnaire to gather opinions about the teaching of 3Rs in Universities.  The BIOSI Director of Research has confirmed that the research cannot be approved on the grounds that it compromises the safety of the University’s staff and students.

157 Research Ethics Procedure

Received and considered paper 20/416, ‘Research Ethics Procedures’.

Noted

157.1  That RIGE has an outstanding action to identify options for training SREC members, applicants and supervisors;

157.2  That some additions have been made to the 2019 Annual Report proforma for the 2020 reporting period. The additions will add further clarity and address some specific matters resolved previously by the Committee;

157.3  That whilst some Schools may not encounter research involving Human Tissue, the Committee was satisfied that the question relating to whether Schools have adopted an ethics protocol for research involving Human Tissue does not require a ‘N/A’ option.  The Committee noted that Schools can utilise the existing ‘No’ option and that including just a ‘Yes’ or ‘No’ option in the Application Form for Ethical Review minimises the risk that researchers may think the criterion is not applicable when, in some cases, it may be;

157.4  That the inclusion of a specific question on workload allocation was a welcomed addition to the Annual Report proforma in light of the resource challenges being faced by some Schools and that capturing whether existing workload allocation (where applicable) is ‘sufficient’ is also important;

157.5  That, if approved by the Committee, the revised proforma will be issued to Schools in February 2021, with responses due by 31 March 2021. As with the previous annual reporting process, an initial review of the SREC Annual Reports will be conducted by RIGE (who will liaise/engage with the College Deans of Research where required on specific issues) and a summary provided to the Committee at its meeting on 20 May 2021;

157.6  That appropriately resourcing SRECs to enable implementation of the new procedures remains challenging in some Schools, particularly AHSS Schools that will be required to review large volumes of student Human Research projects;

157.7  That adequate professional services support is key to the operation of SRECs dealing with high volumes of ethical review applications. Trained and skilled professional services staff can provide a critical initial screening service to the SREC;

157.8  That the Chair and Secretary to the Committee are to consider the extent to which AHSS Schools can be offered any further support in implementing the Committee-approved SREC Procedures;

157.9  That the ‘Dealing with high volumes of student Human Research projects requiring ethical review’ consolidated document will provide clarity and guidance to Schools on the relevant requirements, decisions and the solutions considered by the Committee to date;

157.10          That group/module-wide approval was broadly supported by the Committee (03 November 2020) as a potential solution for Schools dealing with high volumes of ethical review applications;

157.11          That paper 20/416 sets out proposed minimum standards for group/module-wide review. The minimum standards are based on matters raised at the last meeting of the Committee and common criteria used by other Russell Group Universities;

157.12          That the PSYCH and ARCHI SRECs already use a system of group/module-wide review;

157.13          That SRECs will need to consider and determine what groups of projects can be regarded as ‘the same or substantially similar’ given that even projects using the same research method (questionnaires, for example) can follow different models and have differing levels of ethical risk.  This will ultimately be a matter of academic judgment for the SREC;

157.14          That the SREC must be confident that the group applicant (who may be the module leader, but not exclusively) fully understands the ethical issues relevant to the application and the SRECs expectations;

157.15          That SRECs must also be confident that the individual researchers falling within the group/module-wide application understand that they are ultimately responsible for the ethical conduct of their research and must act in accordance with the favourable ethical opinion granted by the SREC;

157.16          That RIGE will adapt the template Application Form for Ethical Review to create a group/module-wide ethics application form;

Resolved

157.17          That the 2020 Annual Research Ethics Report template be amended as follows:

1. Question 2 should identify how many projects have been approved under a group/module wide approval (where applicable);
2. Question 3 should identify individuals that are not members of the SREC but are approved by the School to act as ‘Second reviewers’ for projects eligible for Proportionate Review;
3. Question 10 guidance be amended to state that SRECs should detail if the workload allocation does not reflect the actual workload requirements for the implementation and the ongoing operation of the new ORIEC-approved SREC Procedures;
4. Question 11 be amended to read “…any matters of concern (relating to the SREC Procedures or research ethics more generally) that the SREC wishes to report to ORIEC.”

157.18          That, subject to the changes listed at 157.17, the Annual Research Ethics Report template be approved by Chair’s action and disseminated to Schools;

157.19          that the Transforming Services review should consider the professional services support available to SRECs;

157.20          That a statement be added to the consolidated document to make it clear that it is a ‘live’ document which will be reviewed and updated annually;

157.21          That, in respect of any data collection tools to be used by researchers falling within a group/module-wide application, the applicant needs to provide, as a minimum, clear information about what ‘domain’ themes will be permitted and the parameters from which the data collection tool and other supporting documents (information sheets, consent forms, etc) for individual projects must not deviate (e.g. questionnaire or interview questions limited to a specific topic area and subject to specific assurances or exclusions);

157.22          That where the SREC has been asked to review a template/skeleton of a supporting document, or to approve a proposed set of parameters/exclusions for a data collection tool, the application must set out how the final versions of these documents will be reviewed for each project, and by who, to ensure they align with the favourable ethical opinion granted by the SREC;

157.23          That all researchers falling within the group/module-wide application be required to complete and submit an individual declaration to confirm that they will meet the requirements of the group/module-wide favourable ethical opinion granted by the SREC.  The group/module-wide application must be clear how these individual declarations will be collected and how individual researchers are made aware of the details of the group/module-wide approval;

157.24          That the minimum standards include a feedback loop between the group applicant and the SREC to ensure that the group applicant is supported in any decisions regarding what individual projects do or do not fall within the favourable ethical opinion issued by the SREC;

157.25          That once the amendments set out above have been made (which requires changes to minimum standards 7. and 8. in particular), the group/module-wide minimum standards be approved by Chair’s action and distributed via the SREC Teams page.

158 Research Integrity activity update

Received and considered paper 20/417, ‘Research Integrity Activity Update’.

Noted

158.1  That publication of the UKRIO Self-Assessment Tool, which will be used to assess the University’s performance against the Concordat to Support Research Integrity, is expected imminently;

158.2  That 42% of Doctoral, MPhil and MRes students that have enrolled during the 2020/2021 Academic Year have completed the Research Integrity Online Training Programme (RI Training) to date.  42% of Academic Staff (those on R/T&R/T&S pathways, and clinical equivalent pathways) have completed the RI Training. This increases to 54% when only considering REF eligible staff.  Completion rates for staff have increased slightly since the paper was issued – 60% of REF eligible staff have now completed the RI Training;

158.3  That whilst RIGE is able to provide SRECs with a list of staff and/or students that have completed the RI Training, it is preferable for SREC applicants to provide evidence of RI Training completion as part of the SREC application process (either a completion certificate or appropriate screenshot of achievements/certificate);

158.4  That, in respect of Schools that have provided a named point of contact for receipt of Academic Staff completion reports for the RI Training, RIGE currently provides periodic reports (usually in advance of each ORIEC meeting);

158.5  That, in relation to PGR students, completion of the RI Training is (or at least should be) linked to progress monitoring;

158.6  That previous engagement with HR had indicated that including a specific requirement for RI Training completion in the staff PDR process was not feasible, although RIGE will check the position and ascertain what was agreed;

158.7  That in addition to the MLANG query reviewed 03 November 2020, the Centre for Professional Legal Studies (CPLS) in LAWPL has contacted RIGE seeking an exemption from its staff (an entirely T&S group) completing the online research integrity training.  RIGE has been informed that CPLS staff do not engage in research or teach any research-active students;

158.8  That the Committee was being asked to consider what approach should be taken to T&S staff moving forwards and whether completion of the RI Training should remain mandatory for this group.  The Committee was being presented with three options to consider;

158.9  That the Committee could not support Option 3 (that T&S staff be removed from the mandatory completion group) and reiterated its view (minute 149.3, 03 November 2020) that it is important to ensure that any staff responsible for supervising student research projects are captured by the mandatory completion group;

Resolved

158.10          That, in respect of the approach to be taken to T&S staff moving forwards, the Committee approves Option 2, namely that in exceptional circumstances the Committee may approve the exemption of certain T&S staff groups from completion of the RI Training;

158.11          That Schools wishing to exempt any of its T&S staff (from the requirement to complete the RI Training) must make an application to ORIEC;

158.12          That RIGE prepares a proforma/checklist to be completed by Schools wishing to apply for an exemption and that this must include a list of staff for which the School is seeking an exemption and must contain assurances that such staff have no involvement in research activity, including teaching or supervision related to research;

158.13          That should an exemption request be granted by ORIEC, the School must assure the Committee that those exempt staff will be notified of their exemption and that the exemption will no longer apply if their role changes to include relevant activity;

159 Assurance Services activity update

Received and considered paper 20/418, ‘Assurance Services Activity Update’.

Noted

159.1  That the EU will make a decision within six months as to whether the UK meets ‘Adequacy’ requirements.  In the event that the UK is deemed not to provide an adequate level of protection, the University will need to put in place appropriate legal mechanisms (likely to be Standard Contractual Clauses) for the transfer of Personal Data to and from the EU.  Staff responsible for processing Personal Data should document their dataflows and identify the mechanism permitting continued transmission of Personal Data. Further guidance and resources are available on the ‘Data Protection – Brexit’ pages.

160 Reports received by the committee

Received and noted papers 20/419 ‘OROG report to ORIEC’, 20/420 ‘DWG report to ORIEC’, 20/421 ‘Statement on Responsible Research Assessment’, 20/422 ‘BSC Chair’s report to ORIEC’, 20/423 ‘HTSC report to ORIEC’’ and 20/424 CTIMPGG report to ORIEC’.

Noted

DORA Working Group (DWG)

160.1  That the Statement on Responsible Research Assessment has been approved by UEB;

160.2  That, once approved, the Statement will be published on the internet and intranet and distributed to Schools;

Human Tissue Standards Committee (HTSC)

160.3  That the Committee supports the Human Tissue Officer role proposal.

Resolved

160.4  That the Committee endorses the Statement on Responsible Research Assessment.

161 Any Other Business

No additional items were raised.

Date of next meeting 20th May 2021, at 10.00.