The RGG agrees with the governance structure proposed by Health Innovation Manchester.

It was felt that all relevant stakeholders were appropriately represented through the proposed governance structure.

30-07-2020

Approved

The RGG will need to agree a standpoint on deciding how far the RGG want to go in terms of avoiding duplication of efforts and scrutinise methods.

It was felt that this could infringe academic freedom and therefore needs careful consideration.

30-07-2020

Approved on 18-03-2021

Studies will be put on hold if they are not high priority or do not have a research data engineer (RDE) available to start working on the answer to the research question.

There are a limited pool of RDE’s, whose workload will need to be managed.

30-07-2020

Approved

RGG Chair will join the GM Secondary Uses Oversight & Scrutiny Committee meetings.

As a standing agenda item in the GM Secondary Uses Oversight & Scrutiny meetings, the RGG Chair will provide updates about the RGG and ROG (Research Operations Group).

13-08-2020

Approved

The Joint Commissioning Board (JCB) and the Provider Federation Board (PFB) will sit on the Secondary Uses Expert Review Group (ERG).

The JCB and PFB felt the Secondary Uses ERG would be a natural home for them as they don’t have the research expertise.

13-08-2020

Approved

Clinical academics from Salford Royal Trust and Manchester Foundation Trust will be invited to join the Secondary Uses Expert Review Group (ERG).

Research active clinicians could provide the Secondary Uses ERG with secondary care representation.

13-08-2020

Approved

Research Data Engineers will get access to the entire GMCR database.

This access model is aimed at risk minimisation and embedding experts into the system will help to ensure high quality data access.

13-08-2020

Approved

Two public representatives will be added to the RGG membership.

Having patients or members of the public involved in any research process is valuable.

13-08-2020

Approved

The Principle Investigator will be asked to write a protocol (with their collaborators) if the Research Operation Group (ROG) finds the study is feasible.

The protocol will allow the RGG to understand what the PI is intending to do, how they will do it and establish the studies inclusion and exclusion criteria.

13-08-2020

Approved

The Expert Review Group (ERG) will check the data ask and make an assessment whether they feel the data ask is reasonable in light of the research question that is attempting to be answered.

The ERG represent the data controllers contributing to the GMCR.

10-09-2020

Approved

ERG and RGG will assess whether the findings are plausible based on clinical knowledge and wider literature.

Before study findings are made public, it should be verified whether they are consistent with what we already know.

10-09-2020

Approved

Principle Investigators will be asked on the GM IDCR Research Proposal form whether their submission request is exploratory for a funding bid or whether they already have resource.

If the PI does not have resource yet, there is a possibility that an internal RDE or Data Analyst (DA) can be supplied; provided the analysts become a co-author on the paper.

10-09-2020

Approved

Principle Investigators will be invited to a RGG meeting to give a brief explanation of their study.

The RGG members felt it would be beneficial for PI’s to present their study to understand timescales and available resources.

24-09-2020

Pending

A Patient and Public Involvement (PPI) section will be added to the research proposal form.

Having patients or members of the public at any stage of the research is valuable. Even if PI’s have no plans for PPI involvement, it would be helpful to know that.

24-09-2020

Approved

When Principle Investigators write their study protocol, they will also be asked to provide a lay summary for their proposed study.

For transparency purposes, a lay summary and technical summary for each study currently in progress will be published on the Health Innovation Manchester Covid-19 GMCR website.

24-09-2020

Approved

RGG Chair proposed the minutes of the RGG meetings be made publicly available.

Could lead to specific sensitive comments being publicly attributed to an individual.

24-09-2020

Rejected

A RGG decision log will be published on the Health Innovation Manchester Covid-19 GMCR website. Sensitive information will not be published and individuals will not be named.

A publicly available decision log provides the public with information about what is happening in meetings and shows the RGG are being open, but are also mindful of sensitivities.

24-09-2020

Approved

A data access log will be published and made publicly available.

The data access log will be published to reassure the public that the data is not going to fall into the wrong hands.

24-09-2020

Approved

Time and effort contributed to GMCR related work will be logged for the whole team.

The time log will inform Research Grant applications and enable quantifiable statements to be made in grants.

08-10-2020

Approved

An accompanying glossary will be published with the RGG decision log.

The glossary will also be made publicly available to explain acronyms, jargon and technical language.

08-10-2020

Approved

Studies will require PPI at the stage when the PI presents their study to the RGG.

It was felt requiring PPI at the stage of PI presentations will ensure the inclusion of PPI.

12-11-2020

Approved

RGG study approval decision options: 1. RGG approve the study with no changes required. 2. RGG approve the study subject to minor revisions being made to the protocol (two RGG members will review the revised protocol). 3. The study protocol requires major revisions. The full RGG will review the revised protocol before the study is approved. 4. The RGG advise the study is not suitable for the GMCR; the RGG may suggest the study PI considers an alternative more suitable dataset.

It was felt outlining the RGG study approval decision options would clarify the possible outcomes.

12-11-2020

Approved

The GM IDCR Covid-19 Research Proposal Form (used in stage 1 of the process) will include a question about inequalities impact.

Including a question about inequalities research in the GM IDCR Covid-19 Research Proposal Form will make people aware of this question from the start of the process.

26-11-2020

Approved

The RGG approved the request for a new study proposal: ‘Healthcare utilisation across Greater Manchester during the Covid-19 pandemic, PI: Stuart Grant’. The RGG granted approval with the caveat that at least two PPI representatives should be recruited to the study team before the study can begin.

It was felt this study proposal was really important and valuable work. Additionally, the project will provide some general learning for future studies.

26-11-2020

Approved

Proposed to fast track study IDCR-RQ-25 (PI: Watkinson, Title: Are the proposed COVID-19 phase 1 vaccination priority groups equitable with respect to ethnicity and socioeconomic status?)

Propose to fast track study IDCR-RQ-25, as the study is very important and timely.

16-12-2020

Approved

The duration of RGG member’s term will be defined in the RGG Terms of Reference.

RGG membership will be limited to a maximum of two years and a shadowing process will be put in place for replacement members.

16-12-2020

Approved

The RGG approved the request for the study proposal: ‘Risk of COVID-19 in cancer patients study, PI: Finn’, now the RGG’s feedback has been actioned.

The RGG’s study approval is subject to the study receiving NHS REC (Research Ethics Committee) approval. Additionally, the RGG recommended the study team obtain additional PPI input at the end of each of the 3 study stages.

04-02-2021

Approved

The RGG decided feedback from a statistician and an epidemiologist should be obtained for the study proposal: ‘The predictive non-clinical factors on covid-19 diagnosis by considering the interactive transmissions among individual, organisation and society, PI: Shi’. Additionally, the RGG felt the study team should clarify their plans for PPI Engagement.

The RGG felt that it would be useful to obtain feedback on the study methodology from a statistical and epidemiology viewpoint, to assist the RGG with making an informed approval decision.

04-02-2021

Approved

The RGG approved the study proposal: ‘Are the proposed COVID-19 phase 1 vaccination priority groups equitable with respect to ethnicity and socioeconomic status?, PI: Watkinson’. The RGG confirmed they were happy for the study to proceed once the PPI aspects of the study had been re-phrased and the ROG had confirmed there is not any risk of re-identification.

It was felt the study is very important and timely. Additionally, the study includes strong PPI engagement.

04-02-2021

Approved

The RGG confirmed they are happy for the revised RGG ToR to be published on the Health Innovation Manchester website.

The RGG were happy with the revised RGG ToR and felt they should be made publicly available for transparency purposes.

25-02-2021

Approved

PPI Engagement (PPIE) will not be made compulsory in all cases, but it is strongly encouraged by the RGG. The RGG will offer to provide guidance to applicants and signpost to organisations which can help them make contact with PPI contributors.

The RGG values PPIE and felt it has an important role in shaping research; however, recognised not everything can involve PPI.

25-02-2021

Approved

The RGG approved a RGG review process in which the RGG Chair allocates proposals to RGG members with relevant experience to review.

It was felt the proposed RGG review process would streamline the process. However, the RGG agreed to keep this process under review to check the responsibility of reviewing proposals was shared fairly across the group.

25-02-2021

Approved

The RGG returned the IDCR-RQ-014 proposal to the study team with feedback (PI: Shi, Title: ‘The predictive non-clinical factors on covid-19 diagnosis by considering the interactive transmissions among individual, organisation and society’).

Following feedback received from a statistician and an epidemiologist, the RGG felt the IDCR-Rq-014 proposal requires major revisions in order to reach the required acceptable scientific standard.

25-02-2021

Rejected

The RGG approved the IDCR-RQ-020 proposal (PI: Heald, Title: ‘Greater Manchester collaborative to evaluate why some people with diabetes have a greater risk of becoming seriously unwell or dying with COVID-19‘).

The RGG reviewers felt the IDCR-RQ-020 Heald proposal was well described and had no concerns.

18-03-2021

Approved

The RGG approved the IDCR-RQ-029 proposal (PI: Steeg, Title: ‘Frequency of recording of self-harm episodes in primary care records in Greater Manchester: retrospective cohort study examining the impact of Covid-19’).

The RGG reviewers felt the IDCR-RQ-029 proposal was a high quality study that should progress and appears to be valuable and achievable.

18-03-2021

Approved

RGG agreed to approve the IDCR-RQ-017 proposal (PI: Humphreys, Title: ‘Caught in the cross-fire of COVID – opportunities to improve practice and reduce harm in patients with rheumatoid arthritis taking methotrexate‘). The RGG reviewers provided some advisory recommendations for the IDCR-RQ-017 Humphreys study team to consider.

The RGG reviewers were broadly supportive of the IDCR-RQ-017 Humphrey and confirmed their advisory recommendations do not need to be followed-up before approval can be granted.

18-03-2021

Approved

The RGG decided to decline access to the GMCR for the IDCR-RQ-021 proposal (PI: Bakerly, Title: ‘Using Real World data to investigate the impact of Covid-19 pandemic on microbial and viral secondary infection patterns within respiratory samples obtained from patients within the Greater Manchester area‘). The RGG also decided to provide the PI with the option to re-submit this study in the future, with a thoroughly re-defined proposal. The RGG recommended the study team bring an experienced methodologist onto their team to help with re-defining the proposal.

The RGG felt the proposal was not sufficiently revised in light of the first round of RG feedback. The analysis plan lacked necessary detail and the RGG remained unconvinced by the robustness of the proposal. Additionally, the RGG felt the study would have benefited from PPIE plans, as involve patients could provide an opportunity to check the actual lived-experiences of patients and "sense-check" the findings.

18-03-2021

Rejected

The RGG returned the IDCR-RQ-015 proposal to the study team with feedback (PI: Bakerly, Title: ‘To investigate whether the use of inhaled and/ or nasal corticosteroid influences clinical outcomes in patients with asthma and/ or COPD with COVID-19 ‘).

The RGG advised the proposal should provide a maximum of two primary outcomes. The RGG recommended the study team bring an experienced methodologist onto their team to help with revising the proposal. Additionally, the RGG felt the study would have benefit from PPIE.

18-03-2021

Rejected

The RGG decided no attempts would be made to avoid duplication. However, the ROG will be responsible for informing PI’s if research proposals with overlapping scope have been submitted. The RGG will fulfil the role of scrutinising methods. The ROG will notify the RGG if they believe something has not been thought through; however, the RGG will make the verdict on methods.

The RGG felt duplication adds scientific robustness and offers an independent validation of the results. However, PI’s will be made aware of other proposals with overlapping project scope, in case study team‘s would rather work in collaboration.

18-03-2021

Approved

Decision: RGG agreed to approve the RQ-028 Firth (Hassan) proposal, Examining health disparities in relation to COVID-19 for people with mental illness. Joyce Cox’s advice to be followed.

Joyce Cox advised that it is good to see that it is planned to involve PPI groups at various stages of the research from identifying outcomes of importance to patients, to dissemination and driving impact; however, no detail is given of how or who they will recruit. In recruiting service users for PPI groups, consideration needs to be given to age, sex, different SMIs, and different minority ethnic backgrounds - shown to be disproportionately affected by COVID-19. The Plain English Summary mostly uses a good level of plain English however, the last sentence stretches over 4 lines and needs to be re-drafted.’

29-04-2021

Approved

RGG agreed that a small working group should produce a draft of a version of the form that will align to RGG requirements

SD to lead the group, with Angela Ruddock, Matt Sperrin and Matt Hennessey. Joyce to review the draft prior to circulation to the wider group for comments.

29-04-2021

Approved

RRG decided that PIs could be invited to attend and present to RGG meeting, in exceptional circumstances

In the pre-review form, reviewers will be asked whether they think it would be useful to progress the application for the PI to come to an RGG meeting. The form would have a section with eg "in exceptional circumstances, PIs can be invited to RGG meeting to present and discuss their application further. If you feel that this proposal would benefit from this, please tick here".

29-04-2021

Approved

Decision: ROG will organise a series of seminars

ROG will organise a series of seminars for projects to share and disseminate their analysis outputs for the ERG/RGG/SUOG and wider communities.

29-04-2021

Approved

Proposed process for study results/output details required for RGG.

Results of study analysis are subject to review by the ERG and RGG prior to publication or other dissemination. Once reviewed and approved publication /dissemination can continue.

10-06-2021

Approved

Dr Sarah Steeg presented her study results: Temporal trends in primary care-recorded self-harm during the first year of the COVID-19 pandemic: time series analysis of electronic healthcare records for 2.8 million patients in the Greater Manchester Care Record

Once reviewed and approved publication /dissemination can continue.

10-06-21

Approved

RGG’s remit and purpose to be added to the form.

Once reviewed and approved, dissemination can continue.

01-07-21

Approved

The wording to be amended slightly to distinguish it from the CPRD form

Once reviewed and approved, dissemination can continue.

01-07-21

Approved

Once the above changes have been made, the form will be the final version, and will be disseminated for use.

Once reviewed and approved, dissemination can continue.

01-07-21

Approved

RGG membership will be rolled over for the next term.

Terms of reference indicated that all membership expired at the end of August 2021.

09-09-21

Approved

RGG meeting frequency will remain on a 3 week cycle.

Terms of reference indicated that meeting frequency was up for review.

09-09-21

Approved

DPIA developments will be monitored to ensure that the role of the RGG is clear, alongside any changes related to the governance structure.

The draft DPIA for secondary users will be tabled for discussion in a future meeting as it will be broader than just COVID-19 and include changes not detailed in the current process.

09-09-21

Approved

PPI and primary care clinical reviewers will be assigned to the Diabetes MyWay Rutter-032 study.

Chair expressed a preferance to have at least one reviewer to maintain transparency from governance perspective.

09-09-21

Approved

RGG agreed on a two pronged approach: • A response to the application • Embarking on general work on public views with the Dare study scenario as a case study

Angela Ruddock and Caroline Saunders will review the study proposal and response to PI. Agreement to use study as a case for wider work on public views in collaboration with HinM.

09-09-21

Approved

Members agreed that there would not be a substantial RGG review of REC approved studies. Instead, the RGG will formulate an approach for an advisory review of PPIE instead, depending on the extent to which PPIE is currently included as an element of the NHS REC approval process.

Where a proposal is submitted with previously obtained NHS REC approval, it was felt that a light touch review on PPIE is required as the correct approvals have already been secured.

30-09-21

Approved

A protocol outlining the prompts and process for submitting amendments for researchers will be created by the ROG and submitted for review by RGG.

It was acknowledged that PIs may implicitly or explicitly veer from the remit of their original proposals and wish to change/add different elements to their study. Members were invited to share thoughts on the process in which this request should be made.

30-09-21

Approved

Currently, the RGG will continue to carry out individual study checks prior to publication, however in summer 2022, a date will be set to review moving to a sample based/ post-publication audit-style review.

It was acknowledged that PIs may implicitly or explicitly veer from the remit of their original proposals and wish to change/add different elements to their study. Members were invited to share thoughts on the process in which this request should be made.

30-09-21

Approved

Stage IIb approved with comments to be shared with PI.

The RGG reviewers felt the IDCR-RQ-019 proposal was well described with minor changes proposed to the glossary, plain English summary and PPIE details.

30-09-21

Approved

Stage IIb approved with comments to be shared with PI.

The RGG reviewers felt the IDCR-RQ-032 proposal was well described with minor changes proposed regarding the plain English summary and PPIE detail.

30-09-21

Approved

Terms of reference will be published

The GMCR TOR draft was reviewed and approved by RGG members present

21-10-21

Approved

Plain English summaries will be requested as part of all future presentations to the RGG by PIs

This will make it easier for members outside of the Science community to better understand the nature of the studies undertaken by researchers

21-10-21

Approved

The Heald publication is approved. There is a request for the plain English summary to be clearer.

Plain english summaries were provided by Adrian Heald at the request of the RGG to better understand the results prior to approval.

11-11-21

Approved

RGG approved request for amendment to current study - which involves rolling out neighbourhood vaccine hubs.

Request would require the same data currently held and similar analysis taking place (to the initial proposal) with an additional emphasis on regionality rather than ethnicity.

11-11-21

Approved

The outputs/results review process will be streamlined using an offline email process. RGG members will monitor where plain English summaries are included and will ensure that these are available prior to publication where relevant.

Reducing the risk of delaying research ready to publish/disseminate; reduce in-meeting burden; streamline processes

11-11-21

Approved

Abstract for conference approved

RGG have no issues with content.

11-11-21

Approved

RQ-024 Study application rejected.

The study was determined to be infeasible due to the risk of using partial information which could lead to inaccurate conclusions.

13/01/22

Approved

RQ-036 study application approved with amends.

The study was approved provided a revision of the methodological tools is carried out by the PI.

03/02/22

Approved

RGG members recommend that RQ-037 Heald is approved, pending the Chair’s decision outside of the meeting.

24/03/22

Approved

RGG members recommend that the Firth & Hassan RQ-028 Amendment is reviewed again at the next scheduled RGG meeting.

24/03/22

Pending

RGG members recommend that the Postgraduate Students as PIs recommendation is approved pending the Chair’s approval outside of the meeting.

24/03/22

Approved

The manuscript and plain English summary for RQ-028 were approved.

Both documents were well received.

17/03/22

Approved

Due to the difference of the research question, the cohort and the data request, the RQ-028 Firth/Hassan amendment is rejected, and PIs are requested to submit the study as a new proposal should they wish to pursue it.

This item was raised in the previous RGG meeting, however as the meeting was not quorate, a decision was made for it to be tabled once more.

17/03/22

Approved

The Postgraduate research students as PIs recommendation is approved.

This item was discussed in the last meeting and was approved pending the Chair’s approval outside the meeting as it was not quorate. It was tabled once again as the scope changed from PhD students to Post-doctoral research students in general.

17/03/22

Approved