COVID-19 Research Governance Group

Providing oversight of using the GM Care Record for COVID-19 research.

The purpose of the COVID-19 Research Governance Group is provide oversight of the uses of the GM Care Record data for COVID-19 research purposes.

The group meets fortnightly throughout the COVID-19 pandemic. In line with the COPI notice, the frequency of the meetings will be reviewed on 31st March 2021.

A summary of the key decisions made by the group are listed below:

Decision Log

TitleDescriptionJustificationDate Presented to RGGRGG Decision
Governance structure of the GMCR for Covid-19 related research

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

Handling study proposals

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

Pending

Handling study proposals

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

Governance structure of the GMCR for Covid-19 related research

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

Governance structure of the GMCR for Covid-19 related research

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

Governance structure of the GMCR for Covid-19 related research

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

Approval of access for Research Data Engineers

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

RGG membership review

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

Documentation – Study proposals

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

Handling study proposals (Phase II)

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

Checking study findings (Phase IV)

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

Documentation - GM Integrated Data Care Record (GM IDCR) Research Proposal Form

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

Study proposals

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

Documentation - GM Integrated Data Care Record (GM IDCR) Research Proposal Form

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

Lay summary

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

Transparency

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

Transparency

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

Transparency

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

Funding

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

Documentation / Transparency

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

Handling study proposals

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

Handling study proposals

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

Documentation - GM Integrated Data Care Record (GM IDCR) Research Proposal Form

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

Research study proposal request

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

Handling study proposals

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

RGG membership review

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

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