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Peer reviewed: True, OBJECTIVE: To describe national patterns of National Health Service (NHS) analysis of mismatch repair (MMR) genes in England using individual-level data submitted to the National Disease Registration Service (NDRS) by the NHS regional molecular genetics laboratories. DESIGN: Laboratories submitted individual-level patient data to NDRS against a prescribed data model, including (1) patient identifiers, (2) test episode data, (3) per-gene results and (4) detected sequence variants. Individualised per-laboratory algorithms were designed and applied in NDRS to extract and map the data to the common data model. Laboratory-level MMR activity audit data from the Clinical Molecular Genetics Society/Association of Clinical Genomic Science were used to assess early years' missing data. RESULTS: Individual-level data from patients undergoing NHS MMR germline genetic testing were submitted from all 13 English laboratories performing MMR analyses, comprising in total 16 722 patients (9649 full-gene, 7073 targeted), with the earliest submission from 2000. The NDRS dataset is estimated to comprise >60% of NHS MMR analyses performed since inception of NHS MMR analysis, with complete national data for full-gene analyses for 2016 onwards. Out of 9649 full-gene tests, 2724 had an abnormal result, approximately 70% of which were (likely) pathogenic. Data linkage to the National Cancer Registry demonstrated colorectal cancer was the most frequent cancer type in which full-gene analysis was performed. CONCLUSION: The NDRS MMR dataset is a unique national pan-laboratory amalgamation of individual-level clinical and genomic patient data with pseudonymised identifiers enabling linkage to other national datasets. This growing resource will enable longitudinal research and can form the basis of a live national genomic disease registry.

Macklin and Natanson (2020) raise concerns surrounding the misrepresentation of usual care in three critical care studies. Emergency care research also yields examples of studies where claims of us...

The auditing process is a sequenced, coordinated activity aimed at obtaining a specific result. The audit plan was designed to establish the baseline in each Research Performing Organisation (RPO) and Research Funding Organisation (RFO) to be able to evaluate and change the structural and cultural assets to include RRI (as defined in "D5.1: Self-Tailored RPO&RFO Audit Plans - Parts A&B" of the GRRIP project). This report contains the analysis of the evidence related to the five case study organisations. The audit was designed to collect data at the organisational level from the site leads (i.e., a top-down approach), and a survey was conducted with researchers and stakeholders, as a bottom-up approach. The top-down approach aimed at collecting objective data and documents from the five case study organisations. The bottom-up approach aimed at collecting data: 1) from the staff of the five RP(F)Os, and 2) from the Quadruple Helix stakeholders in conjunction with the activities carried out in "WP4 - Q GRRIP D&C Board". Interviews were conducted with the leaders of the GRRIP working groups established within the five RP(F)Os to complement information collected from the top-down and bottom-up survey to facilitate interconnection with the other Work Packages (WPs). The audit results presented within this report aim to inform the development of the action plans for institutionalising RRI. The findings, however, cannot be considered an exact reflection of the existing organisational processes and procedures about RRI dimensions as they are constrained by low response rates of the sent-out surveys and the use of convenience sampling method. In our analysis, we were interested in the correlation between the answers coming from the bottom-up analysis returning us a picture of the situation, even if it does not have statistical significance due to the number of answers received from the case study sites. We decided to use the Pearson's coefficient, as Pearson correlation coefficient is most appropriate for measurements taken from an interval scale according to Choi et al. [1]; in this respect, see also the response from Abdulvahed Khaledi Darvishan in the ResearchGate post (https://www.researchgate.net/post/Which-correlation-coefficient-is-better-to-use-Spearman-or-Pearson). The analysis of information and data collected is shown in Appendix A and Appendix B of this deliverable. Complete data and information are available only for the Consortium, the project officer and the GRRIP project's evaluators (on request). Section 2 provides a summary of the methodology used to collect data necessary to carry out the audit analysis. Section 3 describes the method to establish the baseline maturity level and definition of the indicators. Section 4 describes the maturity level for the five M&M RP(F)Os. Section 5 concludes the deliverable.

To date, the majority of networks for RRI have ceased on completion of their associated project. It is very difficult to maintain a network, especially if the funding model is not fit for purpose, or if the network relies on volunteers, or perhaps if the network is only virtual. The RRING project has defined the RRING Network implementation plan covering the mechanics of establishment and running of the RRING community. The development of the RRING network is conducted together the WP2 to gain the required exposure through dissemination and communications planning. Furthermore, the deliverable D7.1 has provided an overview of existing model networks, networks and platforms in RRI. This deliverable is a reference for developing considerations for acquiring each objective. The implementation plan is based on a pro-active approach for including identified key RRI players and platforms identified in WPs 3 and 4 and, other leading institutions and practitioners towards engaging in the RRING Community including sharing of knowledge, best practice and institutional change. By the end of the project, it will be essential to ensure the RRING Community (Network and Platform) is operating effectively against defined goals, i.e. that the objective is measured and achieved. This will be measured under the Trials in T7.5 - Implementation Plan for the GE community. There will be a formal handover of the RRING Network as an independent entity at project end. The RRING network implementation plan is structured in 14 Objectives: ? Objective 1: Establish the benefits to be gained through the RRING inter-organizational network approach (value propositions) (from the Structured Democratic Dialogue - SDD workshop series), ? Objective 2: Identify the key services (from the SDD workshop series), ? Objective 3: Identify and describe the services that will be implemented in the trial phase and after the end of the project (top-down and bottom-up divisions) (from the workshop series), ? Objective 4: Establish the network model (taking into account deliverable D7.1 Part A&B and the building blocks of the BMCs), ? Objective 5: Choose the legal form with which the network is officially established. Establish place and date of the launch (taking into account deliverable D7.1 Part A&B), ? Objective 6: Establish the Governance and management bodies and the operational units of the network (organization chart, network body management, collaborative rules, local contacts point, ...) (taking into account deliverable D7.1 Part A&B and the building blocks of the BMCs), ? Objective 7: Identify network key partners (providers) and their roles. (from the BMCs), ? Objective 8: Identify network target consumers (users and key partners) (from BMCs), ? Objective 9: Establish the resources and infrastructures that need to be created (both in the trial phase and once the project ends) (example: office in Brussels, online platform, etc. from the BMCs), ? Objective 10: Establish the revenue streams (from BMCs), ? Objective 11: Identify costs (from BMCs), ? Objective 12: Implement and launch the services of the trial, ? Objective 13: Measure performance of the trial, Objective 14: Create a post-project plan. The objectives of the implementation plan are explained in the next sections of this deliverable. For each one of the objectives, we explain: 1) Aims and steps to acquire the objective, 2) Main considerations related to the network emerged in the study presented in deliverable D7.1 - SoA of RRI networks and identify the best of breed networks and platforms, 3) Outcomes coming from the discussion.

In this response, we first tackle what we take to be the core disagreement between ourselves and Hammersley, namely the justification for our model of social research ethics governance. We then consider what follows from our defence of governance for ethics review and show how these claims attend to the specific concerns outlined by Hammersley.

This deliverable was produced within the activities of the "WP 5: RPO&RFO Working Groups setup, and audit and impact assessment of RRI maturity" and in particular it is the result of the "Task 5.2 - Develop self-tailored Audit plans" of the GRRIP project. The auditing process is a sequenced, coordinated activity aimed at obtaining a specific result. The Audit Plan, as defined in the GRRIP project, aims at establishing the objectives, activities, teams, and timing of the audit activities, for collecting information and assessing the initial state of the institutionalization of RRI into the Research Performing Organisations (RPO) and the Research Funding Organization (RFO) that are the case study demo sites involved in GRRIP. This will enable each organization to establish the baseline to evaluate and change the structural and cultural assets to include RRI. An audit process consists of different phases, i.e. planning, fieldwork, and reporting. This document describes the planning phase, i.e. the Audit Plan of an audit process. It plans the activities to be implemented in the fieldwork for assessing procedures and practices to identify RRI gaps (knowledge acquisition). The task "T5.2 - Develop self-tailored Audit Plans" of GRRIP has to define the Audit plans for RPOs and RFOs that are described in this deliverable. This document will be the basis of the implementation of the Audit Plans (Task 5.3 - Conduct Audit parts A&B for each RPO&RFO). The Audit Plan is delivered in each Organisation through the representatives (the Working Group manager) of the Working Groups, which has been already established in GRRIP (see task T5.1). Each Working Group member is invited to participate in the Audit of her/his organization to assess the maturity level of RRI practices and determine how well the organization is currently performing and is also invited to share and facilitate the dissemination of the survey that is addressed to the researchers of the organisation. The remaining of this document contains one section about the goals of the GRRIP Audit Plan, one section that gives a picture of the type of information and data to be collected with the audit activity and necessary for the audit analysis, one section that describes the process for the Audit Plan definition, and one section containing the General framework of the Audit Plan on which the RPOs ant the RFO base their tailored Audit Plans. Finally, this document includes an appendix containing the Process for Working Group Manager related to the Audit Plan.

There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake— protecting researchers’ freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy—raise relevant ethical considerations that are reasonably contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments.

BACKGROUND: The spread of artemisinin-resistance in Plasmodium falciparum is a threat to current global malaria control initiatives. Targeted malaria treatment (TMT), which combines mass anti-malarial administration with conventional malaria prevention and control measures, has been proposed as a strategy to tackle this problem. The effectiveness of TMT depends on high levels of population coverage and is influenced by accompanying community engagement activities and the local social context. The article explores how these factors influenced attitudes and behaviours towards TMT in Kayin (Karen) State, Myanmar. METHODS: Semi-structured interviews were conducted with villagers from study villages (N = 31) and TMT project staff (N = 14) between March and July 2015. RESULTS: Community engagement consisted of a range of activities to communicate the local malaria situation (including anti-malarial drug resistance and asymptomatic malaria), the aims of the TMT project, and its potential benefits. Community engagement was seen by staff as integral to the TMT project as a whole and not a sub-set of activities. Attitudes towards TMT (including towards community engagement) showed that developing trusting relationships helped foster participation. After initial wariness, staff received hospitality and acceptance among villagers. Offering healthcare alongside TMT proved mutually beneficial for the study and villagers. A handful of more socially-mobile and wealthy community members were reluctant to participate. The challenges of community engagement included time constraints and the isolation of the community with its limited infrastructure and a history of conflict. CONCLUSIONS: Community engagement had to be responsive to the local community even though staff faced time constraints. Understanding the social context of engagement helped TMT to foster respectful and trusting relationships. The complex relationship between the local context and community engagement complicated evaluation of the community strategy. Nonetheless, the project did record high levels of population coverage.

Background Between 2013 and 2017, targeted malaria elimination (TME), a package of interventions that includes mass drug administration (MDA)–was piloted in communities with reservoirs of asymptomatic P. falciparum across the Greater Mekong sub-Region (GMS). Coverage in target communities is a key determinant of the effectiveness of MDA. Drawing on mixed methods research conducted alongside TME pilot studies, this article examines the impact of the community engagement, local social context and study design on MDA coverage. Methods and Findings Qualitative and quantitative data were collected using questionnaire-based surveys, semi-structured and in-depth interviews, focus group discussions, informal conversations, and observations of study activities. Over 1500 respondents were interviewed in Myanmar, Vietnam, Cambodia and Laos. Interview topics included attitudes to malaria and experiences of MDA. Overall coverage of mass anti-malarial administration was high, particularly participation in at least a single round (85%). Familiarity with and concern about malaria prompted participation in MDA; as did awareness of MDA and familiarity with the aim of eliminating malaria. Fear of adverse events and blood draws discouraged people. Hence, community engagement activities sought to address these concerns but their impact was mediated by the trust relationships that study staff could engender in communities. In contexts of weak healthcare infrastructure and (cash) poverty, communities valued the study’s ancillary care and the financial compensation. However, coverage did not necessarily decrease in the absence of cash compensation. Community dynamics, affected by politics, village conformity, and household decision-making also affected coverage. Conclusions The experimental nature of TME presented particular challenges to achieving high coverage. Nonetheless, the findings reflect those from studies of MDA under implementation conditions and offer useful guidance for potential regional roll-out of MDA: it is key to understand target communities and provide appropriate information in tailored ways, using community engagement that engenders trust.