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NIHR Research and Innovation for Global Health Transformation (RIGHT)- Call 3 Remit and Guidance for Stage 2 Applications

 

Contents

INTRODUCTION

The National Institute for Health Research (NIHR) was established in 2006 to improve the health and wealth of the nation through research and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR, through the Global Health Research Programme, supports high-quality applied health research for the direct and primary benefit of people in low- and middle-income countries (LMICs) on the Development Assistance Committee (DAC) list, using Official Development Assistance (ODA) funding. The National Institute for Health Research (NIHR) has established a substantial portfolio of global health research programmes, through open ‘Investigator-led’ and ‘commissioned’ calls. These have positioned the NIHR as a key player in global health research.

The NIHR RIGHT programme forms part of the UK government's commitment to ODA. Through RIGHT, NIHR provides research funding to support cutting-edge interdisciplinary applied health research in key areas in ODA-eligible countries where a strategic and targeted investment can result in a transformative impact

AIMS

NIHR RIGHT Call 3 supports equitable partnerships between LMIC and UK researchers to generate new research knowledge and evidence on interventions to improve outcomes for those affected by multimorbidity in ODA-eligible countries, in particular in the areas identified as priorities (see Focus of the Call below). 

The aims of NIHR RIGHT Call 3 are to:

  • Deliver applied health research for the direct and primary benefit to the health and wealth of people living in ODA-eligible countries affected by multimorbidity
  • Ensure that the research funded through this call strengthens capacity for research and knowledge exchange through development of equitable partnerships between researchers in the ODA-eligible countries and the UK
  • Promote interdisciplinary approaches to working, by specifically encouraging applications necessitating expertise and activities associated with a broad range of health-science disciplines, including but not limited to: clinical, health economics, statistics, qualitative and social sciences

PRIORITIES AND FOCUS OF THE CALL

There is international recognition that multimorbidity is an increasing global health burden, with an aging human population living long enough to accumulate multiple conditions leading to increasingly complex treatment and care needs. While the risk of multimorbidity increases with age in all settings, multimorbidity is also a common concern, particularly in LMICs, in children and adolescence, driven by poverty, infectious diseases and malnutrition.

Multimorbidity is characterised by the clustering of disease conditions. In 2018, the Academy of Medical Sciences (AMS) published a report on multimorbidity: “Multimorbidity: a priority for global health research”. The report recommended the adoption of a uniform definition of multimorbidity, discussed the impact of co-occurring chronic conditions in LMICs, and set out research priorities for countering the growing burden of multimorbidity.

The AMS report gave the following definition of multimorbidity, which is consistent with the World Health Organisation (WHO) definition and is used for this guidance document:

The co-existence of two or more chronic conditions, each one of which is either:

  • A physical non-communicable disease of long duration, such as a cardiovascular disease or cancer;
  • A mental health condition of long duration, such as a mood disorder or dementia;
  • An infectious disease of long duration, such as HIV or hepatitis

Although the rise in multimorbidity is a global issue, it is context dependent and therefore the research and investment priorities for high-income countries (HIC) are often not directly transferable to the LMIC setting. There is generally much less information available about the burden of disease or context dependent factors associated with clustering of conditions and/or management of multimorbidity in LMICs, making generalisation or extrapolation of issues or needs across countries and regions inappropriate.

Understanding multimorbidity and developing patient centric, context-specific care pathways is important for HIC and LMIC settings. Multimorbidity investment needs in a HIC setting is predicated on a need for better management of progression or development of coincident non-communicable diseases (NCDs), whereas the situation in LMICs is confounded by the enduring high burden of infectious disease (notably HIV, tuberculosis (TB) and hepatitis), poverty and poor nutrition.

In contrast to the HIC setting where one of the principal challenges is around change of an existing system, the comparative underdevelopment of health systems in LMIC provides a greater opportunity to develop and invest in new health systems specifically designed to tackle the growing multimorbidity burden.

The AMS report identified a number of research priorities designed to better understand the burden, determinants, prevention and treatment of patients with multimorbidity. Of particular relevance to RIGHT Call 3 are research priorities 4, 5 and 6:

  • Priority 4 - What strategies are best able to facilitate the simultaneous or stepwise prevention of chronic conditions that contribute to the most common multimorbidity clusters?
  • Priority 5 - What strategies are best able to maximise the benefits and limit the risks of treatment among patients with multimorbidity?
  • Priority 6 - Healthcare systems strengthening - How can healthcare systems be better organised to maximise the benefits and limit the risks for patients with multimorbidity?

Applications for NIHR RIGHT Call 3 should address applied health research in the following areas:

  1. Developmentandevaluationofinterventionsandstrategiesforimprovedmanagementofmultimorbidity, including but not limited to:
    1. interventions to prevent stepwise progression of multimorbidity once one long-term condition or infection has been diagnosed
    2. interventions to improve treatment, management and care of patients with infections prevalent in LMICs that have a known association with development or exacerbation of NCD
    3. interventions for the treatment and prevention of the development of multimorbidity in children and young adults driven by malnutrition, multiple chronic infections and poverty
    4. scalable treatment    and    care    approaches    that    integrate    the    management    of multimorbidity/disease clusters associated with infection(s) and/or NCD(s)
    5. new treatment packages, or new models of care and community-based interventions
  2. Healthcare systems strengthening in ODA-eligible countries: research into health care system improvements for improved treatments, management and care for those affected by multimorbidity in LMICs, including capacity building in the primary care

Please note: Research that aims at a better understanding of risk factors, cultural attitudes and practices influencing the development of multimorbidity can be included provided it is part of a wider programme of work contributing to the implementation or evaluation of an intervention.

BUDGET / LENGTH OF FUNDING

Awards of typical range £1-5 million (maximum of £5 million) over 3-4 years are available for eligible research, starting June 2021 (earliest start date) to September 2021 (latest start date). Successful applicants must start within 6 months of notification of the stage 2 application outcome. The amount awarded and the length of the funding period should be fully justified according to the nature of the proposed research.

SCOPE

Awards of typical range £1-5 million (maximum of £5 million) over 3-4 years are available for partnerships led by two Joint Lead Investigators (one from an LMIC and one from a UK institution).

Applications submitted to this call will be required to describe how they address the key criteria for funding.

Key criteria for funding:

  1. Research plans build on partnerships between two Joint Lead Applicants (one from an LMIC and one from a UK institution), and other Co-applicants (maximum of 15 in addition to the two Joint Lead Applicants) who will form a research team able to support knowledge generation and exchange and strengthen relevant capacity and capability
  2. Research plans are based on a review of the local context, and demonstrate how the application is rooted in existing research literature and health system(s).
  3. The proposed research draws on an LMIC-led needs analysis which has refined relevant research questions and priorities through engagement with policy makers, evidence users and local communities, as Where partner institutions/research programmes are in middle-income countries on the DAC list, applications should clearly demonstrate how the research will improve the health and welfare of the most vulnerable populations and how their findings could have wider applicability to other low resource settings.
  4. There are clear plans for developing institutional and individual research capacity and capability (for example research career development programmes and training; exchanges with policy-making institutions/practice-based settings; and grant management, finance management and contracting).
  5. A clear and implementable strategy for pathways to impact including research uptake and dissemination, based on a theory of change or

NIHR RIGHT CALL 3 WILL SUPPORT:

  1. Applications that demonstrate they address the key criteria
  2. Applied health research programmes that are of primary and direct benefit to people and patients in ODA-eligible countries, which address the challenges faced by ODA-eligible countries in the area of multimorbidity.
  3. Interdisciplinary applied research teams with demonstrable expertise and a track-record of ensuring clinical research is transferred into benefits for patients – this can include teams in ODA-eligible countries as well as teams and researchers, who may want to build new research partnerships with colleagues in ODA-eligible countries or apply their research expertise to global health.
  4. Proposals that incorporate research questions around gender, age, social barriers to health, economic impact and equity that demonstrate strong partnerships with institutions in ODA-eligible countries.
  5. Applications that demonstrate joint leadership between the LMIC and UK research partners and have clear plans to engage with other relevant partners. Please note for RIGHT funded programmes two Joint Lead Applicants (one from an ODA-eligible country -LMIC Joint Lead Applicant - and one from a UK institution -UK Joint Lead Applicant - MUST be included on the
  6. Applications that include relevant engagement with policy makers, patients, the public, civil society organisations, communities and
  7. Applications that include PhD and master’s students based in LMICs

NIHR RIGHT CALL 3 WILL NOT SUPPORT:

  1. Applications that are not ODA-eligible (see section 8).
  2. Applications that are not clearly relevant to multimorbidity in an LMIC setting and context and are not based on research priorities identified in LMIC partner
  3. Application that do not include two Joint Lead Applicants, one of which must be in a LMIC and one in a UK
  4. Applications with a focus on basic/discovery research or experimental
  5. Costs to establish and maintain new biobanks and bio-sample collections are not eligible under this initiative.
  6. Applications consisting solely of epidemiological
  7. Applications consisting solely of evaluations of existing services, where the programme of work does not include evidence-based development and improvement of these
  8. Applications solely comprising a single Randomised Controlled Trial (RCT).
  9. Applications that solely replicate research already undertaken in High-Income Countries – research proposals should be clearly relevant to the ODA-eligible country in which the research is being undertaken.
  10. Applications that primarily focus on observational research, secondary research or health policy implementation.

ELIGIBILITY

The research must be for the direct and primary benefit of people in ODA-eligible countries. In order to be eligible to receive ODA funding, applications must demonstrate how they meet ODA compliance criteria and outline:

  1. Which country or countries on the DAC list of ODA-eligible countries will directly benefit?
  2. How the application is directly and primarily relevant to the development challenges of those countries?
  3. How the outcomes will promote the health and welfare of people in a country or countries on the DAC list?

Where all or part of the research is not undertaken in an ODA-eligible country during the course of the award (including where a country graduates from the DAC list during the lifetime of the award or there is a need for specialist expertise) the application must clearly state the reasons for this with due consideration to the benefit of the research to ODA-eligible countries.

All applications must have two Joint Lead Applicants (one at an LMIC institution and one at a UK institution).

The structure of teams funded through the RIGHT programme should consist of the two Joint Lead Applicants based in an ODA-eligible country and the UK. Dependent on the nature of the proposed plans, there may be other affiliated Co-applicants (maximum of 15 in addition to the two Joint Lead Applicants) and Collaborators.

Both Leads must have sufficient standing within their organisations and have demonstrable ability to lead and manage a large-scale programme of global health research. Arrangements for more junior researchers to act as lead may be considered with appropriate plans for mentoring and support in place.

Funding and contracting must take place via the UK administering institution (UK Joint Lead Applicant). UK- based Joint Lead Applicants from Higher Education Institutions (HEIs) and Research Institutes in England, Wales, Scotland and Northern Ireland are eligible to apply.

Joint Lead Applicants and research team members (Co-Applicants and Collaborators) from ODA-eligible LMICs will normally be from a research institution, HEI or a not-for-profit organisation.

Applications proposing non-LMIC Co-Applicants or Collaborators are in scope, provided there is clear justification for their involvement and those resources cannot be found within LMICs.

For-profit organisations cannot be a Joint Lead as they do not fall under any of the eligible categories above. However, these organisations may be included in applications as Collaborator or via service level agreement, providing it is clear what benefit a commercial company would bring to the research programme. In addition, a company’s commercial model must be compatible with the conditions laid out in the NIHR research contract and NIHR’s policies/limitation around funding indirect costs, and the costs are clear in the budget. It is important that any Applicant organisation is aligned with NIHR’s principles including open access to research.

Non-health research institutions, e.g. an institute of engineering, can act as Co-Applicants or Collaborators, provided their expertise is relevant to the plans proposed.

Under this call, an individual cannot be named as Joint Lead Applicant on more than one application.

There are no restrictions on the number of applications an institution can submit under this call provided they are distinct in their objectives.

Existing NIHR award holders are eligible to apply to this call provided there is assurance they have sufficient time and resources available to them to deliver concurrent awards successfully.

If you are unsure of eligibility, please contact ccf-globalhealth@nihr.ac.uk.

SELECTION CRITERIA FOR STAGE 2

The selection criteria for Stage 2 will be:

  1. All eligibility criteria have been
  2. Relevance of the proposed research to the research requirement outlined in the scope (above).
  3. Quality of the research design and work plan (i.e. clear research questions/objectives, sound design and detailed methodology to address the questions/meet the objectives; clear milestones, identification of possible risks and factoring in of ethical considerations)
  4. Quality of the proposed management arrangements (i.e. clear definition of roles, risk management arrangements and how the efforts of individuals will be coordinated)
  5. Strength of the research team (i.e. depth and breadth of relevant expertise and track record of applicants in a related area)
  6. Impact of the proposed work (i.e. likelihood of significant contribution to the evidence base in the relevant area, pathways to improvement in health, wellbeing, lives saved and economic, social and cultural benefits in ODA-eligible countries) and plans for engagement with policy makers, communities and the public at an early stage
  7. Value for money provided by the application
  8. Strength of plans for Community Engagement and Involvement
  9. Equity of partnerships and approach to capacity building (i.e. the research team’s ability and approach to creating sustainable and equitable partnerships; and the potential/feasibility of the proposed research to generate sustainable advances in capacity and capability building in the ODA- eligible countries)

SELECTION PROCESS

NIHR RIGHT Call 3 is a two-stage competition with a mandatory Intent to Submit form during stage 1. Stage 1 is a short-listing outline stage. Stage 2 is for successful applicants at Stage 1 to produce a full application. An Independent International Funding Committee will consider eligible applications at Stage 1 and Stage 2.

This document sets out the process for submitting Stage 2 applications. It should be read in conjunction with the Finance Guidance for Applicants.

All eligible applications will be subject to independent peer and public review and considered by an Independent International Funding Committee that will make recommendations to the Department of Health and Social Care.

TIMETABLE FOR NIHR RIGHT CALL 3 STAGE 2

  • Stage 2 opens for successful Stage 1 applicants – 8 April 2020
  • Deadline for receipt of Stage 2 applications via the online RMS system – 16 September 2020 at 13:00 (UK time)
  • Funding Committee review the applications and make recommendations – February 2021
  • Applicants notified of outcome of Stage 2 – March 2021
  • Funding commences – June 2021

STRUCTURE OF TEAMS/EQUITABLE PARTNERSHIPS

NIHR expects equity to be strongly reflected in programme leadership, decision-making, capacity strengthening, governance, appropriate distribution of funds, ethics processes, data ownership, and dissemination of findings. For example:

  • All parties listed as part of the core research team partnership must have significant input to the research and management of the research programme and form part of the leadership structure
  • The budget should be driven by the work plan, the expectation is that funds are distributed equitably, and the flow of funds will reflect where the majority of work is taking place

Roles and contributions of all members working as part of the partnership must be clearly stated in the application, and full consideration given to the increasing complexity of managing large collaborations. Applicants should consider:

  • Will the number of proposed Co-Applicants and Collaborators introduce undue complexity in the management and set up arrangements within the available timeframes?
  • Will there be sufficient funds available to support all partners to make a meaningful contribution?
  • Is the size and breadth of expertise in the team justified and appropriate for delivery of the proposed programme?
  • Applications must include a signed letter of support for Joint Lead Applicant from non-contracting organisation. This institutional support letter should be signed by an appropriate senior individual at the respective institution, confirming support for the application and the agreement of the employing institutions to undertake the research and willingness to provide the space, facilities and time for their staff to be able to deliver on the proposed research

Further guidance to support developing and sustaining Equitable Research Partnerships can be found at the NIHR website and in A Guide for Transboundary Research Partnerships (Swiss Commission for Research Partnerships with Developing Countries (KFPE) and the UKCDR report on Building effective and equitable research collaborations.

TRAINING AND CAPACITY STRENGTHENING

The NIHR is committed to developing individual and institutional global health research capacity for the long term to support sustainability and the research eco-system as a whole. Applicants must include a global health research and capacity-strengthening component in their application, which may take place in either the ODA- eligible countries or the UK. Funds can be requested for a range of activities incorporating full or partial funding for formal training posts (e.g. PhD, MSc), in-country training, workshops, exchanges and other relevant activities

  • ODA-eligible training hubs, etc, as well as other wider institutional capacity-strengthening activities such as finance, programme management, data management. Individuals funded by the NIHR to undertake a formal NIHR training/career development award would become NIHR Academy members and be eligible for the career development and training support provided by the NIHR Teams are strongly encouraged to consider and cost activities that will build both research capacity and research and financial management capacity. Teams are also encouraged to consider activities such as coaching, buddying and mentorship.

Funded NIHR Awards will be expected to have a named Training Lead to co-ordinate activities across the Award, and act as the liaison point on training with the NIHR Academy and be an active member of the NIHR Global Health Training Forum. This will include developing and leading on a training plan for the NIHR Award.

IMPACT

Applicants should detail the proposed impact of the research

  • likelihood of significant contribution to the evidence base in the relevant area
  • pathways to improvement in health, wellbeing, lives saved and economic, social and cultural benefits in ODA-eligible countries
  • plans for engagement with policy makers, communities and the public at an early stage

If your application is successful, you will be required to submit a clearly outlined theory of change/pathway to impact as a deliverable within 6 months of start of the award. This should outline how the funded activities are expected to contribute to a chain of results that lead to the intended scale up of impacts on policy and practice. To include consideration of:

  • how and when relevant stakeholders (policy makers, practitioners, public) will be engaged (from research design, implementation, analysis, to reporting and dissemination),
  • underlying assumptions/risks,
  • any external factors (social, political, economic, environmental, technological, legal, demographic, cultural context, other funders' activities) which may (either positively or negatively) influence the success of the programme in achieving these impacts,
  • the sustainability of impacts (e.g. how will cost effectiveness be assessed, is there an appropriate exit strategy involving effective transfer of ownership?).

At the end of the award a final report summarising the research findings, contextual learning and impact will be required for publication in NIHR Global Health Research Journal (currently under development) within the NIHR Journals Library.

PROGRAMME MANAGEMENT AND GOVERNANCE

Complex programmes of global health research require significant levels of management to ensure successful delivery. NIHR recommends that a full-time programme manager is allocated to manage the research contract, and sufficient resources are included and costed to manage the regular programme and financial reporting processes. You may also wish to speak to your contracts department to determine the time requirements for contract approvals for this award.

Programme management arrangements should be clearly described in your application, with sufficient resources in place to manage programme/work stream initiation, assurance of due diligence and audit processes, effective risk management (including financial, reputational and legal risks), quarterly financial reporting, monitoring, evaluation and impact tracking, communication management, data management, and compliance with ethics frameworks.

Within your application you will need to describe your proposed governance structure, which should include an external Advisory Group with proposed membership. This group should, as a minimum, have an independent Chair, be gender balanced, and have a range of members and key stakeholders from the partner countries, the UK and beyond, where appropriate. The Advisory Group should advise on strategy and progress and oversee programme risks and meet annually at a minimum. NIHR will act as observers at these Advisory Group meetings.

A Delivery Chain and Risk Map should be included with your application to show the overall structure of the partnerships, risk management, and the distribution of funds.

REPORTING REQUIREMENTS

If your application is successful, you will be required to submit progress reports (once a year, in addition to quarterly financial reports and milestones and deliverable reports). Where appropriate, these progress reports will be based on the programme timetable and milestones. If you are late producing any required reports or these do not meet expected standards for the programme, we may withhold payments in accordance with our retention policy.

Please note: NIHR recognise the need for flexible and agile programme management in the context of global health. However, applicants should note that as this funding must be ODA compliant, applicants will also be required to forecast their expenditure on a quarterly basis (recording actual spend), associated quarterly updates of research progress (proportionate in detail to the risks, milestones and deliverables associated with the programme), and annual reports. Frequency of reporting may change in proportion to the perceived risks related to the individual programme.

RESEARCH CONTRACT, COLLABORATION AGREEMENT AND ASSURANCE

Contracting must take place via the UK contracting institution (UK Joint Lead Applicant). A copy of the current ODA research contract is available on the NIHR website. You may wish to speak to your contracts department to determine the time requirements for contract approvals for this award.

It is NIHR’s advice to ensure draft Collaboration Agreements are developed with Joint Lead and Co-Applicant institutions as soon as a successful funding decision has been communicated. This will reduce potential for delays in transferring funds after the contract start date.

Prior to any transfer of money from the UK to the ODA-eligible partner institution(s) NIHR expect that proportionate due diligence assessments will be undertaken by the administering institution and for draft Collaboration Agreements to be developed between the UK and ODA-eligible partners and submitted for review and approval by NIHR. An example of a due diligence template can be found under the Contracts section of the Global Health Research funding webpage. Copies of completed forms will need to be shared with NIHR during contracting.

In the absence of an approved and signed Collaboration Agreement, the UK administering institution will be transferring funds to ODA-eligible partners at their own risk or will need to make any relevant payments on behalf of ODA-eligible partners until an NIHR approved Collaboration Agreement signed by the partner(s) is in place.

There are mandatory requirements for monitoring and financial assurance relating to the distribution and use of ODA funding. To make effective arrangements for risk management and assurance, you should consider the financial systems and financial management capacity of your DAC list country partner and the level of risk within the country, and tailor your assurance and monitoring processes appropriately.

Applicants are required to adhere to the NIHR position on shared data: https://www.nihr.ac.uk/documents/nihr- position-on-the-sharing-of-research-data/12253.

You may find it useful to refer to the following online resource:

Key milestones and deliverables for the award will be agreed during pre-contracting are as follows and will include, but not limited to. They will be included in schedule of contract:

  • Completed due diligence form for the host/contracting organisation and downstream partners
  • Risk Register
  • Theory of change/ impact pathway

INTELLECTUAL PROPERTY

Background and Foreground IP

Please note that in relation to intellectual property, the NIHR would like the research team to clarify various key points in the application, namely:-

  1. That it will have permission to use any background intellectual property for the purposes of the research and, if necessary due to complicated ownership arrangements, complete schedule C of the NIHR research contract with reference to clause 24.1.5 (a) of the NIHR ODA Global Health research contract;
  1. The proposed ownership arrangements of the Foreground IP, Arising Know How and Research Data (for definitions, please see https://www.nihr.ac.uk/documents/researchers/apply-for- funding/how-to-apply-for-global-health-funding/research-contract-v9-19-ghr-oda.pdf). The parties should consider who is best placed to use, disseminate and/or commercially exploit the relevant intellectual property and/or database to maximise the opportunities to deliver patient There should be license arrangements with collaborators (usually contained within the Collaboration Agreement signed for a project) for research and teaching purposes and/or in the support of the development, promotion or provision of Health Care or for any other purpose that is not a Commercial Use.

Joint IP

With respect to joint IP, please note that the NIHR does not recommend joint ownership of Foreground IP, Arising  Know  How  and/or  Research  Data  arrangements  preferring  that   the  research  team   agrees    the IP ownership arrangements at the application  stage  as  above.  This  is  because  Joint IP (i.e.  owning the IP jointly) can lead to delays about how the IP/data is used, disseminated and/or exploited and we want to avoid this potential barrier to delivering patient benefit. Normally, giving collaborators appropriate licensed rights to use Foreground IP, Arising Know How and Research Data is sufficient to avoid the need for joint IP. If specific circumstances for a proposed project mean that joint ownership of Foreground IP, Arising Know How and/or Research Data may be appropriate, please provide a justification in your application.

Commercial Use

In the event the relevant owner of the IP intends to commercially exploit any Foreground IP, Arising Know How and/or Research Data, then they must seek the NIHR’s prior written consent via IP.Unit@nihr.ac.uk and the relevant NIHR programme manager.

REGULATORY APPROVALS / COMPLIANCE

In your application you must describe any ethical and/or regulatory issues your research project raises and how you intend to address these, taking into consideration the following activities required for responsible conduct of the proposed research. 

You may find it useful to refer to the following online resources:

Ethics and governance

  • If applicable (e.g. research involving human participants), describe plans for ethical review of the proposed activities in the UK and/or ODA-eligible countries)
  • If the research involves vulnerable individuals or groups (e.g. children, individuals lacking capacity to consent or those suffering from stigmatising conditions in their community), then please describe how you will manage their
  • Research requiring ethical approval must have the appropriate approvals in place before it can commence. If there are no plans to obtain ethical review, this must be clearly justified. (Note that work outlined in your application/protocol must adhere to the Research Governance Framework).
  • Further guidance on the approval process is available from the Health Research Authority (HRA). If you are unsure whether your research requires ethical approval please contact the HRA directly and they will be able to
  • In addition to seeking independent/institutional ethics committee approval for planned research from your HEI, you should seek ethical review from an appropriate ethics body in each of the LMICs in which there are study participants. Where an appropriate ethics body does not exist, this should be highlighted clearly in your application or raised separately to the NIHR RIGHT

Data protection and information governance

  • Describe ethics or governance considerations in relation to the project including use and storage of sensitive

SUCCESS CRITERIA

Please set out the measurements of success you intend to use and also the key risks to delivering this research and what contingencies you will put in place to deal with them. This section should identify appropriate actions that would reduce or eliminate each risk or its impact.

COMMUNITY ENGAGEMENT AND INVOLVEMENT

The NIHR encourages active and participatory Community Engagement and Involvement (CEI) (more commonly known in the UK as ‘Patient and Public Involvement and Engagement’) that empowers communities and fosters co-production of research.

Patients and the general public within a given community, especially vulnerable groups who are at the greatest risk, will normally be the key group included in CEI activities. Other community stakeholders such as community leaders, opinion leaders, non-governmental organisations and civil society, service commissioners and providers, policy and lawmakers are examples of other stakeholders who can be involved.

There is no standard model for CEI. Applicants should demonstrate that their CEI approach is appropriate and effective in the local context and for their study design. Applicants should ensure that those in the community who are most affected are empowered to contribute towards decision-making in researching potential solutions to identified issues. Applicants should map out and describe stakeholders in their community, outline how they have been involved in developing the research proposal, and state what influence or change has happened as a result of their engagement and involvement. Applicants should demonstrate how they will engage and involve communities utilising the UNICEF Minimum Standards for Community Engagement which encourage:

  • Participation
  • Empowerment and ownership
  • Inclusion
  • Bi-directional communication
  • Adaptability and localisation
  • Building on local capacity

CEI of key stakeholders should be evident in informing the design, methods and research outcomes as well as managing, monitoring, evaluating and disseminating the research and in any impact evaluation activities, where this is relevant to your study design.

The research team should ensure that there is interdisciplinary expertise that will facilitate partner and stakeholder coordination and integration of community engagement and involvement throughout the research cycle. Appropriate local Co-Applicants or Collaborators, and community members must be involved in leading and delivering CEI activities. The team, and those that are actively engaged and involved in the programme, should co-produce and agree an appropriate CEI strategy and plan as well as training and support to facilitate effective CEI.

CEI requires time for relationship building, transparency, reflection and flexibility and is often an iterative and deliberative participatory approach, which requires significant human resource input and organisational support. As such, applicants should include realistic costs for CEI in their applications. Funded programmes will have their CEI activities monitored against their plans for the duration of the research lifecycle. CEI contributions will be included in our final overall impact assessment at the end of the study.

RESOURCES:

Teams are encouraged to consider the UNICEF Minimum Standards for Community Engagement when preparing their applications.

NIHR have produced a number of useful resources in relation to community engagement and involvement:

Mesh, a collaborative open access web space with resources, encourages networking and sharing of good practice to bridge the gap between the research community and the general public in ODA-eligible countries.

Support is also available from your regional NIHR Research Design Services.

FINANCE / BUDGET

ELIGIBLE COSTS FOR NIHR RIGHT CALLS

Eligible costs for NIHR RIGHT Calls  include but not limited to:

  • Research staff engaged in relevant research
  • Research support staff supporting relevant research
  • Travel, subsistence, meetings, conferences
  • Equipment
  • Consumables
  • Community engagement and involvement
  • Dissemination, including open access publication costs
  • Risk management and assurance
  • External intervention costs
  • Non-pay research costs
  • Other legitimate and reasonable indirect costs (e.g. HR, finance) Please see RIGHT Finance Guidance document for further
  • Costs for awards will be scrutinised as part of the assessment process and the Funding Committee reserve the right to award only part of the funds
  • NIHR will challenge costs that it does not consider appropriate or does not consider providing value for money.
  • RIGHT Award holders will be expected to provide quarterly finance reports of actual expenditure incurred, this will then be combined with reporting against progress set out in the application with an expectation of proportionate due
  • Funds will be distributed to ODA-eligible countries via the UK administrative institution. Payments will be made quarterly in arrears on the basis of expenditure reported through finance

Please note:

VALUE FOR MONEY

The NIHR requires evidence of good value for money and considers this to be the optimal use of resources to achieve the intended outcomes. ‘Optimal’ being considered as ‘the most desirable possible given expressed or implied restrictions or constraints’. Value for money goes beyond achieving the lowest initial price and includes consideration of Economy, Efficiency, Effectiveness, and Equity (as appropriate) and what these mean in the context of a research proposal:

Economy: Are we buying inputs of the appropriate quality at the right price? (Inputs are things such as staff, consultants, raw materials and capital that are used to produce outputs)

Efficiency: How well do we convert inputs into outputs? (Outputs are results delivered by us or our agents to an external party. We exercise strong control over the quality and quantity of outputs)

Effectiveness: How well are the outputs from an intervention achieving the desired outcome? (Note that in contrast to outputs, we do not exercise direct control over outcomes)

Equity: the extent to which the outputs of our interventions are equitably distributed. The reference resource from DFID may be useful

JUSTIFICATION OF COSTS

You are required to provide justification of resources, not just a list of items/cost. You should explain why you need the items. It is to aid reviewers assessing proposals, make informed judgements on whether requested resources are appropriate for the research posed.

HOW TO APPLY TO RIGHT CALL 3 STAGE 2

PROCESS

You must complete an online application via the CCF Research Management System (RMS). The closing date for applications is Wednesday, 16 September 2020 at 1pm UK time.

  • Applications will not be accepted if submitted after the exact closing date and time, the system will automatically prevent this from
  • It is the applicants’ responsibility to allow sufficient time to submit an
  • Applicants must contact the NIHR RIGHT Global Health team by emailing ccf-globalhealth@nihr.ac.uk or calling 020 8843 8080 immediately if they think there is a system problem, whilst attempting to continue with their application.

A word template of the Stage 2 application form is available on the NIHR website for reference only.

SECTION 1: APPLICATION SUMMARY INFORMATION

Host organisation

Provide details of the UK organisation who will be the contractor (i.e. the organisation who will sign the contract with DHSC) if the programme is funded.

NOTE: For contracting purposes there can only be one lead host organisation which must be a UK Higher Education Institution or UK Research Institute. The UK Joint Lead Applicant’s host institution will be the contracting organisation with the Department of Health and Social Care. For application/contracting purposes, the LMIC Joint Lead Applicant will be regarded as a co-applicant.

Research title

The programme title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.

Research type

Select the appropriate research type. If your proposed programme is predominantly primary research, please select ‘Primary Research’. If you are predominantly carrying out new analysis of existing data, select ‘Secondary Research’. If you are not sure which category to select, choose the closest match to your project as this can be adjusted later.

Proposed start date

Note this should be from 1st of the month, regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting and staff recruitment prior to starting your project.

Research duration (months)

Ensure you include sufficient time to complete all aspects of the research including applications approvals (where required) and the final report.

End date

This field will automatically populate once you have entered the start date and research duration information.

Total (Stage 2) Research costs

This will be automatically pulled through from the budget section.

Total (Stage 2) External intervention costs

If you are conducting research that requires an intervention to be delivered in the LMIC you are permitted to claim for External Intervention Costs. These are the costs additional to routine clinical treatment in the local setting. For comparison, in the UK these would be NHS support costs. This will be automatically pulled through from the budget section.

SECTION 2: CV -UK JOINT LEAD APPLICANT

Some of the responses required in this section will have been pre-populated based on your CV details and any remaining fields must be completed.

To update your CV details, please visit the Manage My Details section by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar.

SECTION 3: CV – LMIC JOINT LEAD APPLICANT

It is a requirement to have two Joint Lead Applicants with one being from an ODA eligible country (LMIC Joint Lead Applicant) and one from a UK-based institution (UK Joint Lead Applicant). Joint leadership must be demonstrated with plans in place for equal sharing of responsibilities. The applications will be assessed on the equity and strength of partnerships developed between Joint Lead Applicants and their relevant expertise.

Complete your name, contact details and other requested information.

We encourage the inclusion of public co-applicants where appropriate. Please include a clear description of their role and the reasons why a community co-applicant is joining the team. Co-applicants who are community representatives, patients or carers are not obliged to complete a standard CV, but are required to provide a summary of any knowledge, skills and experience relevant to their role in the application.

We recognise and value the varied perspectives that community representatives, patients and carers bring to a project as applicants. In this section, please provide a summary of any relevant knowledge, skills and experience that you will draw upon to contribute to this project.

This could include information about:

  • Previous or present work (paid or unpaid) with any relevant organisations
  • Links with any relevant groups, committees, networks or organisations
  • Experience of particular health conditions, treatments, use of services - or as a member of a particular community
  • Knowledge and experience of research including previous research undertaken
  • Knowledge and experience of community and public involvement
  • Skills from any other roles that are transferable
  • Relevant qualifications, training and learning

The bullet point list above is not exhaustive.  Please include anything else that is relevant to the application.

SECTION 4: RESEARCH BACKGROUND –JOINT LEAD APPLICANTS AND CO-APPLICANTS

Some of the responses required in this section will have been pre-populated based on your CV details and any remaining fields must be completed to provide the required information.

To update your publications and grants, please visit the Manage My Details area by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar. Once in Manage My Details, the publications and grants are available via the Update CV section of your account.

Each applicant should select the publications and grants that they would like to appear in the CV section of an application. Publications and grants are pulled in from individual ‘My Details’ pages. For further guidance and instructions, please refer to the System Help (https://ccfrms.nihr.ac.uk/).

Publication record

Provide details of a maximum of six of your most recent/relevant publications (in the last ten years) relevant to this application (using Vancouver or Harvard citation format). Please include DOI reference numbers, if needed.

Research grants held

Please select research grants held (as a named applicant) CURRENTLY or IN THE LAST 5 YEARS – as well as any additional previous grants, relevant to this application, stating who the grant is with and the amount of each grant. If no grants are held, please enter N/A (as this is a mandatory field). For more information about resubmission of a research/trainee funding application, or joint funding please contact the NIHR Global Health RIGHT programme team; ccf-globalhealth@nihr.ac.uk or 020 8843 8080.

Has this application been previously submitted to this or any other funding body?

Select ‘Yes’ or ‘No’ from the drop down box to indicate whether this or a similar application has previously been submitted to this or any other funding body.

Applications submitted to other NIHR programmes

Where this application or a similar one has been submitted to this or another NIHR programme or elsewhere, please click the ‘Add’ button and complete the necessary information.

You must inform us if the application has been submitted elsewhere. This includes, but is not limited to, any facts that, should they come to light at a future date, would embarrass either the programme or the individual who withheld the fact (e.g. if a member of the team holds a patent or has a financial interest within the research area).

Failure to disclose accurately or fully will be considered by the programme as academic misconduct and treated accordingly. You should also include in this section information on whether this or a similar application has been submitted to any programme previously, or to any other funder including other NIHR programmes. You should name, and provide dates and outcomes of these. Please indicate whether you hold or have ever held an NIHR programme contract, which has been terminated prior to completion, extended in time or in terms of funding.

SECTION 5: THE RESEARCH TEAM

In the following sections you will need to individually add the names of your LMIC Joint Lead and Co-Applicants. Their roles and equitable contributions to the project should be described in this section. Complete Lead and Co-applicant details. Do not include collaborators, who should be mentioned (if appropriate) in the Detailed Research Plan section of the form.

Definitions and requirements:

Joint Lead Applicants: It is a requirement to have two Joint Lead Applicants with one being from an ODA eligible country and one from a UK-based institution. Joint Leadership must be demonstrated with plans in place for equal sharing of responsibilities. The applications will be assessed on the equity and strength of partnerships developed between Joint Lead Applicants and their relevant expertise.

Co-Applicants: You can add Co-Applicants. Co-Applicants are those individuals with responsibility for the day- to-day management and delivery of the project who form your project team/consortia. Co-Applicants are those forming a core part of the project team and are expected to share responsibility for its successful delivery. Please note that once you enter a Co-Applicant’s details they will receive an automated email informing them that this information has been added into our Management Information System (RMS) in conjunction with your application. Therefore, we would expect Co-Applicants to have been consulted before adding their details into the RMS.

Please note that collaborators are those who provide specific expertise on particular aspects of the project and would form the basis of your wider research team. They do not share in the responsibility for the delivery of the project.

Other supporting roles: As a minimum the following (mandatory) UK, based supporting roles are required to be added to an application:

  1. Director of Finance
  2. Head of Department or Senior Manager

Specify your (UK Joint Lead Applicant) role in this research

Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the research (e.g. co- ordination and project management, analysis, methodological input etc.)

%FTE commitment

Commitment: This refers to the percentage of your time that you will commit to this project.

Specify your (LMIC Joint Lead Applicant) role in this research

Explain in addition to your role as LMIC Joint Lead Applicant, the role that you will be undertaking in the research,

  • co-ordination and project management, analysis, methodological input

%FTE commitment

Commitment: This refers to the percentage of your time that you will commit to this project.

NOTE: For contracting purposes there can only be one lead host organisation for flow of funds which must be a UK Higher Education Institution or UK Research Institute. The UK Joint Lead Applicant’s host institution will be the contracting organisation with the Department of Health and Social Care. For application/contracting purposes, the LMIC Joint Lead Applicant will be regarded as a co-applicant.

Co-Applicants

Add details of all co-applicants and their specific role and % FTE commitment in the programme. Do not include collaborators or partners, who should be mentioned (if necessary) in the ‘Research Plan’ section of the form.

Co-applicants are those individuals with responsibility for the day-to-day management and delivery of the project and can include patients, carers and service users. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery. In contrast, collaborators normally provide specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project.

Members of the team previously invited to participate as co-applicants during Stage 1 will still need to approve their participation in the Stage 2 application before the submission deadline. New team members will need to be invited via email to participate as co-applicants and both confirm and approve their participation before the submission deadline. Once a colleague has approved their participation, their CV details will populate the application; the application cannot be submitted without doing so.

Please allow sufficient time for your co-applicants to complete their sections of the online form before the application deadline.

SECTION 6: OTHER SUPPORTING ROLES –SIGNATORIES (ELECTRONIC)

The following supporting roles from the host organisation must be added to the application:

  1. Director of Finance
  2. Head of Department or Senior Manager

On assigning these contacts an email will be sent to each of them by the system. They will be required to tick a check box indicating that they have read and understood the terms on which they have been nominated for this proposal and accept this role. Ticking this box constitutes an electronic signature of the supporting role for the full application.

At the time of adding the necessary supporting roles required to approve your application, you are advised to inform the Trust R&D office of the site most likely to be the lead site for your proposed research. The aim is to help speed up the permissions process should your application be successful. Please note this will not apply to all proposals.

The Lead Applicant will also be required to tick a checkbox to indicate that they have read and understood the terms on which he/she has been nominated as Chief Investigator for this proposal along with the associated documentation and accept this role.

No original or ‘wet ink’ signatures are required for this application.

SECTION 7: SCIENTIFIC ABSTRACT

The scientific abstract should be a clear and concise scientific summary of the Detailed Research Plan / Methods.

The following is a list of potential elements/headings that might be included depending on the design of the proposed research, the setting and programme being applied to, and whether it is for primary research or evidence synthesis. It will be for researchers to decide the appropriate elements to be included in the scientific abstract and could include elements outside this list. Applicants may find the guidance on the EQUATOR Network website (www.equator-network.org) useful.

  • Research question
  • Background
  • Aims and objectives
  • Methods
  • Timelines for delivery
  • Anticipated impact and dissemination

SECTION 8: PLAIN ENGLISH SUMMARY

A plain English summary is a clear and accessible explanation of your research.

Many reviewers use this summary to inform their review of your funding application. They include clinicians and researchers, who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on National Institute for Health Research (NIHR) and other websites. If your application for funding is successful; the summary will be used on NIHR and other websites and should, therefore, be accessible to members of the public.

A good quality plain English summary providing an easy to read overview of your whole study will help:

  • Those carrying out the review (reviewers and board and panel members) to have a better understanding of your research proposal
  • Inform others about your research such as members of the public, health professionals, policy makers and the media
  • The research funders to publicise the research that they fund

If it is considered that your plain English summary is not clear and of a good quality then you may be required to amend it prior to final funding approval.

It is helpful to involve patients/carers/members of the public in developing a plain English summary. When writing your summary consider including the following information where appropriate:

  • Aim(s) of the research;
  • background to the research;
  • design and methods used;
  • community engagement and involvement (see below); and
  • dissemination

The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary.

Further guidance on writing in plain English is available online at NIHR ‘Make it clear’ http://www.invo.org.uk/makeitclear/.

For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable).

SECTION 9: CHANGES FROM FIRST STAGE

Please list the feedback received at first stage and under separate headings indicate what has changed as a result.

Please describe and explain any additional changes that have been made to this proposal since the Stage 1 application (e.g. in the light of new research or in developing equitable partnerships with LMIC researchers and community and public representatives).

SECTION 10: LOCATION OF RESEARCH

ODA-eligible countries

Please select all ODA-eligible countries where the proposed research will be undertaken.

Other Countries

Please list other countries not listed above where the research will be conducted. If not applicable, please enter ‘None’.

SECTION 11: ODA COMPLIANCE STATEMENT

Please provide a statement that demonstrates how the proposal meets key ODA funding requirements. It should address the following questions:

  1. which country(s) on the Organisation for Economic Cooperation and Development’s (OECD) Development Assistance Committee (DAC) list of ODA-eligible countries will directly benefit;
  2. how the application is directly and primarily relevant to the development challenges of those countries; and
  3. how the outcomes will promote the health and welfare of people in the country or countries on the DAC

Where all or part of the research is not undertaken in an ODA-eligible country during the course of the award (including where a country graduates from the DAC list during the lifetime of the award or there is a need for specialist expertise) the application must clearly state the reasons for this with due consideration to the benefit of the research to ODA-eligible countries.

SECTION 12: DETAILED RESEARCH PLAN

Using all of the headings in the order presented and guidance below, please use this section to clearly explain your proposed research. Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the research plan but they should not clutter the central narrative. Images do not count towards the overall word count but inclusion of them to overcome word limits is not permitted. Images may only be included within the 'Research Plan.' Images included in other sections will be removed from the application and not seen by reviewers. As this is the main part of your application, which will be considered by the funding committee, you should ensure that the information is accurate, succinct, clearly laid out and provides sufficient methodological detail. This section should not exceed 20 pages in Arial Font 11.

Applicants should therefore aim to reserve a significant proportion of the word limit for the research plan to ensure methodological approaches are fully specified.

1. Background and rationale

This section of the application should include why this research is important in terms of improving the health and/or wellbeing of the relevant populations and healthcare services in the ODA-eligible countries.

This should include a brief literature review of previous work and relevant ongoing research. Applicants should provide a clear explanation of the problem to be addressed, the impact on patients and the community as well as health and care services in ODA-eligible countries and how this research would fill a demonstrable evidence gap.

Explain how your proposed research is within the remit of the NIHR RIGHT programme and how it addresses the key aim of the programme to deliver interdisciplinary research in the areas of multimorbidity in ODA-eligible countries.

It is essential that you clearly identify the applied health and care challenges faced by the ODA-eligible countries relevant to the geographic and scientific area of your research proposal. Please outline the anticipated value or contribution the study will provide.

Please detail the nature and importance of the research question(s) to be addressed.

N.B. Any reference citations should be included in the ‘Supporting Documentation’ section of this application. If a key citation is not freely available, a copy should also be included.

2. Aims and objectives

This section of the application should be used to indicate the main aims and objectives of the proposed research.

3. Research plan and methods

Detailed information on the research design should include (where appropriate) descriptions of the following:

  • target population
  • justification of sample size
  • power calculation
  • inclusion and exclusion criteria
  • method of allocation
  • planned interventions and who will deliver them

N.B If any questionnaires have been prepared for use in the proposed research, please include a copy in the ‘Supporting Documentation’ section of this application.

Please provide up to 10 keywords that best summarise the proposed research and then describe the overall research design, including strong justification for the proposed sampling strategies, methods of data collection and analysis. In some cases, it will be appropriate to include discussion of dissemination and implementation here in addition to your response to a specific question on this in the ‘Detailed Research Plan. The key is that the reasoning underlying all stages of the proposed research should be transparent.

4. Research expertise / Structure of the team

Explain why the group is qualified to do this research, describing the track record of the research team in the relevant area, including publication outputs, grant income and impact on health service practice and policy. State clearly the particular contribution that each of the applicants will make towards the research and the particular contribution that any collaborators intend to make.

5. Approach to creating sustainable and equitable partnerships with partners

For the NIHR RIGHT, partnership with researchers in OECD DAC list countries is essential. The award should plan to create sustainable and equitable partnerships with their LMIC partners. It is expected that the principles of equitable partnership will be embedded in the NIHR RIGHT applications across all stages of the research process from research design to dissemination and publication

Describe your approach to creating sustainable and equitable partnerships; and potential/ feasibility to generate sustainable advances in capacity and capability building in the LMIC.

6. Training and Capacity Strengthening in LMICs

Please detail how you intend to develop research capacity in the next generation of researchers, including via your Post-Doctoral and Doctoral appointments and the wider environment.

7. Dissemination, outputs and anticipated impact - including how your research will generate sustainable advances in capacity and capability building in the ODA-eligible

The purpose of this section is for the applicant to describe the planned outputs, outcomes and impact of the proposed research on the health and wealth of the poorest individuals in ODA-eligible countries; detailing how the research will support sustainable advances in capacity and capability in the ODA-eligible countries. Where possible, quantifying the potential benefits and the anticipated timescale for the benefits to the ODA- eligible countries resulting from the proposed research to be realised. NIHR understands that the impact of any research may take time to be realised and will likely involve other funders, institutions and sustained efforts in practice. NIHR also recognises it may be difficult to provide definitive answers or guarantees on longer term impacts. However, applicants should provide details of the pathway to impact of the proposed research. In completing this section it may be useful to consider the following questions?

What do you intend to produce from your research?

Please provide brief details of each anticipated output. N.B. the term ‘outputs’ refers to any tangible product of the research, not just academic publications. Outputs can include but are not limited to:

conference presentation or other workshop events; publications (academic or otherwise); guidelines (clinical, service or otherwise); other copyright (e.g. questionnaires, training aids, toolkits, manuals, software, etc.); new or improved design of medical devices or instrumentation; new or improved diagnostic; trial data that could be used to support a CE mark, market authorisation or equivalent; trial data that could be used to shape or influence a healthcare market or government; potential new drug or healthcare intervention.

How will you inform and engage patients and the wider LMIC community about your work?

Describe who you need to communicate with about your research, and your plans for engaging relevant audiences. For impact, it is unlikely that simply making outputs available will be sufficient. Please consider, and outline the active approach you will take to engaging key parties (e.g. engaging with beneficiaries, national stakeholders, policy makers, decision makers, researchers, practitioners, forming partnerships and influencing other organisations and countries), or identify the process you will use to identify them and formulate an engagement plan. Consider what resources you might need to conduct these activities.

How will your outputs influence the health and care system in the LMIC as a whole?

Describe the process by which the research is expected to influence the healthcare environment in the LMIC, including any known processes through which your outputs will be acknowledged, selected and introduced for use in the health and care service or wider society. Where possible consider how the work will be able to be adopted and implemented longer term. Please describe the proposed route to market (commercial or non-commercial) for your outputs. Describe who is needed to take it forward and the relationship you currently (or propose to) have with these parties. If your outputs are likely to be commercially exploitable, please include details on how you plan to develop this and how revenue will be shared between you and the LMIC partner(s) (in line with the DHSC / NIHR expectation for fair and equitable partnerships).

What further funding or support will be required if this research is successful (e.g. from NIHR, other Government departments, charity, industry, or other non-governmental organisations)?

Consider what will happen when your programme of research concludes? Consider what investment or support may be needed at the end of this project to maximise impact. Not all projects will require this but if so, plans should be linked to the responses in questions b and c above. Describe any known or anticipated dependencies on other partners and funding streams for ensuring sustainable impact and the maintenance or continued development of new capabilities in the LMIC arising from your research (e.g. any commitments required from LMIC partners to continue to deliver a service / intervention).

What are the possible barriers for further research, development, adoption and implementation?

Describe the difficulties which may be faced in delivering impact-related activities and generating impact from your research. These may be difficulties you will face yourself, or challenges faced by those in the implementing context (e.g. clinicians). Be specific: outline the problems in the specific context of your study plans - do not describe general ODA or development challenges.

  • Will the proposed research use data, technology, materials or other inventions that are subject to any form of intellectual property protection (e.g. copyright, design rights, patents) or rights owned by another organisation(s)? If yes, provide brief details including how such third party IP will be accessed (e.g. collaboration agreement, drug supply agreement).
  • What are the key current and future barriers to uptake of any likely output or innovation directly in LMIC, through commercial exploitation or other means, e.g. potential regulatory hurdles?
  • What are the challenges for getting your research implemented in terms of ethics (in the LMIC and in the UK) acceptability, accessibility and feasibility? How will you address this?

What do you think the impact of your research will be and for whom?

Describe the impacts you aim to achieve as a direct result of the project and those which are anticipated longer term; (particularly in relation to improving the health and welfare of the poorest and most vulnerable people in LMICs). Please consider how any smaller, more immediate effects may mature over time into larger scale or more significant effects, and the steps by which this may be achieved. As far as possible, indicate anticipated timescales for these benefits and a quantitative estimate of their scale. Please consider how you will monitor and identify impacts, i.e. how will you know when the impacts identified have been achieved, or that you are making progress towards your impact goal? Impacts may include, but are not restricted to - LMIC patient benefit; LMIC healthcare staff benefits and service enhancements; knowledge gain relevant to UK NHS service (including efficiency savings); commercial return (which could contribute to economic growth in both the UK and the LMIC); public and community wellbeing in the LMIC.

How will you share with study participants the progress and findings of your research?

What strategies will you use to keep your research participants informed of the progress of your project and the findings? Consider the ethical implications of informing study participants and also what the most accessible methods could be, such as newsletters, leaflets, webpages, social media and where relevant different languages and formats. The Health Research Authority provide guidance on the information participants of trials should receive at the end of the study https://www.hra.nhs.uk/planning-and-improving-research/best-practice/publication-and- dissemination-research-findings/.

8. Project / research timetable

It is mandatory to attach a Gantt chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables.

NIHR CCF Global Health team will monitor project delivery against agreed milestones and deliverables, and in relation to the relative delivery risks associated with your project. For the purposes of RIGHT calls “deliverables” are defined as tangible products or outcomes (e.g. documents or recorded evidence of outcome/impact). “Milestones” may also be associated with products but can also be key staging points in the research that enable monitoring of the overall delivery against the objectives (e.g. completion of a specific task or activity).

  • All critical enablers for the project (e.g. collaboration agreements, sub-contracts, ethical consent, risk management, due diligence and safeguarding policies) should be considered to be
  • Quarterly financial assurance reports detailing actual spend are a mandatory requirement for this call and must be listed as
  • Any Stop/Go decision points for research should be clearly reflected in the milestones When uploading, applicants must only use the filename description ’Appendix_Gantt Chart’

9. Project management / Governance (including Approach to Risk management and Assurance / Safeguarding)

Please outline the practical arrangements for managing the research, its constituent components, and governance arrangements.

Identify the project management processes that will ensure that the milestones are reached in a timely manner. This should include the roles and responsibilities of those individuals undertaking the proposed research and set out reporting lines, steering committee involvement, and the schedule of meetings of the proposed research group to permit coordination, evaluation of progress and dissemination of findings.

You should also highlight the role of any Advisory or Reference Groups associated with the proposed research.

You may find it useful to refer to the following online resources:

  • Charity Commission’s guidance on how to manage risks when working internationally: https://gov.uk/guidance/charities-how-to-manage-risks-when-working- internationally#unstable-countries-assess-the-risks
  • The Wellcome Trust’s guidelines on research involving people living in low and middle income countries: https://wellcome.ac.uk/funding/managing-grant/guidance-notes-research-involving- people-low-and-middle-income-countries

Please provide clear details on the risks and challenges, as well as mitigating actions, in delivering the proposed work and pay particular attention to the following issues:

Data protection and information governance

  • Describe ethics or governance considerations in relation to the project including use and storage of personnel and sensitive

Financial assurance, ODA compliance, monitoring and auditing of expenditure in the ODA-eligible countries

  • Describe arrangements for the allocation of funds from the UK host institution to LMIC partners and the financial processes, controls and audit measures in place to ensure appropriate use of funds, including any specific subcontracting arrangements for compliance
  • NB: There are specific mandatory requirements for monitoring and financial assurance relating to the distribution and use of ODA funding (see detail under selection criteria). To make effective arrangements for risk management and assurance, you should consider the financial systems and financial management capacity of your LMIC partner and the level of risk within the country, and tailor your assurance and monitoring processes

You may find the following online resources helpful:

  1. http://www.oecd.org/dac/stats/34086975.pdf
  2. https://data.oecd.org/oda/net-oda.htm#indicator-chart
  3. http://icai.independent.gov.uk/about-us/
  4. http://www.oecd.org/dac/

Fraud and bribery

  • Describe arrangements or governance mechanisms in place to prevent fraud and bribery / ensure compliance.

Safeguarding

  • Describe the arrangements for safeguarding of study participants and If your Research group is funded by the NIHR, you will be expected to take all appropriate measures to prevent actual, attempted or threatened sexual exploitation, abuse or harassment by your employees or any other persons engaged and controlled by the group to perform any activities under your Agreement with NIHR and adopt robust procedures for the reporting of suspected misconduct, illegal acts or failures to investigate.

A risk register (attach template) may also be uploaded if available, to summarise the detail provided in this section. As described previously NIHR will be looking to act in partnership with applicants, expert reviewers and its programme managers to explore a proportionate and contextually-sensitive approach to monitoring and evaluation. A mutually agreed risk register and schedule of milestones and deliverables will be critical tools in informing our approach to monitoring.

NIHR reporting and monitoring requirements: NIHR recognise the need for flexible and agile project management in the context of global health, and will work with successful applicants to develop a proportionate approach to monitoring and reporting. However, applicants should note that due to mandatory conditions for ODA compliance we will require detailed quarterly finance reports (recording actual spend), associated quarterly updates of research progress (proportionate in detail to the risks, milestones and deliverables associated with the project), and annual reports.

10. Ethics / regulatory approvals

Outline any ethical issues that require regulatory approvals.

  • If applicable (e.g. research involving human participants) describe plans for ethical review of the proposed activities in the UK and/or ODA-eligible countries).
  • If the research involves vulnerable individuals or groups (e.g. children, individuals lacking capacity to consent or those suffering from stigmatising conditions in their community) then please describe how you will manage their

11.  Success criteria

Please set out the measurements of success you intend to use and also the key risks to delivering this research and what contingencies you will put in place to deal with them. This section should identify appropriate actions that would reduce or eliminate each risk or its impact.

SECTION 13: COMMUNITY ENGAGEMENT AND INVOLVEMENT

The NIHR has well established requirements for patient and public involvement in the research that it funds. In this global health research call we refer throughout to ‘community engagement and involvement’ rather than ‘patient and public involvement’. This is to emphasise the importance of involving relevant community groups and organisations from ODA-eligible countries in an early and sustained manner throughout the research process.

Community groups and organisations, patients and carers can be involved in every stage of a research project, from developing a proposal through to dissemination and evaluation.

In order to ensure that the research is appropriate as well as scientifically and ethically sound, relevant community groups and organisations from ODA-eligible countries must be involved in a meaningful process that will help guide the research from its design to the dissemination of results.

It is essential to set out your plan to involve relevant community groups and organisations, patients and carers in the Stage 2 application. You may find it useful to consider the following:

  • What changes do you expect to see as a result of community and public involvement in the proposed research?
  • Who are the relevant LMIC community groups and organisations that you will involve?
  • What do you perceive to be the challenges of community and public involvement in the proposed research and how will you mitigate those challenges?
  • What communication methods will you use to reach and involve relevant community groups and organisations and why are they appropriate?
  • How will you go about building and sustaining mutually respectful and productive working relationships?
  • What are the ethical issues, if any, that you need to address in relation to community engagement and involvement in the proposed research?
  • What are the roles and responsibilities agreed, or to be agreed, among the partners?
  • What learning and support will be provided to build capacity for community engagement and involvement?
  • What are your plans for governance, monitoring, review and reporting of community engagement and involvement in the proposed research?

Please ensure that your plans for Community Engagement and Involvement are fully costed in the budget. Information and resources to assist you can be found on the INVOLVE website (a detailed definition of public involvement in research, briefing notes for researchers on how to involve patients and the public, and an involvement cost calculator and budgeting guide).

You may also find it helpful to refer to Mesh (https://mesh.tghn.org/), a collaborative open-access web space that provides resources, encourages networking and shares good practice to bridge the gap between the research community and the general public in LMIC.

In rare cases, where proposals do not involve community representatives, patients and/or carers, clear justification must be provided.

SECTION 14: JUSTIFICATION OF COSTS

Provide overall justification of costs and details of how it provides value for money.

SECTION 15: DETAILED BUDGET

The amount of NIHR funding available for this competition is up to £30 million. Awards of typical range £1-5 million (maximum of £5 million) over 3-4 years are available for eligible research, starting June 2021 (earliest start date) to September 2021 (latest start date). The amount awarded and the length of the funding period should be fully justified according to the nature of the proposed research.

Justification of costs

Provide a breakdown of research costs associated with undertaking the research and provide justification for the resources requested, including the following:

  1. Research staff engaged in relevant research
  2. Research support staff supporting relevant research
  3. Travel, subsistence, meetings, conference
  4. Equipment
  5. Consumables
  6. Community engagement and involvement
  7. Dissemination, including open access publication costs
  8. Risk management and assurance
  9. External intervention costs
  10. Non-pay research costs
  11. Other legitimate and reasonable indirect costs (e.g. HR, finance)

Please refer to the call finance document to assist with preparation of a detailed budget. For help with estimating community engagement and involvement costs, please see the involvement cost calculator and budgeting guide).

SECTION 16: UPLOADS

Mandatory:

  • A list of references cited in the application (maximum 3 pages A4)
  • Project/Research Timetable/GANTT Chart
  • A signed letter of support for the LMIC Joint Lead Applicant from an appropriate senior individual at the LMIC Joint Lead Applicant’s institution
  • Delivery Chain and Risk map

The following file(s) are considered non-mandatory to submission; please number your files and attach: Supporting documentation, including protocols, questionnaires, logic models, flow diagrams, pictures, charts

  • Other Letters of support (see Mandatory uploads above)
  • Papers in press
  • Risk register

N.B. The total file size should not exceed 10Mb. Total files sizes larger than this may not be considered as part of the submission. All supporting documentation must be uploaded with a clear and concise filename description, preceded by a numbered ‘Appendix’ reference.

SECTION 17: ADMINISTRATIVE CONTACT DETAILS

Please provide the details of an administrative lead as a secondary point of contact for any queries relating to the application, should it be supported.

N.B. This person does not need to be a co-applicant.

SECTION 18: RESEARCH AND DEVELOPMENT OFFICE CONTACT DETAILS

Please provide the contact details and job title of a person in the R&D office, so that we are able to notify them of the outcome of this application including any associated feedback.

N.B. This person does not need to be included as a co-applicant.

SECTION 19: ACKNOWLEDGE, REVIEW AND SUBMIT

Conflict of Interest (COI) checks

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal & commercial interest that could be perceived as a conflict of interest. Examples include (this list is not all encompassing) secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In a case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups.

Agreement to terms and conditions

As Lead Applicant, please tick the box to confirm that the information given on this form is correct and that you will be actively engaged in this research and responsible for its overall management. In addition, you will accept responsibility for ensuring that the host institution and interested parties are kept informed.

  • Ticking this box constitutes an electronic signature of the lead applicant with regard to this application

Checklist of information to include when submitting a NIHR RIGHT Stage 2 research application

Applicants should click the checkboxes to indicate that they have included the necessary information prior to submitting their application.

GANTT CHART (mandatory upload)                                                                                                       ?

A full and accurate detailed budget breakdown (mandatory upload)                                                          ?

References (mandatory upload)                                                                                                             ?

Delivery Chain and Risk Map (mandatory upload)                                                                                   ?

Letter of support from the LMIC Joint Lead institution (mandatory upload)                                                 ?

A clear description of team member roles and contribution                                                                       ?

A clear description of the changes from first stage                                                                                   ?

A clear scientific abstract                                                                                                                       ?

A good quality Plain English Summary http://www.invo.org.uk/makeitclear/                                               ?

A clear Detailed Research Plan outlining the study design, methods, dissemination etc.                               ?

A flow diagram illustrating the study design / flow of participants, if appropriate                                          ?

Governance Structure                                                                                                                            ?

Appropriate and relevant community engagement and involvement                                                          ?

A clear justification of costs / value for money                                                                                         ?

The support and agreement from the necessary supporting roles / signatories                                          ?

SECTION 20: VALIDATION SUMMARY

Please follow the next steps in order to complete your application submission process:

  • Validate all mandatory/required fields (that are required to be completed/amended) before submitting
  • Check all co-applicants have completed their CV details as appropriate and review the PDF final version for any formatting issues
  • Click 'Save and Close'
  • Click the ’Submit' option (this must be completed by 1pm, 16th September 2020).

You will receive an automated email containing the acknowledgment that we have received your application.