Research and Innovation for Global Health Transformation - Call 2 Remit and Guidance for Stage 2 Applications

Introduction

The Department of Health and Social Care (DHSC)’s Global Health Research programme supports high-quality applied health research for the direct and primary benefit of people in Official Development Assistance (ODA)-eligible countries as given on the Organisation for Economic Cooperation and Development’s (OECD) Development Assistance Committee (DAC) list, whilst also strengthening UK and low and middle income countries’ (LMICs) research capabilities and expertise.

In line with ODA principles, the NIHR has established a substantial portfolio of global health research programmes, through open ‘Investigator-led’ calls. These have positioned the NIHR as a key player in global health research; including support to 13 NIHR Global Health Research Units, 40 Global Health Groups and 8 Research and Innovation for Global Health Transformation (RIGHT) programme grants.

The NIHR continues to broaden its investments in key areas, where a strategic and targeted investment can result in a transformative impact. Through the provision of focused research funding that prioritises implementable results, DHSC support UK researchers in partnership or collaboration with researchers in ODA-eligible countries in their ability to meet the Sustainable Development Goals while at the same time also benefiting the UK’s own knowledge economy.

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 that addresses the health issues faced by ODA-eligible countries.

Aims and focus of RIGHT Call 2 

NIHR RIGHT Call 2 provides targeted investment in mental health research in ODA-eligible countries, through supporting applied research on the development and evaluation of interventions to improve outcomes for those affected by mental health issues.

The aims of RIGHT Call 2 are to:

• Deliver research for the primary benefit to the health and wealth of the poorest individuals living in ODA-eligible countries, through research for the development and evaluation of interventions to improve outcomes for those affected by mental health issues
• Ensure that the research funded through this call strengthens capacity for research and knowledge exchange through development of equitable partnerships between researchers in the UK and ODA-eligible countries
• 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.

Rationale

Mental health issues represent a major global health challenge with major social and economic consequences. The growing global health burden of mental illness was recognised by world leaders when adopting the Sustainable Development Goals (SDGs) in 2015.

Although, mental health and substance use disorders are common in all regions of the world, affecting every community and age group across all income countries, there is a disproportionate effect on people in LMICs, where 75% of those suffering from mental health issues do not have access to the treatment they need. [WHO Mental Health Gap Action Programme (mhGAP)].

Given the scale of unmet need, a significant body of research at all stages of the development pipeline is required [WHO Discussion Paper: Mental health, poverty and development, July 2009] and a number of national and international funding bodies have made investments seeking to address this challenge. Through RIGHT Call 2, NIHR will specifically target support to the relatively late stage applied research that is needed to develop and evaluate interventions to improve prevention, access to treatment, clinical management and outcomes for those suffering with mental health issues in ODA-eligible countries

The WHO report on mental health and development in 2010 recommended that mental ill-health sufferers should be considered as vulnerable populations. The report highlighted a need for greater coordination between research and practice communities, including research to better understand health seeking behaviours, and/or to develop support mechanisms that are able to reach potentially hard to reach populations. These activities are required to ensure that proven interventions are more accessible to
vulnerable people living with mental ill-health and psychosocial disabilities. And to support the provision of evidence based evaluation of the outcomes and impact of interventions on mental health at a population level.

People with long term chronic physical health issues are understood to be at higher risk for common mental health issues such as depression. However, the mental health aspect of such conditions is often poorly understood or integrated into the overall care package. Similarly, addiction can be a driver or consequence of mental ill health necessitating complex and multidisciplinary approaches (including actors outside traditional healthcare systems) for the development and evaluation of interventions. The knowledge and
evidence base for these issues are currently weak, and research to develop, understand and evaluate interventions in these contexts is needed.

Furthermore, WHO and UN Enable both note that institutionalisation of those with mental illness remains the primary approach to treatment in many LMICs, whereas the evidence base in Higher Income Countries (HICs) supports and encourages an outpatient and community-based treatment for all, but the most severe cases. Identification of effective alternatives to institutionalisation is recognised as a priority unmet need.

The Inter-Agency Standing Committee (IASC) have recently reported significant gaps in the understanding of the effectiveness of mental health support and interventions that are applied during the management of global emergencies (including but not limited to conflict, flood, earthquake, volcanic eruptions etc.).They also acknowledge a deficit of understanding and provision around the application of mental health support and interventions during situations of chronic hardship.

Research and humanitarian aid agencies have invested in interventions to detect and support people with conditions potentially attributable to the crisis, e.g.: post-traumatic stress disorder (PTSD). Mental health issues arising during emergency may be new to the individual concerned but may be an exacerbation or surfacing of an existing condition. These conditions may not be best served by interventions focusing on issues such as PTSD. Therefore, research to evaluate mental health interventions for use in emergencies, alongside research to develop interventions focusing on the more common conditions and/ or potentially pre-existing issues is required.

Focus of the call

Applied research programmes funded through NIHR RIGHT Call 2 should employ inter-disciplinary approaches and link research and practice communities, build and strengthen sustainable and equitable partnerships with partners in LMICs, and support capacity building in global mental health research. Applications should set out how research objectives and priorities are relevant to the local setting and present a clear plan for delivering the research with strong governance and management in place

NIHR encourages applications for NIHR RIGHT Call 2 that address research in (but not limited to) the following areas:

• Development and evaluation of interventions to reduce the incidence of institutionalisation for treatable/manageable mental health conditions
• Development and evaluation of interventions targeting mental health as a co-morbidity
• Development and evaluation of community-delivered interventions in situations of chronic hardship (including better understanding of factors influencing access to treatment)
• Development and evaluation of interventions to tackle addiction as a driver (or consequence) of mental ill-health
• Evaluation of effectiveness of mental health and psychosocial support in post-crisis settings to promote sustainable services that meet enduring needs of the population.

RIGHT Call 2: Outline

NIHR RIGHT Call 2 is a two-stage competition. Stage 1 is a short-listing outline stage. Stage 2 is for successful applicants at Stage 1 to produce a full application. An International Funding Committee will consider eligible applications at both stages.

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

Remit

This call will support competitive interdisciplinary research programmes in global mental health. Dementia is NOT in scope for the current call on mental health.

RIGHT Call 2 will support:

• 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 mental health
• 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 challenges in mental health
• 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
• Applications that include appropriate researchers from LMICs, and demonstrate plans for equitable partnership and engagement between UK research organisations and researchers and other partners in ODA-eligible countries. Please note for RIGHT funded programmes a co-applicant or Joint Lead Applicant from an ODA-eligible country MUST be included on the application
• Applications that include relevant engagement with policy makers, patients and the public, civil society organisations and charities
• Applications that include PhD students based in LMICs

RIGHT Call 2 will not support:

• Applications with a focus on basic research or experimental medicine, including research on animals
• Costs to establish biobanks, bio-sample collections or new patient cohorts are not eligible under this initiative (samples or data from existing cohorts may be used in applications)
• Applications consisting solely of epidemiological studies
• Applications consisting solely of evaluations of existing services, where the programme of work does we not include evidence-based development and improvement of these services
• Applications solely comprising a single Randomised Controlled Trial (RCT)
• 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
• Applications that do not include co-applicants or Joint Lead Applicant from relevant researchers and /or practice communities in the LMIC partner country

RIGHT Call 2 would not typically support applications that primarily focus on observational research, secondary research or health policy implementation.

Eligibility

Applications are invited from UK-based (England, Wales, Scotland, Northern Ireland) Higher Education Institutions and Research Institutes. Non-UK institutions in High-Income Countries can be included in the application if there is a strong justification as to why the expertise they are bringing cannot be found in the UK or in an ODA-eligible country; evidence for this needs to be provided in the application. Applications from joint groupings of UK institutions will be considered, though a lead UK institution must be specified.

Please note that for RIGHT applications, it is mandatory to include a co-applicant or Joint Lead Applicant in an ODA-eligible country relevant to the research proposal. The research must be focused on improving the health and welfare for the direct and primary benefit of people in low and middle-income countries (LMICs). In order to be eligible to receive ODA funding, applications must demonstrate how they meet ODA compliance criteria and outline:

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

Selection criteria for Stage 2

The selection criteria for Stage 2 will be:

• ODA eligibility and compliance
  • The research must be for the direct and primary benefit of the poorest individuals in ODA-eligible countries. In order to be eligible to receive ODA funding, applications must demonstrate how they meet ODA compliance criteria and outline:
  • Which country or countries on the DAC list of ODA eligible countries will directly benefit?
  • How the application is directly and primarily relevant to the development challenges of those countries?
  • How the outcomes will promote the health and welfare of a country or countries on the DAC list? (More information on Official Development Assistance).
• It is a UK aid strategy requirement that “alldepartmentsspendingODA are required to put in place a clear plan to ensure their programme design, quality, assurance, approval, contracting and procurement, monitoring, reporting and evaluation processes represent international best practice”. Consequently, applicants will need to ensure the research proposal includes suitable and sufficient plans and resources to deliver:
  • Robust governance and oversight
  • Effective programme management
  • Robust financial and risk management
  • Assurance of effective due diligence and audit processes
  • Quarterly financial reporting of actual spend and distribution across DAC countries

NB: Proposals that do not demonstrate a credible plan for programme management including provision of appropriate monitoring and mandatory quarterly financial reports will not be considered.

• Relevance of the proposed research to the research requirement outlined in the remit (see section 3.2)
• 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)
• Quality of the proposed management arrangements (i.e. clear definition of roles, risk management arrangements and how the efforts of individuals will be coordinated)
• Strength of the research team (i.e. depth and breadth of relevant expertise and track record of applicants in a related area) 
• Impact of the proposed work (i.e. what’s going to change, and who for and to what extent, as a result of the research?) and plans for engagement with policy makers, communities and the public at an early stage
• Value for money provided by the application
• Community and public involvement, where relevant to the research question(s)
• 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

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

The timetable for Stage 2 selection process will be: 

Stage 2 call launch	17 June 2019
Deadline for receipt of Stage 2 applications	05 September 2019 (1pm)
Selection panel review and recommendations	11&12 November 2019
Applicants notified of outcome of Stage 2	December 2019
Contracting process initiated	December 2019
Funding commences	March 2020

Funding 

Budget

The amount of NIHR funding available for this competition is up to £15 million. Awards of typically in the range £3-5 million (but with a maximum of £5 million) over 3-4 years are available for ODA-eligible research, starting March 2020. The amount awarded and the length of the funding period should be fully justified according to the nature of the proposed research.

Eligible costs for RIGHT Call 2

Eligible costs for RIGHT Call 2 include:

• Research staff engaged in relevant research
• Research support staff supporting relevant research
• Travel, subsistence and conference costs
• Equipment
• Consumables
• Community and public involvement
• Dissemination
• Risk management and assurance
• External intervention costs
• Non-pay research costs
• Other legitimate and reasonable indirect costs (e.g. accommodation, HR, finance)

Please see the RIGHT Finance Guidance for further details.

Completing your application

You must complete an online application via the Research Management System (RMS). The closing date for applications is Thursday 5 September 2019 at 13:00.

Section 1: Application summary information

Host organisation

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

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 for
regulatory 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 - Lead and Co-applicants

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.

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: Research background - lead 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.

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 use DOI reference numbers if needed.

Research grants held

Please select research grants held (as a named applicant) currently or in the last five 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 information about resubmission of an NIHR grant please contact the NIHR Global Health RIGHT programme team ccf-globalhealth@nihr.ac.uk.

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 complete the necessary information. We are keen to know if the application has been submitted elsewhere and you must be as open about this as possible. 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 4: The research team

Specify your (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

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

Joint Lead Applicant

Where appropriate and justified, it is acceptable for the application to be led by Joint Lead Applicants. Where this applies, please complete your name, contact details and other requested information.

Justification for Joint Lead Applicant

Justification should be given to demonstrate why more than one person would be required to lead this research and how this brings added value to the application.

Relevant expertise and experience of Joint Lead Applicant

Please summarise the proposed Joint Lead Applicant’s relevant expertise and track record in applied health research, in terms of skills and experience, previous publications, grant funding and impact on health service provision.

Specify role in research

Please provide a brief overview of your role in the proposed research. You have the opportunity to elaborate upon this further in the ‘Research Plan’ section.

%FTE Commitment

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

Please note: For application/contracting purposes, the Joint Lead Applicant will be counted as a co-applicant.

A researcher based in an ODA-eligible country can be a Joint Lead Applicant but as above for UK based Joint Lead Applicant, for application/contracting purposes, the Joint Lead Applicant from an ODA-eligible country will be counted as a co-applicant and there can only be one lead host organisation for flow of funds which must be a UK HEI or Research Institute.

Co-Applicants

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

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery. 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.

For RIGHT applications it is mandatory to include a co-applicant or joint lead applicant from an ODA-eligible country relevant to the research proposal.

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 in a separate text box. This appears when a co-applicant selects ‘yes’ to indicate that they are a member of the public.

We recognise and value the varied perspectives that community representatives, patients or 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. Please allow sufficient time for your co-applicants to complete their sections of the online form before the application deadline.

Section 5: Other supporting roles – signatories (electronic)

Other supporting roles

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

• Director of Finance
• Head of Department or Senior Manager

Electronic signatures

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 6: 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 useful.

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

Section 7: Plain English Summary of Research

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 the NIHR website and other websites.

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 and public 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.

Read further guidance on writing in plain English.

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

Section 8: 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 9: Detailed research plan

Using all of the headings (in the order presented) and guidance below, clearly explain your proposed research. 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 adequate 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.

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 area of mental health 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.

Aims and objectives

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

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 part 3 of the ‘Detailed Research Plan. The key is that the reasoning underlying all stages of the proposed research should be transparent.

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

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:

a. 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. 

b. 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. 

c. 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).

d. 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). 

e. 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 these?

f. 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. 

Project/research timetable & Gantt chart

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 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 deliverables.
• Quarterly financial assurance reports detailing actual spend are a mandatory requirement for this call and must be listed as deliverables.
• 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’.

Project management

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

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.

NOTE: This section should also highlight the role of any Advisory or Reference Groups associated with the proposed research.

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.

Ethics / regulatory approvals/risk management and assurance

Outline any ethical issues, governance arrangements and risks associated with this research and the arrangements for handling them. You may find it useful to refer to the following online resources:

1. Charity Commission’s guidance on how to manage risks when working internationally
2. The Wellcome Trust’s guidelines on research involving people living in 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:

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 involvement.

Data protection and information governance

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

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 auditing.

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 appropriately.

You may find the following online resources helpful:

• What is ODA? 
• Net ODA awarded to DAC countries per year
• Independent Commission for Aid Impact
• Development Co-operation Directorate

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 staff. 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.

Project/research expertise

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. 

Approach to creating sustainable and equitable partnerships with partners in LMICs

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

Success criteria and barriers to proposed work

Describe what success looks like for your project? Describe any known or anticipated difficulties which may be faced in delivering your research in the LMIC. These may be difficulties you will face yourself, or challenges faced by those in the implementing context (e.g., LMIC researchers or clinicians). Be specific: outline the problems specifically associated with your study plans - do not describe general ODA, aid or development challenges. Remember to include any critical dependencies - especially around specific authorisations, permissions or licences that are critical to the delivery of your research in the LMIC setting.

Section 10: Community and public 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 and public 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 and public 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 and public involvement?
• What are your plans for governance, monitoring, review and reporting of community and public involvement in the proposed research?

Please ensure that your plans for Community and public 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 payment guidance for researchers and professionals).

You may also find it helpful to refer to Mesh, 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 11: Detailed budget

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

• Staff costs
• Travel, subsistence and conference fees
• Equipment
• Consumables
• Community and public involvement
• Dissemination costs
• Risk management and assurance
• Other direct costs
• Indirect costs/overheads
• External intervention costs

Please refer to the RIGHT finance guidance to assist with preparation of a detailed budget. For help with estimating community and public involvement costs please see the payment guidance for researchers and professionals).

Section 12: Management and Governance

Is Clinical Trials Authorisation required?

Yes / No

Does your project require ethics approval?

Yes / No

If yes, has ethics approval already been obtained?

Yes / No

Section 13: Uploads

Mandatory:

• A list of references cited in the application (maximum 3 pages A4).
• Project/Research Timetable/GANTT Chart
• Risk management policy
• Financial assurance and due diligence policy documents

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
• Letters of support
• Papers in press
• Risk register

N.B. The total file size should not exceed 5Mb. 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 14: Recommended review organisation

We would like to contact members of relevant community groups and organisations to provide an assessment of your application and help the decision-making committee determine whether what is being proposed is not just going to work from a scientific point of view but from the community’s perspective too.

Please suggest two groups and/or international non-governmental organisations that you may be aware of that operate in one of the countries where you are looking to carry out the research, and that represent the community for which your research aims to deliver benefit. Please do not recommend groups and/or organisations that are involved in your research in any way. 

Section 15: 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 16: 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 a co-applicant.

Section 17: 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.

N.B. 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 stage 2 research application

• Appropriate and relevant involvement of the community and the public
• A good quality plain English summary
• A clear description of team member roles and contribution
• A clear scientific abstract
• A clear description of the changes from first stage
• A flow diagram illustrating the study design / flow of participants (document upload), if appropriate
• A full and accurate detailed budget breakdown (finance form)
• A clear justification of costs / value for money
• References (document upload)
• A clear Detailed Research Plan outlining the study design, methods, dissemination etc.
• A CTU letter of support if required (document upload)
• The support and agreement from the necessary supporting roles / signatories
• Risk management policy
• Financial assurance and due diligence policy documents
• Risk register (non-mandatory upload).

Section 18: 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, 5th September 2019).

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