Research and Innovation for Global Health Transformation - Call 1 Remit and Guidance for Stage 2 Applications

Introduction

The Department of Health and Social Care (DHSC) Global Health Research funding aims to develop and commission new global health research which will deliver primary benefit to the health and economies of the poorest people living in low and middle income countries (LMICs), whilst also strengthening UK and developing country research capabilities and expertise. In line with Official Development Assistance (ODA) principles, between 2016-18 a substantial portfolio of global health research programmes has been established through open ‘Investigator-led’ calls that has positioned the NIHR as a key player in global health research, including support to 13 new NIHR Global Health Research Units and 40 new Groups.

Building on this broad portfolio base, we now want to focus NIHR investments on 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 LMICs in their ability to meet the Sustainable Development Goals while at the same time also benefiting the UK’s own knowledge economy.

The NIHR Research and Innovation for Global Health Transformation (RIGHT) programme forms part of the UK government's commitment to ODA. Through RIGHT we will provide research funding to support cutting-edge interdisciplinary applied health research that addresses the health issues faced by countries, as defined eligible for ODA funding by the Organisation for Economic Cooperation and Development’s (OECD) Development Assistance Committee (DAC) list, referred to throughout this guidance as Low and Middle Income Countries (LMICs) or DAC-list countries.

The aims and focus of RIGHT programme – Call 1

The aims of RIGHT Programme – Call 1 are to:

• deliver research for the primary benefit to the health and wealth of the poorest individuals living in DAC-list countries, typically through research for the prevention of ill health and optimal disease management;
• strengthen capacity for research and knowledge exchange through equitable partnerships between researchers in the UK and LMICs;
• promote interdisciplinary approaches to working (including, but not limited to: clinical, health economics, statistics, qualitative and social sciences), to ensure that research objectives can be delivered in three research areas
  1. Epilepsy
  2. Infection-related cancers
  3. Severe stigmatising skin diseases

Additional detail on the three focus areas is as follows.

Epilepsy

Rationale

Epilepsy is the most common chronic brain disorder globally and affects people of all ages. According to the World Health Organization (WHO) more than 50 million people worldwide have epilepsy of which almost 80% live in developing countries. With treatment, an estimated 70% of people with epilepsy can be seizure-free. However it is estimated that three quarters of affected people in developing countries do not get treatment and in many parts of the world, people with epilepsy and their families suffer from stigma and discrimination. Causes of epilepsy include; head injury, infection by parasites, and birth injuries including a lack of oxygen during birth. In line with the 2015 World Health Assembly (WHA) resolution on epilepsy, which called for improved investment in epilepsy research and increased research capacity, we welcome applications which address one or more of the following areas:

Focus of the call

To reduce the public health burden of epilepsy in LMICs through addressing one or more of the following:

• research which seeks to improve prevention and/or clinical management of epilepsy in LMICs, in particular in the poorest populations; epilepsy prevention research (including birth events and/or infections);
• research into disease manifestation and prevalence in LMICs, which can inform planning and policy making;
• research seeking to improve appropriate, accessible and acceptable treatment options and addressing stigma;
• mixed method studies across disciplines, for example how to best support effective interventions and improve access to services to improve treatment;
• health systems and/or implementation research addressing access, cost-effectiveness and acceptance of available prevention and treatment programmes.

Infection-related cancer

Rationale

According to Lancet Global Health, up to one-sixth of cancers world-wide are attributable to infections, which are acknowledged to probably represent an under-estimate. Of more than two
million cases of infection associated cancer diagnosed annually, nearly two-thirds occur in developing countries. Suggested reasons include economic disparities, the biology of infection related cancers, immunogenetics and interactions between behavioural, environmental, and infectious factors that predispose individuals to infection-related cancers. Despite progress in vaccine development and implementation of screen and treat programmes for some infection-related cancers the progress in reducing incidence and mortality is uneven globally.

Pathogens associated with the highest number of cancers in low and middle income settings include:

• Hepatitis B and C viruses: infection with hepatitis B virus (HBV) or hepatitis C (HCV) virus may develop a chronic infection that can lead to cirrhosis. The damage that results increases the risk of liver cancer (hepatocellular carcinoma). Access to appropriate vaccination (HepB) or drugs (HepC) is limited in many LMICsl;
• Helicobacter pylori: colonisation of the stomach by H. pylori is an important cause of gastric cancer and of gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Although treatable with antibiotics, this remains a significant issue in LMICs; 
• Epstein-Barr virus: Although identified in 1964 as the first virus identified as causing cancer treatment of this aggressive tumour which is caused by white blood cells multiplying out of control remains a public health issue particularly in sub-Saharan Africa, associated with Burkett’s lymphoma, Hodgkin’s lymphoma and nose and throat cancer;
• Human herpesvirus 8: HHV-8 is found in tumours in patients with Kaposi sarcoma, often associated with HIV infection or other immunocompromised individuals.

The aim of RIGHT Call 1 is to support health research in areas of un-met needs or neglected investment. The five listed infection-related cancers above have been prioritised for RIGHT Call 1 to focus on specific cancers where a targeted investment has the potential for a transformative impact.

Other infection related cancers are NOT within remit of the call.

Focus of the call

We welcome applications which address research in one or more of the four areas outlined above through:

• research which seeks to improve prevention and/or clinical management of infection-related cancer in LMICs, in particular in the poorest populations;
• research into disease manifestation and prevalence in LMICs, which can inform planning and policy making;
• appropriate and effective tools to promote early diagnosis;
• research seeking to improve appropriate, accessible and acceptable treatment options and addressing stigma;
• mixed method studies across disciplines, for example how to best support effective interventions and improve access to services to improve treatment;
• health systems and/or implementation research addressing access, cost-effectiveness and acceptance of available prevention and treatment programmes.

Severe stigmatising skin diseases

Rationale

According to a WHO report, despite the high frequency of certain skin diseases in developing countries they are not often regarded as a significant health problem when public health strategies are developed. Severe stigmatising skin diseases are some of the most neglected conditions and yet are disabling and disfiguring for those who suffer from them, often the poorest and most marginalised individuals in populations. Treatment of severe stigmatising skin conditions depends on the causative organisms and can involve antibiotic combinations, antifungal drugs and surgery and wound-care.

Examples include (but are not limited to)

• Buruli ulcer caused by Mycobacterium ulcerans. Infection can lead to tissue damage and ulcers usually on the legs or arms. Most cases occur in tropical and subtropical regions in Africa; almost half of those affected are children under 15 years. Patients who are not treated early can suffer long-term disability and early diagnosis and treatment are the only ways to minimise morbidity and prevent disability. Treatment relies on antibiotics, wound care and surgery.
• Mycetoma is a chronic, progressively destructive inflammatory disease usually of the foot. Infection is probably acquired by traumatic inoculation of certain fungi or ?bacteria into the subcutaneous tissue. Mycetoma commonly affects young adults, particularly males between 20 and 40 years, mostly in developing countries. Manual workers such as agriculturalists, labourers and herdsmen are the worst affected. Mycetoma has numerous adverse medical, health and socioeconomic impacts on patients, communities and health authorities. Data on
  incidence and prevalence is limited and early detection and treatment is important to reduce morbidity and improve treatment outcomes.

Focus of the call

To reduce the public health burden of severe stigmatising skin diseases in LMICs through research which address one or more of the following areas:

• research which seeks to improve prevention and/or clinical management in LMICs, in particular in the poorest populations;
• research into disease manifestation and prevalence in LMICs, which can inform planning and policy making;
• research seeking improvements in prevention including effective tools to promote diagnosis of early infection;
• research on delivery of timely, appropriate and improved treatment strategies;
• research on how to address issues related to stigma and other social issues related to these conditions;
• mixed method studies across disciplines, for example how to best support effective interventions and improve access to services to improve treatment;
• health systems and/or implementation research addressing access, cost-effectiveness and acceptance of available prevention and treatment programmes.

Please note that research on skin conditions associated with cancer is not eligible under this call.

RIGHT programme Call 1 – outline

Process

The NIHR RIGHT Call 1 is a two stage competition. Stage 1 is a short-listing outline stage. Stage 2 is for successful Stage 1 applicants to produce a full application. There will be an independent peer review at both stages and an international Panel will consider eligible applications at both stages.

Applicants invited to proceed to Stage 2 may also apply for ‘Partnership & Proposal Development Funding’. These funds (up to a maximum of £10,000) will support travel and subsistence costs, and/or legal or advisory service fees, incurred during proposal development. The award will be made to the nominated lead institution only, will cover ‘actual’ expenditure evidenced by receipts and invoices, and  will be paid in arrears. The lead institution will need to make appropriate arrangements (and be responsible for collection of receipts and invoices) for transfer of funds to any collaborators or service providers.

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

Remit

The NIHR RIGHT programme – Call 1 will support:

• applied health research projects/programmes that are of primary and direct benefit to people and patients in DAC-list countries, which address the challenges faced by LMICs in the following areas: epilepsy, infection-related cancers and severe stigmatising skin diseases;
• 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 LMICs as well as teams and researchers who may want to build new research partnerships with colleagues in LMICs or apply their research expertise to global health challenges in these areas;
• proposals that incorporate research questions around gender, social barriers to health, economic impact and equity, that demonstrate strong partnerships with institutions in LMICs;
• applications which include appropriate researchers from disease endemic regions and demonstrate equitable research partnerships;
• applications which demonstrate plans for equitable partnership building and engagement between UK research organisations and researchers and other partners in LMICs;
• applications which include relevant engagement with policy makers, patients and the public, civil society organisations and charities.

The NIHR RIGHT Programme – Call 1 will not support:

• applications with a focus on basic research or experimental medicine, including research on animals, will not be funded through this initiative;
• 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 evaluations of existing services, where the programme of work does 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 LMICs in which the research is being undertaken.

Applicants should also note that NIHR RIGHT – Call 1 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 LMIC. 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.

Selection criteria for Stage 2

The selection criteria for Stage 2 will be:

ODA eligibility and compliance

The research must be focused on improving the health and welfare of the poorest and most vulnerable people in 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?

For more information about ODA read the OECD's definition and coverage of ODA.

It is a UK aid strategy requirement that “all departments spending ODA 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 (above);
• 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 LMICs).

Selection process

All eligible applications will be considered by an International Independent Selection Panel 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 – Tuesday 30 October 2018
• Deadline for receipt of “proposal and partnership development award” application – Friday 9
  November
• Applicants notified of outcome of “proposal and partnership development award” application - Friday 16 November deadline for receipt of Stage 2 applications via the online RMS system – Monday 28 January 2019 at13:00
• selection panel review and recommendations – Thursday 10-11 April 2019
• applicants notified of outcome of Stage 2 – Early May 2019
• contracting process initiated – May 2019
• funding commences – June 2019

Funding

The amount awarded and the length of the funding period will depend on the nature of the proposed work. The total amount of NIHR funding available for this competition is £30 million. Awards of up to £3-5 million over 3-4 years are available, starting June 2019.

Funding will be dispersed to the lead institution, quarterly and in arrears, dependent on achievement of agreed milestones and deliverables. The lead institution will be responsible for dispersal to partners and collaborators.

Eligible costs for RIGHT- Call 1 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 costs
• risk management and assurance
• non-pay research costs
• other legitimate and reasonable indirect costs (e.g. accommodation, HR, finance) 

For further information on costs, please see the Finance Guidance for Applicants.

Proposal and Partnership Development Award funding

Applicants that were successful at Stage 1 and invited to submit a Stage 2 application are also eligible to apply for funding of up to £10,000 to support proposal and partnership development, and the preparation of the full proposal to be submitted for Stage 2.

A one page narrative proposal and a proposed budget for this award should be submitted for consideration to us by Friday 9 November 2018.

N.B. Application deadline for the proposal and partnership development funding will be 10 days after notification of Stage 1 outcomes. Therefore, applicants considering applying for development funding should be prepared to submit an application within this time frame.

Eligible costs for the Proposal and Partnership Development Award include:

• travel and subsistence
• partnership formation and development costs – i.e. costs associated with establishing any MOUs and governance policies with potential partners and undertaking due diligence.

It should be noted that all other costs, including staff costs are NOT eligible under the Proposal and Partnership Award. NIHR may challenge proposed costs that it does not consider appropriate or does not offer Value for Money, for example Business Class travel.

Applicants should include an invoice along with evidence and receipts of actual spend for the approved Proposal and Partnership Award budget with their full application at Stage 2. Please note, Lead Applicant organisations will need to pre-finance these activities once approved by NIHR.

N.B. Applicants should not start spending/activities until Proposal and Partnership proposals have been approved by NIHR.

Completing your application

You must complete an online application via the Research Management System (RMS). The closing date for applications is Monday, 28 January 2019 at 13:00. 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 organisation who will be the contractor (i.e. the organisation who will sign the contract with DHSC) if the programme is funded. If your organisation does not appear on the list, please contact the NIHR.

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.

Enter the total amount of external intervention costs associated with this proposal.

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.

Section 3: Research background - lead and co-applicants

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 more information about resubmission of a research/trainee funding application, or joint funding please contact the appropriate NIHR research funding programme. (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.

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.

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 (see page X).

No original 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 website (www.equator-network.org) useful.

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

Section 7: Plain English summary

A plain English summary is a clear 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 NIHR 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 (Panel members, peer reviewers and lay reviewers) 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 felt 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 the community, patients and members of the public in developing a plain English summary.

When writing your summary consider including the following information where appropriate:

a) Aim(s) of the research
b) Background to the research
c) Design and methods used
d) Community and public involvement – see below
e) 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.

Find 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 reviewing 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 – including why this research is important in terms of improving the health and/or wellbeing of the relevant populations and healthcare services in the LMIC?
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 LMICs 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 epilepsy, infection-related cancer or severe stigmatising skin conditions in LMICs.

It is essential that you clearly identify the applied health and care challenges faced by the LMICs 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 ‘Case for Support’. 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 LMIC

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 LMICs; detailing how the research will support sustainable advances in capacity and capability in the LMIC. Where possible, quantifying the potential benefits and the anticipated timescale for the benefits to the LMICs 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. NB 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, the 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 2 and 3 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 call 1 “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 LMICs).
• 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 LMIC

• 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:
a) OECD data
b) Net ODA
c) Independent Commission for Aid Impact
d) OECD 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  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 LMICs 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 LMICs 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 involvement are fully costed in the budget.

Information and resources to assist you can be found on the NIHR website (a 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 call finance document 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: Suggested Referees

Provide suggestions of two (where possible) and a maximum of three potential referees. This information will not appear on the Selection Panel/Committee members’ version of the application form.

N.B They should be independent and have no conflict of interest with your application.

Section 14: 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 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 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

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