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Supporting Information for Mental Health Research Research Applicants

Contents

Published: 01 September 2023

Version: 1.0 September 2023

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Section 1: Introduction

This document contains information to assist applicants submitting an application to one of the Mental Health Research Group, Development or Leaders Awards. Applications for funding are made online through the NIHR Research Management System (RMS). You must register or log-in to the RMS to complete and submit your application.

Please also ensure that you have read the appropriate application form guidance notes fully. Potential applicants are also encouraged to visit the programme website.

All Higher Education Institutions (HEIs) in England are eligible to apply however the Awards are aimed at HEIs with limited mental health (MH) research capacity wishing to expand, and those with no existing MH research capacity, situated within, or within easy reach of “target areas”. 

Section 2: Privacy and Data Protection

The NIHR Research Management System (RMS) is hosted by Pulsant. The Data Controller for the website is the Department of Health and Social Care (DHSC). The Data Processor is the NIHR Co-ordination Centre (NIHRCC), based at LGC. 

The purpose for which personal information is collected through the RMS is to deliver the work of the NIHRCC in relation to the operation of research programmes, faculty and infrastructure work-streams. Data will not be used for any other purpose without the consent of the supplier.

Use of the registration and application facility on the NIHRCC RMS is entirely voluntary and the personal information stored will be used solely by the NIHRCC, its subcontractors and partners in order to respond to your enquiries and send information relevant to its work.

To prevent unauthorised access, maintain data accuracy, and ensure the correct use of information, the NIHRCC has put in place appropriate physical, electronic, and managerial procedures to safeguard and secure the information it collects online. The information you provide will be held securely and in accordance with the Data Protection Act 2018. The Department of Health and Social Care, National Institute for Health Research (DHSC NIHR) is the Data Controller. Your personal details provided on registration will not be disclosed to third parties. Details that are provided on research application forms must necessarily be shared in confidence with third party individuals involved in making funding decisions.

Your information may also be shared with other DHSC NIHR bodies for the purposes of statistical analysis and other DHSC NIHR management purposes, including targeted communications with selected groups of researchers. In addition, information collected is used by the NIHRCC, its subcontractors and partner organisations:

  • To administer the grant application process
  • To identify peer reviewers for grant applications
  • To notify users about funding opportunities by email
  • To notify relevant users about application deadlines by email
  • To notify users of any issues of service interruptions, holiday closures and other situations affecting the operation of the NIHR RMS.

If we change our privacy policy, for example, in response to changes in legislation, we will post details of any changes on our website. This will help ensure that you are always aware of what information we collect, how we use it, and under what circumstances, if any, we share it with other parties. In some circumstances, explicit consent to continue use of the Services may be required. Otherwise, your consent to changes will be implied by your continued use of the Services. If you do not consent to the changes, then you must terminate your agreement as set out in section 12 of the NIHRCC Grant Application System Terms and Conditions.

More information can be found in the NIHR Privacy policy and Confidentiality guidance.

Section 3: Equality and Diversity Monitoring Information - Applicant Information

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability).  By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation.  Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response.  However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Section 4: Equality and Diversity Monitoring Information - Application Guidance

Guidance for applicants on Equality, Diversity and Inclusion for study participants. Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:

  • Geographical location
  • Age
  • Disability
  • Gender reassignment
  • Marriage and civil partnership
  • Pregnancy and maternity
  • Ethnicity - for example:
  • Religion or belief
  • Sex
  • Sexual orientation
  • Socioeconomic status
  • Access to health or social care

All NIHR applications are expected to include information about how this data will be collected. In addition, applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at.  Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. Costs associated with inclusivity, which may include, but are not limited to justified translation of research participant material into other relevant languages, would be expected and where appropriate should be included in the detailed budget section under ‘Other Direct Costs’. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.

Please see the NIHR INCLUDE Guidance for more information about how to include under-served groups effectively:

Helpful links:

In particular and where appropriate, if involving patients/service users, carers as research participants, please also provide key details about how they will be supported, managed and involved (see below).

  1. ii) Summary of patients/service users/carers/public as research participants:

The successful recruitment and retention of study participants is strategically important for the NIHR. If your proposed study involves patients/service users/carers/public as research participants please use the following bullet points to summarise their characteristics and what would be expected of them throughout the research project lifecycle. The potential burden on study participants can then be understood as well as whether or not the proposed strategies are practical, inclusive and feasible. Please also signpost to where further information on these points can be found in the detailed research plan and application.

Points to cover: 

  • Inclusion and exclusion criteria to help ensure that certain groups were not being excluded without justification
  • Recruitment method and consent process to ensure it is practical and fair
  • Type and content of participant information materials 
  • Overview of research methods to capture data from participants and their frequency e.g. questionnaires/tests/intervention/focus groups/ interviews
  • Study participant support to consider how drop-out and issues of participation would be handled/helplines/ other access arrangements required
  • Methods for sharing study progress and findings with study participants 
  • Payments, rewards and recognition for study participants.

Researchers may find the SPIRIT 2013 statement a useful resource when preparing their protocol.

Section 5: Research Support Service

Applicants may wish to seek advice on the content of an application via the Research Support Service (RSS). It is advisable to make contact as early as possible to allow sufficient time for discussion and a considered response.

Section 6: Clinical Trials Unit (CTU) Support

CTUs are regarded as an important component of any trial application and can advise and participate throughout the process from initial idea development and design through to project delivery and reporting. However they may not be essential for all types of research studies. If you feel this is the case please justify the reasons in your application in the appropriate section.

From 1st October 2023 CTUs will be part of the new Research Support Service (RSS). Please contact the RSS for support on the design of any clinical trials you plan to undertake as part of your application.

Section 7: Public Involvement

NIHR has issued guidance for researchers about involving patients and the public in research. 

A list of PPI resources for applicants to NIHR research programmes is available on the NIHR website, including: Briefing notes for researchers on how to involve patients/service users, carers and the public, including definition of involvement engagement and participation; and Payments Guidance for researchers and professionals with information on budgeting for involvement.

The NIHR Research Support Service provides advice on developing research applications, including involving patients and the public, and the James Lind Alliance has a step-by-step guide on involvement in research identification and priority setting.

Section 8: Systematic Reviews

Applicants undertaking systematic reviews should note the commitment of NIHR to publication in the PROSPERO database. PROSPERO was developed by the NIHR’s Centre for Reviews and Dissemination (CRD), and is the first online facility to register systematic reviews for research about health and social care from all around the world. Access is completely free and open to the public. PROSPERO registration is a condition of NIHR funding for eligible systematic reviews.

Section 9: Ethics / Regulatory Approvals

Guidance on the application process for ethical and other approvals can be found on the HRA website. Please note that if your study involves the NHS in England you should apply for HRA approval.

If you are using patient information from an existing database, you should check whether the patients have given their consent for their data to be included in that database for research purposes, or if not whether the database is exempt under Section 251 of the NHS Act 2006.  Where exemptions are not already in place, approval to use confidential patient information without consent must be requested from the HRA who make decisions with advice from the Confidentiality Advisory Group. (CAG).

NOTE: The programme is interested in taking advantage of the growing utility of routine data (such as HES, GP records etc.), and would like investigators, where appropriate, to ask study participants to consent to long term follow up (e.g. beyond the outcomes to be collected in the funded trial) using routinely collected data, and appropriate linkage to allow this data to be best used.

Section 10: UK Biobank 

UK Biobank is a major national health resource with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank has recruited 500,000 people aged between 40-69 years in 2006-2010 from across the country to take part in this project. They have undergone measures, provided blood, urine and saliva samples for future analysis as well as detailed information about themselves. The health of members of this large cohort will be followed over the coming years and the participants have consented to be approached about health research.

As such, applicants are encouraged to consider whether Biobank may be able to provide suitable data for their study, rather than request funding for unnecessary new data collection. We do not want to discourage establishment of new collections of participants and their data where this is necessary to address the research questions under consideration, our aim is to avoid applications for funding to set up Biobank-like cohorts where the use of Biobank would prevent wasteful duplication of Biobank-like activities.

Section 11: Carbon Reduction Guidelines

Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this can be obtained from the Carbon Reduction Guidelines

Section 12: Transparency Agenda

In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information can be found at the Cabinet Office procurement and contracting transparency requirements guidance.

Section 13: Guidance on Completing the Application Form

To submit an application, you must complete all the relevant sections of the online form available within the NIHR Research Management System (NIHR RMS)

The ‘System Help’ document found on the RMS web pages provides extensive step by step instructions on how to make use of the RMS.

Registration

Only registered users of the NIHR RMS can apply. Applicants new to using the NIHR RMS should register as a new user. Once logged into your account, you will be asked to complete Equality and Diversity Monitoring Information questions (see Section 3 above). The RMS home page is then the starting point to create applications, access co-applications and to update contact information and professional details. 

Managing my details

Lead applicants and co-applicants can manage their basic contact information and curriculum vitae (CV) through the ‘Manage my Details’ link on their RMS home page. Lead and co-applicant contact information and CV details are integrated by the RMS into the relevant fields during the application process.

Creating an application

The lead applicant must initially create the new application. Clear instructions on how to start a new application can be found in the ‘System Help’. The research team can collaborate with the lead applicant to edit the content in the application by being invited to be a co-applicant through the co-applicant section of the application form. 

The lead applicant can use the search tool to find co-applicants and then to invite them to join the application. The RMS will automatically dispatch an email inviting the co-applicant to confirm their participation in the application. Co-applicants can then decide whether to accept the invitation and consent to the application being submitted jointly in their name. They will need to log into the RMS and follow the links to ‘Confirm’ their involvement on the co-application summary page. Once confirmed, the co-applicant will be granted access to edit the online application form.

All co-applicants must ‘Confirm’ their invitation to participate in the application electronically on the co-application summary page in advance of the submission deadline.

Completing an application

From the application summary page, the application can be edited by clicking on the ‘Edit’ button. The different sections of the application form can then be accessed via the list of hyperlinked buttons on the left hand side of the RMS webpage. You can move from page to page either by using the ‘Previous’ and ‘Next’ buttons, or using the list on the left-hand side of the web page.

Most questions are associated with contextual help buttons and clicking on them will open up pop up windows containing guidance, however please note that this will be limited to technical guidance on using the system. All contextual programme and question guidance is available in the published guidance for applicants. It is strongly advised that applicants refer to the published guidance to complete and review each question as the system help is not designed to replace it. Mandatory questions are flagged with a red dot.

The system will prevent your co-applicants accessing your application at the same time as you. This stops applicants and co-applicants inadvertently making changes to the same part of the application at the same time and overwriting each other’s work.

Remember to save your work

You will be prompted to save your work if you leave the browser in application editing mode. We recommend you save your work regularly to minimise the risk posed by any local computer or internet problems. You can save and return to the application form as often as you like prior to submission.

Exiting and returning to work on your form

Should you wish to exit your form, you can return at any time; simply log in using your username and password and select ‘My Applications’ from the menu. You will then be presented with a list of all the applications you are currently involved with as well as providing details as to their stage in the submission process.

Validation and submission of the form

The lead applicant can review the progress of their application at any time by selecting the ‘View/Print’ option on the application summary page to generate the application as a PDF File.

When the application form has been completed, the lead applicant must use the ‘Validate form’ tool within the online application form. The validation step is a check run by the RMS to assess whether all the mandatory questions contain information. It will provide a list of links to any parts of the form where corrections or additional content are needed. 

Once the application has been validated successfully and no further corrections are needed, the lead applicant can submit the application by clicking on the ‘Submit’ button on the lower right hand side of the application summary page.

Following submission

A programme specific reference number will be assigned to the application once it has been submitted. After the relevant competition round closes, the application will automatically enter the process of being considered for funding.