Why are we making these changes? – what issues are we trying to address?
The NIHR is keen to accelerate the pace at which research is carried out so that its benefits reach services and treatments, and the patients and public who use them more quickly. We want to make things simpler and faster for researchers and others who work with us, including public reviewers and committee members. Therefore, we have shortened and simplified the standard application form (SAF) which is used when research teams apply for funding from the NIHR. It is not all about being faster and simpler though, at the same time the NIHR is committed to actively and openly supporting and promoting equality, diversity and inclusion (EDI). We also want to ensure that we keep patients, carers, the public and service users at the heart of all of our work, not losing sight of active public involvement as we changed our SAF. Our SAF guidance now includes improved requirements and advice for EDI and patient, public involvement and engagement (PPIE).
Changes in Equality Diversity and Inclusion Requirements
Our EDI guidance emphasises that 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
- Religion or belief
- Sex
- Sexual orientation
- Socioeconomic status
- Access to health or social care
Applicants are expected to document how they are collecting information on EDI. Applicants should demonstrate how these EDI characterises 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. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.
Changes in Patient and Public Involvement and Engagement Requirements
A detailed evaluation, in partnership with public contributors, was carried out to assess the effect of this change between 2017 and 2019. The aim of the evaluation was to assess the effect of these changes on the quality of patient and public involvement (PPI) in research funding applications as well as the impact on the work required from public reviewers and committee members when assessing applications.
What did we find?
The main finding of the review was that the new form did not increase the workload of public committee members. However, PPI content was felt to have decreased at stage 1 and there was duplication of PPI content in the PPI specific section of the main application form and the Detailed Research Plan (DRP) at stage 2 of the process. A key finding of the review was that guidance on current best practices around PPI was not clearly present in the SAF guidance.
What have we changed? – key highlights
As a result of this evaluation we are now taking steps to improve the guidance for the reporting of PPI at both Stage 1 and 2 of the application process. You can find a list of the specific changes below, however one of the key changes is that we will provide more clarity about how to present PPI within the application form at Stage 2 of the process.
There will only be one PPI specific section which will additionally ask applicants to describe the study's approach to PPI, plans for the PPI infrastructure (management, coordination), reporting, evaluation and impact. It will also ask applicants to signpost to further detail of PPI activities which they will now be expected to provide at each stage of the research project lifecycle within the Detailed Research Plan. The Detailed Research Plan will not have a separate dedicated PPI section. This will remove the duplication and additional burden to applicants and reviewers. Additionally, applicants will be asked to provide a summary of study participant information in the Detailed Research Plan.
Members of the evaluation group, which included public contributors and NIHR staff working in patient and public involvement and engagement, have ensured that PPI remains at the core of NIHR’s work, and that the NIHR continues to further best practices through the provision of clear guidance to applicants and PPI leads.
Summary of agreed PPI related changes to the SAF guidance for research applicants
The PPI changes to the guidance for research applicants include additional text and resources, further clarification on some topics and both the deletion and insertion of new subsections. The tables below give an overview of the approved changes at each stage.
Changes for Stage 1 guidance
- Additional guidance to ensure that there is an explanation of the relevance and importance of the study from the patient/public perspective
- To update text on the definition and role of public co-applicants linking to the new public co-applicant guidance
- Additional guidance which asks applicants how PPI has shaped their thinking to date.
- Addition to ask applicants to Identify areas in design and delivery where PPI will be able to contribute.
- To include the need for a named member of the research team to manage the PPI, noting that it should be someone who has the logistical skills. This may or may not be a public contributor.
- To add text which explains that the PPI lead should be a named fully costed and resourced person with skills and expertise to manage PPI, as there is quite a lot of work to do for this role. Also to include a link to a list of activities the PPI lead may undertake.
- Additional text which explains that should their application reach stage 2, NIHR will will expect PPI evaluation and impact plans. To also include a list of resources on this topic.
- Applicants will receive guidance which states that the results of research projects should be disseminated to study participants.
- To add text which signposts to the UK Standards for Public Involvement in Research to provide information on how the applicant can improve the quality of the PPI in their research.
- To increase the understanding of public reviewer perspective and PPI design the guidance will signpost to the online public reviewing course
Changes for Stage 2 guidance
- Guidance for the PPI section of the Application Form
The guidance will continue to ask applicants to include a description of the PPI in the development of the proposal. In addition, it will also ask for a description of:
a) the planned PPI approach, its management, reporting and evaluation, and
b) a summary of planned PPI activities with signposting to more detailed information threaded through the Detailed Research Plan (DRP) - Guidance for including PPI activities in the Detailed Research Plan (DRP)
Details of the PPI activities will no longer be under a separate Detailed Research Plan (DRP) PPI section as previously required. The PPI activities are expected to be described within and threaded through the relevant DRP project lifecycle subsections. - The guidance will include a new section to the DRP which asks for a summary of “patients/carers/service users as research participants” (where applicable) that all reviewers and applicants will be able to see in one place how the research participants will be supported, managed and involved without undue burden.
- To update text on the definition and role of public co-applicants linking to the new public co-applicant guidance
- To include the need for a named member of the research team to manage the PPI, noting that it should be someone who has the logistical skills. This may or may not be a public contributor.
- To add text which explains that the PPI lead should be a named fully costed and resourced person with skills and expertise to manage PPI, as there is quite a lot of work to do for this role. Also to include a link to a list of activities the PPI lead may undertake.
- The guidance will include the recommendation for applicants to include PPI evaluation and impact plans with signposting to a list of relevant resources.
- Applicants will receive guidance which states that the results of research projects should be disseminated to study participants.
- To add text which signposts to the UK Standards for Public Involvement in Research to provide information on how the applicant can improve the quality of the PPI in their research.
- To increase the understanding of public reviewer perspective and PPI design the guidance will signpost to the online public reviewing course
- The costs section will be updated to explicitly state that costings for study participants should not be included in the PPI costs section.
- Also within the costing section the guidance will state that If voluntary, charity or community groups (third sector) are supporting the research via activities such as facilitating contact with potential participants, hosting research activities or providing advice, an adequate budget must be included to compensate for their time and resources
We would like to thank all the members of the SAF Evaluation Review (SAFER) Group:
- Simon Denegri, (formerly) NIHR National Director for Patients, Carers and the Public
- Doreen Tembo, Senior Research Manager, NIHR PPI and External Review (PPIER) Team
- Katalin Torok, Senior Programme Manager, NIHR PPI and Engagement Team
- Heidi Surridge, Research Manager, NIHR PPIER Team
- Martin Lodemore, (formerly) Senior Public Involvement Manager, INVOLVE
- Steven Blackburn, Research Fellow & PPI Lead, Research Design Service (RDS)
- Una Rennard, Public Committee Member (Policy Research Programme) & Member of INVOLVE Advisory Group and NIHR PPI Senior Leadership Team
- Jane Whitehurst, Public Committee Member (Programme Grants for Applied Health Research) & Member of NIHR Public Involvement Virtual Network
- Judith Williamson, Public Member of the NIHR PPI Senior Leadership Team
- Jon Cole, Assistant Director, PPI and External Engagement, NIHR
- Caroline Eyles, Senior Research Advisor & PPI Lead, RDS
- Katie Porter, Assistant Research Manager, NIHR PPIER Team