Design and applications

Design and applications

Grant applications

Many funders (such as Cancer Australia and Aboriginal Health research bodies) require evidence in the funding application of how you intend to involve consumers in your research, but the incorporation of consumer involvement within the development of the outline grant application itself, is still relatively uncommon (Gamble et al. 2014).

And yet, during the design stage of a trial, many decisions are made that determine the relevance and conduct of the research that is proposed. There are several ways consumers can be involved at this stage and this involvement can help demonstrate to funders that consumer perspectives are truly incorporated into your project.

It can be difficult to involve consumers in the development of a grant before funding has been obtained. But consumers should be adequately reimbursed for the work that they do and so some activities may require you to have sufficient funds at the pre-grant application stage. Alternatively, you may be able to get consumer perspectives by other means that do not incur any costs; for example, using a blog or other social media communications to get feedback.

Consumers as co-applicants

Research may wish to consider whether a consumer co-applicant would add value to the development and delivery of a study.  Guidance from INVOLVE: Public Co-Applicants in Research – guidance on roles and responsibilities, defines the term co-applicant as ‘an individual who is involved in the development of a funding application and, if funded, has some responsibility for the management and/or delivery of the study’.  This guidance provides further information on key considerations.

Funders are aware that involving consumers at the design stage makes trials more likely to be relevant to the people they are trying to help and conducted in a way that is sensitive to their needs (e.g. through better participant information, recruitment processes and general management of the project).

Meaningful involvement takes time, and time is often limited when putting together grant applications. If involving consumers in this area, researchers need to plan well in advance (months) as finding and preparing consumers for any type of involvement can be a lengthy process.


Researchers and research organisations can overcome this issue over the longer term by developing consumer panels or groups that advise across trials.

The TransCelerate Patient Protocol Engagement Toolkit makes available tools and resources for researchers and research organisations to involve consumers in the  development of the protocol.

Applications for ethics review

If consumer involvement is carried out to a high standard, your research is more likely to be:  

  • relevant to the people they are trying to help.
  • beneficial in terms of delivering meaningful outcomes for patients.
  • conducted in a way that is sensitive to the needs of the participants (e.g. through better participant information, recruitment processes and general management of the project).

At the grant application/ethics stage, consumers could help:

  • Develop/ratify your plans for further consumer involvement and make sure appropriate costs are allocated for that involvement (e.g. as a line item in the grant application).
  • Provide a letter of support for your grant application.
  • Advise on the ethical implications of the research and help researchers to understand patient concerns and suggest ways to address these.
  • Help develop/affirm the importance of the research question or make amendments to focus those questions to better reflect consumer’s needs or priorities.
  • Help define participant characteristics and help ensure that inclusion/exclusion criteria are optimised (e.g. whether there are legitimate reasons for strict inclusion criteria such as the age range or for excluding patients with certain co-morbidities).
  • Ensure the methods selected are appropriate.
  • Review and comment on proposed outcome measures (including the use of patient-reported outcomes).
  • Make patient-facing materials easier to understand or more engaging (e.g. writing or reviewing participant information sheets, questionnaires or lay summaries).
  • Identify additional/alternative participant recruitment strategies.
  • Ensure the study is designed to minimise disruption to participants; for example, by making the ‘participant journey’ as convenient as possible by scheduling visits at suitable times and minimising the number of visits.
  • Identify any other barriers to people taking part (particularly to ensure the study is feasible and practical).
  • Write or advise on the appropriateness of the plain language summary and if applicable, the consumer involvement section of the grant application.

Wherever possible, clearly explain to those you involve how your research has changed as a result of working with consumers.

Clinical Trial Transformation Initiative (CTTI) has produced many useful tools designed to encourage consumer involvement at the planning stage to maximize recruitment and successful trial outcome.

What involving consumers at this stage could look like:

  • Identifying a consumer to be a co-applicant to help write the grant application and to work with you throughout the project.
  • Running a focus group to discuss the research idea or to refine the research question to better reflect patients’ needs.
  • Asking consumers from your organisation’s existing advisory panel to improve the communication of your research aims and patient benefit in the funding application or to write the lay summary.
  • Approaching existing patient groups or advisory panels to comment on the protocol and review/develop patient-facing materials (e.g. advertisements, informed consent documents, questionnaires).
  • Asking a local patient support group to identify the most appropriate recruitment strategy for a trial.
  • Working with a consumer organisation or individual consumers to co-produce a research project.

You can access details on where to find consumers to involve from the Recruiting Consumers webpage.

You can access information on consumers training requirements for effective involvement from the Training Consumers webpage.

Further Reading

  • Gamble C et al. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open 2014;4: e005234. doi:10.1136/bmjopen-2014- 005234
  • NIHR/INVOLVE: Public Co-Applicants in Research: Guidance on roles & responsibilities
  • NIHR/INVOLVE: Guidance on co-producing a research project.
  • Tallon, D et al. Relation Between Agendas of the Research Community and the Research Consumer. Lancet 10 (2000): 2037–2040.
  • Staniszewska, S et al. User Involvement in the Development of a Research Bid: Barriers, Enablers and Impacts1. Health Expectations 10.2 (2007): 173–183.
  • Joanna C et al. Impact of Patient and Public Involvement on Enrolment and Retention in Clinical Trials: Systematic Review and Meta-Analysis. BMJ 363 (2018): k4738.
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