Co-designing the consent process of critical care trials with patients and the public: Project protocol

Co-designing the consent process of critical care trials with patients and the public: Project protocol
Timo Tolppa, Arishay Hussaini, Vrindha Pari, Nikhat Ahmed, Arjen Dondorp, Shehla Farooq, Madiha Hashmi, Monaza Khan, Adnan Masood, Saima Saleem, Zahyd Shuja, Marianne Vidler, Shahnaz Zaman, Srinivas Murthy
Wellcome Open Research, 31 March 2025
Abstract
Background
Informed consent processes in critical care trials can be overwhelming for patients and their families as decisions about participation need to be made under distressing circumstances. Existing consent processes have been developed for and by White Western populations, making them less relevant for racialized groups from low- and middle-income countries. One solution is involving patients, their relatives and members of the public from diverse backgrounds in co-designing informed consent processes.
Methods
This project aims to co-design the consent materials and processes for two ongoing critical care trials with an existing Patient and Public Involvement and Engagement group at Ziauddin University in Pakistan. Using experience-based co-design and participatory action research, the process will follow six stages for each trial: (i) Introduction to trial and consent, (ii) Review of existing materials, (iii) Process mapping & recommendations, (iv) Creation of new materials, (v) Vetting, and (vi) Finalization. The final two steps involve collaboration with clinicians, trial teams, sponsors, and members of ethics review boards.
Expected Outcomes
The co-design process will produce new consent materials, aligned with patient and substitute decision-maker needs, that can be implemented to improve the conduct of two active trials. Deliverables include an informed consent process map, recommendations for revising consent materials, and guidelines on patient-centred formats. Additionally, training patient and public members in co-design will build capacity and enable the group to contribute to the design of consent processes of future trials.
Conclusion
Collaboration between patients, researchers and the public has the potential to promote ethical conduct of critical care trials in Pakistan and elsewhere by supporting patient-centered informed decision-making. This co-design process represents the first step towards achieving this goal, with future work evaluating the impact of the new consent materials and processes on trial enrolment rates, participant diversity and consent experiences.