OPTIMISE

Building on the tools we have developed to help researchers design trials to be more inclusive of adults with impaired communication and/or capacity to consent, this project will develop key principles that researchers should follow to ensure consent processes are more accessible in trials.

Background

Informed consent is a fundamental principle of ethical research. People with conditions that affect their ability to communicate and/or make decisions may require additional support to decide whether to take part in a study and provide consent. People with impaired communication and/or ability to make decisions are frequently excluded from trials due to the complex ethical and legal issues surrounding research involving adults lacking capacity to consent. Researchers can find these legal frameworks challenging to navigate and sometimes lack the knowledge and skills to design inclusive consent processes. Researchers have called for greater support.

The CONSULT research programme has previously developed stakeholder-informed e-learning about the legal and ethical frameworks and practical considerations for trials involving adults lacking capacity (CONSULT Training) and a tool to help researchers design trials to include this population (INCLUDE Impaired Capacity to Consent Framework). By bringing these resources together, alongside existing evidence about best practice in supporting consent, we can create a new clear set of universal principles that researchers could use to improve the accessibility of consent processes.

Optimising the design of informed consent processes for research involving adults with impaired communication and/or decision-making (OPTIMISE)

In conjunction with a group of researchers and a lay advisory group, the OPTIMISE project will develop principles to improve the design of informed consent methods in clinical trials to ensure they are equitable and accessible for people with additional communication and/or decision-making needs.

Project design

The aim of OPTIMISE is to improve researchers’ understanding about accessibility in informed consent and equip them to change their practice and design more accessible consent processes to help ensure future research is more inclusive of people with additional communication and/or decision-making needs.

This will be achieved by:

1. Reviewing existing evidence about enhanced consent processes

Enhanced consent processes are well established in healthcare to help maximise peoples’ ability to make/contribute to decisions about their care but have yet to be incorporated into the design of clinical trials. We will review existing enhanced consent processes for research/healthcare decisions and select the key domains for optimising informed consent processes, including language, format, and environment.

2.  Expert stakeholder consultation

We will hold a workshop with key stakeholders with expertise in conducting research involving adults with impaired communication and/or decision-making to seek agreement on the key domains to be included in the OPTIMISE principles, using World Café methods to facilitate dialogue.

3) Mapping training content and resources

We will then finalise the OPTIMISE principles and map existing CONSULT Training content and resources onto the principles and iteratively design and pilot a toolkit to support implementation.