Patient- and family-centered approaches to informed consent in pragmatic critical care trials

Health Research BC is providing matching funds for this project, which is funded by the CANadian Consortium of Clinical Trial TRAINing Platform-Clinical Trials Training Program’s Doctoral Studentship 2023 Award

Individuals considering to take part in research must be given detailed information about the research and understand this information before voluntarily signing a form. This process is referred to as ‘informed consent’. The process does not seem to work in critical care when family members are approached to make decisions about research participation on behalf of their critically ill loved one. Family members often feel too overwhelmed and find the information hard to understand. As a result, individuals end up making uninformed decisions and patients get excluded from research that is needed to improve clinical care. Making informed consent processes better for patients and their families is difficult as we do not currently understand what matters to them, particularly to people from non-White racialized groups. This research tries to tackle this issue by understanding the needs of patients and their family members regarding informed consent in critical care research in Pakistan. To do this, we will use multiple different ways of obtaining information, including questionnaires, public surveys, interviews and group discussions. At the end of the study, we will propose new informed consent processes for two international research studies, operating in both Pakistan and British Columbia, that better suit the needs of South Asian patients and families. Recommendations will also be made to research studies globally to ensure informed consent works for all patients.

The study has been designed by a 2nd year PhD student based at the University of British Columbia, Dr Timo Tolppa, under the supervision of Dr Srinivas Murthy, a Clinical Associate Professor at BC Children’s Hospital, and in collaboration with a public engagement group based in Pakistan led by Dr Madiha Hashmi and Dr Arishay Hussaini.

End of Award Update – January 2025

Results

Our team co-created culturally relevant and patient-centered materials with members of the public to make clinical trials more understandable for patients in Pakistan. The materials were designed in the five main languages of Pakistan and include infographics, information sheets, audio recordings for illiterate patients as well as an animated video created by a Pakistani filmmaker: https://www.youtube.com/watch?v=dCZqm6hW0PM  

Impact

The materials have helped researchers explain clinical trials to patients and their families, assisting them to make more informed decisions about trial participation. The new patient-centered materials have also been used to educate over 350 members of the public about clinical trials and their rights when it comes to research.  

Potential Influence

Better understanding of clinical trials, public involvement in research and culturally appropriate study materials promote active engagement of patients in the decision-making process about health research. This ensures ethical conduct of clinical studies and may even encourage patient participation.

Next Steps

The next step is to evaluate whether the new research materials enhance patient understanding of trials, recruitment of participants into trials and the experiences of patients as well as researchers discussing potential trial participation.  

Useful Links

The project is a collaborative effort with the Critical Care Research Group (https://zu.edu.pk/ccrg/) and the Patient & Public Involvement and Engagement group (https://zu.edu.pk/ppie/) both based at Ziauddin University in Karachi, Pakistan.