Member, Promoting Ethical Design of Clinical Trials Working Group

Randomized controlled trials are a great way to research policy and health service delivery but can be very complicated. There are many ways that people can become involved in research and many questions about how best to obtain consent from participants and how their data should be managed. Come join a working group to help guide researchers develop better ways of balancing the needs of researchers, ethics board members and research participants in doing clinical research that improves health care.

Open to: Patient partners across the province

Lead Organization or Department

UBC Centre for Health Evaluation and Outcome Sciences (CHÉOS)

Aim

The aim of this project is to help researchers understand people's views on consent and how their data is used in clinical trials research. Patient partners on the working group will guide researchers and ethics review board members in developing tools to design clinical trials that are ethical and help with consent issues in clinical research. Partners will provide input on developing a clinical trial consent and data usage framework, help interpret study findings and help with explaining the results of the study to the public. We would also welcome patient partners to take part as co-presenters and/or co-authors as appropriate based on their experience and interests. We would particularly welcome participation in knowledge translation activities.

Level of Engagement

This opportunity is at the level of involve on the spectrum of engagement. The promise to you is that the health care partner will involve patients in planning and design phases to ensure ideas or concerns are considered and reflected in alternatives and recommendations.

Eligibility

We would like to recruit patient partners of diverse backgrounds (e.g., genders, health conditions) from any region of British Columbia. Previous experience participating in or caring for a family member who has participated in clinical trials, or a desire to enrol in clinical trials, would be an asset. As we would like to develop online modules and other materials for patients, any prior experience or interest in multimedia production would be great assets. If you have a strong interest in this work but have not yet completed a PVN orientation and volunteer agreement, are unsure if your experience is a good fit or feel another format of engagement would work better with your availability, please contact the engagement leader directly.

Logistics

• Vacancies: 6
• Location: Vancouver or virtually (telephone or webinar).
• Commitment: This engagement is expected to go from August 2019 to February 2021. We anticipate patient partners will have two meetings a year with the academic research team members; and potentially more frequent discussions among patient partners to be determined in consultation with patient partners once the working group is formed. A call-in option will also be available for those who want to join but are not able to attend meetings in person.

Reimbursement

Eligible out-of-pocket expenses such as parking and mileage to attend in-person meetings will be reimbursed. Meals or refreshment for in-person meetings will be provided. Other options will be discussed with patient partners when they RSVP.

Background

Cluster randomized controlled trials (cRCTs) are increasingly popular to evaluate policy and service delivery interventions. Nonetheless, cRCTs pose distinct ethical and data retention challenges from traditional randomized trials. There are different ways and levels in which people are involved in cRCTs. In cRCTs, groups or clusters (e.g., hospital wards, clinics, medical practices) rather than individuals are randomly allocated to study arms, and the intervention (e.g., handwashing) may be delivered to groups (e.g., healthcare providers) that are distinct from those whose outcome measures or data would be collected (e.g., patients). There are thus questions of whose and what types of consent are necessary, and how data from people who have and have not consented to participation should be managed to balance trust in the research enterprise, respect for individual autonomy, promotion of data integrity, and pursuit of the common good. There are times when the effect of the cluster-level intervention may be unavoidable for everyone associated with the cluster (e.g., flu vaccine mass media campaign for a city), posing ethical and data management questions of individual-level consent or withdrawal. Exclusion of data from people who did not decide to be part of a study even when it poses minimal or no harm may lead to data biases and skewed results that can ironically pose greater harm to the public. This is particularly the case for trials conducted with smaller clusters by necessity (e.g., due to lower population density), raising questions of how researchers may ethically consider the need for consent in cRCTs at the individual level and approach prospective individual participants regarding data usage accordingly. More guidance of designing, conducting, and reviewing cRCTs that respect participants’ autonomy and also protect data integrity is thus needed and will be provided by the working group in this project.

Health Care Partner Contact Information

Larry Mroz, Provincial Engagement Leader, BC SUPPORT Unit
604.806.9958
lmroz@bcsupportunit.ca