Sep 14, 2016

Stephanie Kowal on Ethical Communications

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What do you want to know about clinical trials for your children?

Clinical trials for gene and stem cell therapies for genetic eye diseases are underway. If these early phase trials are successful, they will include children in later phases. Good communication about the risks and benefits of clinical trials is essential. Parents need to understand the risks and benefits so that they can make informed decisions on whether to consent to their child’s participation in a clinical trial. Deciding to enroll a child in a clinical trial of an experimental and complex therapy comes with risks. Informed consent is a legal and ethical requirement in Canada and other similar countries. Informed consent means that potential clinical trial participants (and their legal guardians) understand and can weigh the risks and benefits.

Our team at the University of Alberta is trying to understand what parents and children need to know about the risks and benefits of participating in a clinical trial for an experimental therapy. Our study will help researchers involved in clinical trials communicate the risks and benefits so that parents and their children can make informed decisions. We are interested in understanding what parents and children want to know about clinical trials and how they want to receive the information.

My name is Stephanie Kowal, and I work as a Research Associate for University of Alberta Professors, Drs Tania Bubela and Ian MacDonald. Drs MacDonald and Bubela co-lead the Alberta Ocular Gene Therapy Team and Dr. MacDonald is running Canada’s first gene therapy clinical trial for a genetic eye disease: choroideremia. My job is to research the ethics of gene and stem cell clinical trials for eye diseases and diabetes. I am leading the study on how researchers should communicate with clinical trial participants and their parents or guardians.

My research on ethical communications involve interviews with parents or guardians of children with genetic eye diseases that might be treated with gene or stem cell therapies in the future.  I want to understand their hopes, expectations, and concerns about the clinical trials. Trials are a necessary first step before these therapies can be approved for use in the clinic. I am also interested in practical challenges for clinical trial participation, such as time commitment and travel. Participation in clinical trials will affect other daily activities, other family members, and work commitments. Children may need to miss school. All of these issues are important for us to understand because they can impact the way researchers design the clinical trial. They impact the schedule of the follow-up visits that test whether the therapy is working. Understanding the needs of families will help researchers organize pediatric trials in the least disruptive way.

Meeting parents and children living with genetic eye disease is the favorite part of my job. I appreciate the patience and resilience of families in the blindness community. For this reason, I always look forward to attending FBC’s Vision Quest events, where I get to interact with the community. FBC has been a greater supporter of our research, both practically and financially. We have learned a lot from FBC, especially from their excellent communications team, which supports the community with clear information about ongoing clinical trials.

This year I will be attending the Vision Quest events in Edmonton, Ottawa and Toronto. I look forward to learning from Canada’s vision research leaders. For example, Drs MacDonald and Bubela will participate in a panel in Edmonton on the current state of eye disease research. I am also excited to see Dr. MacDonald and Dr. Elise Héon, from Toronto’s Sick Kids, lead the retinal degeneration session in Toronto.

While I am very interested in the panel discussions and social aspects of Vision Quest events, I will also be working. I will be at each event as an exhibitor where I will provide more information about our study. If you are interested, I would love to set up an interview, so please come say hello! If you are not attending Vision Quest this year, I am also free anytime to speak with you over the phone (780-492-0392) or email (

Story guest authored by Stephanie Kowal. Stephanie studying how researchers should communicate with clinical trial participants and their parents or guardians.


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