By: Allison Currie
Public participation in clinical trials and research studies is essential for advancing our understanding of diseases, treatments and health systems. It’s the foundation of modern medicine and without it, care cannot improve or evolve.
For those who choose to participate, the benefits can be meaningful: playing a crucial role in advancing medical knowledge, improving treatments for future patients, gaining early access to new treatments, greater access to a care team and discovering helpful health insights.
But how do we know participating in research is safe?
Across Canada, strong safeguards ensure research is ethical, respectful and safe.
“Every clinical research study aims to improve health, whether for a single patient or for future generations,” says Dr. Marie-Laurence Tremblay, manager of research ethics at Nova Scotia Health. “Our commitment is to ensure that this care is grounded in the highest ethical and safety standards.”
Participation in research is always voluntary, and a care option you can discuss with your doctor and loved ones. Withdrawing consent at any time, for any reason, is always an option and does not affect the standard of care you receive.
A brief history of research ethics
Canada is the first country in the world to have national policies and standards for human research that provide our institutions with information on what is required to practice safe and ethical research.
Canada’s current framework for research ethics is rooted in lessons learned from past unethical practices around the world.
-
In 1947, after the Nazi war-crimes trials, the Nuremberg Code was created to protect human rights in scientific studies. This code introduced key principles like informed consent, voluntary participation and minimizing harm.
-
In 1964, the Declaration of Helsinki added more guidance, especially for doctors. It emphasized that the rights and well-being of research participants must always come first, and that research must follow strict scientific and ethical standards.
-
In the United States, the Belmont Report (1979) was created after the National Research Act (1974) and it outlined three major principles: honouring people’s right to choose, doing good and avoiding harm, and treating people fairly.
Together with other international milestones, these documents have shaped how we think about and conduct research today.
Research ethics boards
Before any study involving people begins, it must be reviewed and approved by a research ethics board.
Established in Canada in the 1980’s, these are independent committees that evaluate research to ensure it protects participants’ rights, safety and dignity while minimizing risks to people or communities.
They include experts in science, medicine, ethics and law but also members of the local community, ensuring diverse perspectives and cultural understanding in research. These community members provide perspective on recruitment procedures and make sure people are safely and fairly represented and included in research, from the beginning through to the results.
No research on human participants can move forward without the approval of a research ethics board, and they have the authority to pause or stop any study, at any time, if concerns arise.
These boards consider who is conducting the research to ensure they have the proper training and expertise. They also assess whether the study addresses the needs of the community, whether the appropriate safeguards are in place to help keep data protected, and whether the project has sufficient and appropriate funding to be conducted.
Nova Scotia Health has its own Research Ethics Board that rigorously evaluates all research involving people, ensuring it meets national and international standards.
It works with the Research Quality Assurance and Compliance team to monitor research conduct, ensure teams are working ethically and following policies, procedures and federal regulations.
This includes auditing active clinical trials and research studies and providing ongoing training and education for researchers and staff. New team members learn about the rules and guidelines for doing research through workshops, online courses, and mentoring.
“We were one of the first research ethics boards in Canada to implement an audit program,” says Dr. Chris MacKnight, executive chair of the research ethics board at Nova Scotia Health. “This program has been invaluable in guiding improvements in our policies and procedures, to maximize research volunteer safety and simplify the entire research process.”
These processes also ensure that Nova Scotia Health follows all rules, even as things change. For example, Health Canada recently shared new guidelines about using software as a medical device. When new rules like this come out, these teams work hard to ensure research projects stay in line with them.
Federal oversight
In addition to research ethics boards, Canada also has multiple oversight layers, including but not limited to:
-
Health Canada regulates clinical trials and monitors the safety of drugs, medical devices and software aimed for medical diagnosis and natural health products.
-
In Canada, all research ethics boards are required to follow our federal policy for all human-related research called the Tri-council Policy Statement (TCPS) which is managed by the Government of Canada. Receiving research funding is contingent on following these policies.
-
Human Research Accreditation Canada is an independent, not-for-profit accrediting body for human research. It accredits Canadian Human Research Protection Programs through a program based on international and national standards for human research.
Nova Scotia Health has partnered with Human Research Accreditation Canada and is currently pursuing accreditation to strengthen our participant safety, well-being and rights when they participate in research, and reinforce our accountability as an institution.
Research is care
From local studies to international trials, research in Canada is built on a foundation of respect, safety and integrity. Participants can feel confident knowing they are not only helping shape the future of healthcare but doing so within a system designed to protect them every step of the way.
Research is care, and clinical studies help translate research into potentially life-changing therapies that can improve systems and quality of care delivery, and help you, your friends and your loved ones. Want to know more about how to get involved? Visit Nova Studies Connect today: novastudiesconnect.ca
