New Osgoode program helps build community among medical research law professionals

When Jennifer Cox entered the world of medical research law seven years ago, she found the professional networks and professional continuing development a little lacking in her new niche.

“There were a lot of people working disparately across Canada, usually in hospitals and universities – each with their own little legal team,” explains Cox, currently Legal Counsel and Manager for research contracts at Ottawa Hospital Research Institute.

“You get plenty of internal support and resources to figure out the job, but externally, there was not a lot of information being shared between people in different places,” she adds.

In recent years, Cox has made it her aim to make connections and foster a sense of community among the growing number of professionals working in the area.

“We’ve been building up a medical research law bar, having monthly meetings and coming up with solutions, practice norms and precedents that can help us all work better,” she says.   

Cox found a kindred spirit in Hartley Borst, the Director Research Contracts and General Counsel, Kingston Health Sciences Centre Research Institute and her co-chair for Osgoode’s brand new Practical Guide to Medical Research Law in Canada.

Both co-chairs have a history with OsgoodePD programs – Cox completed the Osgoode Certificate in Privacy Law and Information Management in Health Care, while Borst has completed several Osgoode certificates and is a former faculty member of the Certificate in Public Procurement Law. Each of them believed a similar program would fill a gap in their corner of the legal world.  

“I see medical research law as being in its infancy stage,” Borst says. “It’s just starting to gain traction and develop in the same way procurement law did 25 years ago. We want to provide a framework for the lawyers and other professionals who work on these contracts.”

The one-day program – which proceeds online on Nov. 28, with a replay scheduled three months later on Feb. 12 – follows in the tradition of those OsgoodePD courses, with an intensive agenda focused on interactive discussions and practical guidance, delivered by a faculty of experts from across Canada.

According to Borst, medical research law is an almost uniquely complex area of practice for lawyers new to the area, thanks in part to the sheer number of parties involved in clinical trials and research-related contracts.

“You have research institutes and investigators who sign binding contracts with pharmaceutical companies and broader public sector organizations or hospitals,” he says. “Once you enter into these complex contracts, you have privacy obligations, legal commitments such as indemnities, intellectual property clauses and warranties, the regulatory framework from Health Canada, funding obligations to third parties and other legal and ethical principles you have to follow. There are a lot of moving parts.”

Cox says the field has recently been characterized by rapid change, fuelled by the Covid-19 pandemic and the emergence of artificial intelligence tools designed to improve patient care.

“A hospital’s business is caring for patients, but at a research institute, our business is data,” she says. “We’re sitting on a huge amount of personal health information, so working with data protection laws and determining who can access and make use of data is at the crux of our work.”

To the extent that existing continuing professional development programs touch on medical research law, Cox says they do so only fleetingly.

“The current CPD options cover how to review a contract, but they miss the bigger picture,” she says.

“Instead of showing people how to get through an agreement, we make sure people are starting with the basics. This course is to help people get off the treadmill of the day to day grind, and to actually understand the foundations they stand on,” Cox adds, explaining that the aim of the program is to help lawyers, paralegals, compliance and other professionals to lay the foundation of essential knowledge and skills that they need to successfully navigate the highly regulated and fast-changing field of medical research law.   

“This is the first of its kind, but we’d love to do more and go even deeper into some of the harder topics.”

“We will provide practical tips that you can immediately implement and identify traps to avoid throughout this course. An important goal of the practical tips and traps to avoid is to activate trials faster.” Borst says.