Practical Guide to Medical Research Law in Canada

9:00 a.m. Opening Remarks from the Program Chairs

Hartley Borst, Director Research Contracts and General Counsel, Kingston Health Sciences Centre Research Institute
Jennifer Cox, Legal Counsel and Manager, Research Contracts, Ottawa Hospital Research Institute

9:10 a.m. Understanding the Clinical Trial and Research Landscape

Outlining the ecosystem of medical research in Canada and its legal frameworks.

• The who’s who and what they do in medical research
• Funders and how they drive the legal landscape
• Tri-Council Agencies and the Tri-Council Policy Statement
• Health Canada regulations
• Understanding the role of the research ethics board (REB)

Lynne Hiebert, Associate General Counsel, Office of Legal Counsel, University of Manitoba
Eleana Rodriguez, Director, Research Legal – Clinical Trial Agreements, University Health Network

10:00 a.m. Break

10:15 a.m. Understanding Your Data

Break down the Personal Health Information Protection Act, 2004 (PHIPA) and other privacy legislation to better understand what your data is, how to use it legally, and how to best prepare yourself for a changing world in the face of AI. Learn how the ethics process and de-identification processes are critical to compliance with privacy laws in Canada. This session features a hands-on demonstration and practical exercise.

Andrew Drummond, Director, Health Policy, Information and Privacy Commissioner of Ontario
Jennifer Cox, Legal Counsel and Manager, Research Contracts, Ottawa Hospital Research Institute
Mary Jane Dykeman, Partner, INQ Law
Steve Hughes, Legal Counsel, University of Alberta

11:45 a.m. Lunch Break

12:45 p.m. Who Is Your Client? Navigating Ethics and Professionalism in Research Collaborations

An interactive discussion about legal ethics and professionalism obligations in multi-party research initiatives.

•  Identifying your client in a complex corporate structure
• How to work with, but not represent, physicians/investigators who are independent parties
• How to determine whether the REB is your client, and what to do if you think the REB has not complied with the law
• Navigating issues related to the execution of research contracts, including when to refer physicians/ investigators for independent legal advice

Jocelyn Edwards, Director, Grants Development & Research Administration, Office of Research Services, Lawson Research Institute of St. Joseph’s & London Health Sciences Centre Research Institute
Neda Foroughian, Research Legal Counsel (Privacy Projects), Sinai Health System
Barbara Prikrylova, Legal Counsel, Royal Ottawa Mental Health Centre
Zoe Ramirez-Reeves, Research and Corporate Counsel, Unity Health Toronto

1:45 p.m. Understanding the Contract: Choosing the Right Agreement for the Right Purpose

Learn about the various types of medical research contracts, when each is appropriate to use, and how to effectively structure a contract to support the goals of a research initiative. How to create a high-level plan (including the roles and responsibilities of the parties) for the contracts needed for a complex research project.

Catherine Eckenswiller, Legal Counsel, Research Legal Services, Queen’s University
Collin Fletcher, Legal Counsel, Research Contracts, Ottawa Hospital Research Institute

2:20 p.m. Break

2:35 p.m. Managing Intellectual Property

A focused introduction to addressing intellectual property matters in research contracts, including the ownership of research outputs, licensing, and copyright, and how IP considerations overlap with data rights.

Hartley Borst, Director Research Contracts and General Counsel, Kingston Health Sciences Centre Research Institute
Jennifer Cox, Legal Counsel and Manager, Research Contracts, Ottawa Hospital Research Institute

2:45 p.m. Understanding Liabilities in Contracts

• Gain practical insights for navigating liability and indemnity issues in medical research.
• Indemnity or liability: what’s the difference?
• Understanding limitations of liability clauses
• Knowing what your insurance does and does not cover, and how to contract accordingly
• When are warranties appropriate?
• How is participant injury different from an indemnity?
• Examining how these provisions interact within an agreement

Hartley Borst, Director Research Contracts and General Counsel, Kingston Health Sciences Centre Research Institute
Nataly Farshait, Director, Healthcare Safety and Risk Management, Healthcare Insurance Reciprocal of Canada
Hasini McRae, Legal Counsel, University Health Network

3:25 p.m. Drafting Effective IP, Liability, and Indemnification Clauses

In small breakout groups, engage in a real-time mark-up of contractual clauses and discussion of the rationale behind different drafting choices.

Lauren Gogo, Director, Research Contracts and Grants, Hamilton Health Sciences
Jennifer Thurlow, Contracts Manager, Research, Innovation and Discovery, Nova Scotia Health Authority
Shenade Walker, Associate General Counsel and Director, Legal Services, The Hospital for Sick Children

4:10 p.m. Bringing It All Together: Landscape, Data, Clients, and Contracts 

Conclude the day with a recap of key themes, closing thoughts from the Chairs, and an opportunity to ask questions.

Hartley Borst, Director Research Contracts and General Counsel, Kingston Health Sciences Centre Research Institute
Jennifer Cox, Legal Counsel and Manager, Research Contracts, Ottawa Hospital Research Institute

4:30 p.m. Program Ends