Published September 2007, last revised February 2026, and currently in effect.
Physicians may undertake a variety of clinical research activities. CMPA considers clinical research as involving structured investigations that contribute to general knowledge about the treatment of patients. While research can include clinical trials, it may also involve other types of study that aim to improve patient care and healthcare delivery.
CMPA assistance is generally available for civil legal actions in Canada that arise from medical care provided during research performed in Canada involving patients. However, there are some kinds of research and certain activities related to research for which CMPA assistance will not generally be available. The following outlines CMPA's principles of assistance for members who are named in civil legal actions arising from their participation in research.
Before starting clinical research
To be eligible for CMPA assistance, the research must be approved by a Canadian-based independent research ethics board that operates according to applicable regulations and guidelines (e.g. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans). Where applicable, the research must also have regulatory approval from Health Canada (e.g. drugs, devices, software).
CMPA does not generally assist with civil legal matters where the allegations arise from the design, delivery or outcome of the research. Members are expected to turn to the research sponsor for indemnification for allegations arising from the design, delivery or outcome of the research. Similarly, where the research involves creation of a medical device (including software), the member should look to the developer for indemnification. Where there is no sponsor or developer, the member acting as an independent researcher or medical device developer will assume liability for civil actions related to design, delivery or outcome of the research or creation of the medical device.
CMPA does not generally provide assistance for civil legal matters arising from research with healthy volunteers (i.e. non-patients). Members performing such research are advised to seek assistance from the sponsor in the event of a civil action. However, when the research involves patients with a health condition, members would generally be eligible for assistance from CMPA.
International research
CMPA is not structured to assist with medico-legal difficulties brought outside Canada. Therefore, CMPA will generally only assist with civil actions arising in Canada for medical professional work related to research performed in Canada.
In multinational studies, there is an increased risk of civil actions being commenced outside of Canada. Members should seek indemnification or appropriate liability protection for civil actions that could arise outside Canada. The Treating Non-Residents of Canada principles will generally apply for research done in Canada involving patients who are non-residents of Canada.
Members may be approached to act as consultants during clinical research as a safety monitor or another type of advisor. Members who act as consultants should be aware that depending on the facts and circumstances of their role, they may not be eligible for assistance. For example, monitors of multinational studies generally would not be eligible for assistance with civil actions brought outside of Canada. Before agreeing to act as a consultant, members should contact CMPA to discuss their eligibility for assistance.
CMPA will generally assist with civil actions arising inside or outside Canada related to a publication or presentation made to a medical audience (i.e. medical journal) and arising out of research conducted in Canada with patients.
Clinical research contracts
Members may be approached by a third-party sponsor to explore their interests in performing clinical research. Usually, the protocols are not provided to the potential investigator until a confidentiality agreement is signed. Members who sign confidentiality agreements are expected to adhere to the terms of the agreement unless otherwise required or permitted by law. Members would generally not be eligible for CMPA assistance if faced with allegations of breach of this agreement.
When asked to execute a clinical research agreement, members should carefully read the terms and conditions. The CMPA document Medico-legal issues to consider with clinical research contracts identifies issues that typically arise in a clinical research agreement. Generally, CMPA assistance for disputes arising from research contracts is limited to situations where the professional medical work of the member is called into question or the member's ability to practise medicine is jeopardized. Typically, CMPA assists only with aspects of the research contract that concern medical care. CMPA does not generally assist when the allegation concerns a breach of contract pertaining to matters such as the failure to meet a deadline or failure to meet an agreed-upon rate of recruitment into the study.
Physician researchers are often asked to sign agreements that include clauses requiring them to compensate a third party (usually the research sponsor or other parties involved in conducting the research) for certain kinds of specified harm or loss. This is known as “indemnification”. CMPA does not generally consider itself bound by indemnities given by members to third parties.
If an indemnity given by a member in favour of a third party specifically relates to medical care provided by the member or relates to the practice of medicine by the member, the member will generally be eligible for CMPA assistance with respect to that indemnity. Although CMPA may assist in the defence of such a claim, it will not necessarily agree as part of that assistance to reimburse third parties for damages they may have paid in relation to such claims and for which they seek to be indemnified by the CMPA member. CMPA will also not generally assist members with respect to promises of indemnification for non-medical care, acts or omissions that the physician may assume as an obligation under a contract.
Members are advised to review any contract with their personal lawyer. In some provinces and territories, members may also seek assistance from their local medical federation or association.
Research assistants
The research project may require employment of research assistants. CMPA members may be eligible for assistance with civil actions arising from the acts or omissions of research assistants where the research assistants are employed by CMPA members or CMPA-eligible clinics/facilities.
CMPA assistance for research assistants employed by physician members or CMPA-eligible clinics/facilities may be available where the employee is working under the direct supervision of a physician researcher and the employee does not see and treat patients independently.
Members who employ research assistants should be familiar with CMPA’s Principles of Assistance to Clinics and Facilities.
During clinical research
Members performing clinical research are generally required to obtain informed consent and to discuss what reasonable persons would want to know as they decide whether to participate. Research participants must not be coerced as they make their decision about participation. Various provincial or territorial Colleges have issued statements about conflicts of interest that should be reviewed by clinical researchers. Care must be taken to ensure that participants are appropriate for the study and all aspects of the research protocol are followed. When studying newer agents or strategies, particular vigilance is necessary to detect trends and to respond to adverse observations, as unexpected issues may arise.
Careful documentation of encounters with the participants, including any discussion and advice provided, is strongly encouraged. Mandatory reporting to sponsors and monitoring agencies may be required if adverse events occur during the research. Regular reporting to the research ethics committee is a common requirement.
Following the completion of clinical research
Confidentiality requirements are generally in effect until the sponsor permits the release of the results, or the results are made public in a publication or presentation. Disclosure may also be necessary in certain limited circumstances where required or permitted by law. CMPA members may wish to contact legal counsel or CMPA if they have concerns about their duties to disclose results of the clinical research. CMPA assistance with contractual disputes may be considered in limited situations where a member's ethical and professional duties give rise to potential conflict with contractual requirements.
For clinical research trials performed in Canada, Health Canada regulations require records related to the trial to be maintained for 15 years. These records may be accessed by regulatory authorities in their role as inspectors of clinical trial sites. Some provinces and territories may also have specific record-keeping requirements for clinical trials.
