Principles of assistance
Originally published September 2007 / Reviewed July 2013
The following outlines the CMPA's principles of assistance for members who perform clinical research as part of their medical practice.
Before starting a clinical research trial
Members who perform clinical research are expected to be familiar with relevant published statements concerning the conduct of clinical research. These include the Code of Conduct for Research Involving Humans (The Tri-Council Working Group Report), the Canadian Medical Association (CMA) Code of Ethics, and any statements from provincial or territorial regulatory authorities (Colleges) pertaining to performance of clinical research and conflict of interest in clinical research.
The CMPA does not generally provide assistance to members acting as investigators for phase I and II clinical trials performed on normal, healthy volunteers. Members performing such trials are advised to seek assistance from the sponsor in the event of medical-legal difficulties. However when phase 1 and 2 trials involve patients with a health condition, investigators would generally be eligible for assistance from the CMPA, as described below.
Members may be approached to act as consultants during a clinical research trial as a safety monitor or another type of advisor. The CMPA is structured to assist members with medical-legal difficulties arising from their medical practice brought in Canada, but not outside of Canada. As a result, 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 medical-legal difficulties brought outside of Canada. Before agreeing to act as a consultant, members should contact the CMPA to discuss their eligibility for assistance.
Members who initiate trials and develop their own protocols would generally be eligible for assistance with medical-legal difficulties resulting from their professional work of medicine in designing the study. More commonly, a third-party sponsor will approach investigators to explore their interests in performing clinical trials. 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.
Once provided with the protocol and clinical trial agreements, investigators should carefully read the terms and conditions. The CMPA document Medical-legal issues to consider with clinical research contracts identifies issues that typically arise in a clinical trial 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, the Association assists only with aspects of the research contract that concern medical care. The 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. Members are advised to review any contract with their own personal or business lawyer. In some provinces and territories, members may also seek assistance from their local medical organization or association.
Generally, to be eligible for CMPA assistance with medical-legal difficulties arising from a clinical trial, members should ensure that the signed clinical trial agreement is approved by an appropriately structured Canadian-based clinical research ethics committee, which may be hospital- or community-based, or in some provinces or territories may be based within the College.
The research project may require employment of research assistants. When the research assistants are employees of the member, the member may be eligible for assistance with legal matters arising from the acts or omissions of the research assistants.
If patient medical records may be reviewed by a third party to determine the eligibility of study patients, it would generally be necessary to disclose this fact to patients in advance and ensure consent is obtained before accessing patient files. When such consent is not obtained, screening of patient files seeking eligible subjects should not be done.
During a clinical research trial
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 subjects 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 subjects 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 subjects, 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 trial. Regular reporting to the research ethics committee is a common requirement.
Following the completion of a clinical research trial
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 the CMPA if they have concerns about their duties to disclose results of the clinical research.
For clinical research trials performed in Canada, Health Canada regulations require records related to the trial to be maintained for 25 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.