Clinical research — Will the CMPA help me?

An article for physicians by physicians
Originally published September 2007 / Revised June 2008
IS0774-E

Of interest to all physicians

For many CMPA members, clinical research has become a part of their work of medicine. The CMPA occasionally receives enquiries from members asking whether professional liability protection is extended to clinical research work. These enquiries have led to the revisiting of the issue of assistance for members who perform clinical research.

The CMPA participated in the development of a template clinical trial confidentiality agreement, available at www.cma.ca/confidentiality. We have also produced a document entitled General Information on Clinical Research Contracts that outlines general advice regarding clinical trial contracts. The CMPA would generally extend assistance to members who act as investigators in phases I and II studies where the subjects are patients with a medical condition.

This article presents additional information about the extent of assistance available to members who perform clinical research and provides risk management advice for avoiding medico-legal difficulties that may arise during such research.

Before starting a clinical research trial

Members performing clinical research would be 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/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 medico-legal difficulties.

Members may be approached to act as consultants during a clinical research trial, in the role of a safety monitor or another advisory role. The CMPA is structured to assist members with medico-legal difficulties arising from their medical practice brought in Canada, but not outside of Canada. 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 in medico-legal difficulties brought outside of Canada. Members are advised to contact the CMPA in advance of agreeing to act as a consultant to discuss eligibility for assistance.

Members who initiate trials and develop their own protocols would generally be eligible for assistance for medico-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. In such cases, members may want to make use of the template confidentiality agreement recently developed in collaboration with the Federation of National Specialty Societies of Canada and the CMA, with assistance from the CMPA. The Colleges or the law may impose limitations on a physician's ability to enter into such an agreement: for instance, in at least one jurisdiction, the law expressly prohibits physicians from concealing the negative findings of a research project in which they have participated. Members who sign confidentiality agreements are expected to adhere to the terms of the agreement, and if they believe they must ethically breach their agreement, they are advised to contact the CMPA in advance for advice and assistance. Members would generally not be eligible for CMPA assistance if they faced allegations of breach of this agreement.

Once the protocol and clinical trial agreements are provided to the investigator, the investigator should carefully read the terms and conditions. The CMPA has prepared a document that identifies issues that typically arise in a clinical trial agreement. The document is entitled General Information on Clinical Research Contracts and is available from the CMPA on request. 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 and/or the member’s ability to practice medicine is jeopardized. In general, the Association will only assist with aspects of the research contract that concern medical care. The CMPA does not generally assist where the allegation is related to 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/business lawyer. In some provinces or territories, members may also seek assistance from their local medical organization or association.

Generally, to be eligible for CMPA assistance with medico-legal difficulties arising from a clinical trial, members should make all reasonable efforts to 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. In some jurisdictions, research ethics committee approval may be a legal requirement. The research project may require employment of research assistants. Where 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 his/her 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.

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 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. Members should contact legal counsel or the CMPA in such instances. For some clinical research trials, 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. In addition, some provinces and territories may have specific record-keeping requirements for clinical trials.

The bottom line

Before starting a clinical research trial, member physicians may want to refer to the template confidentiality agreement available from the CMA, and also the CMPA’s document General Information on Clinical Research Contracts, which identifies the issues that typically arise in the context of research contracts. Members are generally eligible for assistance from the CMPA for their professional work of medicine as it relates to clinical research subjects in Canada.
Investigators are encouraged to review other pertinent CMPA general principles as these principles may have an impact on the eligibility for assistance related to the performance of clinical research.
The CMPA will continue to monitor this important aspect of medical activity.