Physicians who are considering taking part in a clinical research study in a role that involves recruiting, assessing, treating, or monitoring research participants should be aware that unique obligations and risks may arise.
Duty to research participants
The interaction between a physician and participants will often give rise to a duty of care. For example, physicians may be found by a court to owe a duty of care to participants they recruit for studies, especially if the physician also has a physician-patient relationship with the participant. Physicians may also be found to owe a duty of care when they are involved in assessing whether participation is in an individual’s best interest, or when administering treatment to participants as part of a study.
The question of whether a physician owes a duty of care will be assessed by courts based on the circumstances of each case.
Legal and ethical framework
The Canadian Medical Association's (CMA) Code of Ethics and Professionalism states: "Consider first the well-being of the patient." This ethical principle also applies when the patient is involved in a research study.
Physicians considering recruiting or recommending patients for a study, or treating a patient in accordance with a study treatment protocol, should carefully review the protocol to consider whether it is in the best interest of the patient. Among other things, physicians may consider whether the protocol includes adequate provisions for the safety and best interests of participants, and whether the treatment protocol is appropriate for the specific patient.
The legal obligations of physicians involved in research arise from many different sources and may vary between provinces and territories. The regulations under the federal Food and Drugs Act outline requirements applicable to all clinical trials in Canada involving human participants. Physicians should also be mindful of provincial and territorial laws and regulations relating to the practice of medicine and privacy, as well as medical regulatory authority (College) policies, guidelines, and codes of ethics that impose or address obligations on physicians.
In addition, it is important to consider guidelines and statements published by professional organizations, such as the CMA’s Guidelines for Physicians in Interactions with Industry and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Guidelines and statements do not have the force of law, but are influential in defining the appropriate standard of care to which physicians may be held in a legal proceeding or College complaint.
Ethical and regulatory approvals
Before becoming involved in a research study, it is prudent for physicians to consider whether the study has received the required ethical and regulatory approvals. It is recommended that physicians only participate in research that has been reviewed and approved by an appropriately structured, independent Canadian research ethics board. In some jurisdictions, this may be a legal requirement. In addition, privacy legislation in some provinces and territories requires that a research ethics board approve research that uses identifiable personal health information without the consent of the individual.
If the research is a clinical trial involving a new therapeutic agent, it requires approval by Health Canada. The approval of new drugs for use in Canada is governed by regulations under the Food and Drugs Act, which set out in detail the sponsor's obligations to conduct a clinical trial in accordance with good clinical practices. Clinical trials involving medical devices also require approval by Health Canada.
Consent
As with other medical treatments, study participants must consent to participating in or receiving treatment considered experimental or part of a research study. The challenge with most research studies is providing sufficient information so that a potential research participant can make an informed decision. Courts have held that the standard of disclosure for consent to participate in research is generally higher than for other medical treatment.
While the information to be disclosed varies based on each study, the CMA's Code of Ethics and Professionalism, and similarly the Code of ethics of physicians in Québec, generally require that, at a minimum, the potential participant be informed "about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of [the physician's] participation including any compensation."
The CMA also suggests that potential research participants should be advised "that they have the right to decline to participate or withdraw from the study at any time, without negatively affecting their ongoing care." Additional information may need to be provided depending on the nature of the research study, as well as the applicable legislation and College policies in each jurisdiction.
It is recommended that consent to participate in a study be obtained in writing. Research ethics boards will often approve and require the use of consent forms as part of their approval process. However, a signed consent form will not necessarily be sufficient to prove that informed consent was obtained.
It is often important to demonstrate at a later time that research participants, or substitute decision-makers, generally understood the consequences of participation in the study, as well as the reasonable treatment options and specific issues related to their participation as a research participant. This information is often not adequately captured in a standard form. Physicians should discuss these issues with the research participant or substitute decision-maker and document the discussion in the medical record.
Confidentiality
Physician researchers generally owe a duty of confidentiality to research participants. If the physician intends to disclose identifiable personal health information to other parties as part of the research, or if other parties involved in the research will have access to this information, express consent must generally be obtained from the research participant or substitute decision-maker, unless a legal exception applies.
As mentioned earlier, privacy legislation in some provinces and territories requires that research using identifiable personal health information without the consent of the individual be approved by a research ethics board. In conducting their review, research ethics boards will typically consider factors such as whether the research can be conducted without using identifiable information, what safeguards are in place to protect the information, whether the research is in the public interest, and whether obtaining consent from the research participants would be impractical. In accordance with ethical standards, research ethics boards will generally not approve the use of personal health information in clinical trials without the consent of the individual.
Privacy legislation may impose additional requirements related to the collection, use, and disclosure of participants' personal health information for research purposes. For example, some jurisdictions require custodians of health information (such as physicians) to enter into written agreements with researchers before disclosing personal information to them. Such agreements typically address issues such as the use, security, disclosure, and return or disposal of the information. Physicians should be familiar with any obligations before using patient information in research or disclosing personal health information for the purpose of research.
Confidentiality obligations may also arise from other types of agreements. For example, clinical trial agreements may require that participating physicians keep details of the research confidential.
However, physicians should take care to ensure these restrictions are reasonable and comply with their legal and professional obligations. The CMA’s Guidelines for Physicians in Interactions with Industry advises physicians to "ensure that agreements with industry protect the physician’s right to publish or disclose complete and accurate study data and results or report adverse events that occur during the course of the study." The Code of ethics of physicians of Québec contains similar cautions and, as in some other jurisdictions, prohibits physicians from concealing the negative results of research trials in which they participated.
Conflicts of interest
Physician involvement in research also has the potential to raise questions about possible conflicts of interest. A conflict of interest occurs when the physician's interests might conflict with the research participant's or patient's best interests. Conflicts may arise when physicians have a dual role with potentially opposing interests, for example, as both researcher and physician to the research participant. To reduce the likelihood of conflicts in such situations, physicians should review the research protocol carefully to ensure it does not interfere with their professional independence and clinical judgment in the treatment of a research participant who is also their patient.
Physicians should also take care to avoid the appearance of a conflict of interest in their relationship with companies and organizations that sponsor research. The CMA’s Guidelines for Physicians in Interactions with Industry provides guidance on maintaining appropriate relationships with industry. For example, the CMA suggests that any compensation received by physicians for their involvement in research should be limited to reasonable reimbursement for time and expenses, and approved by the relevant research ethics board. Similarly, Quebec's Code of ethics of physicians advises that physicians must not accept or grant any compensation that would call their professional independence into question, and that any compensation received must be reasonable and known to the ethics committee. Most Colleges also have policies addressing conflict of interest and clinical research.
Clinical trial agreements
Many of the issues identified here may be addressed in a clinical trial agreement between the study sponsor and participating physicians. Physicians asked to sign a clinical trial agreement should carefully review its terms to ensure it does not conflict with their legal and professional obligations.
The CMPA’s 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.
CMPA’s Extent of Assistance
Generally, to be eligible for CMPA assistance, members should make all reasonable efforts to ensure that a signed clinical trial agreement is approved by a Canadian clinical research ethics committee, which may be hospital- or community-based. In some provinces or territories, this committee may be based within the College. The CMPA’s principles of assistance on clinical research provide further guidance on when members can expect CMPA assistance with medico-legal difficulties arising from clinical research.
