Medical research has the potential to advance clinical knowledge and improve patient care, and physicians are often interested in participating in clinical research studies when offered the opportunity.
Physicians can participate in a variety of roles, for example, as a principal investigator, or by providing analytical assistance, or by recruiting, assessing, treating, or monitoring research subjects in accordance with a study protocol. Each of these roles results in unique obligations and risks for physicians.
This article examines the responsibilities and obligations of physicians who have taken on the role of recruiting subjects, or treating and monitoring them. Before agreeing to participate, these physicians should be aware of the wide-ranging legal, ethical, and professional responsibilities and obligations which protect the interests of research subjects.
Duty to research subjects
The interaction between a physician and the subjects in a study 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 research subjects they recruit for studies, especially when the physician also has a physician-patient relationship with the subject. Physicians may also be found to owe a duty of care when they are involved in assessing individuals to evaluate whether participation in the study is in their best interests or when they administer treatment to the subject as part of the study.
The question of whether a physician owes a duty of care is assessed by the courts based on the circumstances of each case.
Legal and ethical framework
The Canadian Medical Association's (CMA) Code of Ethics states: "Consider first the well-being of the patient." This ethical principle applies equally 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 first review the protocol carefully to consider whether it is in the best interests of the patient. Among other things, physicians may consider whether it includes adequate provisions for the safety and best interests of research subjects 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 subjects. There are also provincial laws and regulations relating to the practice of medicine and privacy, policies and guidelines by medical regulatory authorities (Colleges), and codes of ethics that impose or address relevant obligations on physicians.
In addition, it is important to consider guidelines and statements published by professional organizations, such as the CMA policies "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 requires that a research ethics board approve research that uses identifiable personal health information without the consent of the individual.
Research ethics board approval may also be a condition of the CMPA extending assistance to members with medico-legal difficulties arising from involvement in a clinical trial. 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. Assistance may also be conditional on compliance with other CMPA principles of assistance.
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.
As with other treatment or clinical care, 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 the potential research subject 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 Canadian Medical Association's Code of Ethics, and similarly the Code of ethics of physicians in Québec, generally requires that, at a minimum, the potential subject 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 subjects should be advised "…that they have the right to decline or withdraw from the study at any time, without prejudice to 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 subjects, 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 subject. This information is often not adequately captured in a standard form. Physicians should discuss these issues with the research subject or substitute decision maker and document the discussion in the medical record.
Physician researchers generally owe a duty of confidentiality to research subjects. 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 subject or substitute decision-maker, unless a legal exception applies.
Privacy legislation may impose additional requirements related to the collection, use, and disclosure of subjects' 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 policy "Guidelines for Physicians in Interactions with Industry" cautions physicians not to "enter into agreements that limit their right to publish or disclose results of the study or report adverse events which 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.
As mentioned earlier, privacy legislation in some provinces 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 subjects 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.
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 subject'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 subject. To reduce the likelihood of conflicts in such situations, physicians should review the research protocol carefully to ensure that it does not interfere with their professional independence and clinical judgment in the treatment a research subject 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 policy "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. Similarly, Quebec's Code of ethics of physicians advises that physicians must not accept or grant any compensation that would call his professional independence into question, and that any compensation received must be reasonable and known to the ethics committee. Most professional regulatory authorities 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. Members with questions about the obligations and risks of clinical research studies and clinical trial agreements are encouraged to contact the CMPA before signing.