Duties and responsibilities
Consenting to research
Originally published December 2000 / Revised July 2011
Physicians undertaking clinical research are expected to obtain valid consent.
Research is essential for the advancement of medicine. Occasionally the CMPA receives enquiries from physicians about the medico-legal risks of participating in research. As there are many different types of research, the specific questions are varied but always interesting. For example, a member considering participation in a drug trial asked about any special issues related to obtaining patient consent. Another member asked whether there is any obligation to enroll a patient in the study.
Many research projects rely on the recruitment of subjects into a trial by practicing physicians who have not been directly involved in the establishment of the protocol and whose primary purpose is to give the best possible treatment to their patients. These physicians are often motivated to enrol study subjects because they believe the study treatment may prove to be more effective than the current standard. Physicians may also be under a number of other pressures to enroll patients in the study. However, it is important to remember that the courts have affirmed the standard of informed consent in a research context is higher than for routine treatment.
During screening of patients for a trial, the physician should consider inclusion and exclusion criteria outlined in the protocol. Failure to adhere to these criteria may not only invalidate the subject data but also expose the physician to medico-legal risk. Should an adverse event occur, the quality of the informed consent discussion may be relevant. "Informed consent" has been discussed in many CMPA publications, but it is important to reiterate the principles in the context of clinical research:
- The patient should be informed of the condition the physician has diagnosed and for which the patient is to be treated.
- The patient should be told the material risks and benefits of standard treatment, as well as any reasonable alternatives to the standard treatment. If the physician is responsible for enrolling patients into a clinical trial, enrolment may be one of those reasonable alternatives. Put simply, a "material risk" is one that occurs relatively often or has serious consequences. For a more thorough discussion, see the CMPA publication "Consent: a guide for Canadian physicians" by K.G. Evans.
- The patient should be advised of the expected advantages of the new treatment over the previous standard treatment, as well as the known potential material risks attendant upon the new treatment. The same information should be given about alternative treatments as they are discussed. Where the procedure is innovative or experimental in nature, the patient should be made aware that there may be additional risks not yet known and that expected benefits may not be achieved.
- The physician obtaining the consent should be satisfied the patient has been given sufficient information about the research protocol to make an informed decision.
- The patient should have an opportunity to ask questions.
- Of course, a patient's consent must always be voluntary and can be withdrawn at any time. The courts will invalidate consent if it was obtained by coercion.
- The patient should be advised of the right to refuse to participate in the research, or to withdraw after enrolment, without prejudicing his/her right to receive the same treatment he or she likely would have been given had the research trial not been available.
- The patient should be informed of the likely uses that will be made of his/her personal health information in accordance with the relevant privacy legislation.
- Some jurisdictions require the disclosure of any financial benefit the physician may receive from his/her involvement in the study.
In summary, while it is exciting to engage in research that has the potential for a major advance in care, it is important to ensure the research protocol is followed explicitly in order to obtain valid results. It is even more important to ensure the patient receives the information necessary to make his or her own choice about being enrolled in the research, and that the choice is voluntary.
The bottom line
Doctors who choose to be part of a research trial should recognize the increased responsibility this involves, both to provide appropriate information to their patients and to follow the research protocol. They should be aware of the applicable policies of relevant regulatory bodies pertaining to research and possible conflicts of interest.