We thank Dr. Gray for his comments regarding the Canadian legal tradition of informed consent and the concept of “material risk.”1 Our article notes the need for “clinicians to determine the precise standard used in their jurisdiction and to adapt their practice accordingly.”2 Because we were recruited to write for an international audience, further discussion of these points seemed beyond the scope of our review. Indeed, given our charge, we deliberately avoided detailed comparisons of distinctly national legal traditions. Instead, we sought to emphasize how the ethics of informed consent have come to guide medical practice internationally, in a way that goes above and beyond the requirements of unique local laws.
Although the specific legal precedent and lineage of “material risk” is important in Canada, we fail to appreciate how it is substantively different from the “reasonable patient standard,” which we mentioned in our article and which is used in the United States and throughout the world. The difference between the two terms is likely more relevant to lawyers trying to defend cases rather than to clinicians trying to avoid trouble. Whether in the US, Canada or elsewhere, physicians should always explicitly discuss risks that patients would likely want to know about.
That our review reflects a bias toward US law merely reflects that we chose to write about the context we know best. It also reflects that the legal and ethical concepts of informed consent emerged out of the US. Indeed, the still-emerging discipline of bioethics has been increasingly criticized for its latent, often unrecognized, chauvinism that reflects distinctly American philosophical assumptions.3 If our review is perceived to contribute to such cultural bias, we sincerely apologize. That said, we believe that our review provides a balanced summary of the broadest consensus regarding informed consent — one that can guide the practice of physicians in a wide range of legal contexts.
We also agree with Dr. Mann’s comment4 that any robust understanding of consent demands that the patient has been informed about the decision at hand. Yet there is a legal and philosophical distinction between “simple” consent, by which a patient explicitly authorizes an intervention, and the higher bar of “informed” consent. As our review outlines, unfortunately a multitude of forces limit the capacity of clinicians and patients to achieve “ideal” informed consent. These limitations in no way abrogate the need to continually strive for excellent clinical communication. Rather, we contend that excellent informed consent requires clinicians to recognize these limitations so they can develop pragmatic approaches to mitigate their effects.