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Why Is No One Talking About “Informed Consent?”

Published On: December 1, 2021Tags: , ,

By Chuck Black

“Informed consent” is a well understood legal doctrine in healthcare, requiring the healthcare provider (traditionally a doctor) to educate patients about the risks, benefits, and alternatives of any given recommended procedure or intervention, allowing the patient to make informed and “voluntary” decisions about whether to undergo the procedure.

It’s not something we hear a lot about these days, which is kind of odd, given all the drugs our government currently insists that we take and how often the same legal concepts are invoked for aboriginal rights and sexual assault cases.

As noted by Ruth R. Faden and Tom L. Beauchamp in their 1986 book A History and Theory of Informed Consent, the concept of informed consent “is rooted in multiple disciplines, including those of health professions, law, the social and behavioral sciences and moral philosophy.”

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The book notes that:

The law has (until now, at least) focused almost exclusively on clinical (doctor/patient relationships) rather than research (scientist/clinical test subject) contexts.

From the legal point of view, the physician has the duty to both inform patients and obtain their consent. If a patient is injured as a result of a failure on the part of a physician to disclose information about a procedure, then the patient may collect money damages from the physician for causing the injury.

Most informed consent cases focus around concepts of “negligence” and whether the disclosure provided by the health care authority is adequate to provide the patient with the amount and the type of information needed to make an “informed decision.”

Unfortunately, the law often allows exceptions to the types of information heathcare providers are required to supply.

For example, drug manufacturers are normally shielded from liability for the effects of their drugs just so long as they comply with appropriate public health laws and required testing regimes.

In some cases, such as the current pandemic, drugs are authorized for emergency use without completing the full requirements normally mandated under law. In Canada, modern legal concepts of informed consent originate with two landmark Supreme Court decisions.

As outlined in the undated Bottom Line Research and Communications white paper, An overview of the Law Regarding Informed Consent, in 1980, “the Supreme Court of Canada rendered two landmark decisions pertaining to the related matters of the duty of a physician to make disclosure to the patient and the requirement of informed consent of the patient to a surgical procedure.”

In Hopp v. Lepp Chief Justice Laskin considered whether a patient who suffered permanent damages after the performance of a hemilaminectomy had given informed consent to the procedure. After suggesting that the patient had a right to decide what, if anything, should be done with his body, Laskin C.J. went on to hold that there was a duty of disclosure – that is, the surgeon or physician was bound by a duty to provide information to his or her patient.

Shortly thereafter, the Supreme Court of Canada again had reason to address the issue of informed consent, among other issues, in the leading case of Reibl v. Hughes.

In this judgment Hopp v. Lepp was considered in the context of the plaintiff’s claim that he had not given informed consent to an endarterectomy procedure that had left him a hemiplegic.

Broadly speaking, it was the Reibl judgment that introduced the doctrine of informed consent into Canadian law.

Of course, things change and laws “evolve.” What was true in the 1980’s might not be true today.

At the very least and as noted in the December 14, 2020 Global News post, “Coronavirus vaccine makers are shielded from liability. Here’s why officials say that’s normal,” individual doctors are no longer the sole authority in this area.

Come to think of it, no single doctor, level of government, pharmaceutical corporation, medical association governing body or even secret, multinational organization plotting world domination has complete and total control or responsibility over health care decisions these days.

This makes it difficult to figure out who to sue for damages when something goes wrong.

This weakens the law and shrinks the options for accountability.

The concept of “free consent” is also well defined in contract and international law, which focuses on a wide variety of actual and implied contracts between various individuals and groups.

There is at least one international template which attempts to outline the responsibilities of parties involved in medical research. It’s wrapped around the concept of “free consent,’ a term enshrined in the International Covenant on Civil and Political Rights and adopted in 1966 by the United Nations.

According to the Insuranceopedia website, free consent is also a legal term which:

… refers to an agreement when both parties knowingly and willingly enter into a contract of their own will. This includes agreeing to all of its terms and conditions and a mutual level of understanding of the subject matter in the contract.

For a contract to be enforceable and sound, this consensus must have been gained free of any form of coercion, cheating, undue influence, fraud or pressure. In addition, the contract must be free of mistakes or misrepresentation by both parties. If consent is gained by any of these means the contract is considered void and unenforceable by law. The website notes that “in the case of insurance contracts, even if a policyholder agrees upon the same things in the same sense, the contract is still not valid if they did not have free consent during the signing of the contract.”

Article seven of the covenant prohibits experiments conducted without the “free consent to medical or scientific experimentation” of the subject.

The UN concept of “free consent” also overlaps with the concept of “free, prior and informed consent” another UN generated definition originally intended to “establish bottom-up participation and consultation of an indigenous population prior to the beginning of development on ancestral land or using resources in an indigenous population’s territory.”

In essence and to paraphrase the UN concept, the indigenous people weren’t provided with “free, prior and informed consent” as a preliminary to agreements made with the various Western governments. Therefore those previous negotiations are void and must be renegotiated.

Whatever the origin point, the implementation of these concepts in the international arena leaves much to be desired.

As of September 2019, the full covenant (including definitions) has 173 parties and six more signatories without ratification. However, most signatories have failed to make any changes in national law to ensure compliance with Covenant obligations as required under its terms.

In essence, the UN declaration is a paper tiger without teeth.

On the other hand, informed consent is also an important component of Canadian laws governing sexual assault. Those laws are far better defined and far better enforced.

As noted in the March 25, 2016 Armoured Suits Criminal Defence Lawyers post, “The Law of Consent in Canada,” (https://armouredsuits.ca/?s=The+Law+of +Consent+in+Canada) the criminal code defines sexual assault as:

…contact of a sexual nature, applied without consent. For the purpose of this section there is no consent when it is obtained by force, threat, fraud or authority.

For further clarity the criminal code states that no consent is obtained when it is provided by someone other than the complainant, the accused is incapable of consent (for example, because of intoxication), the accused is abusing a position of power, the complainant expresses a lack of agreement or later revokes it.

Based on these rules the court has an objective template by which to assess whether consent has been provided. If sexual contact is established and no consent is present a sexual assault has occurred. That is, unless the accused can avail himself of the defence of a reasonable mistaken belief of consent.

It’s interesting how, at least in this one specific area, the legal definition of assault is clearly defined under Canadian law and almost entirely dependent on the explicit approval of the partners involved in the activity.

This makes it a far easier law to enforce when compared to those surrounding medical consent, which are riddled with exceptions and now even includes “temporary” emergency measures enacted at senior levels of government which override the traditionally private doctor/patient relationship.

The most recent legal influence upon Canadian concepts of informed consent is the 1999 Supreme Court R. v. Ewanchuk case.

Although the case itself was focused on a sexual assault, the underlying argument focused on the victims fear that she would not be hired for a job unless she complied with a request from a potential employer to perform a sexual act.

As noted in the September 29, 2021 Don’t Talk TV YouTube post, “Don’t Talk TV Episode 68: What is #Consent?,” the potential employer argued that the victim had provided “implied consent” to the sexual act since she had not objected to it.

The Supreme Court disagreed, stating that there was no defence available for “implied consent” when the activity was forced under duress. The “duress” was the implication that the victim would lose the possibility of getting hired if she did not comply.

According to the court, “consent given under fear or duress is ineffective” and the threat of job loss is clearly duress under Canadian law.

According to Nicholas Wansbutter, an Ontario lawyer who hosts the Don’t Talk TV vidcast, the concept of consent derived from the R. v. Ewanchuk case is a broad principle application to healthcare and in other areas where informed consent is required.

This includes both coerced sexual acts and forced medical procedures.

There are large swaths of competent, well respected Canadian workers who have been forced out of their jobs over the last six months for failing to comply with union, corporate and government edicts demanding vaccinations as conditions of ongoing employment.

Expect some interesting Canadian court cases to wind their way towards the Supreme Court over the next little while as those unemployed Canadians attempt to use the courts to claim just compensation for their job loss.

Originally posted at: FreedomForumCanada.com