FOUR THINGS REQUIRED BY THE US CODE OF FEDERAL REGULATIONS FOR INFORMED CONSENT.

POPULAR RATIONALISM IS ON YOUR SIDE. ALWAYS. WE CONTINUE THE FIGHT. INFORMED CONSENT IS A HUMAN RIGHT, AND IT HAS BEEN ALL BUT UTTERLY DISMANTLED. THIS MUST CHANGE.

Modern medicine, driven by financial incentives and institutional pressure, has quietly abandoned informed consent and ethical restraint—transforming care into compliance enforcement while convincing itself it is acting in patients’ best interests. That’s why one of the first white papers I wrote was for the interagency harmonization on informed consent across all HHS agencies.

Until those regulating informed consent do it right, nothing will change in medicine and public health. While HHS has many important competing agendas, this one ranks very high.

Proper and legally obtained informed consent, per USCFR, requires all four of the following to be in place:

1. Statements of the benefits of risk of any medical procedure, drug, or device.

2. An attempt by the physician to determine if the patient understands the benefits and risks.

3. An explanation of medically reasonable alternatives.

4. An absence of any threat of negative consequences to the continuance of care to the patient if they decline to provide consent, permission (parent), or assent (minors).

Not an electronic tablet shoved in your face with “sign here”.

These facts are supported by binding U.S. federal law and long-standing bioethics doctrine, not opinion. Here is the evidentiary foundation, point by point, grounded in U.S. Code of Federal Regulations and controlling legal standards.

Informed consent is a protected human right in U.S. law.

Informed consent is not a courtesy, workflow step, or administrative checkbox. It is a legal and ethical prerequisite to medical intervention, grounded in constitutional bodily autonomy and codified in federal regulation.

Two regulatory frameworks govern informed consent in the United States:

• 45 CFR 46 (Common Rule; HHS-regulated research, public health programs, and federally funded activities)
• 21 CFR 50 (FDA-regulated drugs, biologics, and devices)

Both impose substantive requirements that cannot be satisfied by electronic signature alone.

1. Disclosure of risks and benefits is mandatory.

Federal law requires explicit disclosure of both risks and expected benefits, in language understandable to the subject.

45 CFR §46.116(a)(2) requires:

“A description of any reasonably foreseeable risks or discomforts to the subject.”

45 CFR §46.116(a)(3) requires:

“A description of any benefits to the subject or to others that may reasonably be expected.”

Similarly, 21 CFR §50.25(a)(2–3) mandates the same disclosures for FDA-regulated products.

Failure to disclose known risks, minimization of risks, or overstatement of benefits invalidates consent as a matter of law.

Courts have repeatedly held that omission or distortion of material risk constitutes battery, not merely negligence.

2. The physician must assess patient understanding.

Consent is not valid unless the clinician makes a good-faith effort to determine comprehension.

45 CFR §46.116(a)(4) requires information be presented:

“In language understandable to the subject.”

This requirement is not satisfied by presentation alone. Federal guidance clarifies that investigators and clinicians must ensure actual understanding, not passive receipt.

The Belmont Report (1979)—which underlies the Common Rule—states explicitly:

“An agreement to participate in research is valid only if voluntarily given by a subject who is adequately informed and has comprehended the information.”

Courts have reinforced this standard. In Canterbury v. Spence (464 F.2d 772, D.C. Cir. 1972), the court held that informed consent requires information conveyed “in terms the patient can understand,” not merely disclosed.

A tablet signature with no interaction, no questioning, and no comprehension check fails this standard.

3. Medically reasonable alternatives must be explained.

This is not negotiable. Federal regulations require disclosure of reasonable alternatives, including the option of no intervention.

45 CFR §46.116(a)(4) requires:

“A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”

21 CFR §50.25(a)(4) contains the identical requirement.

Courts consistently rule that failure to disclose alternatives—especially when risks differ materially—vitiates consent.

Importantly, “alternatives” include:
• Delayed treatment
• Conservative management
• Non-pharmacologic options
• Declining the intervention entirely

If alternatives are omitted, consent is legally defective even if risks are disclosed.

Absence of coercion or penalty is a core requirement of informed consent

Federal law explicitly forbids coercion, undue influence, or penalty for refusal.

45 CFR §46.116(a)(2) (Common Rule) requires that informed consent be sought “under circumstances that provide the prospective subject… sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”

This is not limited to overt force. Federal guidance defines coercion broadly to include implicit threats, power imbalance, and loss of access to benefits or services.

Crucially, 45 CFR §46.116(a)(8) requires disclosure of:

“A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled…”

This clause is dispositive.

If refusal leads to:
• dismissal from a practice
• denial of unrelated care
• delayed treatment
• labeling as “non-compliant”
• threats of school exclusion, employment consequences, or medical abandonment

then consent is legally void.

FDA regulations mirror this requirement verbatim.

21 CFR §50.20 states:

“No informed consent… may include any exculpatory language through which the subject… is made to waive or appear to waive any of the subject’s legal rights.”

And 21 CFR §50.25(a)(8) requires:

“A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled…”

Loss of access to care is a loss of benefit. Threatening dismissal from care for refusal constitutes undue influence under FDA rules.

OHRP guidance: refusal cannot affect access to care.

The HHS Office for Human Research Protections (OHRP) has repeatedly clarified:

“Subjects should not be pressured to participate and should not be threatened with loss of benefits or services to which they are otherwise entitled.”

This includes medical care, especially when the physician controls access.

A physician who conditions ongoing care on acceptance of a procedure invalidates consent by definition.

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Minors: coercion is even more tightly prohibited.

For children, federal regulations are stricter, not looser.

45 CFR §46.408(a) requires parental permission and child assent where appropriate.

45 CFR §46.408(c) makes clear that dissent by a child must be respected unless a narrowly defined life-saving exception applies.

Threatening a child with:
• school exclusion when no mandate exists
• loss of care
• authority-based pressure

constitutes coercion of a vulnerable population, which is an ethical red line.

Courts treat coerced “consent” as no consent at all

U.S. courts consistently hold that consent obtained under threat or pressure is invalid.

In Canterbury v. Spence (1972), the court emphasized that informed consent requires free choice, not acquiescence to authority.

More broadly, consent obtained under duress converts a medical intervention into battery, regardless of intent.

This is why modern lawsuits correctly frame these cases as:
• battery
• false imprisonment
• fraud

—not malpractice.

Why “sign here or find another doctor” fails legally

Dismissal threats exploit a power imbalance:
• physician controls access
• patient is dependent
• refusal carries consequences

That is undue influence, even if spoken politely.

A consent process that includes any threat—explicit or implied—of negative consequences to continued care is not informed consent under U.S. law.

Electronic consent does not replace substantive consent.

HHS guidance is explicit that electronic or written consent does not substitute for the informed consent process itself.

HHS OHRP Guidance (2016) states:

“Informed consent is a process, not a form.”

The clinician remains responsible for:
• Explanation
• Assessment of understanding
• Opportunity for questions
• Absence of coercion or undue influence

A tablet “sign here” workflow satisfies documentation, not consent.

Legal consequence of failure: battery, not paperwork error.

When informed consent requirements are not met, courts treat the intervention as unauthorized touching.

This is why modern lawsuits—correctly—are pivoting away from injury causation and toward:
• Battery
• Fraud
• False imprisonment
• Deprivation of civil rights

These claims do not require proof of injury—only proof that consent was invalid.

Bottom line, legally and ethically.

Informed consent is a human right embedded in U.S. federal law.
It requires disclosure, comprehension, and alternatives.
Anything less is coercion dressed up as care.

Until HHS agencies harmonize enforcement of 45 CFR 46 and 21 CFR 50 as written—rather than as administratively convenient—medicine will continue to drift toward institutional authority over patient autonomy.

And no amount of calls for convenience for healthcare workers, providers, medical professionals, technology, or public messaging can override that reality.

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