Informed consent: the discussion and the record

Code of Ethics · provisions 3.5 and 3.6

Explain the choice before seeking consent

Provision 3.5 addresses understandable disclosure of diagnosis, treatment options, risks, and prognosis. Provision 3.6 calls for voluntary informed consent and information that allows a patient to accept or refuse the proposed action. The discussion should cover the purpose and likely benefit of the proposal, material risks, reasonable alternatives, and the consequences of declining care where relevant.

Who decides also matters. When a patient cannot decide, identify the person authorized to act under the applicable law and circumstances. Avoid treating the presence of a signed form as proof that the necessary conversation occurred.

Reproductive healthcare involves further distinctions. Imbong v. Ochoa addresses consent and conscientious objection under the RH Law. ALFI v. Garin, read with its 2017 resolution, concerns the FDA’s consideration of scientific objections to product certification. A patient’s consent, the clinician’s professional duties, and a product’s current regulatory authorization each need their own assessment.

For physicians

Make the decision traceable

• Record the proposed treatment, material risks discussed, alternatives offered, and any questions or expressed preferences.
• Check understanding in ordinary language, especially where the decision is complex or a representative is involved.
• Record who participated and decided, when the discussion took place, and whether the patient accepted, refused, or deferred.
• If the plan materially changes, consider what further explanation and consent the new decision requires.

This is a practical documentation approach, not a fixed list of disclosures that will fit every procedure. The clinical situation and applicable professional standard still matter.

Decision-making capacity

Identify the patient’s participation and the representative’s authority

Record what the patient can understand about the particular decision, how it was explained, and what support was offered. If another person proposes to decide, identify the legal basis and scope of that authority. A disability diagnosis and a family member’s signature do not, by themselves, answer every consent question.

In Aguirre v. Secretary of Justice, a vasectomy followed a psychiatric capacity assessment and a legal guardian’s written consent. The Court upheld dismissal of a criminal complaint alleging falsification and mutilation. That result did not establish a general rule authorizing guardians to consent to sterilization.

Versoza v. People concerned a separate child-abuse prosecution arising from the same procedure. The Court’s procedural disposition left the substantive abuse question unresolved. The separate opinions offer differing discussions of autonomy and guardian authority; they should not be treated as one binding consent rule.

For lawyers

Separate disclosure, choice, and injury

Dr. Li v. Spouses Soliman discusses four elements of an informed-consent claim: a duty to disclose material risks, inadequate disclosure, a treatment decision that adequate disclosure would have changed, and injury from the treatment. The Court also addressed expert proof of the disclosure standard. It found adequate disclosure on the record before it; the elements are not a presumption of liability.

• Identify the specific information said to be missing and why it was material to the decision.
• Compare consent forms with contemporaneous chart notes, patient instructions, witness accounts, and the actual clinical choice.
• Analyze alleged negligent performance separately from an alleged failure to obtain informed consent.

Material alternatives

Let the patient assess an available option

In Rosit v. Davao Doctors Hospital, the surgeon had not disclosed an available alternative and had assumed the patient could not afford it. The decision shows why cost assumptions should not replace a discussion of a material treatment choice. It does not require presenting every imaginable intervention.