Informed Consent Spotlight: Signatures and Expiration Dates
March 7, 2022
Dear OMIC Insureds:
The Risk Management Hotline regularly handles informed consent questions. For example:
Q: Is a witness signature required on the consent?
A: Having a witness signature is not usually required. The witness’s role is to verify that it was the patient (or patient’s representative) who signed the form.
Q: Is a patient’s electronic signature sufficient?
A: Signatures can be obtained manually or electronically (e.g., through a system such as DocuSign). Regardless of the medium, the signature shows that the patient gave informed consent, based on a discussion with the surgeon about material risks, benefits, and alternatives.
Q: When does a consent expire?
A: In general, informed consent is considered valid until the patient revokes it, or there are significant changes to the patient’s medical or ocular condition. For a series of treatments, the physician should review risks and benefits with the patient at appropriate intervals, and obtain and document informed consent again if the patient’s medical or ocular condition changes to the point that the risk/benefit ratio is affected.
Physicians often wonder if a consent is valid after a certain amount of time (e.g., 30 days) has passed. Be familiar with state law or facility regulations that may require you to execute a new form. Outside of such requirements, the key from a risk management perspective is to catch any changes in the patient’s overall medical condition, eye health, or surgical goals, and any lingering questions or areas of confusion. A pre-op protocol that includes a brief check-in with the patient to confirm there are no changes can be a helpful tool.
For more on informed consent, see OMIC’s Obtaining and Verifying Informed Consent
If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com. Or call us at 1-800-562-6642, enter 4 for Risk Management.
Sincerely,
Jane Mock, CPHRM
Risk Manager
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