Answering Your Questions About Informed Consent in Healthcare

Informed consent in healthcare can be ambiguous, leading providers to interpret what’s best at any given time. Since the consequences of individual interpretation can be significant, the process of obtaining informed consent requires clarity.

Here’s LHA Trust Funds’ take on informed consent and answers to frequently asked questions from our members.

Explore the Importance of Informed Consent

Informed consent is more than a piece of paper that a patient must sign before a procedure. It serves as a means of communication, documentation, and education for both the patient and the healthcare provider.

• Communication. It is communication between a patient and a provider recommending a procedure(s).
• Documentation. Its purpose is to show that the patient and provider considered all the risks and benefits and agreed to the procedure as the best path of medical care. The consent form shows further documentation of the discussion between the patient and the provider regarding the treatment being proposed, the alternatives that might exist (including not doing it at all), and the patient’s signature indicating their understanding and decision either to proceed or not to proceed with the proposed treatment.
• Education. The primary objective of informed consent is to ensure that patients are well-informed and involved in the decision-making process while being fully aware of the consequences.

Ensure Patient Understanding

The key to meeting this objective is to make the information as clear as possible for the patient to understand even if it means using visual and digital communication tools.

It could be argued that the language used in informed consent documents may be difficult for a layperson to comprehend and is not at an appropriate reading level. Therefore, just having a patient read and sign an informed consent is not, on its own, an effective method of providing informed consent.

The signed informed consent serves to document this discussion. The consent can even be documented “in a progress note or elsewhere in the record” per The Joint Commission although the formal document is preferred.

Frequently Asked Questions

Here are some frequent questions we have recently received and our recommendations:

Can multiple procedures be listed on one informed consent document?

It depends. A new informed consent document should be signed if a new operation is to be performed that is unrelated to the primary procedure and when a new procedure presents a different material risk.

For example, one procedure may require several steps to be taken to correct a condition, this could be considered one event. However, if multiple procedures are done but are unrelated to the primary procedure, a separate informed consent should be obtained for each.

Ensure that any procedure to be performed is listed specifically on the document and has been discussed with the patient.

Can “or other indicated procedures” be used as part of the treatment recommended?

No.

We have noticed situations where physicians have listed “or other indicated procedures” as part of the primary treatment recommended on the informed consent. Unfortunately, this tactic does not make it clear to the patient what they are consenting to and is not recommended.

The purpose of informed consent is to inform the patient so they can actively be engaged in making decisions on their care. This is not possible if the treatment plan contains ambiguous language.

If a surgeon identifies the need for an additional procedure while the patient is under anesthesia for the procedure listed on the signed informed consent, a separate consent must be obtained.

If the procedure is elective, the patient is competent in making their own decisions and no emergency exists the patient should be allowed to make their own decision about the additional procedure. This may mean allowing the patient to recover and then decide.

Does the name of the location where the procedure will be performed need to be written on the informed consent or can we use a hospital sticker?

The organization where the procedure will take place should be written into the appropriate space before the informed consent document is signed.

Although there is no formal indication of this in the regulations, a mock surveyor recently discussed with the LHA Trust Funds that if they can tell it was done afterward, for example, if a hospital sticker is placed, then they see it as altering the document.

If this is the case, then the entire authenticity of the informed consent may come into question. It is best not to take any chances with this one.

Does the date and time the consent was obtained need to be on the informed consent document?

Yes.

Providers neglecting to document the date and time of the signing of the informed consent document is quite common.

Standards and regulations are clear that informed consent must be obtained before the procedure. Adding a date and time is the only way to prove it was obtained before the procedure.