Understanding Informed Consent in Healthcare: Frequently Asked Questions and Insights

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 our answers to frequently asked questions about informed consent that we have received from our members.

Key Aspects of Informed Consent in Medical Settings

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. Here’s how each of these aspects plays a role in medical informed consent today.

Communication
Communication plays an important role in healthcare by ensuring that informed consent is obtained ethically in any healthcare setting. This process isn’t just about getting a signature—it requires mutual understanding between the healthcare provider and the patient. Effective communication here allows for:

• Sharing Information Clearly and Transparently
  Effective communication ensures that healthcare providers present information about a procedure, treatment or intervention in a clear and understandable way. This includes explaining the purpose, risks, benefits, and alternatives of the proposed intervention in language that the patient can comprehend.
  Without clear communication, patients may not fully understand what they are agreeing to, which undermines the validity of the consent and can lead to ethical and legal implications
• Addressing Cultural and Language Barriers
  Cultural competence and language accessibility are key factors in effective communication. Healthcare providers should be aware of cultural differences and use translators or interpreters when language barriers exist.
• Active, Empathetic Listening
  Providers should engage in active listening to understand the patient’s values, beliefs, and preferences. They should also encourage questions and be empathetic to patient concerns. This approach fosters trust, encourages patient participation, and helps ensure that the consent is aligned with the patient’s values and preferences.
• Discussing Risks and Alternatives
  Open communication involves discussing not just the benefits, but also the potential risks of a procedure or treatment, along with available alternatives (including the option to decline treatment altogether). Full disclosure of risks and alternatives ensures that the patient’s decision is truly informed and voluntary.
• Ongoing Consent
  Informed consent in healthcare is an ongoing process, not a one-time event. Providers should continue communicating with patients throughout their care journey, updating them about new information or changes in treatment plans.
  Continuous communication allows for re-evaluation of the patient’s understanding and preferences to ensure that consent remains active.

Documentation

Obtaining proper documentation of the informed consent conversation is critical. It shows that the patient and provider considered all the risks and benefits, and they both agreed to the procedure or treatment route as the best path of medical care.

• Recording for Legal Compliance
  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.
  
  This type of comprehensive documentation protects both the patient and the healthcare provider by serving as evidence that informed consent was obtained appropriately and care was not forced on the patient or given without their acknowledgment or approval.

Education

It could be argued that the language used in informed consent documents is 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 document 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.

At the end of the day, the key to meeting the informed consent 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 to do so.

Here are some ways to ensure your patients are truly informed in their decision making:

• Use Plain, Simple Language
  Avoid niche medical jargon and complex terms that might confuse patients. Instead, use clear language the average layperson can understand or words you know your particular patient is already comfortable with.
• Use the Teach-Back Method
  To verify if your patients understand, ask them to explain the information back to you in their own words. This can help confirm that they know what the treatment or procedure entails and are capable of making an informed decision.
• Use Visual Aids & Teaching Tools
  Some patients may understand complex information better if it is presented in a visual form. By providing learning tools like diagrams, models, or videos to illustrate procedures or treatments, you can simplify complex concepts in a way they can grasp.

FAQs About Informed Consent in Healthcare

Here are some frequent questions we have received from our Trust Fund members along with our best practice recommendations:

• Why is informed consent necessary?
  Informed consent is essential because it respects the patient’s autonomy, allowing them to make decisions that align with their values and preferences. It is also a legal and ethical requirement, to ensure that patients are not subjected to procedures without their knowledge and agreement.
• 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 “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.
• Does signing a consent form mean my patient can’t change their mind later?
  No. A signature does not mean patients are obligated to go through with a procedure or treatment. Every patient has the right to withdraw their consent or refuse treatment at any time, even after signing the form.
• What happens if a patient refuses to give consent?
  If your patient chooses to refuse consent, you should respect their decision. In some cases, though, refusal of treatment may require them to sign a form acknowledging that they understand the consequences of refusing care.
• Can a family member or guardian provide consent on a patient’s behalf?
  Yes. If a patient is unable to provide informed consent due to their age, mental incapacity, or incompetence, then a legally authorized representative (a parent, guardian, or healthcare proxy) can provide informed consent for them.
• What if a patient is unable to provide consent in an emergency situation?
  In emergencies, sometimes immediate medical intervention is required to prevent serious harm or death. If the patient is unable to provide consent and a proxy is unable to be reached within time, providers may proceed without formal consent. This is known as “implied consent” and is used only in situations where delaying treatment would put the patient at serious risk.