Informed Consent in Healthcare: A Process, Not a Paper Trail

A pen rests on a signed document, symbolizing the crucial role of informed consent in ensuring transparent and ethical agreements.

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Informed consent is one of the bedrocks of ethical and legal medical care. It ensures that patients understand the nature of their treatment, the risks involved, the available alternatives, and ultimately, that they agree to undergo the recommended procedures. Yet, across the healthcare industry, the informed consent process is too often reduced to a mere formality, a document signed moments before surgery or a treatment without a real meaningful conversation where shared decision making occurs between the provider and patient. This shortcut undermines patient autonomy and, when improperly handled, can become a significant factor in medical malpractice lawsuits.

This blog examines the inherent challenges in maintaining informed consent as a meaningful, patient-and-family-centered process. We will look at real-world legal cases where failure to provide proper informed consent led to patient harm, and provide actionable guidance on what patients can do to ensure their rights are respected, and that all treatment options are explored, with the final decision being made knowing all potential complications and outcomes of the alternatives. Finally, we’ll share how EvaluCare helps patients review their care and determine whether a provider’s failure to obtain informed consent may have contributed to a poor outcome.

What Informed Consent Really Means

True informed consent is not just about signing a form, it’s about an open dialogue between the patient and the provider. This conversation should cover:

• The diagnosis or condition being treated

• The recommended treatment or procedure

• The risks and potential complications

• Reasonable alternatives and their associated risks

• The expected outcome with or without the treatment

  
  

The process should be led by the physician performing the procedure, not delegated to a nurse or administrative staff. Patients must be given the opportunity to ask questions and receive answers in a language and manner they understand. There must be an understanding of the risks and benefits of all alternatives so that decision making is informed.  

The Challenges of Properly Executing Informed Consent

1. Viewing Consent as a Legal Shield Rather Than a Communication Tool: Many institutions treat informed consent as a catch-all liability form rather than a patient education opportunity. Pre-printed forms listing every imaginable complication often overwhelm patients and do little to help them understand specific risks. Providing consent for different scenarios that arise is a potential point of confusion.

   
   

2. Time Pressures in Modern Healthcare: Physicians may rush through explanations due to overbooked schedules or operating room delays. If you are the first surgical case in the morning and hospital administrators are closely monitoring on-time starts, the chances of an informed consent being rushed is immense. Add on the fact that an anesthesiologist is waiting buy, and has other patients to meet with, it becomes clear that time is a competing factor for thoroughly executed informed consents. This can leave patients inadequately informed about potential side effects, recovery times, or alternative options.

   
   

3. Complex Procedures Require Clearer Communication: Especially in surgery, consent should be procedure-specific. A form for a “laparoscopic abdominal surgery” is not sufficient if the actual procedure is a colectomy or appendectomy. Lack of specificity can lead to confusion and legal vulnerability of the risks and benefits. Additionally an open appendectomy compared with a laparoscopic appendectomy are very different surgeries that require different consents to match the actual procedure and risks and complications of each type.

   
   

4. Keeping Consent Up to Date: For long-term treatment plans, consent should be refreshed. Conditions and risks evolve, and the initial conversation may no longer reflect the patient’s situation or updated medical guidance.

   
   

5. Delegation to Mid-Level Providers: Increasingly, patients receive care from nurse practitioners and physician assistants. While these professionals are highly capable, informed consent, especially for invasive or high-risk procedures, should involve the supervising physician.

   
   

6. Language and Health Literacy Barriers: Patients with limited English proficiency or lower health literacy levels may sign forms they don’t fully understand. Providers must take extra steps to ensure clarity, using interpreters and visual aids when necessary. It is not enough to have a family member translate, in fact that rarely if ever acceptable. Translation services should be provided.

   
   

Legal Consequences of Failing to Obtain Proper Informed Consent

Several lawsuits have highlighted the importance of informed consent

• Wisconsin (2012): In Jandre v. Physicians Insurance Co., a patient underwent a procedure to treat a facial droop, only to later learn that no tests were done to rule out a stroke. The jury found that the physician failed to disclose the alternative of a carotid ultrasound. The court upheld a $2 million verdict.

  
  

• New York (2015): A woman sued after a hysterectomy revealed she had cancer, which she wasn’t told could be a possible reason for the surgery. The court ruled that she wasn’t fully informed of all reasons and risks and awarded damages for lack of informed consent.

  
  

• California (2020): A man underwent spinal fusion surgery without being told of the high complication rate and that the performing surgeon had limited experience. Post-operative paralysis led to a $3.8 million settlement.

  
  

These cases reinforce that informed consent must be patient-specific, understandable, and reflect realistic expectations.

The Changing Face of Care Delivery and Its Impact on Informed Consent

In the past, patients often had long-standing relationships with their primary care physicians who managed their care in and out of the hospital. Today, hospitalists and rotating specialists often take over care in acute settings, leading to fragmented communication and a lack of a long term connection to the patient. This can make healthcare transactional.

The high utilization of mid-level providers and institutional workflows designed for efficiency rather than education means consent can be deprioritized. Online consents can make it harder to review in some cases. Signtature pads make it easy to collect a signature, but if you are signing a electronic pad are you really connected to the consent.

These challenges are especially problematic in fast paced settings like:

• Emergency care

• Surgical centers

• Multispecialty group practices

  
  

As providers shift focus to throughput and documentation, the consent process risks becoming just another checked box.

What Patients Can Do to Ensure They Understand Informed Consent

1. Ask Direct Questions:

   • What exactly is this procedure?

   • What are the most common complications?

   • How often do you, specifically, encounter these complications?

   • What are the alternatives?

   • What happens if I choose not to do this?

     
     

2. Request Written Materials and Illustrations: Diagrams, brochures, or videos can help reinforce your understanding.

   
   

3. Bring a Friend or Family Member: A second set of ears can catch details you may miss and help ask critical questions.

   
   

4. Request a Follow-Up Conversation: If you’re unsure, ask to speak again with the physician before the procedure.

   
   

5. Know Your Rights: You have the right to delay or refuse a procedure if you don’t feel adequately informed.

   
   

6. Speak to Others (Second Opinion): Understand the alternatives and their risks and benefits to make an informed decision.

For More Information on Informed Consents

The following links you can learn more about informed consent.

American Medical Association (AMA) – Informed Consent Guidancehttps://www.ama-assn.org/delivering-care/ethics/informed-consentThe AMA provides ethical guidance and standards on the informed consent process, including what physicians should disclose and how to ensure patient understanding.

U.S. Department of Health & Human Services – Office for Human Research Protections (OHRP)https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.htmlThis site offers detailed FAQs and regulations on informed consent in both clinical and research settings.

National Institutes of Health (NIH) – Informed Consent Resourceshttps://www.nih.gov/health-information/nih-clinical-research-trials-you/basicsAlthough focused on clinical trials, the NIH provides accessible resources on informed consent that are relevant to broader healthcare contexts.

Agency for Healthcare Research and Quality (AHRQ) – Questions to Ask Your Doctorhttps://www.ahrq.gov/patients-consumers/patient-involvement/ask-your-doctor/index.htmlAHRQ helps patients become active participants in their care, offering tools and questions to ask to ensure informed decision-making.

How EvaluCare Can Help When Consent Falls Short

When a procedure results in unexpected harm or complications, and you were never informed those were risks, EvaluCare can help determine if your rights were violated.

EvaluCare’s team of clinicians and healthcare quality experts will:

• Review your medical records and consent documents

• Assess whether the consent was properly executed

• Compare your case against medical standards and documentation protocols

  
  

If informed consent was inadequate or misleading, EvaluCare can help you get answers and, when appropriate, recommend a course for accountability.

Compassion, Clarity, and Justice

When informed consent is handled properly, it empowers patients. When mishandled, it leads to confusion, fear, and sometimes irreversible harm. Patients deserve better than a rushed signature, they deserve a true understanding of their care.

If you believe your provider failed to properly inform you, EvaluCare is here to help. Our compassionate team will work with you to uncover what happened and provide clarity during a difficult time.

You are not alone. With EvaluCare, you have a trusted partner to help you navigate medical uncertainty and fight for the answers you deserve.

Learn more at www.EvaluCare.net or email info@EvaluCare.net

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References:

• American Medical Association. Code of Medical Ethics Opinion 2.1.1.

• Jandre v. Physicians Insurance Co. of Wisconsin, 2012 WI 39.

• CDC Health Literacy Tools.

• Medical Malpractice Verdicts and Settlements Reports, 2015–2022.

• National Institutes of Health: Best Practices in Informed Consent.