What is Informed Consent?
Picture this: It's 7 AM on surgery day. Your patient is in a hospital gown, IV already in, and family members are hovering nervously. A surgical resident walks in with a clipboard full of forms and starts rattling off risks: "There's bleeding, infection, nerve damage, anesthesia complications..."
The patient nods along, signs quickly, and asks just one question: "How long will this take?"
As a practicing physician, I've seen this scenario play out hundreds of times — and I've even been guilty of being that rushed surgeon myself. This is informed consent in 2025 — and I think it's fundamentally broken.
Simplified Definition
Informed consent is the process where the doctor explains a medical procedure to the patient in detail, and said patient agrees to it with full understanding of what's involved. Think of it as a conversation, not just signing a piece of paper.
There are usually two main types of informed consent in medicine:
Informed consent for research - this covers the risks and benefits of joining a clinical trial.
Informed consent for procedures - for things like blood transfusions, biopsies, and surgeries. This is what we are focusing on.
Procedural informed consent is different because the participation tends to be required for a desired health outcome.
For surgery, informed consent should include:
What the surgery involves (the technical details in plain English)
Why it’s needed (the medical reason)
What could go wrong (the risks)
What it should achieve (the benefits)
What happens if one doesn’t have it (the consequences)
Other options available (the alternatives)
Anesthesia and contrast options
Other consents (like blood transfusion, medical research etc.)
What to expect afterward (the recovery)
As we can see, this is an incredibly long list of things and sometimes, in the hurried clinical environment we are in, not all bases are touched upon.
Medical Definition
Informed consent is a core pillar of patient autonomy and shared decision‑making in both clinical care and research. It traditionally involves three essential components:
Capacity – the patient’s ability to understand, reason, and decide
Disclosure – clear communication of relevant information (benefits, risks, alternatives)
Voluntariness – freedom from coercion or undue influence.
In practice, it is delivered via both verbal discussions and written forms. Ideally, it ensures individuals grasp what they are agreeing to and participate willingly.
Unfortunately, the reality of informed consent rarely matches this ideal definition. Instead of meaningful dialogue, we get the rushed clipboard scenario I described at the beginning. Patients can sometimes be overwhelmed by medical jargon, pressed for time, and too anxious to ask meaningful questions. The result? When complications arise — even expected ones that fall within normal surgical risk — patients feel blindsided and unprepared. They remember signing papers, but they don't remember understanding what those papers meant. This gap between what informed consent should be and what it is creates problems for everyone: non-confident patients, confused families, and physicians who thought they had communicated clearly but clearly hadn't.
Why do we have such problems?
Like all things in medicine, reasons are multi-faceted.
1. Time Pressure
Surgical schedules are packed. Physicians are under pressure to see more patients in less time. The consent conversation becomes a checklist item rather than a genuine dialogue.
Insurance companies and hospitals (fee-for-service) measure success by how many procedures get done, not by how well patients understand them.
2. Information overload without much context
Most people have never had surgery before, so they don't know what questions to ask or what information they need. They're often scared and rely entirely on their physician's judgment, though hospitals do provide helpful guides about what to ask before surgery.
3. Legal protection trumps patient understanding
Most consent forms are written by hospital legal teams, not physicians.
And physicians feel legally obligated to mention every possible complication, no matter how rare, because of potential liabilities. Yet, a study published in the Journal of Vascular Surgery found that up to 50% of patients couldn't recall specific risks of their surgery. Consent forms are designed to protect institutions from lawsuits, not help patients make informed decisions.
4. Medical training gaps
We learn how to diagnose and treat, but we rarely receive formal training in explaining complex information to anxious patients. Medical jargon is constantly used, and terms like "minimal risk" mean different things to physicians and patients. When a surgeon says there's a "small chance" of complications, patients might think that means 1 in 1000, while the surgeon means 1 in 100.
While there have been improvements, during my medical school years - we learned how to break bad news (like cancer diagnoses), but not how to counsel patients about procedures like a hemicolectomy.
The hidden costs of broken consent
This isn't just a patient experience problem — it's driving up costs and putting providers at risk:
💰 Legal exposure: Poor informed consent is the second-leading risk management issue after documentation problems.
⏰ Surgical delays: Last-minute patient questions and concerns cause schedule disruptions
🔄 Repeat visits: Patients who don't understand their procedure often require additional consultations and reassurance
😰 Provider burnout: Physicians feel caught between legal requirements and genuine patient care
What Are Some Potential Solutions? And What Have Been Implemented?
The good news? Healthcare organizations are testing and implementing solutions that improve both patient understanding and provider efficiency.
1. More time = better understanding
Some hospitals now require consent discussions > 30 days or weeks before surgery, not the morning of.
2. Tech that teaches
Interactive digital platforms, informative videos, and visual aids make complex procedures easier to understand. Instead of just hearing about a knee replacement, patients can explore an interactive guide on their phone with verified health resources.
Research shows informative videos, interactive digital platforms, and written interventions are making complex procedures easier to understand. These aids can improve patients' ability to remember facts and risks compared to verbal explanations alone.
3. The teach-back method
This simple technique involves asking patients to repeat back what they've learned in their own words. If patients can't explain the procedure or key risks, the physician knows to try a different approach. Recent studies show that teach-back methods enhance patient comprehension while building trust between surgeons and patients
4. Shared Decision-Making Tools
Structured frameworks help doctors and patients work through decisions together, with a clear presentation of options, risks, and benefits.
KPIs for Better Informed Consent
How can we tell if consent solutions are truly effective? Tracking the right metrics across these key domains can shed light.
Patient Understanding & Engagement
📋 Comprehension scores from brief post-consent surveys
✅ Percentage of patients who can accurately describe their procedure
📞 Fewer pre-surgery anxiety-related calls to clinic staff
Operational Efficiency
🕒 Time saved per consent interaction
📂 Fewer consent-related surgical delays
🔄 Reduction in forms requiring correction or rework
Quality & Safety Outcomes
📈 Higher patient satisfaction with the consent experience on a Likert scale
⚖️ Fewer informed consent-related malpractice incidents over years
🏥 Smoother, more predictable surgery-day workflows
Provider Experience
😊 Increased physician satisfaction with the consent process
💼 Lower administrative and documentation burden
🗣️ Improved communication scores between patients and providers
Conclusion
Like most things in healthcare, it takes a team to drive change: for patients - ask questions, request for information, use teach-back to confirm your understanding. For providers - advocate for better consent processes. For administrators - keep track of ROIs, track patient comprehension, and be open to investing in technology that supports communication.
Informed consent for surgery shouldn't be a box-checking exercise.
It should be a real conversation between a patient and a physician about one of the most important decisions in health.
The goal is not a perfect consent - it is a meaningful and informed consent. I truly believe that when patients understand and feel confident about their care, they are empowered in their health and everyone wins: better outcomes, lower costs, less litigation, and more trust.
At Standard Form, we help healthcare teams modernize their informed consent workflows without disruption — supporting better care, clearer communication, and stronger compliance from day one.
