Medical Ethics

Medical Ethics US Medical PG Question 1: A 42-year-old woman presents to the physician with symptoms of vague abdominal pain and bloating for several months. Test results indicate that she has ovarian cancer. Her physician attempts to reach her by phone multiple times but cannot reach her. Next of kin numbers are in her chart. According to HIPAA regulations, who should be the primary person the doctor discusses this information with?

• A. The patient's brother
• B. The patient's husband
• C. The patient's daughter
• D. All of the options
• E. The patient (Correct Answer)

Medical Ethics Explanation: ***The patient*** - Under **HIPAA**, the patient has the **right to privacy** regarding their protected health information (PHI). Therefore, the physician must make all reasonable attempts to contact the patient directly to convey their diagnosis. - Sharing sensitive medical information like a cancer diagnosis with anyone other than the patient, without their explicit consent, would be a **violation of HIPAA regulations**. *The patient's brother* - The patient's brother is not automatically authorized to receive her medical information, even if listed as **next of kin**, without the patient's explicit consent or a documented **healthcare power of attorney**. - Discussing the diagnosis with the brother without the patient's direct consent would be a **breach of patient confidentiality**. *The patient's husband* - Even a spouse does not automatically have the right to access a patient's **PHI** without the patient's express permission, according to **HIPAA**. - While often a trusted contact, without explicit consent, revealing the diagnosis to the husband would still violate the patient's **privacy rights**. *The patient's daughter* - Similar to other family members, the patient's daughter is not legally entitled to receive her mother's confidential medical information without explicit authorization or a medical **power of attorney**. - The physician's primary responsibility is to the patient herself, ensuring her **privacy** is maintained. *All of the options* - According to **HIPAA**, sharing the patient's diagnosis with any family member without her explicit consent would be a **breach of confidentiality**. - This option incorrectly assumes that **next of kin** automatically have the right to receive sensitive medical information.

Medical Ethics US Medical PG Question 2: An 83-year-old man presents to the gastroenterologist to follow-up on results from a biopsy of a pancreatic head mass, which the clinician was concerned could be pancreatic cancer. After welcoming the patient and his wife to the clinic, the physician begins to discuss the testing and leads into delivering the results, which showed metastatic pancreatic adenocarcinoma. Before she is able to disclose these findings, the patient stops her and exclaims, "Whatever it is, I don't want to know. Please just make me comfortable in my last months alive. I have made up my mind about this." Which of the following is the most appropriate response on the part of the physician?

• A. "If that is your definite wish, then I must honor it" (Correct Answer)
• B. "The cancer has spread to your liver"
• C. "As a physician, I am obligated to disclose these results to you"
• D. "If you don't know what condition you have, I will be unable to be your physician going forward"
• E. "Please, sir, I strongly urge you to reconsider your decision"

Medical Ethics Explanation: ***"If that is your definite wish, then I must honor it"*** - This response respects the patient's **autonomy** and right to refuse information, aligning with ethical principles of patient-centered care. - The patient has clearly and articulately stated his desire not to know and wishes for **palliative care**, which the physician should respect. - The patient appears to have **decision-making capacity** based on his clear communication of wishes. *"The cancer has spread to your liver"* - This statement violates the patient's explicit request not to be informed of his diagnosis, potentially causing distress and undermining trust. - Disclosure of information against a patient's wishes is unethical when the patient has **decision-making capacity** and has clearly refused information. *"As a physician, I am obligated to disclose these results to you"* - While physicians have a general duty to inform, this is superseded by a **competent patient's right to refuse information**. - No absolute obligation exists to force information upon a patient who explicitly states a desire not to know, especially when it concerns their own health information. *"If you don't know what condition you have, I will be unable to be your physician going forward"* - This response is coercive and threatening, attempting to strong-arm the patient into accepting information he has refused. - A physician's role includes managing symptoms and providing comfort, even if the patient chooses not to know the full diagnostic details of their condition, particularly in a **palliative care** context. - This statement could constitute **patient abandonment**, which is unethical. *"Please, sir, I strongly urge you to reconsider your decision"* - While it's acceptable to ensure the patient fully understands the implications of their decision, a forceful "urge to reconsider" after a clear refusal can be seen as undermining their **autonomy**. - The physician should confirm the patient's understanding and offer an opportunity to discuss it later if desired, rather than immediately pressuring them.

Medical Ethics US Medical PG Question 3: A research group wants to assess the safety and toxicity profile of a new drug. A clinical trial is conducted with 20 volunteers to estimate the maximum tolerated dose and monitor the apparent toxicity of the drug. The study design is best described as which of the following phases of a clinical trial?

• A. Phase 0
• B. Phase III
• C. Phase V
• D. Phase II
• E. Phase I (Correct Answer)

Medical Ethics Explanation: ***Phase I*** - **Phase I clinical trials** involve a small group of healthy volunteers (typically 20-100) to primarily assess **drug safety**, determine a safe dosage range, and identify side effects. - The main goal is to establish the **maximum tolerated dose (MTD)** and evaluate the drug's pharmacokinetic and pharmacodynamic profiles. *Phase 0* - **Phase 0 trials** are exploratory studies conducted in a very small number of subjects (10-15) to gather preliminary data on a drug's **pharmacodynamics and pharmacokinetics** in humans. - They involve microdoses, not intended to have therapeutic effects, and thus cannot determine toxicity or MTD. *Phase III* - **Phase III trials** are large-scale studies involving hundreds to thousands of patients to confirm the drug's **efficacy**, monitor side effects, compare it to standard treatments, and collect information that will allow the drug to be used safely. - These trials are conducted after safety and initial efficacy have been established in earlier phases. *Phase V* - "Phase V" is not a standard, recognized phase in the traditional clinical trial classification (Phase 0, I, II, III, IV). - This term might be used in some non-standard research contexts or for post-marketing studies that go beyond Phase IV surveillance, but it is not a formal phase for initial drug development. *Phase II* - **Phase II trials** involve several hundred patients with the condition the drug is intended to treat, focusing on **drug efficacy** and further evaluating safety. - While safety is still monitored, the primary objective shifts to determining if the drug works for its intended purpose and at what dose.

Medical Ethics US Medical PG Question 4: A psychiatrist receives a call from a patient who expresses thoughts of harming his ex-girlfriend. The patient describes a detailed plan to attack her at her workplace. Which of the following represents the psychiatrist's most appropriate legal obligation?

• A. Warn the ex-girlfriend and notify law enforcement (Correct Answer)
• B. Only notify the patient's family
• C. Warn only law enforcement
• D. Maintain patient confidentiality

Medical Ethics Explanation: ***Warn the ex-girlfriend and notify law enforcement*** - This scenario directly triggers the **"duty to warn"** and **"duty to protect"** principles, primarily stemming from the **Tarasoff v. Regents of the University of California** case. - The psychiatrist has a legal obligation to take reasonable steps to protect the identifiable victim, which includes directly warning the intended victim and informing law enforcement. *Only notify the patient's family* - Notifying the patient's family alone does not fulfill the **legal obligation to protect** an identifiable third party from a serious threat of harm. - While family involvement might be part of a comprehensive safety plan, it is insufficient as the sole action in this critical situation. *Warn only law enforcement* - While notifying law enforcement is a crucial step, the **Tarasoff duty** specifically mandates warning the **intended victim** directly (or those who can reasonably be expected to notify the victim). - Relying solely on law enforcement might not ensure the immediate safety of the ex-girlfriend, especially if there's a delay in their response or ability to locate her. *Maintain patient confidentiality* - Patient confidentiality is a cornerstone of psychiatric practice, but it is **not absolute** when there is a serious and imminent threat of harm to an identifiable individual. - The **duty to protect** a potential victim *outweighs* the duty to maintain confidentiality in such extreme circumstances.

Medical Ethics US Medical PG Question 5: A 73-year-old man is brought to the emergency department by ambulance after being found to be non-communicative by his family during dinner. On presentation he appears to be alert, though he is confused and cannot follow instructions. When he tries to speak, he vocalizes a string of fluent but unintelligible syllables. Given this presentation, his physician decides to administer tissue plasminogen activator to this patient. This intervention best represents which of the following principles?

• A. Tertiary prevention
• B. Primary prevention
• C. This does not represent prevention (Correct Answer)
• D. Quaternary prevention
• E. Secondary prevention

Medical Ethics Explanation: ***This does not represent prevention*** - The administration of **tissue plasminogen activator (tPA)** during an **acute stroke** is a **therapeutic intervention**, not a form of prevention. - **Prevention** refers to actions taken to prevent disease occurrence, detect it early, or prevent complications after recovery. Treating an acute, symptomatic event is **acute treatment**, not prevention. - This is an active medical intervention to treat an ongoing, symptomatic disease process (acute ischemic stroke), which falls under **therapeutic management** rather than any category of prevention. *Secondary prevention* - **Secondary prevention** involves **early detection** and treatment of asymptomatic or minimally symptomatic disease to prevent progression (e.g., screening mammography, colonoscopy). - For stroke specifically, secondary prevention would include interventions **after** the acute event to **prevent recurrence**, such as starting antiplatelet therapy (aspirin, clopidogrel), anticoagulation for atrial fibrillation, statin therapy, or carotid endarterectomy after TIA. - tPA is given during the acute symptomatic phase, making it treatment rather than secondary prevention. *Tertiary prevention* - **Tertiary prevention** focuses on **rehabilitation** and managing established disease to prevent complications and improve quality of life. - Examples after stroke include physical therapy, occupational therapy, speech therapy, and managing post-stroke complications like depression or spasticity. - This occurs in the recovery phase, not during acute treatment. *Primary prevention* - **Primary prevention** aims to prevent disease before it occurs in healthy individuals. - Examples include controlling hypertension, managing diabetes, smoking cessation, exercise, and healthy diet - all interventions that reduce stroke risk **before** any event occurs. *Quaternary prevention* - **Quaternary prevention** protects patients from **overmedicalization** and excessive or harmful medical interventions. - It involves avoiding unnecessary testing or treatment that may cause more harm than benefit. - Administering tPA for acute stroke (when indicated) is evidence-based treatment, not overtreatment.

Medical Ethics US Medical PG Question 6: A 14-year-old girl presents to the emergency room complaining of abdominal pain. She was watching a movie 3 hours prior to presentation when she developed severe non-radiating right lower quadrant pain. The pain has worsened since it started. She also had non-bloody non-bilious emesis 1 hour ago and continues to feel nauseated. Her temperature is 101°F (38.3°C), blood pressure is 130/90 mmHg, pulse is 110/min, and respirations are 22/min. On exam, she has rebound tenderness at McBurney point and a positive Rovsing sign. She is stabilized with intravenous fluids and pain medication and is taken to the operating room to undergo a laparoscopic appendectomy. While in the operating room, the circulating nurse leads the surgical team in a time out to ensure that introductions are made, the patient’s name and date of birth are correct, antibiotics have been given, and the surgical site is marked appropriately. This process is an example of which of the following human factor engineering elements?

• A. Forcing function
• B. Safety culture
• C. Simplification
• D. Standardization (Correct Answer)
• E. Resilience engineering

Medical Ethics Explanation: ***Standardization*** - The surgical **time-out** is a prime example of **standardization** in healthcare, as it involves a prescribed, uniform procedure followed in every surgery to enhance safety. - It ensures critical safety checks—like patient identification, site marking, and antibiotic administration—are consistently performed, thus reducing variability and the potential for errors. *Forcing function* - A **forcing function** is a design element that makes it impossible to commit an error, such as a specific connector shape that prevents incorrect device attachment. - The time-out, while a critical safeguard, still relies on human compliance and does not physically prevent an error from occurring if the steps are not followed. *Safety culture* - **Safety culture** refers to the shared beliefs, values, and attitudes that employees have about safety within an organization. - While a time-out contributes to a strong safety culture, it is a specific process or tool, not the overarching culture itself. *Simplification* - **Simplification** aims to reduce complexity in a process to minimize cognitive load and potential for error. - The time-out adds a structured step rather than simplifying an existing process; its purpose is to ensure all necessary checks are systematically completed. *Resilience engineering* - **Resilience engineering** focuses on an organization's ability to anticipate, cope with, and recover from failures, maintaining stability in the face of disruptions. - While the time-out promotes safety, it primarily addresses error prevention rather than the broader organizational capacity to adapt and recover from system failures.

Medical Ethics US Medical PG Question 7: A 28-year-old male presents to his primary care physician with complaints of intermittent abdominal pain and alternating bouts of constipation and diarrhea. His medical chart is not significant for any past medical problems or prior surgeries. He is not prescribed any current medications. Which of the following questions would be the most useful next question in eliciting further history from this patient?

• A. "Does the diarrhea typically precede the constipation, or vice-versa?"
• B. "Is the diarrhea foul-smelling?"
• C. "Please rate your abdominal pain on a scale of 1-10, with 10 being the worst pain of your life"
• D. "Are the symptoms worse in the morning or at night?"
• E. "Can you tell me more about the symptoms you have been experiencing?" (Correct Answer)

Medical Ethics Explanation: ***Can you tell me more about the symptoms you have been experiencing?*** - This **open-ended question** encourages the patient to provide a **comprehensive narrative** of their symptoms, including details about onset, frequency, duration, alleviating/aggravating factors, and associated symptoms, which is crucial for diagnosis. - In a patient presenting with vague, intermittent symptoms like alternating constipation and diarrhea, allowing them to elaborate freely can reveal important clues that might not be captured by more targeted questions. *Does the diarrhea typically precede the constipation, or vice-versa?* - While knowing the sequence of symptoms can be helpful in understanding the **pattern of bowel dysfunction**, it is a very specific question that might overlook other important aspects of the patient's experience. - It prematurely narrows the focus without first obtaining a broad understanding of the patient's overall symptomatic picture. *Is the diarrhea foul-smelling?* - Foul-smelling diarrhea can indicate **malabsorption** or **bacterial overgrowth**, which are important to consider in some gastrointestinal conditions. - However, this is a **specific symptom inquiry** that should follow a more general exploration of the patient's symptoms, as it may not be relevant if other crucial details are missed. *Please rate your abdominal pain on a scale of 1-10, with 10 being the worst pain of your life* - Quantifying pain intensity is useful for assessing the **severity of discomfort** and monitoring changes over time. - However, for a patient with intermittent rather than acute, severe pain, understanding the **character, location, and triggers** of the pain is often more diagnostically valuable than just a numerical rating initially. *Are the symptoms worse in the morning or at night?* - Diurnal variation can be relevant in certain conditions, such as inflammatory bowel diseases where nocturnal symptoms might be more concerning, or functional disorders whose symptoms might be stress-related. - This is another **specific question** that should come after gathering a more complete initial picture of the patient's symptoms to ensure no key information is overlooked.

Medical Ethics US Medical PG Question 8: A 28-year-old woman is brought to the emergency department after being resuscitated in the field. Her husband is with her and recalls seeing pills beside her when he was in the bathroom. He reveals she has a past medical history of depression and was recently given a prescription for smoking cessation. On physical exam, you notice a right-sided scalp hematoma and a deep laceration to her tongue. She has a poor EEG waveform indicating limited to no cerebral blood flow and failed both her apnea test and reflexes. She is found to be in a persistent vegetative state, and the health care team starts to initiate the end of life discussion. The husband states that the patient had no advance directives other than to have told her husband she did not want to be kept alive with machines. The parents want all heroic measures to be taken. Which of the following is the most accurate statement with regards to this situation?

• A. The physician may be appointed as the patient’s health care surrogate and may make end-of-life decisions on her behalf.
• B. The patient’s parents may be appointed as her health care surrogate and may make end-of-life decisions on her behalf.
• C. The patient’s husband may be appointed as her health care surrogate and may make end-of-life decisions on her behalf. (Correct Answer)
• D. An ethics committee must be appointed as the patient’s health care surrogate and may make end-of-life decisions on her behalf.
• E. A court-appointed guardian may be appointed as the patient's health care surrogate and may make end-of-life decisions on her behalf.

Medical Ethics Explanation: ***The patient’s husband may be appointed as her health care surrogate and may make end-of-life decisions on her behalf.*** - The **hierarchy for healthcare surrogates** typically prioritizes the spouse over parents when there is no advance directive. The husband's recollection of the patient's wishes, although not a formal advance directive, is also relevant. - State laws generally designate the **spouse as the primary default decision-maker** for incapacitated patients, followed by adult children, parents, and then adult siblings. *The physician may be appointed as the patient’s health care surrogate and may make end-of-life decisions on her behalf.* - A physician's role is to provide medical care and guidance, not to act as a **healthcare surrogate** due to potential conflicts of interest. - Appointing the treating physician as a surrogate undermines the principles of **patient autonomy** and impartial decision-making. *The patient’s parents may be appointed as her health care surrogate and may make end-of-life decisions on her behalf.* - While parents are part of the surrogate hierarchy, they are generally ranked below the **spouse** in most jurisdictions. - The parents' desire for "heroic measures" directly conflicts with the patient's stated wish to her husband, potentially leading to decisions not in the patient's best interest or previously expressed values. *An ethics committee must be appointed as the patient’s health care surrogate and may make end-of-life decisions on her behalf.* - An ethics committee's role is to provide **guidance and recommendations** in complex cases, mediate disputes, and ensure ethical principles are upheld, not to act as the primary healthcare surrogate. - A functional healthcare surrogate takes precedence over an ethics committee in making direct treatment decisions. *A court-appointed guardian may be appointed as the patient's health care surrogate and may make end-of-life decisions on her behalf.* - A court-appointed guardian is typically sought only if there is **no clear or willing surrogate** from the established hierarchy, or if there is a dispute among family members that cannot be resolved. - In this scenario, the husband is the legally recognized next of kin and surrogate by default, making court intervention unnecessary at this stage.

Medical Ethics US Medical PG Question 9: A 26-year-old man comes to the emergency department because of a 1-week history of fever, throat pain, and difficulty swallowing. Head and neck examination shows an erythematous pharynx with purulent exudates overlying the palatine tonsils. Microscopic examination of a throat culture shows pink, spherical bacteria arranged in chains. Treatment with amoxicillin is initiated. A day later, a physician colleague from another department approaches the physician in the lobby of the hospital and asks about this patient, saying, "Did you see him? What does he have? He's someone I play football with and he hasn't come to play for the past 5 days. I'm worried about him." Which of the following is the most appropriate action by the physician?

• A. Inform the colleague that they should ask the patient's attending physician
• B. Inform the colleague that they cannot divulge any information about the patient (Correct Answer)
• C. Tell the colleague the patient's case file number so they can look it up themselves
• D. Tell the colleague that they cannot tell them the diagnosis but that their friend was treated with antibiotics
• E. Ask the colleague to meet in the office so they can discuss the patient in private

Medical Ethics Explanation: ***Inform the colleague that they cannot divulge any information about the patient*** - The **Health Insurance Portability and Accountability Act (HIPAA)** strictly prohibits the disclosure of a patient's **Protected Health Information (PHI)** without their explicit consent. - Even if the inquirer knows the patient, a physician-patient relationship creates a **duty of confidentiality** that supersedes personal acquaintance. - Disclosing any information without patient consent, even to another physician, violates HIPAA regulations. *Tell the colleague the patient's case file number so they can look it up themselves* - Providing the case file number would enable unauthorized access to the patient's medical records, thereby violating **patient confidentiality** and **HIPAA regulations**. - This action does not rectify the breach of confidentiality and escalates the potential for further misuse of PHI. *Inform the colleague that they should ask the patient's attending physician* - Recommending that the colleague ask the attending physician shifts the burden but does not address the underlying ethical and legal obligation of the current physician to maintain **confidentiality**. - The attending physician would also be bound by **HIPAA** and ethical guidelines not to disclose information without consent. *Tell the colleague that they cannot tell them the diagnosis but that their friend was treated with antibiotics* - While seemingly less specific, stating that the friend was treated with **antibiotics** is still a disclosure of **Protected Health Information (PHI)**. - This action violates **patient confidentiality** as it reveals a detail of the patient's medical management without consent. *Ask the colleague to meet in the office so they can discuss the patient in private* - Moving to a private setting does not negate the fact that discussing the patient's information with an unauthorized individual is a **breach of confidentiality**. - The location of the conversation does not change the ethical and legal obligations to protect **PHI**.

Medical Ethics US Medical PG Question 10: A 40-year-old woman presents to her physician's home with a headache. She describes it as severe and states that her symptoms have not been improving despite her appointment yesterday at the office. Thus, she came to her physician's house on the weekend for help. The patient has been diagnosed with migraine headaches that have persisted for the past 6 months and states that her current symptoms feel like her previous headaches with a severity of 3/10. She has been prescribed multiple medications but is generally non-compliant with therapy. She is requesting an exam and urgent treatment for her symptoms. Which of the following is the best response from the physician?

• A. It sounds to me like you are in a lot of pain. Let me see how I can help you.
• B. Do not come to my house when you have medical problems. You should make an appointment.
• C. Your symptoms seem severe. Let me perform a quick exam to see if everything is alright.
• D. Unfortunately, I cannot examine and treat you at this time. Please set up an appointment to see me in my office. (Correct Answer)
• E. You should go to the emergency department for your symptoms rather than coming here.

Medical Ethics Explanation: ***Unfortunately, I cannot examine and treat you at this time. Please set up an appointment to see me in my office.*** - This response appropriately **maintains professional boundaries** by declining an unscheduled visit to the physician's private residence. - While house calls are not inherently unethical, this situation is problematic because: the physician is unprepared, lacks proper medical equipment and documentation resources at home, and the patient's symptoms (3/10 severity, chronic migraine) do not constitute an emergency. - This response is **empathetic yet firm**, redirecting the patient to appropriate care settings where proper examination, documentation, and treatment can occur. - Setting this boundary prevents establishing an inappropriate precedent for future unscheduled home visits. *It sounds to me like you are in a lot of pain. Let me see how I can help you.* - While showing empathy, agreeing to treat the patient at home without preparation creates problems: **lack of proper medical equipment, diagnostic tools, and documentation resources**. - This action **blurs professional boundaries** and sets an inappropriate precedent for future unscheduled patient interactions at the physician's home. - The patient's severity (3/10) and chronic nature of symptoms do not justify an urgent unscheduled home examination. *Do not come to my house when you have medical problems. You should make an appointment.* - This response is **unprofessional and lacks empathy**, potentially damaging the patient-physician relationship. - While the message about boundaries is appropriate, the **harsh tone** fails to provide compassionate guidance for the patient's concerns. *Your symptoms seem severe. Let me perform a quick exam to see if everything is alright.* - Despite acknowledging the patient's concern, performing an unscheduled exam at home is **inappropriate** due to lack of preparation, proper equipment, and resources for thorough assessment. - This decision could lead to **inadequate care and documentation issues**, as the physician would be practicing in an unplanned setting without proper resources. *You should go to the emergency department for your symptoms rather than coming here.* - While this directs the patient to a medical facility, the patient has **3/10 severity** chronic migraine symptoms that do not constitute an emergency, making the ED an **inappropriate over-triage**. - This response may come across as dismissive and could strain the patient-physician relationship, though it does maintain appropriate boundaries.

Medical Ethics Flashcard 1 of 10

Question: The Beers criteria are used to reduce potential inappropriate prescribing and harmful polypharmacy in the _____ population

Answer: geriatric

Medical Ethics Flashcard 2 of 10

Question: What type of disease prevention is identifying patients at risk of unnecessary treatment?_____

Answer: Quaternary

Medical Ethics Flashcard 3 of 10

Question: Examples of the beers criteria include drugs that increase the risk of _____ (benzodiazepines, opioids)

Answer: falls

Medical Ethics Flashcard 4 of 10

Question: beneficience (bioethics)

Answer: duty to act in the best interest of the patient

Medical Ethics Flashcard 5 of 10

Question: respect for patient autonomy (bioethics)

Answer: obligation to respect patient preferences in medical care

Medical Ethics Flashcard 6 of 10

Question: Give examples of four common situations in which breaching patient confidentiality may be justified or required (state specific).

Answer: 1. Reportable disease 2. Child/elder abuse 3. Suicidal/homidical patients 4. Intoxicated driver (Breach may be justified when patient plans to commit any dangerous crime not explicitly listed above.)

Medical Ethics Flashcard 7 of 10

Question: Patient has difficulty taking medications.

Answer: Provide written instructions, simplify treatment regimen, use teach-back

Medical Ethics Flashcard 8 of 10

Question: A drug company offers a "referral fee" for every patient a physician enrolls in the study.

Answer: Eligible patients who may benefit may be enrolled, but it is never acceptable to receive compensation from a drug company. Patients should be informed that a referral fee was offered.

Medical Ethics Flashcard 9 of 10

Question: You order an invasive test for the wrong patient.

Answer: No matter how serious or trivial, a physician is obligated to inform a patient that an error has been made.

Medical Ethics Flashcard 10 of 10

Question: Give three factors, that together, might justify a breach of patient confidentiality.

Answer: 1. patient may harm self or others 2. by breaching confidentiality, harm may be prevented or mitigated 3. no alternate means exist to warn or protect those at risk