Informed consent for research US Medical PG Practice Questions and MCQs
Practice US Medical PG questions for Informed consent for research. These multiple choice questions (MCQs) cover important concepts and help you prepare for your exams.
Informed consent for research US Medical PG Question 1: A research team develops a new monoclonal antibody checkpoint inhibitor for advanced melanoma that has shown promise in animal studies as well as high efficacy and low toxicity in early phase human clinical trials. The research team would now like to compare this drug to existing standard of care immunotherapy for advanced melanoma. The research team decides to conduct a non-randomized study where the novel drug will be offered to patients who are deemed to be at risk for toxicity with the current standard of care immunotherapy, while patients without such risk factors will receive the standard treatment. Which of the following best describes the level of evidence that this study can offer?
- A. Level 1
- B. Level 3 (Correct Answer)
- C. Level 5
- D. Level 4
- E. Level 2
Informed consent for research Explanation: ***Level 3***
- A **non-randomized controlled trial** like the one described, where patient assignment to treatment groups is based on specific characteristics (risk of toxicity), falls into Level 3 evidence.
- This level typically includes **non-randomized controlled trials** and **well-designed cohort studies** with comparison groups, which are prone to selection bias and confounding.
- The study compares two treatments but lacks randomization, making it Level 3 evidence.
*Level 1*
- Level 1 evidence is the **highest level of evidence**, derived from **systematic reviews and meta-analyses** of multiple well-designed randomized controlled trials or large, high-quality randomized controlled trials.
- The described study is explicitly stated as non-randomized, ruling out Level 1.
*Level 2*
- Level 2 evidence involves at least one **well-designed randomized controlled trial** (RCT) or **systematic reviews** of randomized trials.
- The current study is *non-randomized*, which means it cannot be classified as Level 2 evidence, as randomization is a key criterion for this level.
*Level 4*
- Level 4 evidence includes **case series**, **case-control studies**, and **poorly designed cohort or case-control studies**.
- While the study is non-randomized, it is a controlled comparative trial rather than a case series or retrospective case-control study, placing it at Level 3.
*Level 5*
- Level 5 evidence is the **lowest level of evidence**, typically consisting of **expert opinion** without explicit critical appraisal, or based on physiology, bench research, or animal studies.
- While the drug was initially tested in animal studies, the current human comparative study offers a higher level of evidence than expert opinion or preclinical data.
Informed consent for research US Medical PG Question 2: A 19-year-old man presents to an orthopedic surgeon to discuss repair of his torn anterior cruciate ligament. He suffered the injury during a college basketball game 1 week ago and has been using a knee immobilizer since the accident. His past medical history is significant for an emergency appendectomy when he was 12 years of age. At that time, he said that he never wanted to have surgery again. At this visit, the physician explains the procedure to him in detail including potential risks and complications. The patient acknowledges and communicates his understanding of both the diagnosis as well as the surgery and decides to proceed with the surgery in 3 weeks. Afterward, he signs a form giving consent for the operation. Which of the following statements is true about this patient?
- A. He cannot provide consent because he lacks capacity
- B. He has the right to revoke his consent at any time (Correct Answer)
- C. His parents also need to give consent to this operation
- D. He did not need to provide consent for this procedure since it is obviously beneficial
- E. His consent is invalid because his decision is not stable over time
Informed consent for research Explanation: ***He has the right to revoke his consent at any time***
- **Informed consent** for medical procedures is an ongoing process, and a patient retains the right to **withdraw consent** at any point, even after initially signing the consent form.
- This right is a fundamental aspect of patient autonomy and ensures that medical interventions are only performed with a patient's current and willing agreement.
*He cannot provide consent because he lacks capacity*
- The patient is 19 years old, which in most jurisdictions (including the US where the age of majority is typically 18) means he is considered an **adult** and legally capable of providing his own consent.
- The scenario explicitly states he "communicates his understanding of both the diagnosis as well as the surgery," indicating he possesses the **mental capacity** to make an informed decision.
*His parents also need to give consent to this operation*
- As a 19-year-old, the patient has reached the **age of majority** and is legally entitled to make his own medical decisions, including consenting to surgery.
- Parental consent is generally required for minors (individuals under the age of majority), but not for adults like this patient.
*He did not need to provide consent for this procedure since it is obviously beneficial*
- Even for procedures that are clearly **beneficial**, informed consent is ethically and legally mandatory to uphold **patient autonomy** and ensure respect for individual rights.
- The concept of "obviously beneficial" does not negate the requirement for a patient's explicit agreement to a medical intervention.
*His consent is invalid because his decision is not stable over time*
- While the patient might have initially hated surgery at age 12, his current decision at age 19 to proceed with the ACL repair is based on current information and his mature understanding.
- The fact that his previous aversion to surgery has changed does not invalidate his current, well-informed decision; it simply indicates a change in perspective based on new circumstances and greater maturity.
Informed consent for research US Medical PG Question 3: A 15-year-old female presents to her family physician for an annual school physical exam and check-up. She is accompanied by her mother to the visit and is present in the exam room. The patient has no complaints, and she does not have any past medical problems. She takes no medications. The patient reports that she remains active, exercising 5 times a week, and eats a healthy and varied diet. Which of the following would be the best way for the physician to obtain a more in-depth social history, including sexual history and use of alcohol, tobacco, or recreational drugs?
- A. Disallow the mother to be present in the examination room throughout the entirety of the visit
- B. Give the patient a social history questionnaire to fill out in the exam room
- C. Ask the mother to step outside into the hall for a portion of the visit (Correct Answer)
- D. Ask the patient the questions directly, with her mother still in the exam room
- E. Speak softly to the patient so that the mother does not hear and the patient is not embarrassed
Informed consent for research Explanation: ***Ask the mother to step outside into the hall for a portion of the visit***
- This approach allows the physician to speak with the adolescent **privately and confidentially**, which is crucial for obtaining sensitive information such as sexual history, drug use, and mental health concerns.
- Adolescents are more likely to disclose personal information when their parents are not present, fostering trust and ensuring **comprehensive history-taking** vital for their well-being.
*Disallow the mother to be present in the examination room throughout the entirety of the visit*
- This is an **overly restrictive** approach that might create tension or distrust between the physician, patient, and parent, especially at the start of the visit.
- While privacy is essential for sensitive topics, parental presence can be valuable for discussing general health, family history, and **treatment plans**, especially for younger adolescents.
*Give the patient a social history questionnaire to fill out in the exam room*
- While questionnaires can be useful for gathering basic information, they often **lack the nuance** of a direct conversation and may not prompt the patient to elaborate on sensitive issues.
- Furthermore, having the mother present while the patient fills out a questionnaire on sensitive topics still **compromises confidentiality** and may lead to incomplete or dishonest answers.
*Ask the patient the questions directly, with her mother still in the exam room*
- Asking sensitive questions with a parent present is **unlikely to yield truthful and complete answers**, as adolescents may feel embarrassed, judged, or fear parental disapproval.
- This approach compromises the **confidentiality** that is fundamental to building trust with adolescent patients.
*Speak softly to the patient so that the mother does not hear and the patient is not embarrassed*
- Speaking softly is **unprofessional** and still does not guarantee privacy, as the mother might still overhear parts of the conversation.
- This method also **fails to establish true confidentiality**, which is central to building rapport and encouraging open communication with adolescent patients about sensitive topics.
Informed consent for research US Medical PG Question 4: A pharmaceutical corporation has asked you to assist in the development of a randomized controlled trial (RCT) to evaluate the response of renal cell carcinoma to a novel chemotherapeutic agent. Despite all of the benefits that an RCT has to offer, which of the following would make an RCT unacceptable with regard to study design?
- A. Proper treatment response is very common
- B. The treatment is not widespread in use
- C. The treatment does not represent the best known option
- D. The treatment is expensive
- E. The treatment has a known, adverse outcome (Correct Answer)
Informed consent for research Explanation: ***The treatment has a known, adverse outcome***
- If a treatment is already known to cause **significant harm** or an adverse outcome, it would be unethical to randomize patients to receive it, as this would expose them to unnecessary risk.
- **Ethical considerations** are paramount in clinical trial design; exposing patients to a known harmful treatment violates the principle of non-maleficence.
*Proper treatment response is very common*
- A high treatment response rate would make it **easier to detect a difference** between the novel agent and a control group, potentially requiring a smaller sample size.
- This scenario actually **facilitates** an RCT, as it increases the likelihood of demonstrating efficacy for the novel agent.
*The treatment is not widespread in use*
- The purpose of an RCT for a novel agent is precisely to evaluate its efficacy and safety to determine if it **deserves widespread use**.
- Lack of widespread use is the **starting point** for clinical trials, not a contraindication.
*The treatment does not represent the best known option*
- An RCT is often conducted to determine if a novel treatment is **superior or non-inferior** to existing standard-of-care treatments, even if the existing options are not considered "the best."
- Comparing a new treatment against a suboptimal current standard is a common and **valid objective** in clinical research to seek improvement.
*The treatment is expensive*
- The cost of a treatment is a **practical consideration** for healthcare systems and patients but does not inherently make an RCT unacceptable in terms of study design or ethics.
- **Cost-effectiveness** is often evaluated after efficacy and safety are established, usually in addition to the RCT or in subsequent studies.
Informed consent for research US Medical PG Question 5: A 16-year-old female presents to her pediatrician's office requesting to be started on an oral contraceptive pill. She has no significant past medical history and is not currently taking any medications. The physician is a devout member of the Roman Catholic church and is strongly opposed to the use of any type of artificial contraception. Which of the following is the most appropriate response to this patient's request?
- A. Suggest that the patient remain abstinent or, if necessary, use an alternative means of birth control
- B. Explain that he will refer the patient to one of his partners who can fulfill this request (Correct Answer)
- C. Refuse to prescribe the oral contraceptive
- D. Tell the patient that he is unable to prescribe this medication without parental consent
- E. The physician is obligated to prescribe the oral contraceptives regardless of his personal beliefs
Informed consent for research Explanation: ***Explain that he will refer the patient to one of his partners who can fulfill this request***
- Physicians have a right to **conscientious objection** based on personal beliefs, but they also have an ethical obligation to ensure that patients receive appropriate medical care.
- Referring the patient to another qualified provider for the requested service fulfills both the physician's right to object and the patient's right to care, without imposing the physician's personal beliefs on the patient.
*Suggest that the patient remain abstinent or, if necessary, use an alternative means of birth control*
- While abstinence is a valid choice, suggesting it without offering the requested medical service is imposing the physician's personal beliefs on the patient, which is **unethical** in this context.
- Recommending only "alternative means" without directly addressing the patient's specific request for oral contraceptives does not adequately address her healthcare needs or autonomy.
*Refuse to prescribe the oral contraceptive*
- An outright refusal without providing an alternative option or referral **violates the ethical principle** of beneficence and the patient's right to access medical care.
- This action could be seen as abandoning the patient and is not consistent with professional medical ethics for handling conscientious objections.
*Tell the patient that he is unable to prescribe this medication without parental consent*
- In many jurisdictions, minors are legally allowed to obtain contraception **without parental consent** due to privacy and public health considerations (e.g., prevention of STIs and unintended pregnancies).
- This statement may be **legally incorrect** and serves as an excuse to avoid providing the requested service, rather than addressing the ethical dilemma of conscientious objection appropriately.
*The physician is obligated to prescribe the oral contraceptives regardless of his personal beliefs*
- While physicians have an obligation to provide care, they are generally **not obligated to perform services that violate their deeply held moral or religious beliefs**, provided they ensure the patient can access the service elsewhere.
- This option incorrectly states that personal beliefs must always be overridden for every medical service, ignoring the principle of conscientious objection while ensuring patient access to care.
Informed consent for research US Medical PG Question 6: 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)
Informed consent for research 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.
Informed consent for research US Medical PG Question 7: A 32-year-old man is brought to the emergency department by the police for examination. The police have reason to believe he may have swallowed a large number of cocaine-containing capsules during an attempt to smuggle the drug across the border. They request an examination of the patient to determine if this is actually the case. The patient has no history of any serious illnesses and takes no medications. He does not smoke, drinks, or consume any drugs. He appears upset. His vital signs are within normal limits. Despite the pressure by the police, he refuses to undergo any further medical evaluation. Which of the following is the most appropriate next step in the evaluation of this patient?
- A. Examine the patient without his consent
- B. Request a court order from the police
- C. Obtain an abdominal X-ray
- D. Refuse to examine the patient
- E. Explain the risk of internal rupture to the patient (Correct Answer)
Informed consent for research Explanation: ***Explain the risk of internal rupture to the patient***
- The primary responsibility of the physician is to the **patient's well-being**, not to law enforcement. Before any action, the patient must be fully informed of the **potential life-threatening risks**, such as capsule rupture and overdose, associated with concealing drugs internally, especially if they are asymptomatic.
- This approach respects the patient's **autonomy** while ensuring they understand the gravity of their situation, potentially motivating them to reconsider their refusal for medical evaluation for their own safety.
*Examine the patient without his consent*
- Examining an **adult patient without their consent** is a violation of ethical principles and could constitute **assault and battery**, regardless of police requests or suspected criminal activity.
- The patient's **competence** to refuse care is not questioned, and there is no immediate indication of a medical emergency that would override his refusal, as his vital signs are stable and he is not in distress.
*Request a court order from the police*
- While a court order might compel some medical procedures in specific legal contexts, it generally does not override a competent patient's right to refuse medical care, especially when they are **asymptomatic** and not in immediate danger.
- The physician's immediate ethical duty is to the patient's health and safety, not to facilitate legal processes that could infringe on patient rights without clear medical necessity.
*Obtain an abdominal X-ray*
- An abdominal X-ray is a medical procedure that requires patient consent. Performing it without consent would be a breach of **medical ethics** and patient rights, even if requested by police.
- Although an X-ray could confirm the presence of foreign objects, it should not be performed before **informed consent** is obtained or before the patient understands the potential risks they face due to the suspected objects.
*Refuse to examine the patient*
- While the patient initially refused examination, simply refusing to examine him at all would be negligent as it indicates a failure to address the potential medical emergency presented by suspected internal drug smuggling.
- The physician has a duty to at least **educate the patient** about the severe health risks involved, allowing him to make an informed decision about further medical evaluation.
Informed consent for research US Medical PG Question 8: A 32-year-old woman is brought to the emergency department by her husband because of an episode of hematemesis 2 hours ago. She has had dyspepsia for 2 years. Her medications include occasional ibuprofen for headaches. After initial stabilization, the risks and benefits of upper endoscopy and alternative treatments, including no therapy, are explained thoroughly. She shows a good understanding of her condition and an appreciation of endoscopic treatment and its complications. She decides that she wants to have an endoscopy to find the source of bleeding and appropriately manage the ulcer. Her medical records show advance directives that she signed 3 years ago; her sister, who is a nurse, has a durable power of attorney. Regarding obtaining informed consent, which of the following is the most accurate conclusion for providing endoscopic treatment for this patient?
- A. There are reasons to believe that she may not have decision-making capacity
- B. Endoscopic treatment may be performed without further action
- C. Her sister must sign the consent form
- D. Documentation of her decision prior to treatment is required (Correct Answer)
- E. Her decision to have an endoscopy is not voluntary
Informed consent for research Explanation: **Documentation of her decision prior to treatment is required**
- The patient has been fully informed, understands her condition, and has expressed a clear desire for the procedure, demonstrating **decision-making capacity**.
- To ensure ethical and legal compliance, her **informed consent** must be accurately documented in her medical record before any invasive treatment, including endoscopy, is performed.
*There are reasons to believe that she may not have decision-making capacity*
- The patient has clearly demonstrated **understanding of her condition, treatment options, and potential complications**, which indicates preserved decision-making capacity.
- Despite the acute medical situation, her ability to articulate her preference after a thorough discussion confirms her competence for informed consent.
*Endoscopic treatment may be performed without further action*
- While the patient has consented verbally, this does not negate the need for proper **documentation of informed consent** before initiating the procedure.
- Legally and ethically, a verbal agreement alone is insufficient; a signed consent form or detailed chart note confirming her understanding and decision is essential.
*Her sister must sign the consent form*
- Her sister, holding a **durable power of attorney**, would only be authorized to make medical decisions if the patient were deemed to lack **decision-making capacity**.
- Since the patient clearly demonstrates the ability to make her own medical decisions, her sister's consent is not required and would override the patient's autonomy.
*Her decision to have an endoscopy is not voluntary*
- The scenario explicitly states that the risks and benefits were **thoroughly explained**, and she shows a "good understanding" and "appreciation of endoscopic treatment."
- Her decision to "want to have an endoscopy" despite knowing the alternatives suggests a **voluntary and informed choice**, not coercion.
Informed consent for research US Medical PG Question 9: You are the attending physician on duty on an inpatient hospitalist team. A 48-year-old patient with a history of COPD and atrial fibrillation on warfarin is admitted to your service for management of a COPD exacerbation. Four days into her admission, routine daily lab testing shows that patient has an INR of 5. She is complaining of blood in her stool. The bleeding self-resolves and the patient does not require a transfusion. Review of the medical chart shows that the patient's nurse accidentally gave the patient three times the dose of warfarin that was ordered. What is the correct next step?
- A. Do not tell the patient about the mistake as no harm was done
- B. Do not tell the patient about the mistake because she is likely to sue for malpractice
- C. Do not tell the patient about the mistake because you did not make the mistake
- D. Tell the patient that a mistake was made and explain why it happened (Correct Answer)
- E. Tell the patient that the blood in her stool was likely a side effect of the warfarin
Informed consent for research Explanation: ***Tell the patient that a mistake was made and explain why it happened***
- **Transparency** and **honesty** are fundamental ethical principles in medicine, even when an error occurs. Patients have a right to know about medical errors that affect them.
- Explaining the error fosters **trust**, allows the patient to make informed decisions about their care, and is essential for implementing **system-based improvements** to prevent future occurrences.
*Do not tell the patient about the mistake as no harm was done*
- This is ethically unsound; the patient experienced **blood in her stool**, indicating harm, even if not severe enough to require transfusion.
- Withholding information about a medical error undermines the **patient-physician relationship** and violates principles of informed consent and patient autonomy.
*Do not tell the patient about the mistake because she is likely to sue for malpractice*
- While malpractice concerns exist, fear of litigation should not override the ethical obligation to disclose medical errors. **Open communication** can often reduce the likelihood of lawsuits by building trust and demonstrating accountability.
- Focusing solely on medico-legal risk disregards the **patient's right to information** and reinforces a defensive medical culture.
*Do not tell the patient about the mistake because you did not make the mistake*
- As the **attending physician**, you are ultimately responsible for the patient's care and for overseeing the team. Even if you personally did not administer the wrong dose, you are accountable for managing complications and communicating with the patient.
- Ethically, the **healthcare team** is responsible for addressing errors collectively, irrespective of who precisely made the mistake, and the lead physician should facilitate this communication.
*Tell the patient that the blood in her stool was likely a side effect of the warfarin*
- This response is **deceptive** and does not provide an accurate explanation for the event. While bleeding is a side effect of warfarin, attributing it solely to a "side effect" without disclosing the overdose is misleading.
- It avoids accountability and prevents the patient from understanding the true cause of her symptoms, which is crucial for her health decisions and for ensuring **system quality improvement**.
Informed consent for research US Medical PG Question 10: A 34-year-old woman, otherwise healthy, is brought into the emergency department after being struck by a motor vehicle. She experienced heavy bleeding and eventually expires due to her injuries. She does not have a past medical history and was not taking any medications. She appears to be a good candidate for organ donation. Which of the following should contact the deceased patient's family to obtain consent for organ donation?
- A. An organ donor network (Correct Answer)
- B. The organ recipient
- C. A hospital representative
- D. The morgue
- E. The physician
Informed consent for research Explanation: ***An organ donor network***
- **Organ procurement organizations (OPOs)** are federally designated entities responsible for coordinating all aspects of organ donation, including obtaining consent from families.
- Their staff are specifically trained in navigating this sensitive discussion and ensuring the process aligns with ethical and legal guidelines.
*The organ recipient*
- The organ recipient is **not involved** in the consent process.
- Their role begins after successful organ procurement and matching.
*A hospital representative*
- While a hospital representative might be involved in communicating initial information, the **specialized task** of discussing organ donation consent falls to the OPO.
- Hospital staff generally do not have the specific training or mandate for this role.
*The morgue*
- The morgue is responsible for handling the deceased's body **after all medical procedures**, including organ procurement, have been completed.
- They have no role in the consent process for organ donation.
*The physician*
- The patient's treating physician's primary responsibility is to provide **medical care** and declare death.
- While they may identify potential donors, they are typically **not the ones to initiate the organ donation discussion** with the family to avoid perceived conflicts of interest or undue influence.
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