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?

He has the right to revoke his consent at any time

He cannot provide consent because he lacks capacity

His parents also need to give consent to this operation

He did not need to provide consent for this procedure since it is obviously beneficial

His consent is invalid because his decision is not stable over time

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?

Ask the mother to step outside into the hall for a portion of the visit

Disallow the mother to be present in the examination room throughout the entirety of the visit

Give the patient a social history questionnaire to fill out in the exam room

Ask the patient the questions directly, with her mother still in the exam room

Speak softly to the patient so that the mother does not hear and the patient is not embarrassed

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?

The treatment has a known, adverse outcome

Proper treatment response is very common

The treatment is not widespread in use

The treatment does not represent the best known option

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?

Explain that he will refer the patient to one of his partners who can fulfill this request

Suggest that the patient remain abstinent or, if necessary, use an alternative means of birth control

Refuse to prescribe the oral contraceptive

Tell the patient that he is unable to prescribe this medication without parental consent

The physician is obligated to prescribe the oral contraceptives regardless of his personal beliefs

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?

"Can you tell me more about the symptoms you have been experiencing?"

"Does the diarrhea typically precede the constipation, or vice-versa?"

"Is the diarrhea foul-smelling?"

"Please rate your abdominal pain on a scale of 1-10, with 10 being the worst pain of your life"

"Are the symptoms worse in the morning or at night?"

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?

Explain the risk of internal rupture to the patient

Examine the patient without his consent

Request a court order from the police

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?

Documentation of her decision prior to treatment is required

There are reasons to believe that she may not have decision-making capacity

Endoscopic treatment may be performed without further action

Her sister must sign the consent form

Her decision to have an endoscopy is not voluntary

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?

Tell the patient that a mistake was made and explain why it happened

Do not tell the patient about the mistake as no harm was done

Do not tell the patient about the mistake because she is likely to sue for malpractice

Do not tell the patient about the mistake because you did not make the mistake

Tell the patient that the blood in her stool was likely a side effect of the warfarin

Informed consent for research for USMLE Step 3: High-Yield Patient Safety Lessons

Fundamental Ethical Principles in Research

Primary Distinction: Research's main goal is generating generalizable knowledge, not direct patient benefit. This must be explicitly clear to the participant.
Governing Bodies: All research is overseen by an Institutional Review Board (IRB) under federal regulations (the "Common Rule").
Essential Elements:
- Clear statement of research purpose, procedures, and duration.
- Description of foreseeable risks, discomforts, and potential benefits.
- Disclosure of appropriate alternative procedures.
- Assurance of confidentiality.
- Confirmation that participation is voluntary with the right to withdraw at any time without penalty.

⭐ The IRB's foremost responsibility is to protect the rights and welfare of human research subjects, acting as an independent ethics committee.

Full disclosure is a prerequisite for valid informed consent in research. It ensures the participant is fully aware of what their participation entails. Key components can be recalled with the mnemonic below.

📌 Mnemonic: "BRAIN-CV"
- Benefits: A description of any potential benefits to the subject or to others.
- Risks: A description of any reasonably foreseeable risks or discomforts.
- Alternatives: Disclosure of appropriate alternative procedures or courses of treatment.
- Information & Confidentiality: A statement on how confidentiality of records will be maintained.
- Nature & Purpose: An explanation of the research's purpose and the expected duration of participation.
- Contact Information: Who to contact for answers about the research, subject's rights, and in case of injury.
- Voluntary Participation: A statement that participation is voluntary and refusal or discontinuation will involve no penalty or loss of benefits.

⭐ For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs must be provided.

Vulnerable Subjects - Handle with Care

Certain populations require extra protection during research due to potential coercion or undue influence. The Institutional Review Board (IRB) must ensure safeguards are in place.

Key Vulnerable Groups:
- Children & Minors
- Pregnant Women, Fetuses, Neonates
- Prisoners
- Cognitively Impaired Individuals
- Economically or Educationally Disadvantaged
Requirements:
- Research must be vital and not possible with non-vulnerable subjects.
- Consent procedures are more stringent.

⭐ For minors, assent (agreement from the child) must be obtained if they are capable, in addition to consent from parents/legal guardians.

Institutional Review Board - Research Referee

Primary Mandate: Protect the rights & welfare of human research subjects before and during their participation in research.
Composition: Requires at least 5 members with diverse backgrounds to ensure a comprehensive review.
- Must include scientists and non-scientists.
- At least one member with a non-scientific focus (e.g., lawyer, ethicist, clergy).
- At least one member unaffiliated with the institution.
Key Functions: Risk-benefit analysis, protocol review, and ensuring proper informed consent.

⭐ The IRB has the authority to approve, require modifications to, or disapprove all research activities involving human subjects.

Informed consent for research is distinct from clinical consent and requires Institutional Review Board (IRB) approval.

Must clearly state the study's purpose, risks, benefits, and alternatives.

Participation is strictly voluntary; subjects can withdraw at any time without penalty.

Requires special safeguards for vulnerable populations like children or prisoners.

Investigators must avoid all forms of coercion or undue influence.

Assurances of confidentiality are a mandatory component.

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