Ethics in Biomedical Engineering
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Questions and Answers

Which ethical principle emphasizes avoiding harm to patients?

  • Justice
  • Autonomy
  • Beneficence
  • Non-Maleficence (correct)

What was a key ethical violation in the Tuskegee Syphilis Study?

  • Participants were made aware of all risks.
  • There was deception regarding diagnosis. (correct)
  • Informed consent was obtained.
  • Participants were compensated fairly.

The Nuremberg Code established guidelines for ethical research primarily in response to which historical event?

  • Thalidomide Tragedy
  • Jesse Gelsinger Case
  • Nazi Medical Experiments (correct)
  • Tuskegee Syphilis Study

Which ethical framework focuses on outcomes and aims to produce the greatest good for the majority?

<p>Utilitarianism (D)</p> Signup and view all the answers

What does the Common Rule aim to ensure in clinical research?

<p>Informed consent and research oversight (C)</p> Signup and view all the answers

Which case led to increased scrutiny over gene therapy trials due to ethical violations?

<p>Jesse Gelsinger Case (D)</p> Signup and view all the answers

The principle of justice in biomedical ethics is concerned primarily with what aspect?

<p>Fair distribution of benefits and burdens (B)</p> Signup and view all the answers

Which of the following statements is true regarding informed consent in biomedical research?

<p>Full understanding of risks and benefits is essential. (A)</p> Signup and view all the answers

Flashcards

Ethical considerations in biomed engineering

Balancing cost, safety, accessibility, and privacy when developing life-saving technologies.

Informed Consent

Participants must fully understand risks and benefits of research before agreeing to participate.

Utilitarianism

Ethical framework focusing on maximizing good for the greatest number of people.

Nazi Medical Experiments

Unethical medical research WWII on prisoners without consent, inflicting harm.

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Tuskegee Syphilis Study

Unethical study that let untreated syphilis spread among African American men without their knowledge.

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Deontology

Ethical framework emphasizing moral duties and principles – regardless of outcome.

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Bioethical Principles

Autonomy, non-maleficence, beneficence, justice applied to research and clinical practice.

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The Common Rule

US research regulations ensuring informed consent and appropriate oversight for research involving human participants, protecting vulnerable groups.

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Study Notes

Ethics in Biomedical Engineering

  • Biomedical engineers develop life-saving technologies (pacemakers, prosthetics, gene editing).
  • Ethical decisions impact patient safety, equity, innovation, and public trust.
  • Key considerations involve balancing cost, safety, accessibility, and privacy.

Bioengineering Research on Human Subjects

  • Ethical dilemmas exist regarding research oversight. Lax rules harm patients; strict rules may delay lifesaving treatments.

Ethical Frameworks for Decision-Making

  • Utilitarianism: prioritizes the greatest good for the greatest number of people.
  • Deontology: focuses on duties and principles, regardless of outcomes.

Bioethical Principles

  • Autonomy: respecting patients' right to make decisions regarding their own care.
  • Non-Maleficence: avoiding harm.
  • Beneficence: acting in the patient's best interest.
  • Justice: ensuring fairness in distributing benefits and risks.

Historical Ethical Cases

Nazi Medical Experiments (WWII)

  • Conducted on prisoners without consent.
  • Key ethical violations: lacked informed consent, deliberately harmed, and exploited vulnerable populations.
  • Led to the development of the Nuremberg Code (1947), establishing guidelines for ethical research (informed consent, minimizing risk).

Thalidomide Tragedy (1950s)

  • Sedative caused birth defects in ~10,000-20,000 children due to insufficient safety testing before use.
  • Key ethical violations: inadequate testing, poor public disclosure, and weak regulatory oversight.
  • Resulted in stricter drug regulations (U.S. Kefauver-Harris Amendment).

Tuskegee Syphilis Study (1932-1972)

  • Observed untreated syphilis in African American men without informing them or providing treatment.
  • Key ethical violations: deception, lack of consent, racial exploitation, and medical racism.
  • Led to the development of the Belmont Report (1979), establishing principles of respect for persons, beneficence, and justice.

Jesse Gelsinger Case (1999)

  • Gene therapy trial participant died due to undisclosed risks and conflicts of interest.
  • Key ethical violations: lack of full disclosure, and ethical compromise due to financial ties.
  • Triggered stricter oversight of gene therapy trials and conflicts of interest.
  • Informed Consent: participants must fully understand risks and benefits.
  • The Common Rule (1991): outlines requirements for informed consent and research oversight, enhancing protections for vulnerable populations (pregnant women, fetuses, prisoners, children).

Key Ethical Considerations in Clinical Research

  • Beneficence, Non-Maleficence, Autonomy, Justice are critical principles.

Justification

  • Strong reasoning is important when confronting ethical dilemmas with few clear answers.

Lessons Learned

  • Informed consent is essential for ethical research.
  • Rigorous oversight prevents harm and builds trust.
  • Transparency and accountability maintain public confidence.

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Description

This quiz explores the ethical considerations in biomedical engineering, including the implications of emerging technologies on patient safety and equity. Key bioethical principles like autonomy, non-maleficence, beneficence, and justice will be assessed. Join to understand how ethical frameworks guide decision-making in this vital field.

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