bioethics

What is Research Ethics?

The field concerned with protecting human research participants while allowing the production of socially valuable knowledge.

What is the Central Ethical Tension in Research?

Individuals bear the risks of research while society gains the benefits.

What is Generalizable Knowledge?

Knowledge intended to apply beyond the individual participants; the defining goal of research.

What is Informed Consent?

A process by which a competent individual voluntarily agrees to participate in research with adequate understanding of relevant information.

What is Disclosure in the context of informed consent?

Providing sufficient information about risks, benefits, purpose, procedures, and alternatives.

What is Understanding in the context of informed consent?

The participant’s comprehension of disclosed information.

What is Voluntariness in the context of informed consent?

Consent given free from coercion, manipulation, or undue influence.

What is Competence (Capacity) in the context of informed consent?

The ability to understand information and make a reasoned decision.

What is Undue Influence?

An offer so attractive that it compromises voluntary decision-making by distorting risk perception.

What is Structural Vulnerability?

Social or economic conditions (e.g., poverty) that increase susceptibility to exploitation.

What is the Reimbursement Model of payment in research?

Payment covering expenses incurred (e.g., travel, meals); ethically least controversial.

What is the Compensation Model of payment in research?

Payment for time, effort, and inconvenience; analogous to wages.

What is the Incentives Model of payment in research?

Payment designed to encourage participation; raises concerns about undue influence.

What is the Ethical Concern with Incentives?

Large payments may cloud judgment, especially for economically vulnerable participants.

What is Exploitation?

Unfair use of a person or their labor for others’ benefit.

What is the Advantage Clause in research ethics?

Participants must receive a fair level of benefit relative to the risks they bear.

What is the Vulnerability Clause in research ethics?

Researchers must not take unfair advantage of participants’ inability to protect their interests.

When can Research be Mutually Beneficial but Exploitative?

Research can benefit both parties yet still be exploitative if benefits are unfairly distributed.

What is Germline Gene Editing (GGE)?

Genetic modification of embryos that is heritable and affects future generations.

What is the difference between Somatic vs Germline Editing?

Somatic affects only the individual; germline affects descendants.

What is Enhancement in the context of GGE?

Genetic changes that go beyond disease prevention to improve traits.

What is the Enhancement Objection to GGE?

Concern that GGE will lead to inequality, commodification of children, and social pressure to enhance.

What is the Response to the Enhancement Objection?

Regulation could limit GGE to therapeutic uses.

What is the Future Generations Objection to GGE?

GGE violates autonomy because future persons cannot consent to irreversible changes.

What is the Response to the Future Generations Objection?

Parents routinely make irreversible decisions without consent; preventing disease may enhance autonomy.

What is the Safety & Uncertainty Objection to GGE?

GGE involves unknown, irreversible risks passed to future generations.

What is the Response to the Safety Objection?

Uncertainty calls for caution and regulation, not absolute prohibition.

How can Exploitation occur in GGE Trials?

Early trials may violate advantage and vulnerability clauses due to high risk and lack of consent by future persons.

What is Equipoise?

An ethical principle governing when randomization in clinical trials is permissible.

What is Theoretical Equipoise?

Individual physician uncertainty; criticized as unrealistic and unstable.

What is Clinical Equipoise (Freedman)?

Honest professional disagreement within the expert community.

What is the Purpose of Clinical Equipoise?

Ensures no participant is knowingly given inferior treatment.

What is the RCT Ethical Dilemma?

How randomization can be ethical given a physician’s duty of care.

What is Miller & Brody’s Objection to Clinical Equipoise?

Clinical equipoise wrongly applies therapeutic norms to research.

What is the Research vs Therapy Distinction?

Therapy aims to benefit individual patients; research aims to produce knowledge.

What is Therapeutic Misconception?

Mistaken belief that research participation is designed for the participant’s benefit.

What is Miller & Brody's Conclusion regarding Clinical Equipoise?

Clinical equipoise is misguided and risks undermining informed consent.

What is High-Risk Research?

Research involving significant physical, social, or economic risk.

What is Shaw’s Position on High-Risk Research?

Competent adults have a right to participate in high-risk research if consent is informed and voluntary.

What is the Autonomy Argument for High-Risk Research?

Individuals should decide what level of risk is acceptable.

How is the Extreme Sports Analogy used in the context of high-risk research?

If people may take risks in sports, they should be allowed similar risks in research.

What is the Therapeutic Misconception Objection to Shaw’s position?

Participants may misunderstand research as therapy.

What is Shaw’s Response to the Therapeutic Misconception Objection?

Healthy volunteers in high-risk studies are less prone to misconception.

What is the Anti-Shaw Position on High-Risk Research?

Ethics committees should limit excessive risks to protect participants and public trust.

What is Soft Paternalism?

Restricting freedom due to lack of understanding or power imbalance.

What is Hard Paternalism?

Restricting freedom despite full competence.

What was the significance of the Jesse Gelsinger Case?

Death in a gene therapy trial highlighting dangers of excessive risk and conflicts of interest.

Who are Therapeutic Orphans?

Children excluded from research, leading to lack of evidence-based treatments.

What is the main Problem with Pediatric Research?

Children cannot give informed consent.

What is Parental Consent in pediatric research?

Proxy authorization; insufficient on its own.

What is the Good of the Group Justification for pediatric research?

Risks justified by benefits to future children; risks treating children as mere means.

What was Paul Ramsey’s View on non-therapeutic research on children?

Non-therapeutic research on children is unethical.

What did Ramsey mean by “Sin Bravely”?

Society must accept moral wrongdoing to gain knowledge.

What is Wendler’s Alternative to Ramsey’s view?

Broaden the concept of benefit.

What is Educational Benefit in pediatric research?

Moral development through participation.

What are Embraced Contributions in pediatric research?

Children may later value their participation.

What is the Benefit of Improved Life argument for pediatric research?

Physical, non-autonomous contributions to valuable projects can improve a life.

What is an Objection to the Improved Life Argument?

Confuses parental preference with child’s interests.

What is a Key Limitation of Benefit Arguments in pediatric research?

Benefit alone does not justify research; risk thresholds still matter.

What is Sexual Dysfunction Research?

Study of disorders involving desire, arousal, orgasm, or pain.

What is the Ethical Issue of Risk Perception in Sexual Dysfunction Research?

Sexual content is often wrongly treated as high-risk.

What is Minimal Risk?

Risks comparable to everyday life experiences.

What is Binik & Binik’s Position on sexual dysfunction research?

Sexual content alone does not increase risk.

What is the Dirty Work Paradox?

Over-scrutiny and delay of sexuality research due to stigma.

What is the Expertise-Based Account in ethical permissibility?

Ethical permissibility depends on researcher expertise, not role norms.

What is the Role-Specific Objection regarding interventions?

Some interventions fall outside normal professional practice.

What is the Expertise-Based Solution to the Role-Specific Objection?

Focus on training, competence, and suitability to perform interventions.

Undue influence concerns

distortion of judgment, not mere motivation.

Lack of consent alone does not make

parental decisions impermissible.

Benefit does not eliminate ethical concern;

risk thresholds still matter.

Research ethics differ fundamentally from

clinical care ethics.

What is Research Ethics?

The field concerned with protecting human research participants while allowing the production of socially valuable knowledge.

What is the Central Ethical Tension in Research?

Individuals bear the risks of research while society gains the benefits.

What is Generalizable Knowledge?

Knowledge intended to apply beyond the individual participants; the defining goal of research.

What is Informed Consent?

A process by which a competent individual voluntarily agrees to participate in research with adequate understanding of relevant information.

Informed Consent (Evaluation Claim)

Valid consent requires not merely disclosure, but meaningful comprehension and voluntariness under non-coercive conditions.

Limits of Consent

Even fully informed consent may not justify research if risks are excessive or unfairly distributed.

Key Exam Insight (Consent)

Consent is necessary but not sufficient for ethical research.

What is Disclosure in the context of informed consent?

Providing sufficient information about risks, benefits, purpose, procedures, and alternatives.

What is Understanding in the context of informed consent?

The participant’s comprehension of disclosed information.

What is Voluntariness in the context of informed consent?

Consent given free from coercion, manipulation, or undue influence.

What is Competence (Capacity) in the context of informed consent?

The ability to understand information and make a reasoned decision.

What is Undue Influence?

An offer so attractive that it compromises voluntary decision-making by distorting risk perception, especially for structurally vulnerable individuals.

When Undue Influence Is Well-Justified

The concern is strongest when offers are unusually large relative to participants’ economic circumstances and when risks are significant or poorly understood.

When Undue Influence Is Overstated

Payment alone does not invalidate consent if risks are clearly disclosed, understood, and participants retain the ability to refuse without penalty.

What is Structural Vulnerability?

Social or economic conditions (e.g., poverty) that increase susceptibility to exploitation.

What is the Reimbursement Model of payment in research?

Payment covering expenses incurred (e.g., travel, meals); ethically least controversial.

Reimbursement Model (Ethical Strength)

Reimbursement preserves voluntariness by removing financial barriers without creating additional motivation to accept risk.

Reimbursement Model (Ethical Limitation)

Reimbursement may still disadvantage low-income participants if indirect costs (time off work, childcare) are not covered.

Key Evaluation Move (Reimbursement)

While ethically safest, reimbursement alone may be insufficient to ensure fair access to research participation.

What is the Compensation Model of payment in research?

Payment for time, effort, and inconvenience; analogous to wages.

What is the Incentives Model of payment in research?

Payment designed to encourage participation; raises concerns about undue influence.

Incentives Model (Ethical Strength)

Incentives improve recruitment efficiency and promote fairness by recognizing participants’ contribution to socially valuable research.

Incentives Model (Ethical Weakness)

Incentives risk undue influence by encouraging participants to overlook or discount serious risks, particularly in high-risk or early-phase studies.

What is the Ethical Concern with Incentives?

Large payments may cloud judgment, especially for economically vulnerable participants, by distorting risk perception.

Key Evaluation Move (Incentives)

The ethical acceptability of incentives depends on proportionality, transparency, and participant vulnerability rather than the mere presence of payment.

What is Exploitation?

Unfair use of a person or their labor for others’ benefit.

Fairness Standard in Exploitation

Exploitation concerns unjust distribution, not absence of benefit.

Key Evaluation Move (Exploitation)

Ethical assessment focuses on benefit proportionality, not subjective satisfaction.

What is the Advantage Clause in research ethics?

Participants must receive a fair level of benefit relative to the risks they bear.