bioethics

Bioethics

The systematic study of human behavior in the science of life and cure of health, in the light of values and moral principles. Alternatively, the analysis of the ethical, legal, social, and political aspects of biomedicine and biotechnology, framed by respect for human rights.

Disciplinary Specificities of Bioethics

Six defining characteristics of the field: 1) Interdisciplinarity; 2) Global nature; 3) Secularism; 4) Pluralism; 5) Possibilism (between technophobia and techno-utopia); 6) Social nature.

AIMS of Bioethics

The core objectives concerning human beings and society, specifically Dignity, Solidarity, and Equality.

Technoscience

A name for the new science (from the mid-’70s) where science has become technical knowledge (e.g., computing), often consisting in theorizing technical procedures, and melting truth and efficiency.

Autonomy (Principle)

The capacity of an individual to take decisions and to know what their best interest is. It means seeing the world through one's own eyes and according to one's own interests.

Beneficence (Principle)

The act of acting for someone's best interests. It requires maximizing efforts to achieve the well-being of people.

Non-Maleficence (Principle)

The ethical principle of "do no harm," requiring individuals to avoid actions that cause harm to others; it is a universal duty and general obligation.

Justice (Principle)

The act of giving people what they deserve, treating people equally. Specifically, treating the same equally and the different differently.

Prima Facie Duties

Duties that oblige without a conflict between them, meaning the principles of bioethics (Autonomy, Non-Maleficence, Beneficence, Justice) are binding unless they conflict.

Method (Diego Gracia)

The analytical process for resolving bioethical conflicts, involving three core steps: 1) Analyzing the Facts (diagnosis/prognosis, subjects); 2) Identifying Values (the four principles); 3) Determining Duties (what must be done, often defined by law).

Consequentialism

A main form of moral reasoning that locates morality exclusively in the consequences of acts.

Categorical Reasoning

A main form of moral reasoning that locates morality in specific rights and duties, emphasizing respect for persons regardless of outcomes (linked to Kantian ethics).

Moral Reasoning

The two main forms utilized in bioethics are Consequentialism and Categorical reasoning, which often clash (e.g., maximizing happiness vs. respecting duties).

Cultural Relativism

The argument that the moral code of a society determines what is right, and there is no objective standard to judge one society’s code as better than another’s.

Ethical Naturalism

The position that the respect of human dignity stems from a natural order. Its decline contributed to the twilight of medical paternalism.

Medical Paternalism

The classical view of the doctor-patient relationship characterized by the doctor's superiority, restricted information for the patient, and unconditional patient obedience, structured mainly by the principle of Beneficence.

Informed Consent (IC)

A concept built on two basic ideas: 1) an obligation to give information before intervening on the patient’s body; and 2) the power of the patient to reject a health intervention. Information must be given comprehensibly.

Therapeutic Privilege

An exception to informed consent where a doctor may withhold information if its disclosure (e.g., about risks) generates anxiety in patients and rejection of treatments.

Nuremberg Code (1947)

Established the absolute necessity of voluntary and informed consent from human subjects, arising directly from the exposure of Nazi medical experiments.

Belmont Report (1979)

Formalized the three core principles for ethical research: Respect for Persons (Autonomy), Beneficence, and Justice.

Human Dignity

The intrinsic worth and moral value of every person, entitling them to respect and ethical treatment. It is the foundation of all human rights and a key concept in bioethics and law.

Conscientious Objection

The act of refusing to participate in an action or system (e.g., military service, medical procedures) because of strong personal moral, religious, or ethical beliefs. It is not absolute and is limited by the possibility of providing the service to patients.

Oviedo Convention (CHRB)

The Convention on Human Rights and Biomedicine (1997), the first international legally binding instrument on bioethics and human rights, establishing direct application within Council of Europe member states.

Sexual Rights

The rights concerning when, how, and with whom one has sex, and the right to live one's own sexual life without pressure or violence, including sexual orientation and gender identity without discrimination.

Reproductive Rights

Rights concerning whether or not to have children, with whom, how many, and how often, including the right to receive information about and free access to chosen contraceptive methods autonomously and without discrimination.

Negative Eugenics

The aim to avoid reproduction in cases of "weak human beings," imperfects, or those with few intellectual abilities, often by avoiding new human beings that will suffer during life.

Positive Eugenics

The modification of humankind to include conditions that society considers desirable, such as genetic improvement.

Assisted Reproductive Techniques (ART)

Medical techniques used to facilitate human reproduction, such as In Vitro Fertilization (IVF), Gamete Donation, and Pre-implantation Genetic Diagnosis (PGD).

In Vitro Fertilisation (IVF)

A technique involving extracting eggs, fertilizing them with sperm in a laboratory ("in vitro"), and transferring one or more resulting embryos into the uterus.

Pre-implantation Genetic Diagnosis (PGD)

Analysis of embryos created via IVF before implantation to detect genetic or chromosomal abnormalities. Under Spanish Law 14/2006, it is permitted only for medical reasons, such as avoiding severe hereditary diseases.

Gamete Donation Requisites (Law 14/2006)

Key legal conditions include: 1) Voluntary, altruistic, and disinterested donation (compensation only for inconvenience, not payment); 2) Strictly anonymous donation; 3) Donor must be a legally competent adult, in good physical and mental health; 4) Maximum of six live babies born per donor.

Post-mortem Insemination (Law 14/2006)

The permitted use of embryos or reproductive material from a deceased partner only if previous consent was given (in a will or authentic deed) and the material is used within 12 months after the death of the genetic parent.

Surrogacy (Spain)

A contractual arrangement where a woman agrees to carry and give birth to a child for another person or couple. In Spain, all surrogacy contracts are considered void (have no legal effect) under Article 10 of Law 14/2006.

Somatic Gene Therapy

A type of gene therapy that targets the patient's body cells; its effects are not inherited by future generations and are generally considered morally acceptable if risks are proportional.

Germline Therapy

A type of gene therapy that alters reproductive cells, meaning the changes would be passed on to future generations; it is explicitly prohibited by the Oviedo Convention (Art. 13).

CRISPR-Cas9

The most widely used tool for genome editing, which allows precise modification of DNA sequences in living cells by using guide RNA to target specific DNA and the Cas9 enzyme to cut the DNA.

Genetic Identity

The unique information revealed by the human genome, which is permanent, predictive, and familial, meaning it affects not just the individual but also their relatives.

Epigenetics

The study of how environmental factors (e.g., diet, stress) influence gene expression without altering the underlying DNA sequence. It challenges the idea of genetic determinism.

Ontological Difference Thesis (ODT)

The view that human beings have rationality and capacity for freedom, making them moral subjects, whereas animals do not, and thus the duty not to be cruel stems from a general human duty, not from animal rights.

Quantitative Difference Thesis (QDT)

The zoocentric ethical view that moral consideration is based on the capacity for suffering, risking speciesism, but allowing for a gradualist ethic where consideration increases with cognitive and emotional complexity.

Three R's Principle (Animal Research)

A principle to ensure animal welfare in research, consisting of: 1) Replacement (using non-animal alternatives when scientifically possible); 2) Reduction (using the minimum number of animals necessary); 3) Refinement (minimizing pain, stress, and distress in procedures and housing).

Clinical Negligence

A breach of the duty of care by a healthcare professional that results in identifiable harm to the patient; it forms the central basis for civil liability arising from medical errors or omissions.

Legal Elements of Negligence

Three core elements that must be proven to establish liability: 1) Duty of Care (legal obligation); 2) Breach of Duty (falling below the standard of care); 3) Causation of Harm (the breach caused the injury).

Duty of Care

A legal obligation rooted in the doctor-patient relationship, arising when a healthcare professional assumes responsibility for a patient.

Breach of Duty

Occurs when the professional’s conduct falls below the standard expected of a reasonably competent practitioner in the same field, often assessed using the Bolam Test.

Lex Artis Ad Hoc

The technical law or expected standard of professional conduct, meaning a doctor must act according to the best technical standards recognized at that moment, tailored to the specific clinical context.

Bolam Test

The legal principle that a doctor is not negligent if their actions are in accordance with a practice accepted as proper by a responsible body of medical professionals.

Bolitho Refinement

A modification of the Bolam Test, stipulating that courts may reject a medical opinion if it is not logically defensible, introducing judicial scrutiny of medical consensus.

Montgomery Ruling

A landmark case on Informed Consent that shifted the legal standard from a doctor-centered approach to a patient-centered approach, requiring doctors to inform patients of all material risks.

Causation in Clinical Negligence

The requirement to prove that the breach of duty caused the harm, typically evaluated using the "but for" test: Would the harm have occurred but for the professional’s negligence?.

Recognizable Harm

The demonstrable injury required for a finding of clinical negligence, which must be concrete and assessable. It can be categorized as 1) Physical Harm; 2) Psychological Harm; or 3) Economic Harm.

Institutional Liability

Legal responsibility placed on institutions (hospitals/clinics) for harm, either through Vicarious Liability (for employees' negligence within their scope of duties) or Organizational Negligence (for systemic failures like inadequate staffing or deficient protocols).

Administrative Liability (Objective)

Applies to public administrations (e.g., public hospitals) and does not require proof of fault; it is sufficient to demonstrate the existence of damage and a causal link with the malfunctioning of the public healthcare service.

Adverse Event

Any incident that results in harm to a patient during healthcare delivery. Reporting systems are essential tools for identifying and preventing unsafe practices.

Root Cause Analysis (RCA)

A structured, non-punitive method used to analyze serious adverse events by identifying the underlying systemic factors contributing to the outcome, rather than focusing solely on individual blame.

Secularism (Bioethics)

The disciplinary requirement that bioethics implies a political commitment to democracy, the rule of law, and human rights as the ultimate limit of respect for cultural plurality, separate from faith-based dogmatic approaches.

Relational Autonomy

A concept developed from feminist approaches, which suggests autonomy is not just an isolated individual decision, but involves supportive gestures and relations with others, often challenging the traditional doctor-patient vertical relationship.

Brain Death Criterion

The definition of death used since the ability to sustain biological life artificially forced a redefinition of death, enabling organ transplantation.

Accountability

The obligation of professionals and institutions to be held responsible for their actions. It serves as a quality standard and ensures transparency between professionals, institutions, and patients, thereby bridging law and ethics in medicine and preventing professional autonomy from becoming impunity.

Feminist Bioethics

A current that emphasizes inequality and gender aspects in medical ethics. This approach has questioned traditional concepts of marriage, family, and sexuality, leading to the normalization of one-parent families and the recognition of transsexual rights.

Ethics of Care

An approach that focuses on care and relational responsibility. It implies a change of paradigm in medicine, shifting the focus "From cure to care," and suggests that doctors have extra obligations.

Intracytoplasmic Sperm Injection (ICSI)

The injection of a single sperm directly into an egg. This technique is mainly used in cases of male infertility and is regulated under the same framework as IVF in Spain.

Reproductive Autonomy

The right to decide independently about reproduction and family formation. This includes both Positive Reproductive Autonomy (the right to access means of reproduction) and Negative Reproductive Autonomy (the right not to reproduce).

Nasciturus

A legal term for a future child who holds conditional rights. The protection of the nasciturus as a "human life project" is a key issue in debates surrounding abortion.

Genetic Testing

The analysis of DNA to identify hereditary diseases or risks. This process has evolved through three major generations, including DNA-based testing and comprehensive exome/genome sequencing.

Therapeutic Cloning

The cloning of cells or tissues for exclusively medical purposes, distinguishing it from reproductive cloning, which is prohibited.

Predictive Test

A genetic test used to determine the risk of a future disease. According to the European Convention on Bioethics (Art. 12), such tests may be performed only for health purposes or scientific research.

Right not to Know

The right of an individual to refrain from receiving or seeking genetic information. Conflicts regarding this right arise when public interest or family health is involved.

Bioethical Committee

An independent, collegiate body with a consultative nature on matters related to the ethical and social implications of Biomedicine and Health Sciences. These bodies review research projects involving humans, human biological materials, and personal data to ensure they meet ethical and legal standards.

Informed Refusal

The right of the patient to reject a treatment after having been correctly informed. This right is a manifestation of the patient's autonomy.

Therapeutic Exception

A situation in which the doctor is justified in withholding information from the patient. This is permitted if disclosing the information (e.g., about risks) would generate anxiety or rejection of necessary treatments.

Loss of Chance

A legal concept where courts may recognize a compensable harm based on the lost opportunity for recovery or a better outcome. It is particularly relevant in cases involving diagnostic delays.