Moral Dilemma in Human Experimentation

• Study notes for students

Moral Dilemma in Human Experimentation

• Human experimentation has raised ethical concerns since the 18th century, particularly with variolation practices
• An ethical question posed was: Is risking a life to prevent a potential uncertain danger permissible?
• This dilemma affects both individuals and collective political decisions
• Pierre Bongrand rephrased the question in the 20th century to address the community's infectious diseases needing to be studied only on humans
• A follow-up central question: Is it right to deliberately infect individuals to study disease evolution

Ethical research by Pierre Bongrand

• Human experimentation is sometimes needed without therapeutic intent
• It's considered immoral because it sacrifices individuals for the benefit of the community
• Bongrand proposes practices like limiting experiments and maintaining scientific rigor
• Introducing regulatory mechanisms is needed to prevent abuse,especially in participant recruitment
• A clear contract with informed consent is required between the subject and experimenter
• For Bongrand, the law reflects public morals and opinion
• He believes it limits individual liberties for the broader good
• Law must evolve to align with societal needs and ethical research

Regulating Human Experimentation in the 20th Century

• Biomedical research emerged in the 20th century
• Advancement of fundamental knowledge is key for biomedical research
• Objectives: improving fundamental knowledge and addressing public health needs
• Clinical, systems of care, and epidemiological research are examples
• Human experimentation transforms subjects into research objects
• Ethical challenges relate to risks not fully justified by care, raising societal issues

Historical Facts and Regulation

• Nazi actions included experiments during World War II
• The Nuremberg trials judged doctors who experimented on humans
• The Nuremberg Code (1947) is the first framework of 10 fundamental principles for human experimentation
• Clear information, fair participation, informed consent and comprehension, and social utility are key features
• The Helsinki Declaration (1964) is the first international ethics text by the World Medical Assembly
• It acknowledges human research needs with ethical limits
• Physicians have civil, penal, and ethical responsibility
• It has a non-binding but evolving text based on medical advances
• HK Beecher (1966) exposed 22 ethically questionable US studies
• Injecting cancer cells into vulnerable individuals
• Conducting syphilis experiments without available treatment
• Transmitting hepatitis B to children
• Placing catheters in newborns for bladder X-rays
• The Belmont Report (1979) is the basis for US ethical regulations
• Key principles include: respecting individuals, maximizing benefits, and ensuring justice
• Creating independent ethics committees to evaluate research protocols is key

Bioethics Movement

• Bioethics denounces societal and medical practice abuses
• Transparency, rights, and individual rights over corporate interests are promoted
• It questions medicine's nature, is it an exact science or human science?

Foundational International Research Ethics Texts

• The Nuremberg Code (1947) was the first legal text addressing research ethics
• Voluntary informed consent, societal benefit, risk minimization, and transparent information are key
• The Declaration of Helsinki (1964) by the World Medical Assembly
• It focuses on civil, penal, and ethical responsibilities
• It adapts the Nuremberg Code to medical advances and distinction between care and research
• The Belmont Report (1979) is the base for US ethical regulation and identifies respect, beneficence, and justice as principles
• It creates ethics committees for evaluating protocols
• The Declaration of Manila (1981) stresses physicians' research accountability
• It details subject protection
• The Oviedo Convention (1997) addresses human rights in biological and medical applications
• It defines clear limits

General Principles for Research

• Societal benefit is needed, research must aim to deliver collective advantages.
• Prior research requires a specific protocol distinguishing it from treatment.
• Risks should be limited and justified
• Independent ethics committees are needed to ensure research acceptance
• Respect autonomy through informed consent, including accurate and transparent information

French Law evolution

• Before 1988, no French law governed French research
• Doctors were subject to civil code, and could face criminal charges for assault
• Experimentation was illegal, except for therapeutic necessity
• From 1975 an EU directive mandated drug tests on healthy volunteers
• From 1978 a commission mandated scientific proof of drug efficacy

Adoption of Research Laws

• The Huriet-Sérusclat Act (1988) gave first legal framework for French biomedical research
• Implemented informed consent and ethics committee approval
• Modifications in 2004 strengthened participant protections.
• Jardé Law and Data Protection Law (1978, 2004, 2018) updated data rules and transparency

Medical Ethics Reflections

• Codes of ethics are philosophies that regulate medical practices and protect patients
• Ethics questions actions without evident solutions at individual and collective levels
• The goal is informed decisions based on principles
• Ethics guides actions toward better choices by relying on teleological and deontological foundations
• It questions what is right or least wrong
• Ethics emphasizes reflection, possibilities, and responsibility
• Norms are boundaries imposed by social, moral, or legal guidelines
• Ethics may evolve norms for complicated situations

Defining ethics

• Ethics from Greek "ethikos," means behavior or conduct
• Ethics guides conduct and theorizes morality
• It studies principles, codes, rules, and value systems
• It comprehends how actions head toward the good, it's beyond just conduct rules

Definitions of Deontology and Morality

• Deontology means Greek "ta deonta" means obligations or duties as moral rules
• Morality is how "mos, mores" (Latin) conduct oneself
• Both ethics, morality, and deontology have no difference in problems and questions
• Normative is how it "should be"
• Social sciences norms create value judgements with ethic, law, and politics
• Biology and physics are descriptive since they're fact-based
• Norms seek ideal, description is what is

Differences

• Law is rules for all citizens that are universal, cohesive, and systematic
• Ethics is flexible, individual, and adaptive to unique challenges

Contemporary Ethics Types

• Metaethics focuses on questioning in ethics by targeting nature of values and norms
• Conceptual foundations of ethics are analyzed
• Normative ethics focuses on rules to guide towards perfection
• Principals and rules are targeted by normative ethics
• Applied: deals with specific practices
• Relations in medicine is target of medical ethics

Ethics for living

• Medical are relationship questions for health workers and patients
• Bioethics focuses on living conflict from living technology

Key Approaches

• Deontological theories focus on duties, and values
• Action is moral if intention respect universal ideas, independant of consequence
• Human rights follow deontological theory
• Consequentialism are about results of the right action
• Action moral if consequences maximise good
• Example: Utilatarianism