Week 10 Health Ethics and Health Law Flashcards
Introduction – Possible start of bioethics
o 1847 American Medical Association published Code of Medical Ethics based on English Physician Thomas Percival -> learned profession based on scientific principles for services of patients/society
o 1947 Nuremberg Code Nazi Germany -> consent of human subject for research
o 1970 Van Rensselaer Potter published article called Bioethics, the Science of Survival, Kennedy Institute at Georgetown University = 1st bioethics institute
o Author’s pov: 1970s U.S. bioethics greatly influenced by law’s adoption of bioethics principles
The 1970s: Decade of bioethics
o Influence of historical/political events: 1960s U.S. military in Vietnam -> anti-war movement, 1970’s Watergate -> ethics in government and morality, 1970s scientific advancements in reproductive health -> women’s liberation
o 1970s events that directly affected start of bioethics: safer/successful organ transplant techniques -> scarce resource allocation, hospital ethics committees -> organ allocation, end-of-life issues etc., deinstitutionalization of people with mental illness, debates about safety of recombinant DNA tech, start of medical ethics classes at American medical schools
Law and bioethics
o Rise of bioethics in 1970s paralleled growth in law
o Issues of concern to bioethics scholars -> social policy through legislation, regulation, litigation
o 1972 Canterbury v. Spence -> truth-telling, informed consent, patient autonomy
o 1973 Roe v. Wade -> abortions
o 1976 Tarasoff v. Regents of the University of California -> mental health professionals obligation to confidentiality
Research on Human Subjects
o 1932 Tuskegee Syphilis Study: African American men with syphilis promised free lunches, medical care and burials not told they were part of research study and not provided penicillin treatment although became available -> 1973 National Research Act -> National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research -> National Bioethics Advisory Commission -> President’s Council on Bioethics -> precedent that public policy issues like research ethics, human cloning, stem cell research should be considered by bioethics experts in public process
o National Commission -> Belmont Report applied 3 basic ethical principals: informed consent, assessment of risks and benefits, selection of subjects
o The Common Rule: procedural protections for human subjects e.g. lawful research is the favorable review of the protocol by a neutral board = Institutional Review Board (IRB), every university/institution conducting research on human subjects has its own IRB, minimizes risks to subjects, equitable subject selection, informed consent, privacy and confidentiality
o Bioethics led to the development of legal rules integral to research, law made mandatory the analytical framework for ethical research developed by bioethics experts
End-of-life Decision Making
o Quinlan case with 21 year-old woman in vegetative state parents want to end life support but doctors disagree -> creation of ethics committees, advance directives for end-of-life care
o Patient’s preferences for healthcare very important
o 1990 Patient Self-Determination Act: Medicare and Medicaid payment to HCWs if they 1. Provide patients w/ written info on advance directives 2. Document in medical record whether patient has advance directive 3. Not condition care on whether an individual has advance directive 4. Ensure compliance w/ state law regarding advance directions 5. Provide staff and consumer education on advance directives
Conclusion
o Bioethics developed in U.S. in 1970s when role of law in social change was expanding along with medical advancements and research and healthcare along with civil rights movement of 1960s
o Law relied on bioethics for guidance e.g. bioethics concepts like autonomy and respect for persons embraced by law while legal concepts like procedural due process and freedom of speech and inquiry embraced by bioethics. Relationship b/w bioethics and law strengthened and each field affected the other
o Connection b/w bioethics and law raises challenges
1. Law doesn’t change as quickly as science or societal values thus laws must be reassessed continually and revised to reflect current conditions
2. Law’s emphasis on procedural regularity applied to science, tech, and healthcare can result in slow, formalistic, burdensome, expensive processes that interfere w/ scientific research and clinical care thus laws regulating biomedical research/healthcare should be designed carefully w/ due consideration for consequences
3. Law sets minimum standards of what must be done while ethics set loftier goals of what should be done thus minimum legal standards should not replace more demanding ethical standards
THE LAW
Law is a system of rules created and enforced through social or governmental institutions to regulate behavior, with the aim of maintaining order, ensuring justice, and preventing
harm to individuals and the broader community.
It shapes politics, economics, history, and society in various ways and serves as a mediator of relations between people.
CLINICAL ETHICS COMMITTEE
Multidisciplinary body tasked
with addressing and resolving
ethical issues that arise in the
context of patient care.
Typically comprises:
healthcare providers,
(bio)ethicists,
hospital administrators,
legal advisors
community representatives
THE LAW AS A REFLECTION OF
SOCIO-CULTURAL NORMS AND
VALUES
- Protest for abortion rights, 2020.
- Protest against the dictatorship
and for the return of
“niños desaparecidos”, 1977
PART II: BIOETHICS
“Systematic study of the moral
dimensions – including moral
vision, decisions, conduct, and
policies – of the life sciences and
health care, employing a variety
of ethical methodologies in an
interdisciplinary setting.
-Clinical ethics
-Research ethics
-Health policy
LAW VS ETHICS
Law
-“System of rules which a particular
country or community recognizes as regulating
the actions of its members and
which it may enforce by the imposition of
penalties.”
-What must be done (sets minimum standards)
Ethics
-“1) Moral principles that govern a person’s
behavior or the conducting of an activity; 2)
branch of knowledge that deals with
moral principles.”
-What should be done (beyond or in
contradiction with existing standards)
Influence action or behavior
KEY DIFFERENCES
Source: Law is based on statutes, regulations and precedents, while bioethics is grounded in moral and ethical principles.
Scope: Law is predictable, relatively stable and the same for everyone. Law is often slower than ethics. Ethics has a broader scope
but is more flexible and subjective. Ethical norms are often faster to adopt.
Enforcement: Law is enforceable (legal sanctions), while bioethical norms are generally not.
EXAMPLES OF TOPICS AT THE INTERSECTION
OF LAW AND BIOETHICS
Reproductive rights
Biotech innovation
AI in health
Medical profession regulation
Organ transplant
Assistance in dying/euthanasia
Human remains
Pyramid
Law
Regulation
Policy
Guidelines and Codes
o Law and regulation similar but law more applicable to entire population while regulation applicable to subset
o Ethical norms (“soft law”) that
have ethical and social
implications but not
necessarily legal ones
TRI-COUNCIL POLICY STATEMENT: ETHICAL CONDUCT FOR RESEARCH
INVOLVING HUMANS
- For example, a violation of the TCPS 2 (Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans) by a researcher does not incur legal/criminal sanctions
(unless the violation also breaches a legal norm such as the Civil Code of Quebec or the
Charter of Rights). - However, it may result in institutional sanctions (e.g., expulsion from the university),
financial penalties (e.g., loss of funding from the sponsor), professional and/or social
consequences (e.g., reputational damage and impact on the career).
-Defines standards for
researchers across
Canada
-It is a requirement
for researchers
funded by the TriCouncil
-May serve as a
point of reference
in case of judicial
issue
