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AN INTRODUCTION TO BIOETHICS

LEARNING OUTCOMES
Introduce

bioethics through an overview of the tools of the trade ability to identify, analyse, and solve ethical dilemmas in the biomedical sciences

Develop

WHY DO WE NEED AND WHAT IS BIOETHICS?


y Many

(or all?) people feel the need to justify their behaviour To explain why their behaviour is (un)acceptable how scientists and health professionals ought to behave in the biomedical sciences

y Bioethics:

WHAT IS BIOETHICS?
The

attempt to understand and justify the link between values (fundamental principles) and actions

WHY IS BIOETHICS IMPORTANT?


Realisation

y y y y y

that not everything goes, e.g. Tuskegee Syphilis Experiment Nazi human experimentation (Nuremberg Trials, 1945-1949) TGN1412 trial: Did something go wrong? Dr Shipman DDT (Rachel Carsons Silent Spring) need for justification

Therefore:

HOW DOES IT WORK?


Establishing

knowledge of the relevant legal and professional guidelines your ability to reflect: How?

Exercise

A RANGE OF TOOLS
Principle

of non-contradiction

Analogies

Thought

experiments

PRINCIPLE OF NON-CONTRADICTION
A

researcher who carries out research on patients with advanced dementia says the following:

I believe that researchers who want to carry out research on patients should only proceed if patients give their voluntary, informed consent to research participation.

ANALOGIES
When

a research project is likely to kill human research subjects, research should not proceed.

When

a research project is likely to kill nonhuman research subjects, research should not proceed.

Is this a valid analogy? Why/why not?

THOUGHT EXPERIMENTS
Imagine

the explosion of a nuclear reactor, leaving your one year old child exposed to nuclear fall out. Numerous children develop leukaemia. marrow can now be generated most successfully by reprogramming brain cells, which are more resistant to radiation damage than bone marrow.

Bone

SOME ETHICAL THEORIES


Consequentialism Deontology Virtue Theory Principlism

CONSEQUENTIALISM
Good: what is likely to produce more good than bad consequences. Bad: what is likely to produce more bad than good consequences. y E.g.: utilitarianism: good is what produces the greatest utility (usually understood in terms of happiness) for the greatest number. Often used for resource allocation issues: how can we promote the largest amount of happiness with limited resources?

CONSEQUENTIALISM
Problems:

y y

Can we know the likely consequences of our actions? What if there is great uncertainty? Impartial moral theory m Some would say that we have a duty to be partial. Certain rules may be ignored (yet some forms of consequentialism take some deontological principles into consideration)

DEONTOLOGY

From the Greek word for duty rules, which express our duties y E.g. killing someone to give their organs to someone else may ignore our duty to respect that persons right to life.

DEONTOLOGY

Problems: y Always following rules of conduct can lead to negative consequences e.g. allowing a massive bomb to explode by refusing to torture someone e.g. not fabricating a research result might mean admitting that your study found nothing that is interesting.

VIRTUE THEORY
Focus on the agent of action, rather than on rules or consequences Role-model Problems: y It may fail to guide our actions, as there are no clear, golden rules that can be applied. y What is virtue? Might virtue be vice?

PRINCIPLISM

The four principles approach y The most widely used approach in Western bioethics y Incorporates elements from both consequentialist and deontological theories

WHAT ARE THESE 4 PRINCIPLES


Autonomy Right of self-determination Related to informed consent In order to give consent: autonomy/competency/capacity must be possessed. y Beneficence to do well, to promote well-being y Non-male ficence to do no harm, to avoid doing harm y Justice treat like alike
y

THE LEGAL CONTEXT OF BIOMEDICAL RESEARCH IN THE UK


The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031): regulation in relation to clinical trials Mental Capacity Act 2005: provides legal definition of capacity and details how to research involving adults who lack capacity (apart from clinical trials) MRC Ethics Guide, Medical Research Involving Children, London, 2004: provides guidance on the role of children in research

DOES MY RESEARCH NEED ETHICAL APPROVAL?


Two possibilities: My research involves: y A: NHS staff or patients y B: others

IF A
research

needs to be approved by a LREC (Local Research Ethics Committee)

NATIONAL RESEARCH ETHICS SERVICE


a directorate within the National Patient Safety Agency, replaced COREC co-ordinates activities of the Research Ethics Committees in England

IF B
Many research councils and other funders have their own research ethics committees. Universities (and some Faculties/schools) have research ethics committees.

SOME QUESTIONS TO ASK


IN RELATION TO

PERSONAL RESEARCH PROJECTS

What is the aim of my research? Whose interests will be served by my research? What are the risks? What are the opportunity costs?

PROMINENT ETHICAL CODES


Oath of Hippocrates (4th c BC) Nuremberg Code (1947): issue of human experimentation Declaration of Helsinki (1964) (WMA): issue of human experimentation y First serious attempt of medical community to regulate itself Declaration of Geneva (1948) y Issued as a development on the Oath of Hippocrates CIOMS Guidelines (1993) y International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS: the Council for International Organizations of Medical Sciences) Universal Declaration on Bioethics and Human Rights (UNESCO; United Nations Educational, Scientific, and Cultural Organisation) (2005)

The Tuskegee syphilis experiment (also known as the Tuskegee syphilis study or Public Health Service syphilis study) was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S. government. The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama; 399 who had previously contracted syphilis before the study began, and 201 without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood," a local term used to describe several illnesses, including syphilis, anemia and fatigue.

The Nuremberg Trials were a series of military tribunals, held by the main victorious Allied forces of World War II, most notable for the prosecution of prominent members of the political, military, and economic leadership of the defeated Nazi Germany. The trials were held in the city of Nuremberg, Bavaria, Germany, in 1945-46, at the Palace of Justice. The first and best known of these trials was the Trial of the Major War Criminals before the International Military Tribunal (IMT), which tried 24 of the most important captured leaders of Nazi Germany, though several key architects of the war (such as Adolf Hitler, Heinrich Himmler, and Joseph Goebbels) had committed suicide before the trials began. The initial trials were held from November 20, 1945 to October 1, 1946. The second set of trials of lesser war criminals was conducted under Control Council Law No. 10 at the US Nuremberg Military Tribunals (NMT); among them included the Doctors' Trial and the Judges' Trial. This article primarily deals with the IMT; see the Subsequent Nuremberg Trials for details on those trials.

Harold Fredrick Shipman (14 January 1946 13 January 2004) was a convicted English serial killer. A doctor by profession, he is among the most prolific serial killers in recorded history with 218 murders being positively ascribed to him, although the actual number is probably much higher. On 31 January 2000, a jury found Shipman guilty of 15 murders. He was sentenced to life imprisonment and the judge recommended that he never be released. The whole life tariff was confirmed by the Home Secretary a little over two years later.

DDT (from its trivial name, dichlorodiphenyltrichloroethane) is one of the most well-known synthetic pesticides. It is a chemical with a long, unique, and controversial history. First synthesized in 1874, DDT's insecticidal properties were not discovered until 1939, and it was used with great success in the second half of World War II to control malaria and typhus among civilians and troops. The Swiss chemist Paul Hermann Mller was awarded the Nobel Prize in Physiology or Medicine in 1948 "for his discovery of the high efficiency of DDT as a contact poison against several arthropods. After the war, DDT was made available for use as an agricultural insecticide, and soon its production and use skyrocketed.

In 1962, Silent Spring by American biologist Rachel Carson was published. The book catalogued the environmental impacts of the indiscriminate spraying of DDT in the US and questioned the logic of releasing large amounts of chemicals into the environment without fully understanding their effects on ecology or human health. The book suggested that DDT and other pesticides may cause cancer and that their agricultural use was a threat to wildlife, particularly birds. Its publication was one of the signature events in the birth of the environmental movement, and resulted in a large public outcry that eventually led to DDT being banned in the US in 1972. DDT was subsequently banned for agricultural use worldwide under the Stockholm Convention, but its limited use in disease vector control continues to this day and remains controversial. Along with the passage of the Endangered Species Act, the US ban on DDT is cited by scientists as a major factor in the comeback of the bald eagle, the national bird of the United States, from near-extinction in the contiguous US.