An Introduction to BioethicsAn Introduction to Bioethics

Jan DeckersJan Deckers

Institute of Health and SocietyInstitute of Health and Society

University of NewcastleUniversity of Newcastle

Jan.deckers@ncl.ac.ukJan.deckers@ncl.ac.uk

Learning outcomesLearning outcomes

• Introduce bioethics through an overview of the tools of the Introduce bioethics through an overview of the tools of the tradetrade

• Develop ability to identify, analyse, and solve ethical Develop ability to identify, analyse, and solve ethical dilemmas in the biomedical sciencesdilemmas in the biomedical sciences

Why do we need and what is bioethics?Why do we need and what is bioethics?

– Many (or all?) people feel the need to justify their Many (or all?) people feel the need to justify their behaviourbehaviour

• to explain why their behaviour is (un)acceptableto explain why their behaviour is (un)acceptable

– Bioethics: how scientists and health professionals ought to Bioethics: how scientists and health professionals ought to behave in the biomedical sciences behave in the biomedical sciences

What is bioethics?What is bioethics?

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

Why is bioethics important?Why is bioethics important?

• Realisation that ‘not everything goes’, e.g.Realisation that ‘not everything goes’, e.g.

– Tuskegee Syphilis ExperimentTuskegee Syphilis Experiment

– Nazi human experimentation (Nuremberg Trials, 1945-Nazi human experimentation (Nuremberg Trials, 1945-1949)1949)

– TGN1412 trial: Did something go wrong?TGN1412 trial: Did something go wrong?

– Dr ShipmanDr Shipman

– DDT (Rachel Carson’s ‘Silent Spring’)DDT (Rachel Carson’s ‘Silent Spring’)

• Therefore: need for justificationTherefore: need for justification

Bioethics and environmental ethicsBioethics and environmental ethics

• Both developed significant momentum in last quarter of 20Both developed significant momentum in last quarter of 20 thth centurycentury

• Increasingly considered to be inseparable Increasingly considered to be inseparable

Some key resourcesSome key resources

• Journal of Medical EthicsJournal of Medical Ethics

• BioethicsBioethics

• Cambridge Quarterly of Healthcare EthicsCambridge Quarterly of Healthcare Ethics

• Hastings Center ReportHastings Center Report

• American Journal of BioethicsAmerican Journal of Bioethics

• Journal of Agricultural and Environmental EthicsJournal of Agricultural and Environmental Ethics

• Environmental PoliticsEnvironmental Politics

• Ethics and the EnvironmentEthics and the Environment

• Journal of Public Health Ethics (new in 2008)Journal of Public Health Ethics (new in 2008)

• Journal of Animal Ethics (new in 2008)Journal of Animal Ethics (new in 2008)

Two dimensionsTwo dimensions

• law and professional guidelineslaw and professional guidelines

• reflectionreflection

How does it work?How does it work?

• Establishing knowledge of the relevant legal and professional Establishing knowledge of the relevant legal and professional guidelinesguidelines

• Exercise your ability to reflect: How?Exercise your ability to reflect: How?

A range of toolsA range of tools

• Principle of non-contradictionPrinciple of non-contradiction

• AnalogiesAnalogies

• Thought experimentsThought experiments

Principle of non-contradictionPrinciple of non-contradiction

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

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

Analogies Analogies

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

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

• Is this a valid analogy? Why/why not?Is this a valid analogy? Why/why not?

Thought experimentsThought experiments

• Imagine the explosion of a nuclear reactor, leaving your one Imagine the explosion of a nuclear reactor, leaving your one year old child exposed to nuclear fall out. Numerous children year old child exposed to nuclear fall out. Numerous children develop leukaemia, including your own. Bone marrow can develop leukaemia, including your own. Bone marrow can now be generated most successfully by reprogramming brain now be generated most successfully by reprogramming brain cells, which are more resistant to radiation damage than bone cells, which are more resistant to radiation damage than bone marrow. Unfortunately, a whole brain must be destroyed. The marrow. Unfortunately, a whole brain must be destroyed. The extracted stem cells could be reprogrammed to treat ten extracted stem cells could be reprogrammed to treat ten children.children.

• Since a one in eleven chance of certain death seems preferable Since a one in eleven chance of certain death seems preferable to a one hundred percent chance of imminent death, the to a one hundred percent chance of imminent death, the question is: would you enter your child into a lottery and risk a question is: would you enter your child into a lottery and risk a 1/11 chance of your child being sacrificed (by being killed to 1/11 chance of your child being sacrificed (by being killed to treat others) or refrain from entering your child into such a treat others) or refrain from entering your child into such a lottery (which would mean certain death for your child)? lottery (which would mean certain death for your child)? (Savulescu J. The Embryonic Stem Cell Lottery and the (Savulescu J. The Embryonic Stem Cell Lottery and the Cannibalization of Human Beings. Cannibalization of Human Beings. BioethicsBioethics 2002; 2002;1616:508-:508-529.) 529.)

Some ethical theoriesSome ethical theories

• ConsequentialismConsequentialism

• DeontologyDeontology

• Virtue theoryVirtue theory

• PrinciplismPrinciplism

ConsequentialismConsequentialism

• Good: what is likely to produce more good than bad Good: what is likely to produce more good than bad consequences. consequences.

• Bad: what is likely to produce more bad than good Bad: what is likely to produce more bad than good consequences. consequences.

– E.g.: utilitarianism: good is what produces the greatest utility E.g.: utilitarianism: good is what produces the greatest utility (usually understood in terms of ‘happiness’) for the greatest (usually understood in terms of ‘happiness’) for the greatest number. number.

• Often used for resource allocation issues: how can we Often used for resource allocation issues: how can we promote the largest amount of happiness with limited promote the largest amount of happiness with limited resources?resources?

– Example: Savulescu’s thought experimentExample: Savulescu’s thought experiment

ConsequentialismConsequentialism

• Problems:Problems:

– Can we know the likely consequences of our actions? What Can we know the likely consequences of our actions? What if there is great uncertainty?if there is great uncertainty?

– Impartial moral theory Impartial moral theory Some would say that we have a Some would say that we have a duty to be partial.duty to be partial.

– Certain rules may be ignored (yet some forms of Certain rules may be ignored (yet some forms of consequentialism take some deontological principles into consequentialism take some deontological principles into consideration)consideration)

DeontologyDeontology

• From the Greek word for ‘duty’From the Greek word for ‘duty’

• rules, which express our duties rules, which express our duties

– E.g. killing someone to give their organs to someone else E.g. killing someone to give their organs to someone else may ignore our duty to respect that person’s right to life. may ignore our duty to respect that person’s right to life.

DeontologyDeontology

• Problems:Problems:

– Always following rules of conduct can lead to negative Always following rules of conduct can lead to negative consequencesconsequences

• e.g. allowing a massive bomb to explode by refusing to e.g. allowing a massive bomb to explode by refusing to torture someonetorture someone

• e.g. not fabricating a research result might mean e.g. not fabricating a research result might mean admitting that your study found nothing that is admitting that your study found nothing that is interesting. interesting.

Virtue theoryVirtue theory

• focus on the agent of action, rather than on rules or focus on the agent of action, rather than on rules or consequences consequences

• Role-modelRole-model

• Problems:Problems:

– It may fail to guide our actions, as there are no clear, It may fail to guide our actions, as there are no clear, golden rules that can be applied.golden rules that can be applied.

– What is ‘virtue’? Might ‘virtue’ be ‘vice’?What is ‘virtue’? Might ‘virtue’ be ‘vice’?

PrinciplismPrinciplism

• ‘‘The four principles’ approachThe four principles’ approach

– The most widely used approach in Western bioethicsThe most widely used approach in Western bioethics

– Incorporates elements from both consequentialist and Incorporates elements from both consequentialist and deontological theoriesdeontological theories

What are these 4 principlesWhat are these 4 principles

– AutonomyAutonomy

• Right of self-determinationRight of self-determination

– Related to ‘informed consent’Related to ‘informed consent’

– In order to give consent: In order to give consent: autonomy/competency/capacity must be possessed.autonomy/competency/capacity must be possessed.

– Beneficence – to do well, to promote well-beingBeneficence – to do well, to promote well-being

– Non-maleficence – to do no harm, to avoid doing harmNon-maleficence – to do no harm, to avoid doing harm

– Justice – treat like alikeJustice – treat like alike

(T. Beauchamp and J. Childress, Principles of Biomedical Ethics, (T. Beauchamp and J. Childress, Principles of Biomedical Ethics, 55thth edition, New York/Oxford: Oxford University Press, 2001.) edition, New York/Oxford: Oxford University Press, 2001.)

Theories in environmental ethicsTheories in environmental ethics

• Strong anthropocentrism (speciesism)Strong anthropocentrism (speciesism)

• Weak anthropocentrismWeak anthropocentrism

• PathocentrismPathocentrism

• BiocentrismBiocentrism

• EcocentrismEcocentrism

A selection of prominent issuesA selection of prominent issues

• Should scientists consider the possibility that their research Should scientists consider the possibility that their research might encourage bioterrorism?might encourage bioterrorism?

• Should regulations underpinning good research be the same Should regulations underpinning good research be the same everywhere?everywhere?

– E.g. research on Aids/HIVE.g. research on Aids/HIV

• Why are health resources scarce (in some countries) and how Why are health resources scarce (in some countries) and how should resources be allocated?should resources be allocated?

– E.g. malaria tablets, HIV/Aids drugsE.g. malaria tablets, HIV/Aids drugs

• When is withholding/withdrawing treatment appropriate?When is withholding/withdrawing treatment appropriate?

• Should euthanasia be legalised in the UK?Should euthanasia be legalised in the UK?

A selection of prominent issuesA selection of prominent issues

• Is research on those who cannot give consent permissible?Is research on those who cannot give consent permissible?

– E.g. children, adults who lack capacity, nonhuman animalsE.g. children, adults who lack capacity, nonhuman animals

• How should we assess capacity/competence?How should we assess capacity/competence?

• Should human embryos be used for research?Should human embryos be used for research?

• Should abortion legislation be changed?Should abortion legislation be changed?

• Should nonhuman animals be used for research?Should nonhuman animals be used for research?

• Is genetic modification acceptable?Is genetic modification acceptable?

A selection of prominent issuesA selection of prominent issues

• Should people who suffer from ‘self-inflicted diseases’ be Should people who suffer from ‘self-inflicted diseases’ be treated in the same way as people who suffer from diseases not treated in the same way as people who suffer from diseases not caused by their own lifestyles?caused by their own lifestyles?– E.g. alcohol, smoking, obesity, …E.g. alcohol, smoking, obesity, …

• Should people be encouraged to take their health (more) Should people be encouraged to take their health (more) seriously? Why?seriously? Why?

• Which measures to promote public health are acceptable?Which measures to promote public health are acceptable?– E.g. compulsory vaccination?E.g. compulsory vaccination?

• What are the purposes of pre-implantation genetic diagnosis and What are the purposes of pre-implantation genetic diagnosis and pre-natal diagnosis? Can these purposes be justified? Which pre-natal diagnosis? Can these purposes be justified? Which means are acceptable?means are acceptable?

• Should treatments which are not recommended by NICE be Should treatments which are not recommended by NICE be available on the NHS anyway?available on the NHS anyway?

The legal context of biomedical research in the UKThe legal context of biomedical research in the UK

• The Medicines for Human Use (Clinical Trials) Regulations The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031): regulation in relation to clinical trials2004 (S.I. 2004/1031): regulation in relation to clinical trials

• Mental Capacity Act 2005: provides legal definition of Mental Capacity Act 2005: provides legal definition of ‘capacity’ and details how to research involving adults who ‘capacity’ and details how to research involving adults who lack capacity (apart from clinical trials)lack capacity (apart from clinical trials)

• MRC Ethics Guide, MRC Ethics Guide, Medical Research Involving ChildrenMedical Research Involving Children, , London, 2004: provides guidance on the role of children in London, 2004: provides guidance on the role of children in researchresearch

Does my research need ethical approval?Does my research need ethical approval?

• Two possibilities: My research involves:Two possibilities: My research involves:

– A: NHS staff or patientsA: NHS staff or patients

– B: othersB: others

If AIf A

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

National Research Ethics ServiceNational Research Ethics Service

• a directorate within the National Patient Safety Agency, a directorate within the National Patient Safety Agency, replaced CORECreplaced COREC

• co-ordinates activities of the Research Ethics Committees in co-ordinates activities of the Research Ethics Committees in EnglandEngland

If BIf B

• Many research councils and other funders have their own Many research councils and other funders have their own research ethics committees.research ethics committees.

• Universities (and some Faculties/schools) have research ethics Universities (and some Faculties/schools) have research ethics committees.committees.

Some questions to ask in relation to personal research projectsSome questions to ask in relation to personal research projects

• What is the aim of my research?What is the aim of my research?

• Whose interests will be served by my research?Whose interests will be served by my research?

• What are the risks?What are the risks?

• What are the opportunity costs?What are the opportunity costs?

Prominent ethical codesProminent ethical codes

• Oath of Hippocrates (4Oath of Hippocrates (4thth c BC) c BC)• Nuremberg Code (1947): issue of human experimentationNuremberg Code (1947): issue of human experimentation• Declaration of Helsinki (1964) (WMA): issue of human experimentationDeclaration of Helsinki (1964) (WMA): issue of human experimentation

– First serious attempt of medical community to regulate itselfFirst serious attempt of medical community to regulate itself• Declaration of Geneva (1948)Declaration of Geneva (1948)

– Issued as a development on the Oath of Hippocrates Issued as a development on the Oath of Hippocrates • CIOMS Guidelines (1993)CIOMS Guidelines (1993)

– ‘‘International Ethical Guidelines for Biomedical Research Involving International Ethical Guidelines for Biomedical Research Involving Human Subjects’Human Subjects’

(CIOMS: the Council for International Organizations of Medical (CIOMS: the Council for International Organizations of Medical Sciences)Sciences)

• Universal Declaration on Bioethics and Human Rights (UNESCO; United Universal Declaration on Bioethics and Human Rights (UNESCO; United Nations Educational, Scientific, and Cultural Organisation) (2005)Nations Educational, Scientific, and Cultural Organisation) (2005)