Research Ethics

Question 1

Meta-ethical positions:

Answer 1

• Moral absolutism
• Moral relativism
• Pyrrhonian moral scepticism

Question 2

Moral absolutism =

Answer 2

I know that X is right and anyone who disagrees is wrong

Question 3

Moral relativism =

Answer 3

X might seem right to me, but what is right and wrong is subjective

Question 4

Pyrrhonian moral scepticism =

Answer 4

I believe that X is right but those who disagree may be right

Question 5

Reportive definitions =

Answer 5

to reflect the existing meaning of a term

Question 6

Stipulative definitions =

Answer 6

to assign new meaning to a term

Question 7

Analogies =

Answer 7

a comparison of different things to show their similarity

Question 8

Ethical theories: Consequentialism

Answer 8

focus on consequences

e.g. utilitarianism = consequences are measured in terms of whether they produce happiness, where we should try to create the greatest amount of happiness for the greatest number

Question 9

Problems of Consequentialism =

Answer 9

What if trying to bring about positive consequences ignores certain rules?

Should happiness be all that matters?

How can an act that produces good consequences be good if it was motivated by bad intentions?

Question 10

Ethical theories: Deontology

Answer 10

Duty

Intentions matter

Ethical decisions are good if they are made on the basis of some rules, which are based on the recognition of particular duties

Question 11

Problems of Deontology =

Answer 11

Always following rules of conduct can lead to negative consequences

Question 12

Ethical theories: Virtue Ethics

Answer 12

Focus on role models, on the agent’s character, rather than on consequences or rules.

Question 13

Ethical theories: The ethics of care

Answer 13

Ethical theory and right conduct would emerge from caring relationships - ethics come from relationship with others

Careful attention to specific situations is required.

Question 14

Ethical theories: Principlism

Answer 14

The ‘four principles’ approach

1. Autonomy: the duty to allow for autonomous choices (‘informed consent’)
2. Beneficence: the obligation to promote well-being
3. Non-maleficence: the duty to avoid harm
4. Justice: the duty of fairness

Question 15

Ontologies =

Answer 15

Ontologies = the philosophical study of entities/things)

How we value things is connected to our ontologies

Intrinsic value: value for oneself

Instrumental/use value: value for others

Question 16

Western philosophy has for a long time been dominated by two ontologies:

Answer 16

Mechanistic materialism and Dualism

Both adopt the view that there are things that are utterly devoid of experiential properties.

Things that are devoid of experiential properties cannot possess intrinsic value.

Question 17

Ontology: Mechanistic materialism =

Answer 17

The view that reality is composed of bits of stuff that act in a machine-like fashion

It accepts ‘determinism’: the view that all events are determined by causes that lack free will

Question 18

Ontology: Dualism =

Answer 18

The view that reality is composed of two fundamentally distinct things: things with minds and things that lack minds

Question 19

Ontology: Panexperientialism =

Answer 19

The view that everything material, however small, has an element of individual consciousness.

There are different levels of agency/subjectivity/mentality.

Question 20

The non-consensual analysis of DNA is prohibited under the Human Tissue Act 2004.
However, there are exceptions to this:

Answer 20

Where consent is not needed as a result of incapacity

Work of coroners, the police and the courts.

Question 21

Research in resource-poor settings:

Answer 21

Inequalities in resources (journal subscriptions, internet access, protected time for research) between researchers from high- and low-income countries

Inequalities in resources and power between researchers and research participants

Limited healthcare infrastructure, socioeconomic disadvantage, illiteracy, poor general health, or unfamiliarity with the scientific rationale behind medical research, can all represent substantial barriers to an individual’s agreement and proper consent to participate in a clinical trial

How voluntary is ‘informed consent’ in contexts where a clinical trial may be the only access to care, and the usual standard of care is no care at all?

Marketisation of access to health care (experimental labour = nothing left to sell but exposure itself) → What happens post-trial?

Question 22

Three requirements in relation to consent:

Answer 22

The patient or participant…

has capacity

is informed adequately

gives consent voluntarily, i.e. without being coerced or without being exploited

Question 23

Capacity:

Answer 23

legal presumption: every person has capacity from the age of 16

If in doubt: assess

Question 24

The Mental Capacity Act 2005:

Answer 24

A person lacks capacity if they…

have an ‘impairment in the functioning of the mind

is unable:

• to understand information relevant to the decision
• to retain that information
• to use or weigh that information as part of the process of making the decision
• to communicate their decision

Question 25

Research on adults who lack capacity is possible under Mental Capacity Act if:

Answer 25

it involves minimal risk

relates to the person’s condition

cannot be done as effectively on people who have capacity

(unpaid) carers or nominated third parties (i.e.: consultees) are consulted

the person is not entered or is withdrawn if any resistance is shown

the research project has been approved by an appropriate body, such as a Research Ethics Committee.

Question 26

Might children have capacity?

Answer 26

Children above 16 are legally assumed to have capacity

Children below 16 may be ‘Gillick competent’

Question 27

Informed consent:

Answer 27

Must provide adequate information that might have been used by the patient to refuse treatment

Information must be tailored to each individual

Question 28

Consent must be given voluntarily:

Answer 28

People may be incentivised to do something by the offer of a financial incentive.

Sometimes, the law prohibits this.

There is no law that prohibits the use of financial incentives in research. However, the offer of payment may jeopardise one’s capacity to consent voluntarily.

Question 29

Human tissue (Relevant Material) is defined as…

Answer 29

material that has come from a human body and consists of, or includes, human cells.

Question 30

Summary of the Human Tissue Act 2004: listed as offences:

Answer 30

Removing, storing or using human tissue without appropriate consent.

Storing or using human tissue donated for a certain purpose for another purpose.

Trafficking in human tissue for transplantation purposes.

Carrying out licensable activities without holding a licence.

Having human tissue, including hair, nail, and gametes with the intention of its DNA being analysed without consent (Medical diagnosis and criminal investigations are excluded).

Question 31

Many laws associated with the use of nonhuman animals now defend the value of the three R’s…

Answer 31

Replacement

Reduction

Refinement

Question 32

Replacement =

Answer 32

means the substitution for conscious living higher animals of insentient material.

Question 33

Reduction =

Answer 33

means reduction in the numbers of animals used to obtain information of a given amount and precision.

Question 34

Refinement =

Answer 34

means any decrease in the incidence or severity of inhumane procedures applied to those animals which still have to be used (minimising pain, distress and discomfort plus optimising wellbeing)

Question 35

Alternatives to nonhuman animal research include:

Answer 35

micro-dosing

observational studies

randomised controlled trials

use of human tissues, cells, and genes (in vitro testing)

computer testing

Question 36

Human Fertilisation and Embryology Act 1990

Answer 36

allows research under strict conditions

a licence must be provided by the Human Fertilisation and Embryology Authority

embryos must not have developed beyond 14 days after conception

Question 37

The ‘high status’ position for the human embryo:

Answer 37

the ‘high status’ position = used here to refer to the position that attributes a status to an embryo that is equal to that of an adult human being

Question 38

The argument from probability produced by supporters of the ‘low status’ position:

Answer 38

The probability that a young embryo may not survive beyond implantation is high = Young embryos should not be granted a high status.

Problems = Higher probability ≠ more worth = Some young embryos may have a high probability

The argument from probability fails to establish that young embryos should not be granted a high status.

Question 39

The argument from sentience produced by supporters of the ‘low status’ position:

Answer 39

Young embryos lack the capacity to feel pain = young embryos should not be granted a high status.

Question 40

The argument from ensoulment produced by supporters of the ‘low status’ position:

Answer 40

As long as something can still divide into more than one ensouled being, it cannot possess a soul. Young embryos can still divide into more than one organism = Young embryos are not ensouled.

Problem = the view that young embryos are not ensouled is implausible on scientific grounds (as it would deny that they are living individuals)