Use of non-human animals in biomedical science + What is good biomedical research?

Lecture 9

What ethical question does the rifapentine mouse study raise?

Whether animal research should only be permitted in circumstances where comparable research on humans would also be permitted.

What is the central ethical challenge of animal research?

Weighing potential and actual benefits against potential and actual harms to animals, and considering whether less harmful alternatives can provide the benefits.

When did animal ethics become an increasingly prominent field?

From around 1970, when more moral philosophers began questioning human use of nonhuman animals.

What was Tom Regan's central argument about animal exploitation?

The fundamental wrong is a system that treats animals as human resources, not merely the pain or suffering caused by individual acts.

What was Marti Kheel's criticism of animal experimentation?

She argued that experimenting on animals may distance researchers from feelings of connection, love and compassion towards other living beings.

What is Peter Singer's principle of equal consideration of interests?

The interests of animals should receive equal consideration where relevant; human benefits alone do not automatically justify animal experimentation.

What is speciesism?

Discriminating between beings or giving different moral consideration based on their species membership.

What was Nathan Nobis's argument about moral status?

Biological membership of the human species, by itself, has little to do with what moral consideration a being is owed.

Which animals does Nobis suggest can be harmed?

Many animals, at least mammals and birds, and perhaps all vertebrates.

What criterion did Richard Haynes propose for animal research?

Whether the benefits to the animal being used outweigh the costs to that animal.

Why did Haynes criticise the role of animal welfare scientists in regulation?

Some are animal users or colleagues of users, may favour self-regulation, and scientific expertise does not automatically establish expertise in ethics.

What distinction does Haynes make between science and ethics?

Science concerns what is the case; ethics concerns what ought to be the case.

What did Mary Midgley identify as a problem in human attitudes towards animals?

People tend to favour beings like themselves and their own species, leading to relative disregard for other creatures.

Which UK law regulates scientific procedures involving nonhuman animals?

The Animals (Scientific Procedures) Act 1986 (ASPA), as amended.

Which animals are covered by ASPA, according to the lecture?

Living vertebrates other than humans and living cephalopods, from the specified developmental stages.

When does ASPA protection begin for mammals, birds and reptiles?

When two-thirds of the species' gestation or incubation period has elapsed, as stated in the lecture.

When does ASPA protection begin for other covered animals?

When they become capable of independent feeding.

What types of procedure fall within ASPA's definition?

Procedures causing pain, suffering, distress or lasting harm beyond that caused by inserting a needle.

What are the Three Rs of animal research?

Replacement, Reduction and Refinement.

What does Replacement mean?

Replacing conscious living animals with non-animal alternatives, such as insentient material, wherever possible.

What does Reduction mean?

Using fewer animals to obtain a given amount and precision of information.

What does Refinement mean?

Reducing the incidence or severity of suffering and discomfort, and improving the welfare of animals that must still be used.

Who developed the Three Rs?

Zoologist and classicist William Russell and microbiologist Rex Burch; their principles were published in 1959.

What are the main alternatives to nonhuman animal research listed in the lecture?

Micro-dosing, observational studies, randomised controlled trials, human tissues/cells/genes (in vitro testing) and computer-based testing (in silico testing).

What is micro-dosing?

Administering extremely small doses of a substance, typically in the picogram-to-nanogram range described in the lecture.

What does in vitro testing mean?

Testing using biological material outside a living organism, such as human cells or tissues.

What does in silico testing mean?

Using computers or computational models to investigate biological or medical questions.

What should be considered when evaluating animal research?

Potential and actual benefits, potential and actual harms, and whether less harmful alternatives could achieve the benefits.

What is the purpose of biomedical research?

To investigate the causes of health and illness in biological organisms.

What methods does biomedical research frequently use?

Using biological organisms or parts of organisms to identify the causes of health and illness.

Why does ethics matter in biomedical research?

Research may involve interventions that harm or affect others, so benefits must be maximised, harm minimised and autonomy respected.

What are the three key requirements for valid consent listed in the lecture?

The person has capacity (or competence), is adequately informed, and gives consent voluntarily without coercion.

What does respect for autonomy require?

Respecting a person's ability to make their own decisions, including through voluntary, informed consent.

Is it always unethical to carry out an intervention that a participant would not welcome?

Not necessarily. An intervention may still be beneficial, but its justification and ethical acceptability must be assessed.

Can people who lack capacity be included in clinical research?

The lecture identifies this as a complex legal and ethical issue and directs students to Deckers (2023), sections 6.2 and 6.3.

What is a cross-sectional study?

A study that examines a population at a particular point in time.

What is a case-control study?

A study that compares people with a particular condition (cases) with people without it (controls), often looking back at previous exposures.

What is an interventional study?

A study in which researchers actively introduce an intervention to investigate its effects.

What is a randomised controlled trial (RCT)?

An interventional study in which participants are randomly allocated to different groups, often to compare an intervention with a control.

What is clinical equipoise?

Genuine uncertainty within the relevant expert medical community about which of the treatments being compared is preferable.

What ethical question does the lecture raise about clinical equipoise?

Whether a clinical trial can ever be appropriate when clinical equipoise is absent.

What is confidentiality in research?

Protecting information shared or collected in a context where it should not be disclosed inappropriately.

Which human right is linked to confidentiality in the lecture?

The right to respect for private life under Article 8 of the Human Rights Act 1998.

Which laws relating to confidentiality and data protection are identified in the lecture?

The Freedom of Information Act 2000, GDPR and the Data Protection Act 2018.

What is the purpose of the Freedom of Information Act 2000?

To promote openness by public authorities and provide the public with a statutory right to access information held by bodies such as universities and the NHS.

What does the lecture say about anonymised information under the Freedom of Information Act?

Some anonymised information must be disclosed if requested.

What is the role of the Data Protection Act 2018?

It tailors and supplements GDPR for UK law and applies to identified or identifiable natural persons across the UK.

What are the six data protection principles listed in the lecture?

1. Lawful, fair and transparent processing.

2. Specified, explicit and legitimate purposes.

3. Adequate, relevant and non-excessive data.

4. Accurate and up to date data.

5. Retention no longer than necessary.

6. Secure processing.

When might consent be needed for processing personal data?

The lecture notes that, in many situations, the data subject must consent for processing to be lawful.

What is the ethical challenge in balancing confidentiality and data sharing?

Protecting privacy while enabling appropriate access to information for research and other legitimate purposes.

What ethical question does the lecture raise about genetically engineered organisms?

Whether they are 'unnatural', and why their naturalness or unnaturalness might matter morally.

What are the four types on Deckers' spectrum of naturalness?

Type 1: human influence and human alteration of essence.

Type 2: human influence and autonomous alteration significantly different from natural development.

Type 3: human influence and autonomous alteration significantly similar to natural development.

Type 4: no human influence.

What examples does the lecture give for the naturalness spectrum?

Type 1: genetically engineered animals.

Type 2: conventionally farmed animals.

Type 3: wild animals living today.

Type 4: an aurochs living before humans emerged.

What is ghostwriting in academic research?

Paying someone to write a piece that is then credited to someone else, often the person who commissioned it. The lecture identifies this as academic misconduct.

What is falsification?

Manipulating the research process or data so that the results better fit a desired conclusion.

What is fabrication?

Making up research results.

What is plagiarism?

Using another person's work without proper acknowledgement or presenting it as your own.

What is self-plagiarism?

Publishing extracts from your own previously published work again.

What is gift authorship?

Giving someone authorship or co-authorship recognition despite their having made no more than minor contributions.

Does legal biomedical research automatically count as good biomedical research?

No. The lecture explicitly distinguishes good biomedical research from merely legal biomedical research.

How should ethical theories be used in biomedical research?

They should be applied to specific cases to identify and resolve ethical dilemmas, rather than simply memorised as abstract theories.

What are the essential questions to ask when evaluating animal research?

What are the benefits and harms? How likely and serious are they? Who benefits and who suffers? Could less harmful alternatives achieve the same purpose?

What are the key features of good biomedical research overall?

Ethical justification, respect for autonomy, valid consent, confidentiality, appropriate data protection, scientific integrity, honest reporting and careful consideration of benefits and harms.