Biomedical Research

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Biomedical Research

• Animal Experimentation
• Public Perceptions
• The Law
• Human Experimentation

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Public Perceptions
3
Public Perceptions
MORI Poll 2000, 1,014 adults aged 15 were
sampled
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Use of Animals in the UK
700,000,000
8,000,000
5
Animal Research The LawAnimals (Scientific
Procedures) Act 1986

• Competence of the scientists undertaking the
  research
• Premises where the animals are housed and used
• Balance between the likely benefits of the
  research and possible distress to the animals

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Home Office Licensing

• Home Office Inspectorate
• Certificate of Designation
• Personal Licence
• Project Licence
• Likely benefits of the research
• Likely effects on the animals and how distress
• will be minimised
• Type and number of animals to be used
• Techniques (procedures to be used)
• Why alternative methods cannot be used

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Biomedical Research on Humans

• Basic Biomedical Research
• Clinical Trials

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Biomedical Research on Humans

• Ethical Principles for Medical Research Involving
  Human Subjects the World Medical Association
  Declaration of Helsinki, 1964.
• Medical progress is based on research which
  ultimately must rest in part on experimentation
  involving human subjects.
• In medical research on human subjects,
  considerations related to the well-being of the
  human subject should take precedence over the
  interests of science and society.

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Biomedical Research on Humans

• Committee of Ministers of the Council of Europe
  (1990)
• Principle 3 ..No medical research may be
  carried out without informed, free, express and
  specific consent of the person undergoing it

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Biomedical Research on Humans

• Approval of Full Protocol by Local Ethics
  Committee of the NHS Trust
• Subjects Must Give Informed Consent
• Subjects Can Refuse to Participate Must Not
  Affect Level of Treatment for Current Patients
• Must Comply with the Data Protection Act
• Must Carry Liability Insurance

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Biomedical Research on HumansAbility to give
consent

• Legally Incapacitated Subjects Have Special
  Protection e.g. Children, Mentally Disabled.

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Clinical Trials Drug Development
Basic Research
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Clinical Trials

• Phase I Usually in normal volunteers, small
  groups for safety testing
• Phase II On patients to confirm the
  effectiveness of the drug
• Phase III Large groups of patients for
  statistical confirmation of effect and incidence
  of side-effects.

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Drug Development
In-Vitro Tests Can Show Whether
1. A compound has the desired effect on isolated
cells or tissues
2. There are adverse effects on those tissues
In-Vitro Tests Cannot Show Whether
1. The desired effect will occur in a complete
living system
2. There will be any adverse effects in a
complete living system
ABPI 2001
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Drug Development
Animal Tests Can
1. Suggest which drugs are likely to be effective
in humans
2. Indicate which drugs may not be harmful in
humans
Animal Tests Cannot
1. Predict with absolute certainty what will
happen in humans
Animal Testing is necessary for veterinary
products
ABPI 2001