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AP0611 Guided Revision Questions > Bioethics > Flashcards

Bioethics Flashcards

1
Q

Principal of Equipoise (6)

A
  • Provides ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial
  • Means that there’s genuine uncertainty in expert medical community over whether a treatment will be beneficial
  • Applies also for off-label treatments performed before or during their required clinical trials
  • As trial progresses, findings may provide sufficient evidence to convince investigator of intervention or drug’s efficacy
  • Once a certain threshold of evidence is passed, there’s no longer genuine uncertainty about most beneficial treatment, so there’s an ethical imperative for investigator to provide superior intervention to all participants
  • Some ethicists suggest investigators should only continue the study until they’re convinced that one of the treatments is better, other ethicists argue that the study should continue until evidence convinces the entire expert medical community
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2
Q

What is a double-blind study? (2)

A
  • Both the subjects or participants and the researcher are blinded
  • The researcher is unaware of who is receiving what treatment and the participants are unaware of the treatment they are receiving
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3
Q

Pros and cons of double-blind study (2)

A
  • Pros: it tests for three groups (treatment, placebo, control), reduces experimental bias, results can be duplicated
  • Cons: expensive, low representation, patients may respond negatively to drug or placebo
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4
Q

What is a randomised trial? (1)

A
  • Study in which the participants are divided by chance into separate groups that compare different treatments or other interventions
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5
Q

Pros and cons of randomised trials (2)

A
  • Pros: minimises bias, minimises confounding factors, statistical reliability
  • Cons: results may not always mimic real life treatment situation, requires clinical equipoise, informed consent is impossible
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6
Q

What is a placebo? (2)

A
  • An inactive substance that looks like the drug or treatment being tested
  • Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance.
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7
Q

Purpose, Methods and Justification of Risks of Medical Care/Practice (3)

A
  • Purpose: individualised care
  • Methods: routine/established care
  • Justification of risks: risks of diagnostics/treatments are justified by potential benefits to patients
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8
Q

Purpose, Methods and Justification of Risks of Medical/Clinical Research (3)

A
  • Purpose: advance medical knowledge for society/generalisable knowledge for groups of patients
  • Methods: randomisation, blinding, restrictive doses, tests to measure study outcomes
  • Justification of risks: risks of discomfort or harm and/or without a prospect of benefit from participating are justified and anticipated by the knowledge to be gained
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9
Q

Ethical issues linked with Data Protection Act 1998 and General Data Protection Regulation 2018 (2)

A
  • Confidentiality
  • Anonymity
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10
Q

Ethical issues linked with Animals (Scientific Procedures) Act 1986, 2013 (1)

A
  • 3 Rs (Reduce, Replace, Refine); Animal Welfare (high standards)
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11
Q

Ethical issues linked with Alder Hay Scandal, Human Tissue Act 2004 (1)

A
  • Consent
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12
Q

Ethical issues linked with Medicines for Human Use Regulations 2004 & 2017 UK Policy Framework for Health & Social Care (2)

A
  • Informed consent
  • All clinical trials to have Research Ethics Committee (REC) approval
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13
Q

Utilitarianism (3)

A
  • Asserts that right and wrong are best determined by focusing on outcomes of actions and choices
  • A person’s rights are of less importance than the good outcomes of actions
  • Underpins universal healthcare and public health approaches
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14
Q

Deontology (4)

A
  • Distinguishes right from wrong, an action is intrinsically right or wrong
  • Doesn’t consider outcomes/consequences of an action
  • Basic interests & rights of a person are of primary importance
  • Underpins universal human rights and duties
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15
Q

Principlism (2)

A
  • ‘4 Principles’: Autonomy, Justice, Non-maleficence, Beneficence
  • On occasion, ethical dilemmas are complex, and one or more of the four principles come into conflict with each other
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16
Q

What are the 4 core ethical principles of biomedical research? (4)

A
  • Autonomy
  • Justice
  • Non-maleficence
  • Beneficence
17
Q

Autonomy (3)

A
  • Underpins right of competent individuals to self-determination
  • Increasingly important (shift away from paternalism)
  • Basis for informed consent
18
Q

Justice (2)

A
  • Underpins individuals right to be treated equitably and access resources without bias or prejudice
  • Basis for fair selection/discrimination
19
Q

Beneficence (2)

A
  • Underpins obligation to take action which promotes the wellbeing in others
  • Basis for taking actions in the best interest of the patient
20
Q

Non-maleficence (2)

A
  • Underpins obligation to do no harm
  • Basis of much medical malpractice litigation
21
Q

What is the best practice associated with participant recruitment to research? (1)

A
  • Fully Informed Consent
22
Q

How can Fully Informed Consent be achieved? (8)

A
  • Up front participant information which includes clear aims, what’s required of the participant, risks etc.
  • Participant information in appropriate lay language and format
  • Provide opportunity to ask Qs, clarify understanding etc.
  • Voluntary participation (free from coercion)
  • Consent should be recorded
  • Provide capacity to withdraw consent (without prejudice)
  • Provide debrief opportunity
  • Only competent people can provide consent, consent must be sought from proxy of non-competent person e.g., parent or guardian of a child etc.
23
Q

Scientific Review (4)

A
  • Independent peer review process
  • Focus on clinical equipoise, originality and importance of proposed research
  • Likely benefits of the new treatment are greater than probable side effects
  • Likelihood of successful outcome e.g., trial is well planned, researchers are well qualified, correct facilities/equipment are in place etc.
24
Q

Research Ethics Committee (REC) Review (4)

A
  • Focus is on rights, safety, dignity and well-being of voluntary participants
  • ≥1 in 3 must be lay numbers (outsider’s point of view)
  • Each hospital involved must have a SSA (Site Specific Assessment) undertaken by their NHS R&D department, ensures that the right staff, equipment and expertise to carry out the trial are in place
  • Extra permissions may be required e.g., if a trial is using methods that would expose participants to radiation that they would not have had otherwise, they would have to achieve additional permission from specialist group

AP0611 Guided Revision Questions (12 decks)

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