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MD3000 - Ethics > Research Ethics > Flashcards

Research Ethics Flashcards

1
Q

What does research ethics apply to?

A

Animal and human research

Also human gametes and embryos but under different law

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2
Q

What dictates research ethics?

A
  • laws
  • guidance
  • committees
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3
Q

What areas are animals used in research?

A
  • basic research - how things work (no clinical application)
  • applied research - treatments, toxicity
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4
Q

What does the term procedure refer to?

A

any act tgat may cause an animak a level of pain, suffering or distress equivalent to or greater than the introduction of a hypodermic needle

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5
Q

Aspects that should be considered when doing animal research

A
  • benefits (is the cost justifyable)
  • model (for the question being asked)
  • sentience (similarity to humans)
  • value
  • moral agency
  • spiritual/religious potential
  • human achievement
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6
Q

What did Peter Singer say in 1979 regarding animals?

A

there seems to be no morally relevant characteristic that such humans have which nonhuman animals lack

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7
Q

What laws apply to animal research regulation in the UK

A
  • cruelty to animal acts 1876
  • Animals (scientific procedures) act 1986 (ASPA)
  • Home Office:
    • “on what basis to grant a project license the Secretary of State shall weigh the likely adverse effects on the animals concerned against the benefir likely to accrue as a result of the programme to be specified in the license”
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8
Q

What are the 3 key principles in ASPA?

A
  • Replacement
    • alternatuve technologies; use lower organisms
  • Reduction
    • better study design to allow use of fewer animals; better storage of data
  • Refinement
    • improve housing, minimise pain, improve welfare
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9
Q

What does the Home Office do?

A
  • advised by Animal Procedures Inspectorate
  • Each local arena has an animal ethics committee - review and monitor all eligible research, using ASPA and home office guidelines
  • Licenses are granted
    • Site license
    • Personal license
    • Project license
  • Concorat on openness
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10
Q

What was the first code to regulate experimentation on human? And what did it include?

A

Nuremberg Code 1947

  • voluntary consent of the individual is essential
  • based on the results of animal research
  • risk must not exceed the benefits
  • experiments designed to minimise harm
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11
Q

What significant legislation has there been since the Nuremberg code?

A
  • Declaration of Helsinki (1964)
  • Tuskegee Syphillis Study (USAA 1932-1972)
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12
Q

What is the declaration of Helsinki?

A

a statement of ethical principles for medical research involving human sibjects, includong research on identifable human material and data

  • consent
  • confidentiality
  • risks and burdens
  • post-trial provision
  • publication
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13
Q

What dictates human research in the UK involing NHS staff, patients or premises?

A

National Research Ethics Service (NRES)

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14
Q

What are the four principles for valid consent?

A
  1. patient must have capacity
  2. patient must give consent voluntarily
  3. patient must be informed
  4. Consent must be continuing
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15
Q

What must researchers be aware alert to when obtaining informed consent?

A
  • participant feeling pressure into agreeing
  • problem of incentives
  • sufficient information
  • vulnerbale participants
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16
Q

What should researchers be aware of regarding consent?

A
  • importance of coding and anonymisation of results
  • distinction between theraputic and non-therapuetic research
  • difference in ethical frameworks in different populations
17
Q

Outline the key points of the Tuskegee Syphillis Trials

A

“a study to record the natural history of syphillis in hopes of justifying a treatment programme for blacks”

  • No informed consent - paticipants told they were being treated for “bad blood” - no diagnosis or effective treatment
  • Meant to last for 6 months and lasted 40 years
  • Incentives = free medical exams, free meals and burial insurance
  • Examined regularly but not treated even after oneicillin became the drug of choice
18
Q

Describe the guatemalan STD trials

A
  • Guatemalan experiments were uncovered in 2010, took place in 1946-48
  • President Barack Obama apologized to Guatemala, launched an investigation: “the Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers’ own understanding of the practices and requirements of medical ethics of the day”.
  • US govt, with Guatemalan colleagues, experimented on 5000+ Guatemalan soldiers, prisoners, people with psychiatric disorders, orphans and prostitutes
  • Justified as “results would have widespread benefits and help Guatemala to improve its public health service”
  • No evidence that consent was sought (NB: cf US)
  • Exposed 558 soldiers, 486 patients at psychiatric hospital, 219 prisoners, 6 prostitutes, and 39 others to gonorrhoea, syphilis or chancroid
  • Measured accuracy of diagnostic tests on orphans, those with leprosy, people at psychiatric hospital, prison and army
19
Q

Describe the case of Henrietta Lacks

A
  • 1951: cells from Henrietta’s cervix are cultured in vitro, and become the first immortal human cell line HeLa
  • 1951: Henrietta dies from cervical cancer
  • HeLa cells are shipped all over the world, and used in all kinds of medical research
  • But… Henrietta herself didn’t know this, nor did her family
  • No knowledge shared or consent sought
  • HeLa cells have made some people a lot of money, Lacks family have struggled to access the healthcare they need
  • Justification? Material was no longer “hers”, material would have been thrown away, for the common good
20
Q

Main areas of publication ethics

A

Authourship and conflicts of interest

21
Q

What are the 4 criteria that need to be met to be an author?

A
  • Substantial contributions to the conception or design of the work ;or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

MD3000 - Ethics (4 decks)

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