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HLTH1002 > Week 12 Lecture: Ethics > Flashcards

Week 12 Lecture: Ethics Flashcards

1
Q

Nuremberg Code (1947)

A

= first international document to provide guidelines on research ethics
- result of Nuremberg trial (trial for doctors war crimes in WWII)
- adopted by UN general assembly 1948
- made voluntary consent a requirement in clinical research studies

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2
Q

Nuremberg code emphasizes consent can be voluntary only if participants:

3

A
  1. are able to consent
  2. are free from coercion
  3. comprehend all risks and benefits
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3
Q

10 Elements of Nuremberg Code (Permissable Medical Experiments)

A
  1. Voluntary consent
  2. Benefit society,
    unprocurable by other methods or means of study, and not random and unnecessary
  3. Designed and based on the results of animal
    experimentation + knowledge that anticipated results will justify the performance of the experiment
  4. Avoid all unnecessary physical and mental
    suffering and injury.
  5. No a priori reason to believe that
    death or disabling injury will occur; except if self-experiment
  6. Degree of risk < humanitarian importance of the problem to be solved
  7. Proper preparations, adequate facilities provided to protect against injury, disability, or death.
  8. Conducted only by scientifically qualified persons. Highest
    degree of skill and care required through all stages of the experiment
  9. Withdraw consent at any time
  10. Prepared to stop experiment at any time if likely injury, disability, death of subject
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4
Q

Helsinki Declaration (1964)

=

A

= set of principles to guide physicians on ethical considerations related to biomedical research
- adopted by World Medical Association (WMA) in 1964, 18th World Medical Assembly in Helsinki, Finland
- built on Nuremberg Code

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5
Q

Belmont Report 1979

=, 3

A

= from National Commussion for the Protection of Human subjects of biomedical and behavioural research
Three Principles:
1. Respect for persons - autonomy and dignity
2. Beneficence - protection from harm
3. Justice - fair distribution of benefits and burdens

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6
Q

NHMRC

=, 7

A

= National Health and Medicine Research Committee = main funding body for research + overarching body for Australian Health Ethics Committee (AHEC)
Research merit and integrity:
- beneficial
- well-directed and well-grounded
- enshrines respect for participants
- competent
- honest
- impartial
- open to scrutiny

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7
Q

Justice

2

A
  • fair: recruitment, treatment, benefit
  • accessible and timely
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8
Q

Beneficence

4

A
  • benefit justifies harm
  • minimise harm and maximise welfare
  • if in any doubt, stop it
  • almost never no risks
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9
Q

Respect

A
  • regard welfare, beliefs, customs, culture
  • privacy, confidentiality, cultural sensitivity
  • voluntary participation, freedom to withdraw, consent
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10
Q

3 key domains that ethics committees examine

3

A
  1. research participants
  2. researchers
  3. sponsors or funding bodies
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11
Q

AITSIS Code of Ethics

=, 2

A

= additional code of ethics specific to doing research within Indigenous communities
- complementary set of guidelines
- needed due to potential for racism and eugenics

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12
Q

Data Raid

=

A

= come in, grab data, leave without giving anything back –> no respect

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13
Q

Principles of responsible research conduct

8

A
  1. Honesty - in developing, undertaking, reporting research
  2. Rigour - in developing, undertaking, reporting reserach
  3. Transparency - declaring interests, reporting methodology, data, findings
  4. Fairness - in treating others
  5. Respect - for participants, environment, and community
  6. Recognition - of the right of Aboriginal and Torres Strait Islander peoples to be engaged in research that affects/is not significant to them
  7. Accountability - you’re accountable for what you submit - for development, undertaking, reporting of research
  8. Promotion of responsible research practices
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14
Q

6 core values that underpin Principles of responsible research conduct

6

A
  1. Spirit and integrity : joins all values together
  2. Cultural continuity
  3. Equity
  4. Reciprocity = shared responsibility
  5. Respect
  6. Responsibility = do no harm
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15
Q

Nothing about us, without us

=, 4

A

= AIATSIS Code of 4 Principles that underpin ethical and responsible research:
1. Indigenous leadership
2. Impact and value
3. sustainability and accountability
4. Indigenous self-determination

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16
Q

3 Tiers of Ethical Review (Aus)

3

A
  1. AHEC (fall under AHMRC)
  2. Registered HRECs report anually
  3. all researchers follow duty ethics: conduct over complicance
17
Q

ANU Ethics Committees

7

A
  • AEEC - Animal ethics biomedical wildlife
  • HRC - Human full committee
  • Indigenous advisory group
  • Humanities and Social Sciences group
  • Asia Pacific group
  • Science and Medical
  • Final person: lawyers or deputy vice chancellor of research (DVC-R)
18
Q

Different levels of review

3

A
  • E1 = expedited level 1 protocol = very low risk/prior approval: reviewed by relevant DERC chair ad hoc, out of session
  • E2 = Expedited Level 2 Protocol = greater than negligable risk, non-vulnerable participants: reviewed in DERC fortnightly meetings
  • Full Review = risk, vulnerable participants: reviewed by full committee in monthly meetings
19
Q

Key elements of research ethics review

3

A
  • Proportionality : more risk = more scrutiny (most intense scrutiny)
  • Special scrutiny : more novel = closer scrutiny
  • Expedited review : need for speed
20
Q

Procedural Ethics (NHMRC Values)

4

A

i. Research merit and integrity
ii. Respect for persons
iii. Non-maleficence, beneficence (non-maleficence overrides beneficence)
iv. Justice

21
Q

Monster Study

=, 4, 5

A

= ethics fail, 22 orphans divided into ‘normal speakers’ and ‘stutterers’
- ‘normal’ - positive encouragement
- ‘stutterers’ - criticised
- members of both groups developed serious psychological problems
- Issues: informed and voluntary consent, information dissemination, freedom to withdraw w/o consequence, capacity of understanding, harm etc.

22
Q

5 Requirements of Free and Prior Informed Consent (FPIC)

4, =

A
  1. Informed = information disclosure
  2. Comprehension = information comprehension
  3. Voluntariness = no coercion, deceit, persuasion, exercise continuous free choice to participate that lasts throughout the study
  4. Capacity = participants are capable of giving consent (mentally)
  5. Consent = authorisation by way of verbal agreement, signature, or both
23
Q

Special Groups

8

extra ethics considerations

A
  • orphans: in many of most unethical experiments (nobody there to provide consent)
    • Monster study 1939
    • Pavlov (did experiments on orphans)
    • Little Albert (conditioned fear)
    • Nazi experiments under Dr Mengele
  • pregnant women and foetus
  • vulnerable groups
    • dependent groups
    • unable to consent through impairment of incapacity
    • under 18
  • mental illnesses and institutions
  • people in illegal activities e.g. in jail
  • given diseases ie. syphilis, malaria, hepatitis, herpes, tuberculosis, cholera, plague
  • overseas research
  • Indigenous peoples: over-surveyed, cultural awareness
24
Q

Types of consent

4

A
  • written
  • verbal (recorded)
  • implied: e.g. by filling out a survey
  • waiver of consent: in low-risk situations e.g. using de-identified medical record
25
Q

Confidentiality vs Anonymity vs Privacy

=, =, =

A

Confidentiality = keeping things secret (identities hidden)
Anonymity = even researcher doesn’t know (identities missing)
Privacy = ability of participant to control flow of information and not be observed

26
Q

Stanford Prison Experiment (1971)

=, 3 (3) (3)

A

= get participants to act as guards and prisoners –> did it too well –> escalate –> called off
- by Zimbardo, 1971
- Ethics satisfied:
- participants were volunteers
- withdrawal was allowed
- safety was monitored
- Ethics failed:
- not sufficiently informed about risk
- vulnerable
- research may not have had enough use for the benefit to outweigh the risk: small sample size, lack of clear methodology, etc.

27
Q

Issues with Clinical Trials

5

A
  • scientifically valid?
  • conflicts of interest?
  • realistic benefits?
  • clinical trials registry (ANZTR)
  • insurance (+ cost)
28
Q

Ethical Responsibilities of Researchers

6

A
  • Do not bring research into disrepute
  • Avoid deliberate bias = data manipulation, scientific misconduct and fraud (changing the data), scientific advocacy
  • Transparency = sufficient detail to allow others to evaluate and replicate
  • Acknowledge contributions of colleagues
  • Publicly funded research should be archived so that others can make use of the data
  • In case of sponsors, shouldn’t deviate from agreed purposes of research, sponsors cannot manipulate research to meet sponsors’ needs
29
Q

Ethics and sponsors issues

, 4

A

Don’t suppress a study/findings or tailor findings to suit personal outcomes, via:
- conditional publication: violates integrity of research and researchers’ autonomy
- exaggerating researcher expertise within particular methodology
- exaggerating findings/lessons learned
- ignoring limitations

30
Q

Types of Harm

A
  • psychological
  • phsyical
  • legal
  • social
  • economic
  • reputational

HLTH1002 (26 decks)

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