Week 12 Lecture: Ethics Flashcards
Nuremberg Code (1947)
= 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
Nuremberg code emphasizes consent can be voluntary only if participants:
3
- are able to consent
- are free from coercion
- comprehend all risks and benefits
10 Elements of Nuremberg Code (Permissable Medical Experiments)
- Voluntary consent
- Benefit society,
unprocurable by other methods or means of study, and not random and unnecessary - Designed and based on the results of animal
experimentation + knowledge that anticipated results will justify the performance of the experiment - Avoid all unnecessary physical and mental
suffering and injury. - No a priori reason to believe that
death or disabling injury will occur; except if self-experiment - Degree of risk < humanitarian importance of the problem to be solved
- Proper preparations, adequate facilities provided to protect against injury, disability, or death.
- Conducted only by scientifically qualified persons. Highest
degree of skill and care required through all stages of the experiment - Withdraw consent at any time
- Prepared to stop experiment at any time if likely injury, disability, death of subject
Helsinki Declaration (1964)
=
= 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
Belmont Report 1979
=, 3
= 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
NHMRC
=, 7
= 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
Justice
2
- fair: recruitment, treatment, benefit
- accessible and timely
Beneficence
4
- benefit justifies harm
- minimise harm and maximise welfare
- if in any doubt, stop it
- almost never no risks
Respect
- regard welfare, beliefs, customs, culture
- privacy, confidentiality, cultural sensitivity
- voluntary participation, freedom to withdraw, consent
3 key domains that ethics committees examine
3
- research participants
- researchers
- sponsors or funding bodies
AITSIS Code of Ethics
=, 2
= additional code of ethics specific to doing research within Indigenous communities
- complementary set of guidelines
- needed due to potential for racism and eugenics
Data Raid
=
= come in, grab data, leave without giving anything back –> no respect
Principles of responsible research conduct
8
- Honesty - in developing, undertaking, reporting research
- Rigour - in developing, undertaking, reporting reserach
- Transparency - declaring interests, reporting methodology, data, findings
- Fairness - in treating others
- Respect - for participants, environment, and community
- Recognition - of the right of Aboriginal and Torres Strait Islander peoples to be engaged in research that affects/is not significant to them
- Accountability - you’re accountable for what you submit - for development, undertaking, reporting of research
- Promotion of responsible research practices
6 core values that underpin Principles of responsible research conduct
6
- Spirit and integrity : joins all values together
- Cultural continuity
- Equity
- Reciprocity = shared responsibility
- Respect
- Responsibility = do no harm
Nothing about us, without us
=, 4
= 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
3 Tiers of Ethical Review (Aus)
3
- AHEC (fall under AHMRC)
- Registered HRECs report anually
- all researchers follow duty ethics: conduct over complicance
ANU Ethics Committees
7
- 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)
Different levels of review
3
- 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
Key elements of research ethics review
3
- Proportionality : more risk = more scrutiny (most intense scrutiny)
- Special scrutiny : more novel = closer scrutiny
- Expedited review : need for speed
Procedural Ethics (NHMRC Values)
4
i. Research merit and integrity
ii. Respect for persons
iii. Non-maleficence, beneficence (non-maleficence overrides beneficence)
iv. Justice
Monster Study
=, 4, 5
= 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.
5 Requirements of Free and Prior Informed Consent (FPIC)
4, =
- Informed = information disclosure
- Comprehension = information comprehension
- Voluntariness = no coercion, deceit, persuasion, exercise continuous free choice to participate that lasts throughout the study
- Capacity = participants are capable of giving consent (mentally)
- Consent = authorisation by way of verbal agreement, signature, or both
Special Groups
8
extra ethics considerations
- 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
Types of consent
4
- 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
Confidentiality vs Anonymity vs Privacy
=, =, =
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
Stanford Prison Experiment (1971)
=, 3 (3) (3)
= 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.
Issues with Clinical Trials
5
- scientifically valid?
- conflicts of interest?
- realistic benefits?
- clinical trials registry (ANZTR)
- insurance (+ cost)
Ethical Responsibilities of Researchers
6
- 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
Ethics and sponsors issues
, 4
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
Types of Harm
- psychological
- phsyical
- legal
- social
- economic
- reputational
