Ethics-Epidemiology week 6 Flashcards
What is human research?
- Involves human beings
- Observational
- Interventional
Principles of research ethics
Research merit and integrity
Justice
Beneficence
Respect
Research merit and integrity
- Likelihood of success
- Based on sound information
- Conducting research honestly
Justice
- Reduces any unfair burden of the research
* Fair distribution of the benefits
Beneficence
• Risk benefit balance
Respect
- Privacy and confidentiality
- Freedom to choose / Informed consent
- Vulnerable participant
Human Research Ethics Committee (HREC)
• Independent • Assesses a project prior to its commencement - Ethically acceptable - Designed in accordance to standards and guidelines • Composition - Chairperson - 2 Lay people - Lawyer - Healthcare professional - Minister of Religion - 2 Researchers
undue inducement
which is a reward for participating in research that is potentially coercive, e.g. offering money to an impoverished person such that they feel they cannot afford to refuse.
conflict of interest
Unethical research practices are more likely to occur when researchers or institutions have conflicts of interest
The term “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising a researcher’s professional judgment in conducting or reporting research.
Libertarianism
focused on individual freedom, rights and responsibilities
defines fairness as equal ability to enjoy what one has earned
sometimes criticised for failing to acknowledge the impact of social disadvantage on opportunity
Consequentialism:
- focuses entirely on the consequences of actions to determine whether they were right or wrong
- if the ends are good this justifies the means
- includes utilitarianism, a theory that focuses on achieving the greatest good for the greatest number e.g. maximising the happiness, health or preference satisfaction of as many people as possible
- sometimes criticised for reducing people to numbers in an equation
Confidentiality:
Personal information we share (to a doctor, lawyer
etc) that they can’t legally share without our consent.
Privacy:
Freedom from intrusion by others in our personal
matters and personal information.
Sensitive information
Information about or an opinion of an individual: • racial or ethnic origin; • political opinions; • membership of a political association; • religious beliefs or affiliations; • philosophical beliefs; • membership of a professional or trade association; • membership of a trade union; • sexual preferences or practices; or • criminal record.
Health information
Information about or an opinion of an individual:
• Physical, mental or psychological health
• A disability
• Their wishes about their future health care
When can we use Sensitive and Health information in Research
• With the individual’s consent
• When disclosure is required by law e.g. reportable diseases such as HIV
• The information does not identify the person e.g. research where the
information is de-identified
• To other health professionals who are actually responsible for treatment –
“need to know” basis
Vulnerable populations
- Dependent relationships
- Prisoners and residential care patients
- Patients with incurable diseases or emergencies
- Unemployed or impoverished persons
- Ethnic minorities, homeless, nomads, refugees
- Minors
- Those incapable of giving consent
INFORMED CONSENT
Voluntary, autonomous choice to participate
AUTONOMY
The freedom to direct one’s own fate
COERCION
Methods of forcing someone’s decision
UNDUE INDUCEMENT
A payment or reward that pressures the person into participating (esp.
if very poor)
EXPLOITATION
Taking advantage of someone’s disadvantage
The National Statement on Ethical Conduct in Human
Research (2007):
“Consent should be a voluntary choice and should be
based on sufficient information and
adequate understanding of both the proposed research
and the implications of participation in it.”
• Participants must be informed of new developments
throughout the trial.
• Signing a consent document is not a contract, and
participants may withdraw from the trial at any time.
In the National Statement the NHMRC identify certain vulnerable
groups of participants that require special ethical consideration to
avoid exploitation, including:
• Pregnant women and fetuses
Unique situation in which a treatment may be given to a patient that is
not intended for their own benefit
• Children and young people
Consent from a legal guardian AND from the child where possible
• Medically-dependent persons
People heavily reliant on medical care
• People with cognitive impairment or mental illness
Intellectually disabled, temporary and permanent cognitive impairment.
• People who may have engaged in illegal activity
Particular concern for confidentiality. Some discoveries would carry legal
obligations of disclosure
Vulnerable population
People in dependent or “unequal relationships”
• eg. Financially dependent persons including the elderly, doctor/patient,
government/refugees, etc.
• Aboriginal and Torres Strait Islander Peoples
• Respect for core cultural values. The research should benefit the
community.
• Overseas participants
• Language and educational barriers to informed consent.
• Special issues for avoiding exploitation
Non-maleficence:
• No undue risks or harms should befall research participants, including
physical, psychological and social harms.
Beneficence:
• Research should be beneficial for society, and any risks to participants
should be justified in terms of the potential benefits of the results.
Justice:
• Risks and benefits of research should be fairly distributed across a
population and involves transparent recruitment methods with clear
inclusion and exclusion criteria.
Scientific Integrity:
• Results of studies should be disseminated for critical review, methods
should be replicable so their validity can be confirmed, and
experimenters should not hide any of their results.
ETHICAL PRINCIPLES IN CLINICAL RESEARC
Scientific Integrity: Justice: Beneficence: Non-maleficence: Respect for persons:
