Ethics-Epidemiology week 6

Question 1

What is human research?

Answer 1

• Involves human beings
• Observational
• Interventional

Question 2

Principles of research ethics

Answer 2

Research merit and integrity
Justice
Beneficence
Respect

Question 3

Research merit and integrity

Answer 3

• Likelihood of success
• Based on sound information
• Conducting research honestly

Question 4

Justice

Answer 4

• Reduces any unfair burden of the research

* Fair distribution of the benefits

Question 5

Beneficence

Answer 5

• Risk benefit balance

Question 6

Respect

Answer 6

• Privacy and confidentiality
• Freedom to choose / Informed consent
• Vulnerable participant

Question 7

Human Research Ethics Committee (HREC)

Answer 7

• 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

Question 8

undue inducement

Answer 8

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.

Question 9

conflict of interest

Answer 9

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.

Question 10

Libertarianism

Answer 10

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

Question 11

Consequentialism:

Answer 11

• 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

Question 12

Confidentiality:

Answer 12

Personal information we share (to a doctor, lawyer

etc) that they can’t legally share without our consent.

Question 13

Privacy:

Answer 13

Freedom from intrusion by others in our personal

matters and personal information.

Question 14

Sensitive information

Answer 14

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.

Question 15

Health information

Answer 15

Information about or an opinion of an individual:
• Physical, mental or psychological health
• A disability
• Their wishes about their future health care

Question 16

When can we use Sensitive and Health information in Research

Answer 16

• 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

Question 17

Vulnerable populations

Answer 17

• 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

Question 18

INFORMED CONSENT

Answer 18

Voluntary, autonomous choice to participate

Question 19

AUTONOMY

Answer 19

The freedom to direct one’s own fate

Question 20

COERCION

Answer 20

Methods of forcing someone’s decision

Question 21

UNDUE INDUCEMENT

Answer 21

A payment or reward that pressures the person into participating (esp.
if very poor)

Question 22

EXPLOITATION

Answer 22

Taking advantage of someone’s disadvantage

Question 23

The National Statement on Ethical Conduct in Human

Research (2007):

Answer 23

“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.

Question 24

In the National Statement the NHMRC identify certain vulnerable
groups of participants that require special ethical consideration to
avoid exploitation, including:

Answer 24

• 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

Question 25

Vulnerable population

Answer 25

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

Question 26

Non-maleficence:

Answer 26

• No undue risks or harms should befall research participants, including
physical, psychological and social harms.

Question 27

Beneficence:

Answer 27

• Research should be beneficial for society, and any risks to participants
should be justified in terms of the potential benefits of the results.

Question 28

Justice:

Answer 28

• Risks and benefits of research should be fairly distributed across a
population and involves transparent recruitment methods with clear
inclusion and exclusion criteria.

Question 29

Scientific Integrity:

Answer 29

• 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.

Question 30

ETHICAL PRINCIPLES IN CLINICAL RESEARC

Answer 30

Scientific Integrity:
Justice:
Beneficence:
Non-maleficence:
Respect for persons: