Week 4: Ethics

Question 1

Ethical research on humans…

Answer 1

• can involve investigations of people, their data and tissues
• should be conducted with an abiding respect and concern for people
• has the intention of producing a positive outcome for individuals or humanity

Question 2

Describe the Tuskegee Syphillis Study

Answer 2

• Examined low-income, African-Americas males infected with syphillis
• received regular free medical exams for 40 years
• treatment with penicillin was deliberately withheld
• other physicians prevented from providing penicillin

Question 3

Describe the Nuremberg code

Answer 3

• emphasised the importance of voluntary consent
• subjects should be free to withdraw at any time
• subjects should avoid unnecessary suffering
• benefits should outweigh the risks

Question 4

What did Joseph Mengele look at?

Answer 4

• pain thresholds

- ability to survive infection etc

Question 5

What does the Declaration of helsinki bind all physicians to do?

Answer 5

• require informed consent
• the risks must not exceed the benefits
• research protocols must be reviewed and approved by an independent committee

Question 6

What was the Belmon report?

Answer 6

• a response to the Tuskegee study

- principles of respect, beneficence and justice

Question 7

The NHMRC…

Answer 7

• has overarching jurisdiction over human ethics in Australia
• oversees 200 committees in Aus
• each university has one or more HREC

Question 8

What are the four principles underpinning the National Statement

Answer 8

• research merit and integrity
• justice
• beneficence
• respect

Question 9

Describe Merit

Answer 9

• the experimental design of projects should enable an answer to the question
• research personnel should be trained
• research should benefit the community

Question 10

Describe integrity

Answer 10

• research follows accepted scientific practice
• honesty and transparency
• results should be disseminated view peer reviewed channels

Question 11

What are important integrity considerations?

Answer 11

• sample sizes
• control groups
• statistical power
• data storage and analysis
• bias
• commercial interest

Question 12

Describe Justice

Answer 12

• fair and balanced selection and recruitment, including marginalised or minority groups
• evidence that participants will benefit
• research outcomes made clear to participants

Question 13

Describe Beneficence

Answer 13

• appraise participants with limitations
• minimise possible harm
• benefits outweigh risks

Question 14

What is harm?

Answer 14

Where a persons reactions exceed discomfort and become distress

Question 15

Examples of physical harm

Answer 15

• injury, illness, pain

Question 16

Examples of psychological harm

Answer 16

• feeling worthless
• distress
• guilt
• anger
• could be from disclosure of of sensitivity or embarrassing information

Question 17

Examples of devaluation of personal worth

Answer 17

• humiliation
• manipulated
• disrespected

Question 18

Examples of social harm

Answer 18

• damage to social networks

- discrimination in access to benefits, services, employment etc

Question 19

Examples of economic harm

Answer 19

• the imposition of direct or indirect costs on participants

Question 20

Examples of legal harms

Answer 20

• discovery and prosecution of criminal conduct

Question 21

Describe respect

Answer 21

Individuals must be given an adequate understanding of the purpose, methods, demands, risks and benefits of the research

Question 22

What affects the right to participate freely

Answer 22

• inducements
• power relationship
• vulnerable persons

Question 23

When working with indigenous people…

Answer 23

Engage in a way that demonstrates understanding, respect for their welfare, beliefs, perceptions, customs and cultural heritage

Question 24

What is CHEAN

Answer 24

College human ethics advisory network

Question 25

What does the CHEAN do

Answer 25

Responsible for the review and approval of low and negligible risk ethics applications

Question 26

Negligible risk

Answer 26

Where the only foreseeable risk is inconvenience (e.g. time taken to complete a brief non-identifiable survey)

Question 27

Low risk

Answer 27

Where the only foreseeable risk is one of discomfort (e.g. caused by anxiety from an interview or having blood pressure taken)

Question 28

What is HREC

Answer 28

Human research ethics committee

Question 29

What does the HREC do

Answer 29

Responsible for reviewing and approving applications classified as more than low risk

Question 30

What does more than low risk mean

Answer 30

Where the risk, even if unlikely, is more serious than discomfort

Question 31

List the process of applying for ethics approval

Answer 31

- submission of application - governance review of application - ethical review by ethics committee - review outcome - secretary provides formal response

Question 32

What are three kinds of ethics approval

Answer 32

- approved without requiring amendment - approved subject to minor amendment - approved subject to major amendment (resubmission)

Question 33

List qualities of a poor ethics application

Answer 33

- inadequate detail - contradictory information - no attachments - not clearly written - inconsistent with national statement - responses do not address the question - current versions of form not used