POPH192 Lecture 22 - Research Ethics

Question 1

what are the 6 basic ethical considerations to make research ethically okay?

Answer 1

1) asses the benefits and risks and ensure the ratio is acceptable (beneficence and non-maleficence)
2) be aware of potential vulnerabilities of participants
3) avoid or manage conflicts of interest]
4) obtain informed consent from participants
5) consider how the benefits and burdens of the research should be shared across society
6) introduce regulations and processes to ensure these all happen

Question 2

what are the 3 NEAC guidelines for ethical principles?

Answer 2

1) respect for people
2) justice
3) beneficence and non-maleficence

Question 3

what is beneficence?

Answer 3

the obligations that we have to ‘benefit’ others

Question 4

what is beneficence in regards to research?

Answer 4

the obligation to ensure that the research is generating something of value that justifies the costs

Question 5

what is non-maleficence?

Answer 5

the obligation that we have not to harm others without a justifying reason

Question 6

what is non-maleficence in regards to research?

Answer 6

being aware of the various potential harms to participants and others, and either taking steps to avoid these or ensuring that the benefits are sufficient to justify the harms

Question 7

what does the research ethics committees require applicants to show?

Answer 7

-an awareness of the various costs or harms to participant, including time, resources, coercive factors, and any opportunity costs (including other treatments)
-strategies to address these harms or costs
-an awareness of potential cultural sensitivities or interests, including (in NZ) the implications for Maori
Evidence of the scientific validity of the research

Question 8

what is clinicial equipoise?

Answer 8

the requirement that researchers only provide an experimental treatment if the evidence for the experimental treatment is equal to that available for the standard treatment. the idea is that the participant should not suffer any substantial disadvantage from being in the study

Question 9

what are some doubts about equipoise?

Answer 9

• there can be disagreement about when evidence is ‘equally poised’
• there can be debate about which ‘standard treatment’ the intervention should be compared to (e.g is it the best available or what the participant could plausibly access

Question 10

what is a vulnerable person?

Answer 10

any person who is more at exploitation, because of social or physical disadvantages

Question 11

what are examples of a vulnerable person?

Answer 11

• poorer people
• those subject to racial or religious discrimination
• people who are less educated
• those suffering cognitive impairments
• older people
• prisoners
• children
• people who are ill (patients)

Question 12

what is a conflict of interest?

Answer 12

a situation where a person holds two or more potentially incompatible interests

Question 13

why is conflict of interest an issue in research?

Answer 13

a concern where the researcher(s) have interests that might compromise the values discussed

Question 14

what are the 4 ways conflicts of interests can arise in research?

Answer 14

1) professionally
2) academically
3) financially
4) politically

Question 15

what are the ways a conflict of interest can be managed?

Answer 15

through peer review, binding, open to access to data, auditing, and using independant people to recruit participants

Question 16

when is informed consent required?

Answer 16

required when participants are enrolled in research studies

Question 17

what 4 things does adequately informed consent require?

Answer 17

1) disclosure of the purpose, risks, and processes of the study
2) reasonable efforts from the searcher to explain this information
3) that the person is competent to give consent
4) the absense of any coercive factors (including financial inducements)

Question 18

what 3 things does justice require?

Answer 18

1) transparency
2) that all people are considered of equal worth
3) that efforts are made to society equitable

Question 19

what does it mean when justice is applied to research?

Answer 19

• within a population, there should be a fair distribution of the benefits and burdens of a participation in a study. Investigators must avoid imposing on particular groups an unfair burden of participation
• studies should be designed so that the inclusion and exclusion conditions for participants are fair. people should not be excluded on the basis of sex, ethnicity, national origin, religion, education or socioeconomic status, except where such exclusion or inclusion is essential to the purposes of the study
• funders and researchers should support and design research that could help reduce inequity

Question 20

what does NEAC stand for?

Answer 20

New Zealand 
National
Ethics
Advisory 
Committee