W3 - Ethical Conduct in Research Flashcards

1
Q

What are the 4 guiding principles of NHMRC

A

RJBR R-Justin-Bieber-R

Research merit and integrity

Justice

Beneficence

Respect

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is the key principle? What is the key relationship central to ethical human research?

A

Respect

  • Acting in the right spirit based on abiding respect for fellow human beings

Between Research and Participants (not subjects)

  • One of trust, mutual responsibility, ethical equality.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Elaborate Principle #1

A

Respect

  • Recognising each human being has value
    • This value must inform all interaction between people
  • Recognising value of human automony
    • Capacity to determine one’s own life and make one’s own decisions
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What are the codes relevant to Principle #1

A

1.10, 1.11, 1.12, 1.13

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Explain the codes relevant to Principle #1: 1.10 and 1.11

A

1.10

  • Recognising intrsinic value
  • By abiding the 4 principles
  • Due regard of culture heritage, beliefs, etc.

1.11

  • Respecting privacy, confidentaility, cultural sensitivites
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Explain the codes relevant to Principle #1: 1.12 and 1.13

A

1.12

Involves giving due scope for human autonomy (making their own decisions)

1.13

If unable to make own decisions or have diminished capacity, must empower them and protect them as necessary

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Elaborate Principle #2

A

Justice

  • Regard for human sameness
    • Procedural
      • “Fair Treatment” in recruitment and review of research
    • Distributive
      • Fair distribution in benefits and burden of research
  • While benefit to humankind is an important result of research, benefits of research are achieved through
    • just means
    • distributed fairly
    • no unjust burden
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What are the codes relevant to Principle #2

A

1.4 and 1.5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Explain the codes relavant to Principle #2

A

1.4

(a) Taking into account scope and objective of proposed research
(b) Fair recruitment
(c) No unfair burden
(d) Fair distribution of benefits of participation
(e) No exploition in conduct
(f) Fair access to benefits of research

1.5

Outcomes must be made accessible timely and clearly

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Elaborate Principle #3

A

Beneficance: Harm vs Benefits

Assessing (a) risks of harm and (b) potential benefits of research to participants and to the wider community

  • Sensitivity to welfare and interests of people involved in their research (including social and cultural implications)
  • Balance of individual and public benefit:
    • When is it OK for a researcher to risk harm to a willing volunteer to do research with the intent to develop knowledge which will better humanity?
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are the codes relevant to Principle #3

A

1.6, 1.7, 1.8, 1.9

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Explain the codes relevant to Principle #3: 1.6 and 1.7

A

Beneficence

1.6

  • Benefit of the research (to participants/wider community) must justify any risks of harm to participants.

1.7

  • (a) minimise risk of harm
  • (b) clarify benefits and risk
  • (c) participant’s welfare
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Explain the codes relevant to Principle #3: 1.8 and 1.9

A

Beneficence

1.8

  • Where there are no likely benefits to participants, the risk to participants should be lower than would be ethically acceptable where there are such likely benefits.

1.9

  • If risk not justified by benefits, research must be suspended (either discontinued/modified)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Elaborate Principle #4

A

Research Integrity and Merit

Unless the proposed research has merit, and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What are the codes relevant to Principle #4

A

1.1 (Merit) and 1.3 (Integrity)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Explain the codes relevant to Principle #4: Merit

A

1.1

Research that has merit is:

(a) justifiable by its potential benefit
(b) appropriate methods for achieving aims
(c) based on thorough study of the current/previous literature
(d) respect for the participants is not compromised by the aims, methods, results
(e) conducted by qualified people

(f ) conducted using appropriate logistics

17
Q

Explain the codes relevant to Principle #4: Integrity

A

1.3

Commitment to:

(a) Knowledge
(b) Recognised principles of research conduct;
(c) Honest research
(d) Communicating results that permit scrutiny and contribute to public knowledge and understanding.

18
Q

What is a Risk? What does it involve accessing?

A

Risk

Potential for harm, discomfort or inconvenience. It involves assessing:

  • Likelihood
  • Severity (Including consequence)
  • Extent it can be minimised
    • And how it can be managed
  • Whether risks are justified by potential benefits
19
Q

What are the 5 potential harms in research

A
  1. Physical: Injury
  2. Psychological: Feelings
  3. Social: Damage to social network
  4. Economic: Imposition of direct/indirect cost
  5. Legal: Discovery and prosecution of criminal conduct
20
Q

What are the 2 terms similar to harm?

A

Discomfort

  • Less serious than harm (Body and/or mind)
    • When a person’s reaction exceed discomfort and become distressed, it becomes a harm

Inconvinience

  • Less serious than discomfort
  • Giving up time, etc…
21
Q

The greater the risk to participants, what must be done?

A

The greater the risk to participants:

  • the more certain it must be that the risks will be managed as well as possible,
  • and that the participants clearly understand the risks they are assuming.
22
Q

What is “Low risk” and “negligable risk”

A

Low Risk

Only foreseeable risk is discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.

Negligable Risk

No foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.

23
Q

What is consent and what are the guiding principles involved

A

Respect and Justice

Consent must be:

  • Voluntary
  • Based on sufficient information and adequate understanding of both the proposed research and the implications of participating
24
Q

What is informed consent and what are some requirements?

A

Informed Consent

  • Mutual understanding between researchers and participants.
  • Opporunity for participants to ask questions and discuss
  • No pressure involved
    • Even without overt pressure, consent might reflect deference to researcher’s perceived position
25
Q

What are some situations where one cannot consent? What must be done then?

A

Lack the capacity to consent:

  • Children and young people
  • Highly dependent on medical care, unable to consent
  • Cognitive impairment, an intellectual disability, or a mental illness.

A person or appropriate statutory body exercising lawful authority for the potential participant should be provided with relevant information

26
Q

Within some communities, consent may be required by more than 1 person. Who are they?

A

Properly interested parties such as formally constituted bodies, institutions, families or community elders.

  • Researchers need to engage with all properly interested parties in planning the research.