L3 Ethical Research and Practice

Question 1

What does the research code set down?

Answer 1

The Research Code sets down the broad principles of responsible and accountable research practice, and identifies the responsibilities of institutions and researchers in areas such as data and record management, publication of findings, authorship, conflict of interest, supervision of students and research trainees, and the handling of allegations of research misconduct.

Question 2

What is the purpose of the national statement? (2)

Answer 2

The purpose of this National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community.

The National Statement is therefore designed to clarify the responsibilities of:

• institutions and researchers for the ethical design, conduct and dissemination of results of human research; and
• review bodies in the ethical review of research.

Question 3

What is ethos?

Answer 3

A way of thinking, that should pervade everything related to the conduct of research and is not simply a set of rules of do’s and don’ts, but acting in the right spirit based on abiding respect for fellow human beings.

Question 4

What are the 4 guiding principles governing the NHMRC National statement on ethical conduct in Human research?

Answer 4

1. Respect
2. Research merit and integrity
3. Justice
4. Beneficence

(RJBR: Run Justin Bieber Run)

Question 5

What is respect? (6)

Answer 5

• Foundation for the other principles, Respect for human beings is the common thread through all the discussions of ethical values
• Recognition that each human being has value (equal value) and that this value must inform all interaction between people
• Underlying respect is recognising the value of human autonomy which refers to the capacity to determine one’s own life and make one’s own decisions
• Part of respect is thinking bout ways you allow the participant to make their own key decisions in an informed manner (e.g. whether they participate in the research, for how long, whether they want to withdraw)
• Ensuring the participants is fully informed about the research being conducted to the fullest extent that they can be informed and that they understand the risks and benefits.
• Respecting each individual’s autonomy is important in thinking about consent and agency

Question 6

What is clause 1.10 for respect?

Answer 6

Respect for human beings is a recognition of their intrinsic value. In human research, this recognition includes abiding by the values of research merit and integrity, justice and beneficence. Respect also requires having due regard for the welfare, beliefs, perceptions, customs and cultural heritage, both individual and collective, of those involved in research.

Question 7

What is clause 1.11 for respect?

Answer 7

Researchers and their institutions should respect the privacy, confidentiality and cultural sensitivities of the participants and, where relevant, of their communities. Any specific agreements made with the participants or the community should be fulfilled.

Question 8

What is clause 1.12 for respect?

Answer 8

Respect for human beings involves giving due scope, throughout the research process, to the capacity of human beings to make their own decisions.

Question 9

What is clause 1.12 for respect?

Answer 9

Where participants are unable to make their own decisions or have diminished capacity to do so, respect for them involves empowering them where possible and providing for their protection as necessary.

Question 10

What is research merit and integrity?

Answer 10

1. Merit: merit of a proposal includes the aim of the study and whether the study has a useful or meaning outcome. Other things include rationale and motivation – why is the study important, quality of the literature review (existing knowledge base) that is the basis of this study—how is the literature motivating the research. Research must merit in methodology – true and valid data.
2. Integrity: we look at the credentials of the researchers themselves and their own insight in how to conduct research – the extent to which the researchers demonstrate these principles. Part of the integrity as a research is to know the NHMRC code of ethical conduct.

If we fail on merit and integrity in the research proposal, then the research needs to be reviewed

Question 11

What is clause 1.1A on what a research needs to have merit?

Answer 11

1. 1 Research that has merit is:
   (a) justifiable by its potential benefit, which may include its contribution to knowledge and understanding, to improved social welfare and individual wellbeing, and to the skill and expertise of researchers. What constitutes potential benefit and whether it justifies research may sometimes require consultation with the relevant communities;

Question 12

What is clause 1.1B on what a research needs to have merit?

Answer 12

1. 1 Research that has merit is:

(b) designed or developed using methods appropriate for achieving the aims of the proposal;

Question 13

What is clause 1.1C on what a research needs to have merit?

Answer 13

1. 1 Research that has merit is:
   (c) based on a thorough study of the current literature, as well as previous studies. This does not exclude the possibility of novel research for which there is little or no literature available, or research requiring a quick response to an unforeseen situation;

Question 14

What is clause 1.1D on what a research needs to have merit?

Answer 14

1. 1 Research that has merit is:
   (d) designed to ensure that respect for the participants is not compromised by the aims of the research, by the way it is carried out, or by the results;

Question 15

What is clause 1.1E on what a research needs to have merit?

Answer 15

1. 1 Research that has merit is:
   (e) conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research; and

Question 16

What is clause 1.1F on what a research needs to have merit?

Answer 16

1.1 Research that has merit is:

(f ) conducted using facilities and resources appropriate for the research.

Question 17

What is clause 1.3A on what a research needs to be conducted with integrity by commitment of researchers?

Answer 17

1. 3 Research that is conducted with integrity is carried out by researchers with a commitment to:
   (a) searching for knowledge and understanding;

Question 18

What is clause 1.3B on what a research needs to be conducted with integrity by commitment of researchers?

Answer 18

1. 3 Research that is conducted with integrity is carried out by researchers with a commitment to:
   (b) following recognised principles of research conduct;

Question 19

What is clause 1.3C on what a research needs to be conducted with integrity by commitment of researchers?

Answer 19

1. 3 Research that is conducted with integrity is carried out by researchers with a commitment to:
   (c) conducting research honestly; and

Question 20

What is clause 1.3D on what a research needs to be conducted with integrity by commitment of researchers?

Answer 20

1. 3 Research that is conducted with integrity is carried out by researchers with a commitment to:
   (d) disseminating and communicating results, whether favourable or unfavourable, in ways that permit scrutiny and contribute to public knowledge and understanding.

Question 21

What is justice?

Answer 21

Justice involves a regard for the human sameness that each person shares with every other
It refers to fairness and treating people equally and fairly in research. Treated fairly is a basic human need. Human beings have a deep need to treated in accordance with such justice. While benefit to humankind is an important result of research, it also matters that benefits of research are achieved through just means, are distributed fairly, and involve no unjust burdens

• Includes distributive justice and procedural justice

Question 22

What is distributive justice?

Answer 22

Distributive justice in research is expressed in the fair distribution of the benefits and burdens of research.

Question 23

What is procedural justice?

Answer 23

Procedural justice is expressed in fair treatment in the recruitment of participants and the review of research. This refers to the processes in interacting with participants and how the researcher informs them about the research.

Question 24

What is clause 1.4A in a just research?

Answer 24

In research that is just:

(a) taking into account the scope and objectives of the proposed research, the selection, exclusion and inclusion of categories of research participants is fair, and is accurately described in the results of the research;

Question 25

What is clause 1.4B in a just research?

Answer 25

In research that is just:

(b) the process of recruiting participants is fair;

Question 26

What is clause 1.4C in a just research?

Answer 26

In research that is just:

(c) there is no unfair burden of participation in research on particular groups;

Question 27

What is clause 1.4D in a just research?

Answer 27

In research that is just:

(d) there is fair distribution of the benefits of participation in research;

Question 28

What is clause 1.4E in a just research?

Answer 28

In research that is just:

(e) there is no exploitation of participants in the conduct of research; and

Question 29

What is clause 1.4F in a just research?

Answer 29

In research that is just:

(f) there is fair access to the benefits of research.

Question 30

What is clause 1.5 in a just research?

Answer 30

Research outcomes should be made accessible to research participants in a way that is timely and clear.

Question 31

What is beneficence? (4)

Answer 31

• Assessing and taking account of the risks of harm and the potential benefits of research to participants and to the wider community
• Sensitivity to the welfare and interests of people involved in their research
• Reflecting on the social and cultural implications of research (thinking broadly about the social and cultural impacts of the research)
• A need to balance individual and public benefit:

Question 32

What is clause 1.6 for beneficence?

Answer 32

1.6 The likely benefit of the research must justify any risks of harm or discomfort to participants. The likely benefit may be to the participants, to the wider community, or to both

Question 33

What is clause 1.7 for beneficence?

Answer 33

1. 7 Researchers are responsible for:
   (a) designing the research to minimise the risks of harm or discomfort to participants;

(b) clarifying for participants the potential benefits and risks of the research; and
(c) the welfare of the participants in the research context.

Question 34

What is clause 1.8 for beneficence?

Answer 34

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.

Question 35

What is clause 19 for beneficence?

Answer 35

1.9 Where the risks to participants are no longer justified by the potential benefits of the research, the research must be suspended to allow time to consider whether it should be discontinued or at least modified. This decision may require consultation between researchers, participants, the relevant ethical review body, and the institution. The review body must be notified promptly of such suspension, and of any decisions following it.

Question 36

When will research be ethically acceptable?

Answer 36

2.1.2 Risks to research participants are ethically acceptable only if they are justified by the potential benefits of the research.

Question 37

What is a risk?

Answer 37

A risk is a potential for harm, discomfort or inconvenience.

Question 38

What are the steps needed to arrive at a judgement on the ethical acceptability of risks? (5)

Answer 38

1. The likelihood that a harm (or discomfort or inconvenience) will occur; and
2. The severity of the harm, including its consequences
3. The extent to which risks can be minimized
4. Whether risks are justified by the potential benefits of research
5. Determining how risks can be managed (if risks are present in the research, the proposal should include how the researcher is going to manage them; this is part of integrity and merit)

Question 39

What are the 3 levels of risk?

Answer 39

Highest level is harm, then discomfort, and then inconvenience

Question 40

What determines the degree of scrutiny a proposal requires?

Answer 40

The degree of risk

Question 41

What are the potential harms in research?

Answer 41

1. Physical harms: Potential for injury, illness, pain
2. Psychological harms: Potential for the procedures proposed to cause the participants to have feelings of worthlessness, distress, guilt, anger or fear, devaluation of personal worth
3. Social harms: Damage to social networks or relationships with others; Discrimination in access to benefits, services, employment or insurance; Social stigmatsation
4. Economic harms: Imposition of direct or indirect costs on participants
5. Legal harms: Discovery and prosecution of criminal conduct

Question 42

What is discomfort?

Answer 42

Less serious than harm is discomfort, which can involve body and/or mind (Where a person’s reactions exceed discomfort and become distress, they should be viewed as harms). What is considered a discomfort for someone may be perceived as harmful for others .

Question 43

What is inconvenience?

Answer 43

Less serious than discomfort is inconvenience.
Examples of inconvenience may include filling in a form, participating in a street survey, or giving up time to participate in research.
These are the standard inconveniences that come with research that needs to be minimally compensated for

Question 44

How do researchers manage risk?

Answer 44

Researchers must include mechanisms in the design of their research to deal adequately with any harms/discomfort/inconvenience that occur; and there must be a process to monitor that the mechanisms are being carried out.

The greater the risk to participants in any research:

• 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

Question 45

What is consent? (2)

Answer 45

Consent is thought about with regards to:
- Respect for human beings which involves giving people capacity to make their own decisions.

• Justice also requires informed consent. It is the idea of providing participants with the information they need to make an informed decision that this is the research they would like to participate in

Question 46

What does a consent must be? (2)

Answer 46

1. a voluntary choice
2. based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.

Question 47

What is informed consent? (3)

Answer 47

• The aim is the mutual understanding between researchers and participants., not a transaction, but a discussion.
• This aim requires an opportunity for participants to ask questions and to discuss the information and their decision with others if they wish.
• There must be no coercion or pressure involved

Question 48

Which participant groups lack the capacity for consent? (4)

Answer 48

• Children and young people
• People highly dependent on medical care who may be unable to give consent
• People with a cognitive impairment, an intellectual disability, or a mental illness
• For whom the first language isn’t the language that the research is being conducted in: In such cases a person or appropriate statutory (permitted) body exercising lawful authority for the potential participant should be provided with relevant information and decide whether he or she will participate on the participant’s behalf. That decision must not be contrary to the person’s best interests.

Question 49

When is informed consent a community decision?

Answer 49

When decisions about participation in research may involve not only individuals but also properly interested parties such as formally constituted bodies, institutions, families or community elders. This is especially the case when thinking about research with Aboriginal and Torres Strait Islander people
Researchers need to engage with all properly interested parties in planning the research.

Question 50

What is the Clause 2.3.2 for informed consent and deception? (3)

Answer 50

Where limited disclosure involves active concealment or explicit deception, and the research does not aim to expose illegal activity, researchers should in addition demonstrate that:

a) participants will not be exposed to an increased risk of harm as a result of the concealment or deception

b) a full explanation, both of the real aims and/or methods of the research, and also of why the concealment or deception was necessary, will subsequently be made available to participants.
c) there is no known or likely reason for thinking that participants would not have consented if they had been fully aware of what the research involved.