HUMAN RESEARCH ETHICS

INTRODUCTION TO RESEARCH ETHICS: ISSUES, GUIDELINES, PRINCIPLES AND VALUES

PART C:

CASE STUDY ONE: Consumer movements in mental health

For each of the selected issues from this case study, which VALUE, which PRINICPLE and which GUIDELINE(S) would help you to answer the question? To assist you, in addition to chapters 1 (Principles) 2.1 (Risk) and 2.2 (Consent), it is likely that chapters 3.1 (qualitative methods) and 4.5 (People with a cognitive impairment, an intellectual disability or a mental illness) will be relevant.

You are encouraged to make some choices of your own in the free text box provided before clicking the VALUE, PRINCIPLES AND GUIDELINE(S) buttons after each question to take you to the suggested answers.

[Revise Case Study]

QUESTIONS

1. Will the sample of people selected as participants through the researcher's previous contacts be large enough to produce meaningful results?

  1. Which is the relevant VALUE?

Research merit and integrity are discussed first. Unless 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. (NS p. 11)



  1. Which is the relevant PRINCIPLE?

Research merit and integrity

1.1 Research that has merit is:

  1. 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;
  2. designed or developed using methods appropriate for achieving the aims of the proposal;
  3. 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;
  4. 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;
  5. conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research; and
  6. conducted using facilities and resources appropriate for the research.

(NS p. 12)



  1. Which is or are the relevant GUIDELINE(S)

3.1.4 Qualitative research emphasises the significance of particular contexts and settings. It is not necessary to be able to generalise the results of qualitative research. Even so, qualitative research should aim to provide a sufficiently detailed account and/or analysis to enable others to determine whether there are other circumstances to which the findings may be applicable.

3.1.5 If a sampling strategy is used, the most common type is purposive sampling, which aims at the selection of information-rich cases relevant to the research question. While random and representative sampling are not precluded in qualitative studies, many sampling frames are grounded in the specific aims of the research question.

3.1.6 The rigour of a qualitative study should not be judged on sample size. When sampling is appropriate, the objectives and theoretical basis of the research should determine the size of the sample and the sampling strategy. For example, some qualitative methods use a principle of ‘saturation’, where sampling occurs until no new information is being obtained. This is only one of several criteria for assessing sample size.

3.1.7 Research proposals that include sampling should clearly describe the recruitment strategy and criteria for selecting participants.

3.1.8 The rigour of qualitative research should be assessed primarily by criteria of quality and credibility of data collection and analysis, and not by matters of validity and reliability as defined in research designs that employ quantitative methods. (NS p 27)




2. Will the sample of people selected as participants through the researcher's previous contacts impose an unfair burden of participation on them?

  1. Which is the relevant VALUE?

At a profound level, justice involves a regard for the human sameness that each person shares with every other. Human beings have a deep need to be treated in accordance with such justice, which includes distributive justice and procedural justice. In the research context, distributive justice will be expressed in the fair distribution of the benefits and burdens of research, and procedural justice in ‘fair treatment’ in the recruitment of participants and the review of research. 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. (NS p.11)



  1. Which is the relevant PRINCIPLE?

1.4 In research that is just:

  1. 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;
  2. the process of recruiting participants is fair;
  3. there is no unfair burden of participation in research on particular groups;
  4. there is fair distribution of the benefits of participation in research;
  5. there is no exploitation of participants in the conduct of research; and
  6. there is fair access to the benefits of research. (NS p. 12)



  1. Which is or are the relevant GUIDELINE(s)?

3.1.9 The criteria for inclusion and exclusion of participants in qualitative research are often complex. For this reason, researchers should state these criteria clearly and be able to justify them (see also paragraphs 3.1.14 to 3.1.16). (NS p. 27)

4.5.3 People with a cognitive impairment, an intellectual disability, or a mental illness are entitled to participate in research, and to do so for altruistic reasons. (NS p.65)




3. Will the people interviewed have sufficient competence to understand and consent to be involved?

  1. Which is the relevant VALUE?

Among these values, respect is central. It involves recognising that each human being has value in himself or herself, and that this value must inform all interaction between people. Such respect includes recognising the value of human autonomy - the capacity to determine one's own life and make one's own decisions. But respect goes further than this. It also involves providing for the protection of those with diminished or no autonomy, as well as empowering them where possible and protecting and helping people wherever it would be wrong not to do so. (NS p. 11)



  1. Which is the relevant PRINCIPLE?

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

1.13 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.



  1. Which is or are the relevant GUIDELINE(s)?

4.5.5 Consent to participation in research by someone with a cognitive impairment, an intellectual disability, or a mental illness should be sought either from that person if he or she has the capacity to consent, or from the person's guardian or any person or organisation authorised by law. Where the impairment, disability or illness is temporary or episodic, an attempt should be made to seek consent at a time when the condition does not interfere with the person's capacity to give consent.

4.5.9 Researchers should inform HRECs how they propose to determine the capacity of a person with a cognitive impairment, an intellectual disability, or a mental illness to consent to the research. This information should include:

  1. how the decision about the person's capacity will be made;
  2. who will make that decision;
  3. the criteria that will be used in making the decision; and
  4. the process for reviewing, during the research, the participant's capacity to consent and to participate in the research. (NS p. 66)




6. Will the researcher's mental health condition impair his competence to conduct the interviews?

  1. Which is the relevant VALUE?

Research merit and integrity are discussed first. Unless 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. (NS p.11)



  1. Which is the relevant PRINCIPLE?

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;

1.3 Research that is conducted with integrity is carried out by researchers with a commitment to:

  1. searching for knowledge and understanding;
  2. following recognised principles of research conduct;
  3. conducting research honestly; and
  4. disseminating and communicating results, whether favourable or unfavourable, in ways that permit scrutiny and contribute to public knowledge and understanding. (NS p. 12)



  1. Which is or are the relevant GUIDELINE(s)?

3.1.2 Where a researcher has professional skills (for example, counselling) that become relevant to the relationship with a participant, the researcher needs to decide, when continuing the research, whether:

  1. it is ethically acceptable to exercise those skills; or
  2. to refer that participant to another professional.

3.1.3 Researchers have a duty to inform participants whenever they are acting in a non-research professional role. (NS p. 27)




8. Will interviewees be exposed to any harm or distress by the interview?

  1. Which is the relevant VALUE?

Researchers exercise beneficence in several ways: in assessing and taking account of the risks of harm and the potential benefits of research to participants and to the wider community; in being sensitive to the welfare and interests of people involved in their research; and in reflecting on the social and cultural implications of their work. (NS p.11)



  1. Which is the relevant PRINCIPLE?

1.7 Researchers are responsible for:

  1. designing the research to minimise the risks of harm or discomfort to participants;
  2. clarifying for participants the potential benefits and risks of the research; and
  3. the welfare of the participants in the research context.

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. (NS p. 13)



  1. Which is or are the relevant GUIDELINE(s)?

2.1.3 Steps to arriving at a judgement on the ethical acceptability of risks should include:

  1. identifying the risks, if any;
  2. assessing the likelihood and severity of the risks;
  3. identifying whom (participants and/ or others) the risks may affect;
  4. establishing the means for minimising the risks;
  5. identifying the potential benefits;

    and
  6. identifying to whom benefits are likely to accrue.

2.1.4 In determining the existence, likelihood and severity of risks, researchers and those reviewing the research should base their assessments on the available evidence, whether qualitative or quantitative. They should consider whether to seek advice from others who have experience with the same methodology, population and research domain.