HUMAN RESEARCH ETHICS

HUMAN RESEARCH ETHICS: BENEFICENCE

PART C:
Using the National Statement

For each of the selected issues from the case study, which aspect of the VALUE and PRINICPLE of beneficence and which GUIDELINE(S) would help you to answer the question?

In addition to chapter 1 (Values and Principles), it is likely that chapters 3.1 (Qualitative methods), 3.3 (clinical research), 4.2 ( Children and young people), 4.3 (People in dependent or unequal relationships) and 4.4 (People with a cognitive impairment, an intellectual disability or a mental illness) and 4.7 (Aboriginal and Torres Strait Islander Peoples) will be relevant.

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

  1. What are said to be the benefits of this study?

A. Which is the relevant aspect of the Value and Principle of Beneficence?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

1.7 Researchers are responsible for:
(a) . . .

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



B. Which is or are the relevant guidelines?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

2.1.3 Steps to arriving at a judgement on the ethical acceptability of risks should include:
(a) ...
(b) ...
(c) ...
(d) ...
(e) identifying the potential benefits; and
(f) identifying to whom benefits are likely to accrue.

3.5.5 Identifiers of genetic material or related information:
(a) should not be removed without the consent of participants, if removal would make it difficult to communicate personal results;
(b) should be removed if participants request it, provided they have been informed that the material or information would remain from potentially identifiable.



  1. Will the Aboriginal community benefit?

A. Which is the relevant aspect of the Value and Principle of Beneficence?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

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.



B. Which is or are the relevant guidelines?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

4.7.7 The benefits from research should include the enhancement or establishment of capabilities, opportunities or research outcomes that advance the interests of Aboriginal and Torres Strait Islander Peoples.

4.7.8 The described benefits from research should have been discussed with and agreed to by the Aboriginal or Torres Strait Islander research stakeholders.



  1. What are the risks to the participants who are children?


A. Which is the relevant aspect of the Value and Principle of Beneficence?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

1.7 Researchers are responsible for:
(a) …..

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



B. Which is or are the relevant guidelines?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

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.

3.3.9 The prospect of benefit from research participation should not be exaggerated, either to justify to an HREC a higher risk than that involved in the participant’s current treatment or to persuade a participant to accept that higher risk.

3.3.10 The use of a placebo alone or the incorporation of a non-treatment control group:
(a) is ethically unacceptable in a controlled clinical trial where:
(i) other available treatment has already been clearly shown to be effective; and
(ii) there is known risk of significant harm in the absence of treatment;
(b) may be considered if there is genuine uncertainty as to whether currently available treatments have a net clinical benefit.’

4.2.5 The circumstances in which the research is conducted should provide for the child or young person’s safety, emotional and psychological security, and wellbeing.



  1. In relation to all of the identified risks, have they been minimized?

A. Which is the relevant aspect of the Value and Principle of Beneficence?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

1.7 Researchers are responsible for:
(a) designing the research to minimize the risks of harm or discomfort to participants;



B. Which is or are the relevant guidelines?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

2.1.3 Steps to arriving at a judgement on the ethical acceptability of risks should include:
(a) identifying the risks, if any;
(b) assessing the likelihood and severity of the risks;
(c) identifying whom (participants and/or others) the risks may affect;
(d) establishing the means for minimising the risks;
(e) identifying the potential benefits;
and
(f) identifying to whom benefits are likely to accrue.

3.3.7 In research without likely benefit to participants, any known risk to participants should be lower than would be ethically acceptable where there are such likely benefits. In ‘first time- in-humans’ research projects, risks are uncertain, and recruitment into the
study should therefore be gradual and monitored with special care.

3.5.6 Genetic information can sometimes be misused to stigmatise people or to discriminate against them unfairly. Researchers should therefore take special care to protect the privacy and confidentiality of this information. Statutory or contractual duties may require participants to disclose the results of genetic tests or analysis to third parties (for example, insurance companies, employers, financial and educational institutions), particularly where results provide information about health prospects. Genetic research should be designed to minimise any resultant risk that participants will be deprived of benefits available to others in the community. Potential research participants should be advised of any such risks.

4.3.7 A person declining to participate in, or deciding to withdraw from, research should not suffer any negative consequences, such as unfair discrimination, reduction in the level of care, dismissal from employment, or any other disadvantage (see paragraphs 2.2.19 and 2.2.20, page 21).



  1. Are all of the risks justified by the intended benefits?

A. Which is the relevant aspect of the Value and Principle of Beneficence?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

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.



B. Which is or are the relevant guidelines?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

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

2.1.5 In considering whether the potential benefits of the research justify the risks involved, those reviewing research should take into account any willingness by participant populations to assume greater risks because of the potential benefits to them, their families, or groups to which they belong.

3.3.8 In clinical research, where patient care is combined with intent to contribute to knowledge, any risks of participation should be justified by potential benefits to which the participants attach significance.