National Ethical Standards
- Part one
- Part two
- 1. Scope of the Standards
- 2. Ethical principles
- 3. Research and Māori
- 4. Research and Pacific peoples
- 5. Disability research
- 6. Ethical management of vulnerability
- 7. Informed consent
- 8. Research benefits and harms
- 9. Research development and design
- 10. Ethical features of studies
- 11. Research conduct
- 12. Health data
- 13. Health data and new technologies
- 14. Human tissue
- 15. Biobanks
- 16. Research with stem cells and reprogrammed cells
- 17. Compensation for injury in commercially sponsored intervention studies
- 18. Quality improvement
- Part three
8. Research benefits and harms
Research can generate benefits for individuals now and in the future. However, all research carries some risks of harm (‘harms’ are defined in these Standards as events or experiences that set back the interests of one or more individuals).
Different studies carry different levels of risk of harm. Risks of harm to research participants are ethically acceptable only if they are outweighed by potential benefits. Framing and conceptualising research therefore involves not only identifying a gap in knowledge, but also thinking about who will benefit from the research, what risks of harm the research may create and who will be exposed to the risks. Including participants in the design of research is an important part of recognising the benefits. Striking the right balance between potential benefits and risks of harm requires paying attention to the context of the particular study. Some studies are exploratory, in which case the benefits and harms can be more difficult to anticipate.
Benefits are events or experiences that advance the interests of one or more individuals. Categories of prospective benefits include:
- direct benefit for the individual, such as improvement in health condition
- indirect benefit for the individual, such as feeling helpful, gaining access to medical care that may not be available outside of the study
- benefits to others, through generating knowledge that may improve the lives of people in the future rather than the lives of the individuals in the study.
To justify any risks of harm to study participants, research must have social and scientific value: that is, the potential to generate knowledge and methods that can protect and promote the health, wellbeing and independence of individuals, the population and groups within that population. Researchers must minimise risks and ensure that any that remain are outweighed by the potential benefits. The level of risk that is acceptable is up to the potential participants to determine.
In the New Zealand context, researchers should especially consider risks and benefits for Māori: see ‘Research and Māori’.
Identifying and assessing potential benefits and risks of harm
8.1 Researchers must identify and assess potential risks of harm. They must ensure that those risks are either outweighed by the prospect of potential benefit to the individual or appropriate in relation to the social and scientific value of the knowledge gained.
8.2 In assessing potential benefits and risks of harm, researchers must:
- identify the potential benefits and risks of harm
- assess the likelihood of potential benefits and harms occurring and their magnitude or severity
- identify who may receive the potential benefits and who may bear the risks.
8.3 Researchers must minimise risks of harm.
Managing and minimising risks of harm
In designing a study, researchers have an obligation to minimise risks of harm to participants, and manage any residual risks. Minimising risk involves assessing research aims and their importance and identifying the safest methods of achieving them.
8.4 To manage risks, researchers must ensure that:
- participants clearly understand the risks of harm associated with the research, and
- mechanisms are in place to adequately identify and manage harms that may occur at any time during the research, and the research protocol specifies these measures.
8.5 Researchers must continue to manage the risks of harm throughout the study. Where available data demonstrates that the risks of harm outweigh the potential benefits or establishes clear evidence for or against the research interventions and procedures in the study, researchers must assess whether to continue, modify or immediately stop the study.
8.6 The research protocol should document the processes for minimising and managing risks of harm. See ‘Monitoring studies’.
Benefits of research
|Recipients of benefits||Potential benefits|
8.8 Researchers must also consider the risks of harm to others, such as potential stigma and whakamā to communities or groups. In addition, they must be aware of and plan to minimise potential harms for research personnel, such as the distress research assistants working with very sensitive data may experience.
8.9 Table 8.2 presents a non-exhaustive list of harms research participants may suffer.
|Disrespect or harm to dignity||
|Social or cultural harm||
Levels of risk are used to determine ethical oversight in health research, including whether ethical review is required, and, if so, at what level. Risk levels are also relevant when considering the complexity of study documents, or whether modifications to consent procedures are ethical. In assessing risk, it is crucial to distinguish between harms that may be caused by the research participation itself and harms that are not, but rather may be caused by the life situation or characteristics of research participants. Risks can also be generated for populations after the research has been completed, see Interpretation of Study Results.
8.10 Ethical oversight should be commensurate to risk. Table 8.3 describes risk categories.
|More than minimal risk||
|Departure from normal care||
|Use of stored samples||
Exceptions to this rule include
|Secondary use of identifiable health information without consent||
Exceptions to this rule include:
The justification for this is that the use is related to the primary purpose of the data collection, and in such settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have access to identified or potentially identifiable information.
Significantly-greater-than-minimal-risk research is research in which there is a probability of an event that is serious, prolonged and/or permanent occurring as a result of study participation, or there is significant uncertainty about the nature or likelihood of adverse events.
The distribution of potential benefits and risks of harm
8.11 Having identified potential benefits and risks of harm, researchers must carefully assess the likelihood and potential severity of the risks of harm to individual participants and groups, in comparison with the potential benefits.
8.11.a When doing so, researchers should consider whether to seek advice from others who have experience with the same methodology, population and research domain.
8.11.b They should also consider participants’ own perceptions of risks and benefits.
8.11.c No mathematical formula or algorithm can precisely calculate an appropriate ratio of benefit to risk of harm (Rid, 2010). Therefore, the comparison process may involve making intuitive judgements, which can be inconsistent and cause disagreement. The process must be transparent and defensible, and the results of the consideration clearly understandable.
8.12 Researchers must demonstrate a good understanding of the context in which a study is to be conducted.
8.12.a The context is especially important when the research offers direct benefits to the participants, their families and whānau, or to particular communities with whom the participants identify. In such cases, participants may be ready to take on a higher risk of harm than they would otherwise. For example, people with cancer with limited treatment options may be willing to accept research risks (such as treatment side effects) that would be unacceptable to well people.
8.13 When research interventions or procedures offer no potential individual benefits to participants, researchers must minimise the risks and ensure they are appropriate in relation to the social and scientific value of the knowledge.
8.14 In assessing potential risks and benefits, researchers must consider the relevant choices, experience, perceptions, values and vulnerabilities of different populations of participants.
8.15 Researchers should consult communities when determining whether the potential benefits of a study are outweighed by the risks of harm, or whether the balance is appropriate.
8.15.a The best approach is to follow a two-step process, looking first at potential harms and benefits to individuals, and then at potential harms and benefits to relevant groups.
8.16 In assessing potential risks and benefits, researchers should ensure that:
- the benefits of research are distributed fairly, and no group or class of people bears more than its fair share of the risks of harm
- the research does not disproportionately focus on the health needs of a limited class of people, but instead aims to address diverse health needs across different classes or groups (e.g. where the under-representation of particular groups results in or perpetuates health disparities, equity may require special efforts to include members of that group in research)
- groups that are unlikely to benefit from any knowledge gained from the research do not bear a disproportionate share of the risks of harm
- individuals, communities or populations that are socially or economically disadvantaged or marginalised are not over-represented in or unfairly exposed to risks of harm, or denied access to benefits.
8.16.a In some cases, overrepresentation may be statistically justified. Similarly, sometimes a study within a narrow group is justified, and can serve equity goals (e.g. research into subgroups of populations, where risks and benefits would not extend to whole populations).
8.17 When potential benefits or risks of harm are to be distributed unequally among individuals or groups, researchers must scientifically and ethically justify the criteria for the unequal distribution, rather than choosing them arbitrarily or conveniently.
8.18 When the potential benefits do not justify the risks of harm in a research proposal, the researchers must reconsider their research aims, the methods proposed to achieve those aims or both.
 See guidance on risk-based monitoring published on the website of the United States National Institute of Mental Health. For more information on categories of risk in general, see the International Ethical Guidelines for Health-related Research Involving Humans (CIOMS and WHO 2016).
 These risk categories can be used by QI activities.