Chapter 3.1: The elements of research. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Chapter 3.1

Human research projects must adhere to the core ethical principles described in Section 1 of this National Statement. These principles apply at all stages of a research project from inception to post-completion.

Human research can involve a wide range of methods and practices: it can be qualitative, quantitative or mixed; interventional, experimental or observational in nature; and involve various degrees of collaboration between researchers and participants. Each research project is shaped by the field to which the research question relates, the research question itself, the desired outcome, and the context in which it is conducted.

Effective research ethics review incorporates appropriate expertise related to relevant methods or areas of practice. Reviewers should be aware of expectations and apply requirements that are relevant to the areas of practice or methods used in projects that they review. This requires becoming familiar with methods or areas of practice that are unfamiliar or novel.

A range of relationships between participants and researchers may develop as a result of the duration and nature of the research interaction. Some methodological approaches require careful boundaries to be maintained between researchers and research participants. In contrast, other research fields require data collection methods that involve the development of close personal relationships with participants, or degrees of collaboration that blur the lines between researcher and participant (for example, co‑researchers in action research).

Researchers may have an impact on research participants and vice versa and this impact may compromise a researcher's role or professionalism. If this is anticipated and/or occurs, it may become necessary to modify those relationships, or to modify or discontinue the research.

Additionally, a researcher may have other professional skills (for example, counseling or clinical care) that become relevant to the relationship with a participant. In this event, it is important to consider whether it is ethically acceptable to exercise those skills or, alternatively, to refer that participant to another professional.

The guidance provided in Chapters 4.3 and 5.4 is relevant to the researcher's duty to inform participants that they are acting in a professional role other than the research role.

Research may involve risks to participants. To the extent that it is appropriate, the development of clear protocols for managing any distress that might be experienced by participants during the process of data collection or conduct of research procedures is an important component of planning research. Predicting what topics are likely to lead to distress and how to manage this distress will not always be easy. Access to sufficient training to help researchers and reviewers in making such predictions is valuable. Refer to Chapter 2.1 for a further discussion about the identification and handling of risk in research.

This chapter discusses the manner in which the core principles of this National Statement should be reflected in the elements of research project design. The chapter should be considered as a whole, however, the order in which these elements are discussed does not imply a hierarchy or a sequence, or that all of these elements will have equal relevance in every design. The elements are:

  • Element 1: Research Scope, Aims, Themes, Questions and Methods
  • Element 2: Recruitment
  • Element 3: Consent
  • Element 4: Collection, Use and Management of Data and Information
  • Element 5: Communication of Research Findings or Results to Participants
  • Element 6: Dissemination of Research Outputs and Outcomes
  • Element 7: After the Project

Chapter 3.1 should be read in conjunction with other sections of the National Statement and is supplemented by the guidance in Chapters 3.2, 3.3 and 3.4.

Researchers conducting clinical interventional research should also refer to additional guidance in Chapters 5.2 and 5.5.

Guidelines – Chapter 3.1

Element 1: Research Scope, Aims, Themes, Questions and Methods

A critical feature of good research is clarity regarding how the research project will meet the ethical requirement that research has merit, as described in paragraph 1.1 of the National Statement. This Element of Chapter 3.1 offers advice and guidance about meeting this obligation.

Key questions include:

  • What is the research theme or question that this project is designed to explore?
  • Why is the exploration of this theme or answer to this question worth pursuing?
  • How will the planned methods explore the theme or achieve the aims of the research?

3.1.1 In an application for review of their research, researchers should determine and state in plain language:

  1. (a) the research question or questions that the project is intended to explore
  2. (b) the potential benefit of exploring the question or questions including:
    1. (i) to whom that potential benefit is likely to flow
    2. (ii) whether that benefit is a contribution to knowledge or understanding, improved social or individual wellbeing, or the skill and expertise of researchers
  3. (c) the basis for that potential benefit as described in either relevant literature or a review of prior research unless, due to the novelty of the question, there is scarce literature or prior research
  4. (d) how the design and methods of the project will enable adequate exploration of the research questions and achieve the aims of the research
  5. (e) how the design of the project will maintain respect for the participants
  6. (f) where relevant, that the research meets the requirements of any relevant regulations or guidelines authorised by law (such as those related to privacy and reporting requirements for disclosure of child abuse)
  7. (g) whether or not the project has been reviewed by a formally constituted academic, scientific or professional review process, and, if so, the outcome of that review.

3.1.2 The merit and integrity of research should be assessed by criteria and standards relevant to the research field/s and methodology/ies, such as:

  1. (a) the objectives and conceptual basis of the research
  2. (b) the quality and credibility of data collection and analysis
  3. (c) how to assure validity and reliability of results, taking account of relevant statistical, thematic and other forms of generalisability.

3.1.3 Reviewers should be aware that some research designs will be informed and shaped by the experience, insights and/or needs of participants. Such designs can be a valid and powerful way to collect qualitative information and to inform practice.

3.1.4 For interventional research conducted in the context of health care or public health, researchers should additionally determine and state:

  1. (a) whether the project involves the systematic investigation of the safety, efficacy and/or effectiveness of an intervention
  2. (b) if the research involves exposure to an intervention for which the safety or efficacy, or both, is not well understood:
    1. (i) whether it is likely or possible that the intervention will be of therapeutic benefit
    2. (ii) whether there is a realistic possibility that the intervention being studied will be at least as beneficial overall as standard treatment, taking into account effectiveness, burden, costs and risks
  3. (c) where patient care is combined with intent to contribute to knowledge, that any risks of participation should be justified by potential benefits to which the participants attach significance. The prospect of benefit from research participation should not be exaggerated, either to justify to the reviewing body a higher risk than that involved in the participant's current treatment or to persuade a participant to accept that higher risk
  4. (d) whether the intervention or other research procedures are without likely benefit to participants. For such research to be ethically acceptable, any known or emerging risks to the participants must not be greater than the risks that would be associated with the health condition and its usual care.

3.1.5 Where current and available treatments are known or widely believed to be effective and/or there is known risk of significant harm in the absence of treatment, placebo or non-treatment groups are not ethically acceptable. Non-treatment (including placebo alone) groups may only be used:

  1. (a) where the existing standard of care comprises or includes the absence of treatment (of the type being evaluated), or
  2. (b) where there is evidence that the harms and/or burdens of an existing standard treatment exceed the benefits of the treatment.

3.1.6 In health research involving an intervention, the risks of an intervention should be evaluated by researchers and reviewers in the context of the risks of the health condition and the treatment or treatment options that would otherwise be provided as part of usual care.

3.1.7 For any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes, researchers must register the project as a clinical trial on a publicly accessible register complying with international standards (see information on the International Clinical Trials Registry Platform (ICTRP) on the World Health Organisation website) before the recruitment of the first participant.

3.1.8 Where the total project cannot be described in advance because the design and detail of successive stages will be informed by preceding stages, researchers should provide a description of the stages that are foreseen and how they intend to seek ethics approval for each stage.

3.1.9 Researchers should confirm and reviewers should be satisfied that:

  1. (a) a plan is in place to ensure that resources are sufficient to conduct and complete the research as designed
  2. (b) the facilities, expertise and experience available seem to be appropriately allocated and sufficient for the research to be completed safely.

3.1.10 Researchers should provide assurance that any proposed payment in money or kind, whether to institutions, researchers or participants, will not adversely influence the design, conduct, findings or publication of the research.

3.1.11 Researchers seeking approval for a program of research (that is, a series of related research projects), or to establish infrastructure for research such as a database or a biobank, should adequately describe their plans to reviewers.

Element 2: Recruitment

When research will involve the direct participation of people (for example, testing, surveys, interviews, focus groups, observation and health or behavioural interventions) the recruitment phase of a project is fundamental to the success of the research. Depending upon the design of a project, this element can include such matters as identifying individuals as potential participants, contact between the research team and potential participants, screening or exclusion of some individuals, and preparing to seek consent from the potential participants.

A single project may employ more than one recruitment strategy, especially where discrete cohorts are required to meet the objectives of the research. For some research designs, the recruitment and consent strategies occur concurrently; for others, they are separate. It is essential that recruitment strategies adhere to the ethical principles of justice and respect.

Key questions include:

  • Who will be recruited?
  • How will participants be identified and recruited?
  • Will the potential participants be screened?
  • What is the impact of any relationship between researchers and potential participants on recruitment?
  • How will the recruitment strategy facilitate obtaining the consent of participants?
  • How will the recruitment strategy ensure that participants can make an informed decision about participation?
  • Are there any risks associated with the recruitment strategy for potential participants or for the viability of the project?

3.1.12 Research proposals should clearly describe the recruitment strategy and the criteria for the selection of potential participants.

3.1.13 The recruitment strategy for a project should be relevant to the research methodology, topic/subject matter, the potential participants and the context.

3.1.14 The criteria for the selection of potential participants for a project and the cohort that is recruited should align with both the objectives and theoretical basis of the research.

3.1.15 The inclusion/exclusion criteria for the potential participants in a project must be justifiable and should be fair. The exclusion of some groups may amount to unfair discrimination, and/or exclude individuals and groups from the potential benefits of research. Researchers should consider the degree to which including/excluding groups may limit (or compromise) the value of the results of a project, with consequent impact on the merit of the project.

3.1.16 Researchers and reviewers should consider the degree to which potential participant populations might be over‑researched or may require special consideration or protection and the degree to which the flow of benefits to that population (or to individual participants) justify the burdens. Equally, people should not be denied the opportunity to exercise selfdetermination or obtain the potential benefits of research solely because they are a member of a population that might be over-researched or may require special consideration or protection, such as Aboriginal and Torres Strait Islander peoples.

3.1.17 The recruitment strategy must be respectful of potential participants and their culture, traditions and beliefs and facilitate their voluntary participation.

3.1.18 In developing and implementing their recruitment strategy, researchers should consider:

  1. (a) the potential for coercion/exploitation
  2. (b) any risks to participants related to recruitment (see Chapter 2.1) and how the pattern of recruitment might be structured to mitigate any risks to participants
  3. (c) any privacy matters relating to the recruitment of participants
  4. (d) the potential impact of existing relationships on recruitment (including, but not limited to, hierarchical relationships that may generate an unequal or dependent relationship, such as teacher and student, manager and employee, supervisor and team member or treating health care professional and patient)
  5. (e) the potential impact of participation on existing relationships
  6. (f) whether participants will be recruited by co-researchers or other members of the project team who are unfamiliar with the guidance provided by this National Statemen
  7. (g) whether the research requires community engagement or agreements related to the research to be in place prior to individual recruitment.

3.1.19 Researchers should describe and justify their approach to potential participants (that is, how do they find out about the possibility of participating, or not, in the research). The level of detail that is required by reviewers should be proportional to the foreseeable risks and appropriate to the methodology selected.

3.1.20 For many research projects, researchers should provide reviewers with proposed recruitment materials (for example, notices, flyers, advertisements, and social media posts) prior to use, including those materials that are developed subsequent to the initial review of the research proposal. However, for some research designs or where recruitment material needs to be ad lib, adapted or tailored to the context (such as some social media, radio or other oral communication) a description of the strategy and broad messages is sufficient.

3.1.21 Researchers and reviewers should consider the potential impact of the recruitment strategy upon the consent process (for example, the degree to which the recruitment strategy might undermine the voluntary nature of the consent of individual potential participants).

3.1.22 Researchers and reviewers should consider the degree to which any payment in money or incentives of any kind, whether to researchers, participants or others involved in recruitment, could result in pressure on individuals to consent to participate (see paragraphs 2.2.10, and 2.2.11). This is especially important with respect to research that involves more than a low risk of harm.

Element 3: Consent

Well-designed consent strategies are appropriately tailored to the potential participants, the research design, the topic and the context. Obtaining consent in a manner that shows respect for participants facilitates valid consent. This may involve obtaining consent as part of an ongoing process. Obtaining consent may be a component of broader processes of consultation, engagement and negotiation, such as in the context of research involving Aboriginal and Torres Strait Islander Peoples (see Chapter 4.7).

The guidance in Element 3 should be considered in the context of the guidance provided in Chapters 2.2 and 2.3. These chapters provide essential guidance on the selection and framing of a consent strategy or alternatives to consent, such as an opt-out approach or waiver of the requirement for consent. The guidance in Chapters 2.2, 2.3, and this Element should be considered in applying the guidance on consent included in Chapters 3.2, 3.3 and 3.4.

Key questions include:

  • What strategy(ies) for obtaining consent, or alternatives to consent are appropriate for the specific project?
  • Does the nature of the project design, the participants or the context necessitate the use of more than one strategy?
  • Do the proposed strategy(ies) satisfy the relevant requirements of Chapters 2.2 and 2.3?
  • Are there any project-specific matters that warrant specific attention (for example, whether the research could generate results of significance to participants, whether the data will be added to an open or mediated access repository or whether the data or materials will be used for any other purpose)?

3.1.23 Researchers should ensure that any proposed consent strategy:

  1. (a) provides all of the required information and assurances as set out in Chapters 2.2 and 2.3, as relevant to the proposed research
  2. (b) uses tools and language that are appropriate, respectful and relevant to the research design, objectives, potential participants and context, including relevant cultural sensibilities.

3.1.24 Researchers and reviewers should recognise that research involving multiple methods or different groups of potential participants may require more than one consent strategy or may require consent to be revisited and renegotiated over time.

3.1.25 There is a range of strategies that may be appropriate for obtaining consent. While these may include the provision of a written information and consent document, other strategies may be more appropriate. It is not a requirement of the National Statement that participants' consent must, routinely, be witnessed.

3.1.26 An information and consent document or other consent strategy should be appropriate to the needs of the participants and proportional to the project's risks and ethical sensitivity. Specifically:

  1. (a) information provided in any format should not be unnecessarily long or detailed, even for complex interventional research
  2. (b) strategies such as the use of staged or tiered information should be considered in order to address variations in the needs or characteristics of potential participants
  3. (c) adequate time should be allowed for prospective participants to understand and consider what is proposed and for their questions and expression of concerns to be addressed by those obtaining their consent (See 2.2.2 – 2.2.6).

3.1.27 Researchers should ensure that participants understand whether or not third parties (including supervisors of participants) will know who has been approached about participating, who has been selected from the participant pool, and which individuals have chosen to participate.

3.1.28 In circumstances where there may be significant risks if the participatory status of individuals becomes known, researchers must select a consent strategy that masks the identity of participants.

3.1.29 When those who are recruiting participants will receive some form of payment per recruited individual or other benefit, this must be disclosed to potential participants during the consent process.

3.1.30 Researchers should explain to potential participants that their access to any services or supports normally provided by the person trying to recruit them will not be affected by their decision to accept or decline research participation.

3.1.31 In any information provided to potential participants during the consent process, researchers should include information on data management and storage and any relevant intellectual property and copyright arrangements.

3.1.32 Researchers should describe to potential participants any limitations on/consequences of withdrawing consent and whether or not it will be possible to withdraw their data or information.

3.1.33 Where research may yield findings that are potentially significant for individuals, the consent strategy should clarify whether participants will be provided with these findings or whether individuals will have a choice about receiving the findings.

3.1.34 Researchers should disclose to potential participants whether, and under what circumstances, research results or information that has been collected may be reported to relevant authorities.

3.1.35 During the consent process, researchers should advise participants whether, and, if so, in what form, they will receive or can obtain access to a summary of the outcomes of the research.

3.1.36 If researchers are planning to add data obtained in a research project to an open or mediated access repository or make the data or materials available for re-use, any implications of these plans should be provided to participants. The use of 'extended consent ' or 'unspecified consent ' (see 2.2.14 to 2.2.16) may be appropriate for this purpose.

3.1.37 When researchers seek consent to collect information that is considered to be of historical, cultural or other long term value, they should obtain consent for its perpetual retention, including any planned re-use and sharing with others.

3.1.38 When a project relates to a health intervention or treatment, researchers must make it clear to potential participants, if relevant:

  1. (a) that it is a novel intervention that has not yet been approved for any health condition, or an intervention that is not used in the usual care of the relevant health condition, or an intervention that is being investigated for use in a new health condition or in a new or modified setting
  2. (b) whether there is likely to be any therapeutic benefit to them from the intervention and whether access to the intervention is available only through participation in the research
  3. (c) whether they will have access after completion of the project or active treatment phase of the project to the intervention, treatment or information that they have received, and, if so, with what limitations, if any.

3.1.39 For research that is not explicitly or primarily genomic, but that may, during recruitment or data collection, generate information with hereditary implications, consent processes should be designed to take account of this potential (see Chapter 3.3: Genomic Research).

Element 4: Collection, Use and Management of Data and Information

This section addresses ethical issues related to generation, collection, access, use, analysis, disclosure, storage, retention, disposal, sharing and re-use of data or information.

Human research projects incorporate one or more methods to generate, collect, or access data or information so as to achieve the objectives of the research. Collection, use and management of data and information must be in accordance with the ethical principles discussed in Section 1 of this National Statement.

Research may involve access to large volumes of data or information not explicitly generated for research purposes. The size and accessibility of such sources make them attractive for some research designs, the use of which may raise difficult privacy and consent questions. However, because research using populationwide datasets is inclusive of all members of the population in question, it promotes the core principle of justice. In addition, benefits and burdens may be spread more evenly than research based on selected participants.

The increased ability to link data in ways that preserve privacy has greatly enhanced the contribution that collections of data can make to generating knowledge, as it enables researchers to match individuals in different data sets without explicitly identifying them.

Key questions include:

  • What data or information are required to achieve the objectives of the project?
  • How and by whom will the data or information be generated, collected and/or accessed?
  • How and by whom will the data or information be used and analysed?
  • Will the data or information be disclosed or shared and, if so, with whom?
  • How will the data or information be stored and disposed of?
  • What are the risks associated with the collection, use and management of data or information and how can they be minimised?
  • What is the likelihood and severity of any harm/s that might result?
  • How will the collection and management of the data or information adhere to the ethical principles in Section 1 of this National Statement?

What is data and what is information?

The terms 'data ' and 'information ' are often used interchangeably. Data can refer to raw data, cleaned data, transformed data, summary data and metadata (data about data). It can also refer to research outputs and outcomes. Likewise, information takes many different forms. Where information is in a form that can identify individuals, protecting their privacy becomes a consideration.

For the purposes of the National Statement, 'data ' is intended to refer to bits of information in their raw form, whereas 'information ' generally refers to data that have been interpreted, analysed or contextualised. Data and information may include, but not be limited to:

  • what people say in interviews, focus groups, questionnaires/surveys, personal histories and biographies
  • images, audio recordings and other audio‑visual materials
  • records generated for administrative purposes (for example, billing, service provision) or as required by legislation (for example, disease notification)
  • digital information generated directly by the population through their use of mobile devices and the internet
  • physical specimens or artefacts
  • information generated by analysis of existing personal information (from clinical, organizational, social, observational or other sources)
  • observations
  • results from experimental testing and investigations
  • information derived from human biospecimens such as blood, bone, muscle and urine.

Identifiability of information[3]

Researchers and reviewers must consider the identifiability of data and information in order to assess the risk of harm or discomfort to research participants or others who may be at risk.

The risks related to identifiability of data and information in research are greatest where the identity of a specific individual can reasonably be ascertained by reference to an identifier or a combination of identifiers (examples of identifiers include the individual's name, image, date of birth or address, attribute or group affiliation). Risk may also arise where identifiers have been removed from the data or information and replaced by a code, but where it remains possible to re-identify a specific individual (by, for example, unlocking the code or linking to other data sets that contain identifiers). Due to technological advances, risks may arise in relation to data and/or information that has never been labelled with individual identifiers or from which identifiers have been permanently removed.

The identifiability of information is a characteristic that exists on a continuum. This continuum is affected by contextual factors, such as who has access to the information and other potentially related information, and by technical factors that have the potential to convert information that has been collected, used or stored in a form that is intended to protect the anonymity of individuals into information that can identify individuals. Additionally, contextual and technical factors can have a compound effect and can increase the likelihood of re-identifiability and the risk of negative consequences from this in ways that are difficult to fully anticipate and that may increase over time.

Furthermore, the identifiability of information may change during the life of a research project, for example, data or information might initially be collected in a form that could identify individuals, then coded for analysis and correlation to other collected data or information, and, finally, once all the data or information has been collected, the code key might be destroyed, rendering the data or information anonymous. Therefore, it is important for researchers and reviewers to focus on the risk of harm to affected individuals if their identity is ascertained and the effort that would be required to achieve this at each stage of a research project.

Factors that should be taken into consideration when determining the degree of identifiability of information and when evaluating the associated risks include the type and quantity of the information, any other information held by the individual who receives the information and the capacity (skills and technology) available to the individual who receives it. Identifiability of information is also conditioned by contextualfactors, such as whether only the person/s who collected the information could use it to identify (an) individual/s, or whether those to whom it is disclosed or with whom it is shared for research purposes could also use it for this purpose. Identifiability may also reflect features of the project such as the nature of the participant cohort: for example, whether it includes high-profile individuals or members of small communities versus larger populations.

Data and information that is contained in data sets, such as those held in government databases and by social media organisations, may be used (in sum or in part) to identify individuals. This potential is due to the impact of predictive analytics, machine learning, increased commercial accessibility, proliferation of data sets, data breaches or degradation of privacy protections and other developments on access to and use of data and information. In this increasingly complex environment, researchers are encouraged to consult guidance promulgated by expert bodies such as the Office of the Australian Information Commissioner and its state and territory equivalents, the Australian Bureau of Statistics and the Australian National Data Service in addition to this National Statement.

3.1.40 The removal of personal identifiers may or may not be ethically required. Some research projects may legitimately require the retention of personal identifiers, for example, to link information or data from a number of different sources or to return results to participants. In addition, some research populations (for example, academics, activists and some public figures) are amongst those who may prefer to be identified in the collection, use, and reporting of research data. Where participants choose to be identified, researchers and participants should collaboratively determine and agree upon whether all research data or information collected from them will be identified, or only certain components of the collected data or information.

3.1.41 Researchers should adopt methods to reduce the risk of identification during collection, analysis and storage of data and information. Methods to reduce identifiability and the consequent risks may include:

  1. (a) minimising the number of variables collected for each individual
  2. (b) separation and separate storage of identifiers and content information
  3. (c) separating the roles of those responsible for management of identifiers and those responsible for analysing content.

3.1.42 In any publications, researchers should ensure that the identity of participants cannot be reasonably ascertained from the data or information that they use or report, unless they have agreed to be identified. This may require minimising, obscuring, or changing identifiers, either in the collection process or when presenting and publishing the research results.

3.1.43 Where research involves linkage of data sets with the consent of participants, researchers should advise participants that use of data or information that could be used to identify them may be required to ensure that the linkage is accurate. They should also be given information about the security measures that will be adopted, for example the removal of identifiers once linkage is completed.

Data management

3.1.44 When multiple researchers are collaborating on collection, storage and/or analysis of data or information, they should agree to the arrangements for custodianship, storage, retention and destruction of those materials, as well as to rights of access, rights to analyse/use and re-use the data or information and the right to produce research outputs based upon them. Researchers should consider whether any intellectual property will be generated by the project and agree on the ownership of any intellectual property created. Agreements on such arrangements and ownership need not necessarily be in the form of a contractual document, but should facilitate a clear resolution of these issues.

3.1.45 For all research, researchers should develop a data management plan that addresses their intentions related to generation, collection, access, use, analysis, disclosure, storage, retention, disposal, sharing and re-use of data and information, the risks associated with these activities and any strategies for minimising those risks. The plan should be developed as early as possible in the research process and should include, but not be limited to, details regarding:

  1. (a) physical, network, system security and any other technological security measures
  2. (b) policies and procedures
  3. (c) contractual and licensing arrangements and confidentiality agreements
  4. (d) training for members of the project team and others, as appropriate
  5. (e) the form in which the data or information will be stored
  6. (f) the purposes for which the data or information will be used and/or disclosed
  7. (g) the conditions under which access to the data or information may be granted to others
  8. (h) what information from the data management plan, if any, needs to be communicated to potential participants.

Researchers should also clarify whether they will seek:

  1. (i) extended or unspecified consent for future research (see paragraphs 2.2.14 to 2.2.16), or
  2. (j) permission from a review body to waive the requirement for consent (see paragraphs 2.3.9 and 2.3.10).

3.1.46 The security arrangements specified in the data management plan should be proportional to the risks of the research project and the sensitivity of the information.

3.1.47 Researchers must comply with all relevant legal and regulatory requirements that pertain to the data or information collected, used or disclosed as well as the conditions of the consent provided by participants.

3.1.48 In relevant research, particularly that which involves the use of materials of biological origin, records should be preserved for long enough to enable participants to be traced in the event that evidence emerges of late or long-term health-related effects, taking into account the conditions of consent that apply.

3.1.49 Data, information and biospecimens used in research should be disposed of in a manner that is safe and secure, consistent with the consent obtained and any legal requirements and appropriate to the design of the research.

3.1.50 In the absence of justifiable ethical reasons (such as respect for cultural ownership or unmanageable risks to the privacy of research participants) and to promote access to the benefits of research, researchers should collect and store data or information generated by research projects in such a way that they can be used in future research projects. Where a researcher believes there are valid reasons for not making data or information accessible, this must be justified.

Secondary use of data or information

Research may involve access to and use of data or information that was originally generated or collected for previous research or for non‑research purposes, including routinely collected data or information. This is commonly called'secondary use of data or information'. The main ethical issue arising from this use is the scope of consent provided or, alternatively, the impracticability of obtaining consent.

Administrative data or information is data or information routinely collected during the delivery of a service, for example, by a government department or private service provider and may involve collections of data or information from large numbers of people or whole populations. It is usually impractical to obtain consent from individuals for secondary use of this data or information. In these circumstances, respect for participants can be demonstrated in other ways, including, but not limited to, community consultation, ensuring that the research results are translated into improvements in services and practices, acknowledging the source of the data or information in publications and/or publishing the research results in a location and language suitable for the general community. In particular, using data or information without consent may undermine public trust in the confidentiality of their information.

Privacy concerns arise when the proposed access to or use of the data or information does not match the expectations of the individuals from whom this data or information was obtained or to whom it relates. These issues are especially complex in the context of the access to or use of information relating to individuals that is available on the internet, including social media posts, tweets, self‑generated 'lifelogging' data emitted from mobile phones and other'smart ' appliances and data or information generated through applications and devices related to personal pursuits, such as fitness activity, gambling, dating and web‑based gaming.

Data or information available on the internet can range from information that is fully in the public domain (such as books, newspapers and journal articles), to information that is public, but where individuals who have made it public may consider it to be private, to information that is fully private in character. The guiding principle for researchers is that, although data or information may be publicly available, this does not automatically mean that the individuals with whom this data or information is associated have necessarily granted permission for its use in research. Therefore, use of such information will need to be considered in the context of the need for consent or the waiver of the requirement for consent by a reviewing body and the risks associated with the use of this information.

3.1.51 For research involving the secondary use of data or information, researchers should make study designs publically available, including information about:

  1. (a) the form in which the data or information will be stored (that is, whether it can identify individuals)
  2. (b) the purposes for which the data or information will be used.

3.1.52 Unless a waiver of the requirement for consent is obtained, any research access to or use of publicly available data or information must be in accordance with the consent obtained from the person to whom the data or information relates.

3.1.53 Researchers should understand the context in which data or information was collected or disclosed, including the existence of any relationship of confidence or, if available on the internet, the privacy settings that apply. This includes avoiding the use or disclosure of information that was obtained unethically or illegally.

3.1.54 Researchers should take account of any terms and conditions applicable to social media platforms when using data or information from these sources or platforms and other web-based communities that do not permit the removal of the name of the author of a post or any changes to the wording of a post.

Sharing of data or information

While data or information may be collected, aggregated and stored for an initial purpose or activity, it is common for researchers to 'bank ' their data or information for possible use in future research projects or to otherwise share it with other researchers. It is also increasingly common for funding agencies to require the sharing of research data either via open access arrangements or via forms of mediated access controlled by licenses.

To this end, data or information may be deposited in an open or mediated access repository or data warehouse, similar to an archive or library, and aggregated over time. Archived data or information can then be made available for later analysis, unless access is constrained by restrictions imposed by the depositor/s, the original data custodian/s or the ethics review body.

3.1.55 All data collections should have an identified custodian to enable access by researchers or participants to the data while maintaining it in a protected form. The custodian of the data may be the individual researcher or agency who collected the information, or an intermediary that manages data coming from a number of sources.

3.1.56 When planning to share data or information with other researchers or to establish or add them to a databank, researchers must develop data management plans in accordance with the guidance provided in 3.1.45. This plan should enable the sharing of data and information and propose appropriate conditions on the sharing of data and information.

3.1.57 Researchers must make data custodians aware of the data management plans for banking or sharing of the data or information, and, in particular, of any confidentiality agreements or other conditions on the identifiability or re-use of the data or information.

3.1.58 Any sharing of data or information between research collaborators and research sites must be secure and proportional to the risks associated with, and the ethical sensitivity of the information.

3.1.59 In any proposals to share or disclose research data or information, researchers should distinguish between disclosure to specific third parties, sharing with other researchers and disclosure to the public and clarify whether the sharing or disclosure of data or information is subject to participant consent, other voluntary agreements or mandatory requirements.

3.1.60 Researchers should be aware of expectations and policies regarding the sharing or re-use of participant data or information in any form and should consider the value of the data or information for future research. At the time of initial consent, participants should be informed of these expectations and given appropriate options, including the potential to provide extended or unspecified consent (see paragraphs 2.2.14 to 2.2.16). If consent to future use was not obtained at the time of collection, then reviewers considering the proposed re-use of this data or information in further research may consider a waiver of the requirement for consent or whether it is appropriate to seek additional consent for the sharing or re-use of the data or information. Whether there is an ongoing relationship with the participants and the burden on the participants of re-contact should be considered in this decision.

3.1.61 Before publishing data or information, or adding data or information to a repository, researchers should consider the degree to which it may be possible for the data or information to enable participants to be identified through efforts made by other researchers or third parties.

3.1.62 Shared or banked data or information that is stored in a form that can identify individuals can sometimes be used in research that qualifies as negligible or low risk research, however, it cannot be used in research that is exempt from ethics review (see paragraph 5.1.22).

Element 5: Communication of research findings or results to participants

Research across a range of fields and methodologies can generate findings or results of significance to participants and others. Some research (for example, analysis of human biospecimens) can generate findings or results of significance to the health of individual participants, and, potentially, their relatives and other family members.

Providing research findings or results to participants can be a benefit, but it can also be a source of risk (for example, psychological, social, legal). The approach taken to communicating findings and results should reflect principles of good science and adhere to the ethical principles of justice, respect and beneficence discussed in Section 1, including consideration of the values and preferences of traditional custodians, such as Aboriginal and Torres Strait Islander peoples.

Communicating findings or results may be required or optional, appropriate or inappropriate, and/or intentional or unintentional depending on the nature of the research and other circumstances.

Key questions include:

  • Could the research generate findings or results of interest to participants?
  • Could the findings or results be of significance to the current or future welfare or wellbeing of participants or others?
  • Are potential participants in the research forewarned of this possibility?
  • Will the consent of participants be obtained to enable any planned or necessary disclosure of findings or results?
  • Who will communicate the findings or results and how?
  • Will the findings or results be disclosed to third parties and/or the public?

3.1.63 In considering whether to return results of research, researchers should distinguish between individual research results and overall research results and, if individual and/or overall results will be provided to participants:

  1. (a) how these results will be provided to participants
  2. (b) how the process of returning results will be managed
  3. (c) the risks of the return of individual research results and overall research results.

3.1.64 Where information could be of significance to the health of participants, relatives or other family members, researchers should prepare and follow an ethically defensible plan to disclose or withhold findings or results of research (see Chapters 3.2: Use of Human Biospecimens in Laboratory Based Research and 3.3: Genomic Research). Ethically defensible plans may be required for other types of research addressing, for example, any significant social, economic or psychological implications of the research.

3.1.65 An ethically defensible plan for research other than that described in Chapters 3.2 and 3.3 should:

  1. (a) indicate whether the research will be likely to generate findings or results of significance to participants or others
  2. (b) clarify whether the researchers intend to disclose any findings or results to participants directly and which types of findings or results, if any, are returnable to participants or others (for example, clinicians or relatives)
  3. (c) confirm that participants will be advised in advance whether they will be offered the option to receive their findings or results
  4. (d) if applicable, enable participants to decide whether they wish to receive the findings or results and who else may be given the findings or results
  5. (e) in appropriate circumstances, set out a process for finding out whether family members wish to receive the information
  6. (f) outline how the findings or results will be provided in a manner that is appropriate and accessible
  7. (g) include the relevant expertise of the person who may be communicating the findings or results
  8. (h) include measures to protect the level of privacy desired by participants.

Disclosure to third parties of findings or results

There can be situations where researchers have legal, contractual or professional obligations to disclose findings or results to third parties. Additionally, researchers may believe that they have a moral obligation to disclose findings or results to third parties.

3.1.66 Where the potential disclosure of findings or results to third parties can be anticipated, researchers should identify:

  1. (a) whether, to whom and under what circumstances the findings or results will be disclosed
  2. (b) whether potential participants will be forewarned that there may be such a disclosure
  3. (c) the risks associated with such a disclosure and how they will be managed
  4. (d) the rationale for communicating and/or withholding the findings or results and the benefits and/or risks to participants of disclosure/ non‑disclosure.

3.1.67 Researchers should be aware of situations where a court, law enforcement agency or regulator may seek to compel the release of findings or results. In such circumstances, researchers should:

  1. (a) have a strategy in place to address this possibility
  2. (b) advise reviewers of the potential for this to occur.

3.1.68 In circumstances where the imperative to disclose findings or results emerges after the research has commenced, researchers must develop a strategy for addressing this and promptly advise and seek advice from reviewers.

Element 6: Dissemination of project outputs and outcomes

It is consistent with the ethical principles of respect, beneficence and justice to make the outputs or outcomes of research publicly available. Doing so is also a requirement for research merit and integrity. A principal goal of dissemination of outputs/ outcomes is to make a contribution to knowledge or practice or to serve a public good. Common mechanisms for achieving this objective include publication in peer-reviewed journals or books, conference presentations, commissioned reviews for public bodies, or dissemination via other forms of media such as creative works and performances. The form of the disseminated outputs (for example, a conference paper) will be shaped by the research field, the topic, the research design, researcher preference and experience. Publication of outcomes should not be withheld on the basis that they are negative or inconclusive. However, there may be justifiable reasons to delay or restrict the dissemination of the outputs or outcomes out of consideration for the privacy of the participants or other risk factors.

Key questions include:

  • What is the plan for reporting, publishing or otherwise disseminating the outputs/outcomes of the research?
  • Will participants in the research be offered a timely and appropriate summary of the project outputs/outcomes?
  • How will the planned dissemination of the outputs/outcomes contribute to knowledge or practice or serve the public?

3.1.69 Researchers should consider and advise reviewers as to whether

  1. (a) they intend to disseminate the outputs or outcomes widely in order to contribute to scientific, academic, professional or general knowledge or practice
  2. (b) there are any risk factors or commercial interests that might legitimately delay or restrict the dissemination of the outputs or outcomes
  3. (c) the risks of dissemination of the outputs or outcomes are justified by the benefits of dissemination (for example, the public interest).

3.1.70 Researchers should ensure that reports of their research outputs or outcomes adhere to prevailing standards for ethical reporting, referencing and authorship (for example, the Australian Code for the Responsible Conduct of Research).

3.1.71 Researchers should advise participants on the format and medium or media that will be used to disseminate outputs or outcomes of research to them (such as a lay summary, a research manuscript or published paper, or both) and, to the extent known, when such information about the outcomes will be made available to them. Dissemination of outputs or outcomes of research should occur in a timely fashion.

3.1.72 Researchers should ensure that any outputs or outcomes disseminated to participants are provided in language that is clear and understandable to participants.

Element 7: After the project

Researchers continue to have ethical responsibilities after projects are completed. These responsibilities relate to disposal or retention of data and information, potential secondary (future) use of data or information and any necessary follow up or long term monitoring of research participants.

Key questions include:

  • Will the data or information be retained only for the minimum period required by relevant policy?
  • Do the data or information have cultural, historical or other significance that could warrant longer, or perpetual retention?
  • Are the arrangements regarding intellectual property (individual, community, organisational, commercial) and copyright related to the outputs of the research clearly understood and communicated?
  • Will the data or information be banked or added to a repository, such as an open or mediated access facility, for future use?
  • Is any follow up or monitoring of research participants required and is this clear in the research plan and consent information?

3.1.73 With respect to the retention, storage and subsequent disposal of the data and information, researchers

  1. (a) must adhere to the ethical principle of respect for persons (for example, with regard to culture and beliefs of the participants)
  2. (b) should maintain the confidentiality of individuals in accordance with any assurances made to them (for example, during the consent process)
  3. (c) should be aware of and adhere to applicable national and/or state or territory codes and legislation, as well as to relevant international guidelines and regulation.

3.1.74 Data and information may be of cultural, historical or other significance such that they should be retained beyond the minimum retention period. Disposing of these data or information without consideration of these factors violates the ethical principle of respect. These matters should be appropriately addressed in the research plan and in consent processes and documentation.

 

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.

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