Chapter 4.8: People in other countries. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Chapter 4.8

When a researcher from an Australian institution proposes to conduct research in another country, additional ethical considerations may arise. In some situations, regard for the beliefs, customs and cultural heritage of participants will require recognition of values other than those of this National Statement. Sometimes these values will be in tension with one or more of the ethical values of this National Statement. Sometimes the legal, regulatory or ethical review processes of another country may also demand conduct that is in tension with the ethical values of this National Statement. The guidelines in this chapter must inform any resolution of these tensions.

Values, principles and themes that must inform the design, ethical review and conduct of all human research are set out in Sections 1 and 2 of this National Statement. The guidelines and headings below show how those values, principles and themes apply specifically in research that is the subject of this chapter.

Guidelines – Chapter 4.8

Research merit and integrity

4.8.1 Research conducted overseas by researchers from Australian institutions must comply with this National Statement.

4.8.2 Local cultural values should be acknowledged in the design and conduct of the research. It should be clearly established that such acknowledgement will result in participants being accorded no less respect and protection than this National Statement requires.

4.8.3 As far as is necessary to satisfy the requirements of paragraphs 1.10 to 1.13, the design and conduct of the research should reflect continuing consultation with the local participant population and the communities to which they belong (paragraph 4.8.19).

4.8.4 Researchers should inform ethical review bodies in Australia:

  1. (a) whether, in the country in which they intend to do research, there are ethics approval processes that are relevant to that research, and whether any such processes are mandatory or voluntary in relation to the proposed research
  2. (b) how such processes function, the values and principles on which they rely, and whether they require reporting of the Australian review body's approval.

4.8.5 Where there are no ethics approval processes in an overseas country, this National Statement may provide the only applicable process for ethical approval. In this case, the Australian ethical review body should take account of the available resources and means to conduct the research and avoid imposing unrealistic requirements, providing always that research participants are accorded no less respect and protection than this National Statement requires.

4.8.6 Some funding or national requirements will direct researchers and review bodies to conform to the ethics guidelines of local institutions or to recognised international guidelines or instruments. Research conducted under those guidelines or instruments should be approved only if participants will be accorded no less respect and protection than this National Statement requires.

4.8.7 Researchers should have enough experience or access to expertise to enable them to engage with participants in ways that accord them due respect and protection.

4.8.8 When research is to be conducted overseas by a researcher who is subject to academic supervision, researchers should inform the Australian ethical review body of how that supervision is to be effected so that due respect and protection will be accorded to participants.

4.8.9 When co-researchers are to be recruited in an overseas country, researchers should inform a review body of how the capacity and expertise to conduct that part of the research assigned to the co-researchers will be established.

4.8.10 It is the responsibility of researchers to satisfy themselves that those coresearchers will carry out the research in a way that accords participants no less respect and protection than this National Statement requires.

Justice

4.8.11 The distribution of the burdens and benefits of research in overseas countries, for the participants and in some instances the broader community, should be fair and the research should not be exploitative.

4.8.12 The conduct of the research in other countries should take into account the opinions and expectations of participants and their communities about the effect of any limits of resources on:

  1. (a) the way the research will be conducted
  2. (b) participants' post-research welfare
  3. (c) application of the results of the research.

4.8.13 Institutions and researchers should find out whether research they are planning to do in another country is lawful in that country.

Beneficence

4.8.14 Researchers need to inform review bodies when participants will be in dependent relationships with researchers, whether through previous or proposed arrangements (see Chapter 4.3: People in dependent or unequal relationships).

4.8.15 Researchers need to know enough about the communities, and how to engage with them, to be able to assess the burdens and benefits of their research to the communities. Political and social factors that may jeopardise the safety of participants need to be taken into account. Researchers should inform review bodies about these likely burdens and benefits.

4.8.16 A local, readily accessible contact should be available to participants to receive responses, questions and complaints about the research. Responses and questions should be handled by the researcher. Researchers should ensure that there is a process independent of the researcher for dealing with complaints (see Chapter 5.6: Handling complaints).

4.8.17 In proposing mechanisms for monitoring research, researchers should take account of local circumstances.

4.8.18 Conducting research in other countries can expose researchers to risks of harm. Institutions and researchers should try to identify and evaluate any such risks, and make provision for dealing with them, for instance by establishing local academic or institutional affiliations.

Respect

4.8.19 Respect for participants in other countries requires having due regard for their beliefs, customs and cultural heritage, and for local laws.

4.8.20 Local beliefs and practices regarding recruitment, consent, and remuneration to participants or contributions to communities for participating in research should be taken into account in the design and the conduct of the research, and in the ethical review process.

4.8.21 It should be clearly established that the processes to be followed in recruiting participants and through which they choose whether to be involved are respectful of their cultural context.

 

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.

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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