35.0 Research in other countries
- 35.1 Ethical clearance and other approvals
- 35.2 Legal considerations
- 35.3 Respect for persons
- 35.4 Benefits
- 35.5 Risks
- 35.6 Language considerations
- 35.7 Recruitment and consent issues
- 35.8 Applying for ethics approval
- 35.9 Data storage for overseas research
- 35.10 NEAF Questions
Research conducted overseas by Australian researchers must comply both with the National Statement and with guidelines that apply in that country. Where there are differences between the local and Australian requirements, the higher standard applies.
When planning a project you will conduct in another country you must establish the requirements and processes that apply to research in that country. Information on ethics requirements for many countries is available on the website of the Office for Human Research Protections (USA). Information on current warnings or advice about your proposed research destination is available on the Australian Department of Foreign Affairs and Trade (DFAT) advisory page.
To avoid unnecessary delays in your ethical approval, provide copies of all research approvals/permits with your application. You may choose to submit your application with a list of approvals/permits you are currently seeking, your application can gain conditional approval - all required documents must be provided before you start the project.
|If the nature or context of your research makes local approvals inappropriate (eg seeking approval would expose researchers or participants to additional risks) contact the Human Ethics Unit to get specialist advice. Such research raises significant and extremely serious ethical and legal issues.|
When planning a project you will conduct in another country, you must determine if any regulatory or legislative frameworks apply to the conduct of your planned research will need to be addressed eg:
some countries require that foreign researchers obtain permission from government before conducting a project.
You should also be aware of any laws which impact on the project itself eg:
- a project which considers homosexual behaviour in a country where such behaviour is illegal.
- Consider any such issues carefully as part of the project risks.
To avoid unnecessary delays in your ethical approval, provide details of the regulatory or legislative requirements that apply to your project, and how these will be addressed. If there are no regulatory or legislative requirements in the country where you will conduct the research, say so in your application.
When you do research overseas, you should state that you have checked the regulatory or legislative requirements that apply to the proposed research, and if there are any, how these will be addressed.
Victorian and Commonwealth requirements still apply to research conducted overseas because, even though the research is being conducted in another country, the it is being conducted by a researcher based at a Victorian state university. If you feel this is not the case in relation to your proposed research project, contact the Human Ethics Unit to get specialist advice.
Respect is a key ethical principle described by the National Statement. Among other things, this ethical principle requires that the design and conduct of your project respects the culture and beliefs of participants.
In practice, when seeking ethics approval for a human research project to be conducted in another country, you must demonstrate that:
- you are aware of any cultural, religious or other social sensitivities, traditions or practices that are relevant to the conduct of the project, and the research team have the expertise (collectively) to conduct the research in a culturally sensitive manner,
- you can ensure the design and conduct of the research will be appropriate for the local context,
- there has been appropriate consultation with the community,
- the research will not perpetuate prejudice or discrimination against members of the community, and
- your project will make a genuine attempt to share the results of the research with the host country and/or the participants' community.
For example, where an international student will collect data in their own country rather than in Australia, they may invite a local academic to oversee the research data collection.
Whether community consultation is needed (or not) will depend upon the culture, the community, the nature of the research, the potential burdens, risks and impacts of the research, and the vulnerability of the potential participants. In some societies nearly all research would require the approval of community leaders. Your application for ethics approval of overseas research, should explain your approach to this matter.
As with all human research, an important ethical consideration of your research project is the degree to which the risks to and burdens upon participants are balanced by benefits to those participants.
It would be highly unethical for research participants in another country to carry all or most of the burdens/risk, while the researcher, and the Victorian or Australian community reap all the benefits. Different cultures can place different emphasis of some benefits, or regard some benefits as trivial. When you plan research overseas confirm whether the planned benefits would genuinely be valued by participants, and the degree to which the benefit balances the burdens / risks.
As with all human research, the risks incurred must be balanced by the benefit expected from the project. When you plan research in another country, you must reflect upon any special risk factors that might apply in that context:
- public health, etc.
For example, interviewing people moving through a public space - in a country ruled by a repressive regime - may raise significant issues of potential harm (or perceived harm), even if the subject matter appears relative innocuous.
Consult with the DFAT advisory page for current warnings or concerns about the proposed research location. In many - perhaps most - cases, there will be no additional risk factors, only those that apply wherever the research was conducted.
If the issues to be raised or the behaviour to be investigated are considered illegal or otherwise inappropriate in the country where your research will take place, you must demonstrate that the research method can safeguard both researchers and participants
- while the research is being conducted, and
Where there is a significant risk to researchers or participants, your project must include a detailed risk assessment supported by the Head of School or research centre. The signature of the Head of School or research centre which is required on every ethics application will not be sufficient.
When research is conducted in a country where English is not the first language, this raises two issues in relation to language.
Your application should include the following
- The language in which your research will be conducted.
- Whether member/s of the research team are familiar with the language to be used, and if not, how communication will be managed.
- Whether this language will be familiar to all participants.
- Whether interpreter/s or translated materials will be used, and if so, how this process will be managed (eg how will the interpreters be recruited, who will be translating the documents etc).
No single approach to the provision of language support will be right for every project.
- In high risk research, it may be appropriate to include an independent interpreter, who can be present to enable communication between potential participants and the researcher(s).
- In the case of an anonymous - and innocuous - questionnaire, it may be appropriate to have the questionnaire coversheet translated into the relevant language.
You will need to identify such matters in your ethics application, and explainhow you will manage them.
If any of the supporting documents of your ethics application are in another language (eg recruitment and informed consent materials, or approval from the local authority) you must provide them in both the original form and a translation.
If your project is high risk, or involves extremely serious ethical issues, Deakin HREC may insist upon a certified translation.
In addition to potential language issues, when you plan to conduct research overseas, consider the following:
- In some cases collective, as well as individual consent, will apply. If this is the case, you must demonstrate a genuine process for consultation and negotiation with the collective authority.
- If an incentive will be offered to potential participants, is this appropriate to the context?
A $1 value incentive to general-population participants is likely to be considered insignificant in Australia, but might be considered coercive in a country where $1 is equivalent to the average daily wage.
- If some or all participants cannot read or write, a partially or fully verbal consent process will be required.
If fully verbal, the question becomes how to record consent. If your research is highly sensitive, some kind of documentation (or audio recording) might be considered necessary. In lower impact studies it could be as simple as recording time, place and person giving consent. In an anonymous 'vox pop', it might be enough to record the time and place and that consent was given.
- Local risk factors may require special recruitment and/or informed consent strategies to protect the anonymity of participants.
- A local contact person or body (eg an academic at a local university, a local NGO or support service) that is not a member of the research team should be provided for complaints and concerns.
You application for ethics approval for a project to be conducted overseas must address the following issues.
- Ethics or other requirements for conducting research in that country, and where you are up to with the process.
- Any security issues relating to you or your participants as part of the project.
- Sufficient experience or appropriate supervision to conduct research in that country.
- Any local affiliation or support (such as a local research supervisor for a student project).
- If the project is to be primarily conducted in another language, copies of the documentation for participants should be submitted in both English and the translation.
- A local contact for complaints and concerns should be included.
- The standard complaints clause must include the email address email@example.com
|Ethics approval from outside Australia will not be accepted as 'prior review' for the executive process, so please make sure that you allow sufficient time for a full review.|
In general the data storage requirements for research taking place overseas are the same as for any other research data.
|While data are being collected, interim storage at the locality is appropriate, but backup or transfer of data to Deakin or alternative long term storage should be part of your research plan. Depending on the nature of the research and timelines, this may be at regular intervals or as soon as possible after the completion of data collection.|
As with all human research, the preference is for the original data to be stored at Deakin. Where there is appropriate secure storage for the data (which satisfies the requirements set out in section 2 of the Australian Code) eg a local university or hospital, then the original data may remain there and a copy be stored at Deakin.
This table lists some of the question on the NEAF especially relevant to overseas research.
|NEAF No.||NEAF Question|
|2.6.1||Are there any relevant certification, accreditation or credentialing requirements relevant to the conduct of this research?|
|18.104.22.168||In how many overseas sites, or site types, will the research be conducted?|
|4.2.1||Are there any local requirements which are necessary for the conduct of this research?|
|22.214.171.124||Describe the requirements and how they will be met?|
|5.3.11 or 8.6.6||Is there a risk that the dissemination of results could cause harm of any kind to individual participants - whether their physical, psychological, spiritual, emotional, social or financial well-being, or to their employability or professional relationships - or to their communities?|
|126.96.36.199.1 or 188.8.131.52||Describe the risk and explain how it will be managed.|
|6.3.8||Are there any other risks involved in this research? eg. to the research team, the organisation, others? What are these risks? Explain how these risks will be negated/minimised/managed.|
|6.5.5||If it became known that a person was recruited to, participated in, or was excluded from the research, would that knowledge expose the person to any disadvantage or risk?|
|184.108.40.206.1||What are the risks or disadvantages?|
|220.127.116.11.2||How will these issues be addressed?|
|7.51.||In what language(s) will the research be conducted?|
|18.104.22.168.2.2||Will an interpreter to be present during discussions with the participants about the research project? [And if not, why not?]|
|7.5.2||Will participants be provided with written information in the language in which the research will be conducted? [And if not, why not?]|
|7.5.3||Describe the procedures by which overseas participants can obtain further information or complain about the research project?|
|7.5.4||What cultural sensitivities are relevant to the participants in this research project?|
|9.9.1||You have indicated that this research will be conducted overseas. Please list the countries/jurisdictions that this research will be undertaken in.|
|9.9.2||How will the principal researcher / investigator monitor the conduct of the members of the research team who will be working overseas?|
|9.9.3||How have the researchers / investigators taken into account the opinions and expectations of participants and their communities about the effect of any limits of resources on: (a) the way the research will be conducted; (b) participants' post-research welfare; and (c) application of the results of the research?|
|9.9.4||On what basis is the research lawful in the jurisdiction(s) where it is to be conducted?|
|9.9.5||Will this research project involve access to, use, collection or acquisition of culturally sensitive artefacts?|
|22.214.171.124.1||Describe the artefacts and how cultural sensitivity will be respected.|
|9.9.6||Are there local factors which make it problematic to comply with ethical standards expressed in the National Statement|
|126.96.36.199.1||Describe these factors and what steps will be taken to address these matters in a responsible and appropriate manner.|
These guidelines were produced by Deakin Research Integrity in consultation with the Deakin University Human Research Ethics Committee and Human Ethics Advisory Groups
© Deakin University 2010. This material incorporates or is based upon part or all of Griffith University's research ethics arrangements.