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All research involving human subjects that is conducted at or sponsored by the University of Illinois at Urbana-Champaign, whether funded or unfunded, and whether conducted by Illinois faculty or others, must comply with applicable policies for the protection of human subjects. Under a formal assurance made by the campus and approved by the federal Office for Human Research Protections (OHRP), and per federal regulations, the Institutional Review Board (IRB) is given broad authority and wide-ranging responsibilities for ensuring the ethical and legal conduct of human subject research at Illinois.
When conducting research outside of the United States, protocols are to meet certain criteria before study-related research may commence. Procedures normally followed outside the United States for research engaging human subjects may differ from those mandated in federal and institutional policies. These may be the result from differences in language, culture, social history, and societal norms. Researchers are to be cognizant of relevant national policies and take special consideration in cases such as, the availability of national health insurance, different philosophical legal systems, and social policies that may make U.S. research forms and procedures inappropriate. Investigators will ensure full disclosure of the nature of their research to participants and follow an informed consent process appropriate to the population. Requests for waivers of informed consent and waivers of documentation of informed consent in these cases will be considered carefully by the IRB.
Approval will be sought from local IRBs or Independent Ethic Committees. Documentation of permission or approval must be submitted with the IRB application materials. In the absence of these laws or guidance, the researcher is required to obtain approval from the local government or community leaders or provide information as to the absence of the local review. Examples of local reviews may include the following:
- Ethics committees
- Drug approval agencies
- Local ministries
- Local governance
At the time of initial review, the investigator must demonstrate that he/she and key project personnel possess the appropriate qualifications for conducting research in a specific country or region. The Data Collected in International Sites document is used to provide information to evaluate the qualifications of the research personnel. For initial and continuing review if there is no IRB member familiar with local context the IRB will consult with University faculty, international campus organizations or community individuals experienced in the local law, culture and social values of the community where the research will take place.
The Office for Human Research Protections [OHRP] works to ensure that that human subjects outside the United States who participate in research projects conducted or funded by DHHS receive the same level of protections as research participants inside the United States. OHRP International Activities program offers consultation services, disseminates pertinent reports, and provides research ethics training. A list of countries who have met these international research human subjects standards can be found on the OHRP website.
Special Considerations for Research at International Sites
When evaluating risk, different considerations may apply to research conducted outside the US:
- research methods that have virtually no risk in the US might have risk when conducted in other countries;
- questions that may be innocuous in the US could be offensive in other countries;
- breach of confidentiality could have much more dangerous consequences than in the U.S.; and/or
- assuring and maintaining confidentiality in foreign countries may be difficult
Local Research Context
If not already knowledgeable, researchers must become knowledgeable in local context issues that are relevant to the specific research. Specifically, researchers may need to:
- consult with community leaders and stake holders who may be able to provide important insights about the local research context, including information about local customs, norms, and laws;
- communicate and coordinate with local IRBs or ethics groups as well as work with their U.S. IRB;
- develop local collaborative relationships to assist in the approval, design, and conduct of the research;
- identify and communicate with a local contact who is fluent in the local language; and/or
- provide approval documentation for the research received by the PI from the local IRB or ethics group, as applicably defined by the specific community in which the research will be taking place. Examples of acceptable documentation include: local IRB or ethics group approval documents, letters from community leaders and stakeholders, etc.
Confirmation of need for additional oversight
Although it is asked of the investigators to identify local laws and determine if additional oversight is required, the OPRS will independently confirm the accuracy of the information and whether or not additional oversight/review by a local IRB or EC is necessary. These include items to consider when research takes place outside the United States.
- Is additional Ethics Committee or human research protection review required?
- Is local context review required?
- Are letters of support provided?
- Does the consent form include a local point of contact that is not a member of the research team?
- If compensation is given, can it be considered coercive?
- If compensation is given, is it in the appropriate currency?
Consideration should be given to the most appropriate method of obtaining informed consent, including literacy levels, confidentiality concerns, and cultural norms. Different cultures have different authority structures for approval and consent. Researchers should be aware of and honor different cultural attitudes regarding consent. These attitudes may include differences with regard to autonomy and coercion (e.g., what we might consider to be coercive in the US may not be so in a different culture and vice versa). If written informed consent will be obtained, please complete the Certificate of Translation Form.
All informed consent documents must provide the name and contact information a subject may reach out to should they have questions regarding their role and participation in a research study. For studies conducted outside the United States, researchers must be cognizant that participants may be unable to make an these international phone call or may not have access to email. Furthermore, the language barrier on both sides can pose significant problems when neither party is able to communicate. Research subjects must be provided with a designated representative that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol or plan.
In some cases, a waiver of documentation of written consent (verbal consent) may be more appropriate because signing a consent document would put participants at greater risk. In some cases, even when a consent document is appropriate, it may not be appropriate to include some of the required information in the document. For example, email addresses or phone numbers in consent documents may not be realistic or feasible in a foreign country. Consent is best obtained using the language that is most familiar to the prospective subject and ideally the researcher or research team is fluent in the local language. If not, the investigator might seek collaborators or hire assistants who are fluent in the local language. A third option is to hire interpreters.
When hiring interpreters, the following elements should be considered:
- In a small population, the relationship between the interpreter and the subjects must be considered.
- The interpreter might exert influence or undue pressure that could lead to selection bias.
- The interpreter may not relay information in a clear and unbiased manner (e.g., he/she may leave out information they believe is unpleasant or culturally inappropriate).
- In addition to the initial consent process, fluent researchers or interpreters should be available to answer questions, address complaints, or relay instructions throughout the conduct of the study.
- Some languages are not written and sometimes people speak a language but may not be able to read or write it.
- There may not be any translations of important words like a placebo or a randomization.
- It may be culturally inappropriate to ask for a signature and may indicate a lack of trust.
- It may be appropriate to use alternative consent procedures, such as the use of a short form and witness, photos or videos, or other alternate forms of documentation
Research with Children
Children may have different statuses in foreign countries than in the US. Questions that may need to be considered are:
- What is the age of majority?
- What is the relationship between parents and their children in that country?
- What is an acceptable and effective parental permission process?
- What is an acceptable and effective child assent process and are there laws pertaining to orphans in that country?
Levels of Review
Through consultation with experts, the IRB must ensure that the risk assessment holds true at the foreign site. Thus, knowledge of local context is important even in research that may be exempt. Note: even in exempt research, informed consent, parental permission, or child assent may still be ethically appropriate and/or required under local law. The researcher should include information in the research submission to address the local community ethical standards where the study will be conducted. This information should include details regarding local review (as applicable) and the investigatorâ€™s experience with the locality. This information will be considered when approving exempt research conducted at a performance site outside of the U.S.
To assist researchers who are conducting expedited or full board research in a foreign country, the IRB requires that the International Research Form be completed. This allows the researcher to consider and detail relevant political, social, cultural, and economic norms or issues and gives the IRB a sense of how knowledgeable the researcher is about the region where the research will take place.
What is General Data Protection Regulation
The European Union (EU) General Data Protection Regulation, known as the GDPR, is a comprehensive privacy regulation enacted by the EU Parliament. Although the GDPR primarily protects the personal data of persons physically located in the European Economic Area (EEA), it may protect the personal data of persons located in other countries, as well.
The GDPR applies to controllers (someone who determines the purposes and means of processing personal data—principal investigators are often controllers) and processors (someone who processes data on behalf of a controller) in three circumstances:
- When they are established in the EEA; or,
- When they are not established in the EEA but they:
- Offer goods or services to persons in the EEA; or,
- Monitor the behavior of persons in the EEA.
The GDPR defines personal data broadly as any information associated with an identified or identifiable natural person.
When Did the GDPR Become Effective?
The Effective Date for the GDPR was May 25, 2018.
Which Countries Are in the Area?
The EEA includes all of the countries in the European Union plus Iceland, Lichtenstein and Norway.
The following countries are in the European Union: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
Though the UK is no longer in the EU, they have maintained a similar version of the GDPR called UK-GDPR. Please reach out to our office if you are working in the UK.
How Does the GDPR affect Human Subjects Research?
The GDPR may affect to your research if:
- Your research involves the personal data of persons physically present in the EEA;
- You want to re-use personal data you previously collected from persons in the EEA (e.g., for a previous research project) or you want to obtain existing personal data about persons in the EEA from other persons or units at the U of I (e.g., admissions data) to use in your research;
- A person or entity physically present in the EEA is providing you with the personal data of research subjects located anywhere in the world;
- You intend to conduct data scraping involving the accounts or websites of persons or entities physically present in the EEA; or,
- You are collaborating with researchers or entities physically present in the EEA.
The university has developed an online tool to help you assess whether the GDPR applies to your research. The tool asks a series of yes/no questions to determine if the GDPR applies. If it does, the online tool identifies templates you should use to address GDPR requirements. In addition to requiring adequate security over the personal data of research subjects and collaborating partners, the GDPR imposes certain notice and consent requirements you will need to consider when designing your research protocol. The notice and consent requirements can be complex if the research involves certain special categories of personal data identified in Article 9 of the GDPR.
- These special categories include data revealing racial or ethnic origin, political opinions, religious beliefs or philosophical beliefs, or trade union membership; genetic data; biometric data for the purpose of uniquely identifying a natural person; health data; and data concerning a person’s sex life or sexual orientation.
- The GDPR also prohibits processing criminal conviction and offense data in Article 10 of the GDPR, except in very limited circumstances (none of which currently apply to the U of I).
As a further GDPR security measure, data protection agreements are generally required when persons or entities other than the U of I process personal data for your research. The GDPR defines processing very broadly so that it covers essentially any operation performed on personal data or sets of personal data, whether or not by automated means. Processing includes collecting, recording, organizing, structuring, storing, adapting, altering, retrieving, consulting, using, disclosing by transmission, disseminating or otherwise making available, aligning, combining, restricting, erasing or destroying personal data. Learn more about data protection agreements on the University of Illinois System GDPR website.
Whom Should I Contact with Questions?
If you are planning or conducting research that may be covered by the GDPR, or if you have questions regarding whether the GDPR applies to your research, please contact the following offices for guidance:
Office for the Protection of Research Subjects
- Email: firstname.lastname@example.org
To ensure that a protocol fulfills the requirements of GDPR, UIUC’s IRB may have to coordinate with the University Ethics and Compliance Office, University Counsel, or the Grants and Contracts Office. Consequently, the time from IRB submission to approval may be much longer than is usual, so investigators should submit far in advance of their intended date to start data collection.
There are several resources available to help determine if your research is subject to the GDPR.
- GDPR Full Text
- Online GDPR Tool: This tool will help you determine if the GDPR applies to your research. If it does, the tool will identify consent templates you should incorporate into your study’s informed consent notice.
- Consent Templates
- University of Illinois System GDPR Webpage
- OHRP Guidance on International Research
- U.S. Department of State
- University of Illinois OVCRI Policy Export Control
- Before making travel arrangements, investigators should review the Overseas Study travel policies regarding countries under travel warnings.