International Human Subjects Research

Overview

Human subjects research studies are considered to have an international component when investigators travel abroad to collect data, or investigators use or collect data from participants who are outside of the United States.

When conducting human subjects research in another country, Emerson and its researchers must ensure that these activities not only meet the ethical and legal requirements for conducting research at Emerson or other domestic sites, but also respect the norms and research regulations in the host country. Each country has different cultures, values, laws, and regulations. Emerson College and its researchers thus must ensure that local regulations and ethical requirements are followed, and that cultural norms and customs are respected. The safety of Emerson researchers, as well as the legal and reputational implications for the College, must also be considered.

Accordingly, the IRB expects researchers who wish to conduct international research to acknowledge and understand the following principles and guidelines:

• You must obtain IRB approval before your study can begin. Any study deemed to be human subjects research must be approved by the IRB before it can begin. To reduce confusion, make sure you have Emerson IRB's approval before you leave the country. We suggest you apply to the IRB a minimum of three months prior to the planned start of your study, allowing adequate time for reviews before you leave.
• A study should have an in-country/on-the-ground partner or collaborator. Having a local, on-the-ground expert as a member of your research team – one who is thoroughly versed in the study population’s cultural norms, the country’s laws, and prior experience in local research – will help reassure the IRB that your research will be conducted in a manner that respects local culture, values and regulations. Studies that do not include an on-the-ground partner will receive a higher level of scrutiny and require more ancillary information in order for the IRB to determine how issues of local regulations and ethical conduct will be adhered to.
• Approval from a local IRB, ethics board, or equivalent oversight body may also be required. Both the U.S. and host country’s standards for protecting human participants must be respected during the IRB’s review and approval process and the conduct of the research. Applications for international research should identify whether there is a local IRB, ethics committee, or government entity that must be consulted or that will perform a review within the host country. If already obtained, a copy of the approval notice or supporting documents for the local review must be included in the Emerson IRB application.
  • When federal funds are awarded to a U.S. institution to conduct human subjects research outside the U.S., in most cases the protocol will need to be reviewed by both a U.S.-based IRB and an IRB or ethics board in the host country.
  • If the project does not involve federal funding, you must confirm whether the host country’s national or local laws require in-country IRB review and approval.
• Where the two sets of IRB/ethics board standards present a conflict, the research must meet the higher standard for protection of subjects and meaningful consent.
• For Countries in which there are no regulations governing research or local oversight bodies to review research: In some countries, local regulations do not require review of the research (e.g. social/behavior/educational research or use of existing data/samples) or there is no local ethics committee to review the research in the host country.

In these cases, researchers are advised to provide a letter of support from an individual in the host country who has the relevant expertise or institutional authority to review the research. The letter must support that there is no formal review process available or needed, and that the research is acceptable according to local context. This person cannot be associated with the conduct of the proposed research.

Planning Ahead of Review of International Protocols

Researchers should anticipate that IRB (and institutional, if deemed necessary) review of international protocols will take additional time, and should endeavor to submit their completed application and materials at least two months prior to their planned start date.

Submission of an International IRB Protocol Application

Applying for IRB review and approval of an international protocol follows the same process as that for a domestic project. An application should be created and submitted via the IRB Application Form on InfoReady. While filling out the form, applicants for international projects will be prompted to provide additional information where needed.

IRB Review of International Protocols

International protocol applications will be reviewed and approved by the IRB according to the standards outlined in the Common Rule (45 CFR 46 and its Subparts).

To facilitate the IRB’s review, applicants will be prompted to provide additional information on the following – all of which fall under the purview of the Common Rules’ existing standards:

• Local Context. Countries, regions, cities where the study will take place; justification for conducting research in this locale; current events or socio-political environment that could impact research or alter risk/benefits to subjects or the researchers, etc.
• Cultural Understanding and Sensitivity. A demonstrated understanding of the societal and cultural beliefs in the country that may impact the research or alter the risks or benefits to subjects, including risks to vulnerable groups and populations.
• On-The-Ground Partners/Collaborators. Information on in-country collaborating institutions or researchers. No local partner will create a higher institutional standard for approval.
• Documentation of local partner’s approval from local IRB-equivalent or ethics committee.
  • For Countries in which there are no regulations governing research or local oversight bodies to review research, applicants should provide a letter of support from an individual in the host country who has the relevant expertise or institutional authority to review the research (not a member of the research team)
    • Note: for research that is supported by federal funding, the aforementioned approval and documentation is required.
• Translations of any research recruitment materials (informed consent, etc.) from local language to English.

Additionally, projects that are subject to the European Union’s (or the United Kingdom’s) General Data Protection Regulation (GDPR), or China’s Personal Information Protection Law (PIPL) will need to include additional language in their informed consent forms. For more information, refer to GDPR and PIPL below.

Additional Institutional Review of International Human Subjects Protocols

International human subjects research may touch upon issues that fall outside of the purview of the Common Rule. Accordingly, in addition to the IRB’s review, international projects will be forwarded to Academic Affairs, Risk Management, and the Office of General Counsel for discretionary review. These entities may require additional information– particularly in cases where the research will take place in travel-restricted countries, areas prone to violence, or other factors that rise to the level of institutional (rather than the IRB’s) jurisdiction.

Researchers should note that Emerson College can overrule the IRB’s approval of a protocol. However, the College cannot overrule the IRB’s rejection of a protocol.

Region-Specific Additional Requirements and Considerations

In certain international locations, human subjects research is subject to additional regulations or requirements.

EU/UK: General Data Protection Regulation (GDPR)

The GDPR is a European law that regulates how organizations collect, use, store, and protect personal data of individuals within the EU (the UK GDPR is similar, but applies to individuals within the UK).

When Emerson College is working with personal data collected in, or transferred from, any EEA country (any EU member states plus Norway, Iceland, and Liechtenstein) or the UK, GDPR will be relevant. “Personal data” means any information relating to an identified or identifiable person. Data that is coded with links to identifiers (or “pseudonymized” in GDPR terminology) is still subject to GDPR. Failure to follow GDPR, if it applies, puts the College at risk of noncompliance, monetary fines, and reputational harm.

To comply with GDPR, Emerson human subjects research studies must obtain consent from participants that is freely given, specific, informed, and unambiguous as to the data subject’s wishes by a statement or by a clear affirmative action. Data subjects must also be sufficiently informed of their rights under GDPR. Emerson researchers thus must incorporate the supplemental language found in this guidance document into their informed consent form and recruitment materials. Studies must adhere to the data collection, retention, and security requirements outlined in the document.

China: Personal Information Protection Law (PIPL)

The PIPL is a comprehensive privacy law intended to protect the personal information of persons in Mainland China, which refers to the continental landmass under the direct control of the People’s Republic of China (PRC), including the islands of Hainan Province and five major autonomous regions (i.e., Tibet, Inner Mongolia, Xinjiang, Ningxia and Guangxi).

The PIPL defines "personal information” broadly as information related to an identified or identifiable natural person recorded electronically or by other means. Accordingly, Emerson researchers must obtain explicit, documented consent before collecting or processing any personal information related to an identified or identifiable natural (living) person located in mainland China.

To comply with the PIPL, Emerson studies must include specific additional information in the Informed Consent Form. The Informed Consent Form Requirements for Studies in the People’s Republic of China document includes guidance on incorporating it into your Informed Consent Form.

For questions about the GDPR or PIPL, please contact the eric_asetta [at] emerson.edu (Executive Director of the Office of Research and Creative Scholarship).