280. For Investigators Conducting International Research

Updated October 6, 2022

University and affiliate researchers involved in human research must adequately protect the rights and welfare of the research participants at foreign sites by providing participants in other countries with the same level of protections as research participants inside the United States. If the foreign site will be engaged in human research and if the research is federally funded in whole or in part, the foreign site must file an International Federalwide Assurance (FWA). The International FWA number should be provided in the IRBNet package.

When research is sponsored by a U.S. federal agency, the regulations of that agency apply. Providing equivalent protections is unacceptable in lieu of providing the required federal protections. Preliminary information about ethical and human research protection requirements for individual countries may be obtained from the United States (US) Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) website, International pages by referencing the US DHHS OHRP International Compilation of Human Research Protections. Investigators may need to provide the IRB with documentation of permission to conduct research in the country.

In international settings, special attention should be given to the involvement of local participants in the design and conduct of the research to account for differences in language, education, cultural and social history, and social mores; and to comply with local law.

Other countries' national policies may have implications for international research such as the availability of national health insurance, philosophically different legal systems, and socioeconomics.

For any human research activity conducted at a non-local domestic or international institution or site, the following must be addressed:

name of the site
the anticipated scope of the research activities to be conducted at the non-local institution or site;
the types of subject populations likely to be involved and the languages spoken by them;
the size and complexity of the institution or site where the research is being conducted;
description of relevant cultural norms and local laws;
the methods for ensuring equitable selection of participants;
the methods for protecting participants’ privacy;
the methods for maintaining the confidentiality of the research data;
the methods for minimizing the possibility of coercion or undue influence in seeking consent;
the safeguards to protect the rights and welfare of vulnerable participants;
the Federalwide Assurance number assigned to the site, if applicable;
description of any licenses, permits, or other permissions necessary for the procedures to be performed at that site;
either a letter of authorization to conduct the research at the facility or a signed statement of work.

Qualifications of Principal Investigators

University and affiliate Principal Investigators (PIs) must be sufficiently qualified to conduct the proposed international research. The IRB may require information to verify the researcher's qualifications such as curriculum vitae, list of other studies conducted, letters of reference, information from the sponsor of the research, or information from licensing boards and professional societies. US investigators and their research team members who interact with research participants or have access to their identifiable data must complete the Collaborative Institutional Training Initiative (CITI) “International Research” module.

Identification of Foreign Investigators

All foreign investigators collaborating in the human research must be listed on the IRB protocol application and provide evidence of human research protection training. If the site is engaged in research, the investigator must provide the qualifications of the PI and co-investigators at each site, as well as the resources available to the research team at the specific location(s) where the research will be conducted, including but not limited to facility resources such as the testing and safety equipment available. The site PI is expected to maintain appropriate professional credentials and licensing privileges.

Oversight of Students Engaged in International Research

Ideally, the University or affiliate PI for international research will travel with students to provide direct oversight. If this is not possible, University students conducting international research must identify a person at the local site with the knowledge and qualifications to oversee all student research activities. In the latter case, the PI should routinely communicate with the designee to assess the implementation and progress of the research and discuss any concerns that may need to be addressed.

Requirements for Local Review and Permission

University or affiliate researchers conducting international human research must:

obtain and provide the IRB with permission from the applicable authority in the country, province or community where the research will take place, and the local site;
determine if review by a local IRB, Ethics Board or Independent Ethics Committee (IEC) is required and must comply with the local requirements;

NOTE: If local review is required but no local Board or Committee is available or willing to review the research, the PI must identify a review board within the general region or a local institution that can serve in a comparable capacity (e.g., a tribal council, school board, town committee, or hospital board) or submit a letter to the University IRB stating that such review is not possible and explaining why.

have procedures in place to ensure the University IRB and local oversight bodies are informed of reviews, approvals, and problems that may arise in the execution of the research.

NOTE: The external IRB's or IEC's review should address local issues related to human research protection, including legal concerns or considerations.

Researchers may consider having periodic discussions with appropriate consultants knowledgeable about the local research context (as applicable) to assess the progress of the research.

When the research activities involve greater than minimal risk to participants and the investigators are interacting or intervening with participants at the non-local site, the IRB has the following responsibilities:

Meeting minutes must document that the IRB has obtained appropriate information about the local research context through one or more of the following means:
- Personal knowledge of the local research context on the part of one or more IRB members, such knowledge having been obtained through extended, direct experience with the non-local research site, its subject populations, and its surrounding community;
- Participation by one or more appropriate consultants in the IRB meeting discussion of the research study, either physically or via teleconferencing;
- Prior written review of the proposed research by one or more appropriate consultants, with consultants available either in person or via teleconference to address questions, when needed, raised during the IRB meeting.
Research that is complex or presents significant risk to participants may require consultation with the University's or the external site's legal counsel to ensure that the rights of participating participants are appropriately protected, and that the research is conducting in accordance with local law.

Understanding Local Context and Law

The IRBNet package must be accompanied by a letter from the chair of the local IRB or equivalent entity specifying that the local IRB or equivalent entity has determined that:

The study complies with local laws and customs;
The local facilities/resources are adequate;
The local investigator and key personnel are appropriately qualified to conduct the study;
Whether a local representative from the research site is required to participate during the University IRB review.

University and affiliate researchers conducting international research are advised to consider the following to enhance the research and protection of human participants:

The economic prosperity of the area and the prospective study population;
The political stability of the area;
The influence of local officials or leaders on the population;
Whether the country or area allows foreign visitors;
The nature of the procedures conducted (some countries, societies, or areas may not allow invasive procedures);
The literacy rate of the area;
The legal rights of the population under local law (confer with local consultants as necessary to determine, for example, age of legal consent, disclosure and required reporting of illegal activities, and applicable privacy laws);
How complaints will be reported and to whom;
The relevance of the research to the region's health or socio-economic needs; and
The possibility of including officials from the area in the monitoring of the research.

NOTE: With all due sensitivity for local customs, minors who are treated as adults in their own country will be treated minors for the purpose of protection in research.

Requirements for Informed Consent

IRB-approved study personnel must obtain voluntary, informed consent from each prospective participant or in the case of an individual who is not capable of giving informed consent, the surrogate consent as determined by local law or custom.

Informed consent processes must be sensitive to local cultural norms.

Informed consent discussions and documents must be in the language understood by participants, or a local translator must be present during the consent process.

Investigators must be sensitive to perceptions of a power differential between potential participants and the researchers and proceed accordingly to mitigate the possibility of coercion or undue influence in seeking consent.

Participants in human research are provided with the University international telephone number as part of the informed consent.

(As relevant, see IRB policy for research involving persons who do not speak English.)

Alternatives to Standard Informed Consent Processes

It may not be possible or even necessary to obtain written informed consent from participants. For example, written consent may not be possible due to illiteracy levels among the local population, is not warranted because the research poses minimal risk, or is ill-advised because written consent may place participants at risk.

In such cases, the PI may request a waiver of written consent; however, researchers requesting a waiver of written consent must use an acceptable alternative method of informing potential participants about the research and obtaining their agreement to participate. The alternative method must be appropriate for participants and their culture. Alternative methods may be a simple combination recruitment/consent script.

At a minimum, recruitment/consent scripts should:

use the simplest language possible,
refrain from use of jargon,
tell participants what they will experience during the research,
describe the risks of participation,
emphasize the voluntary nature of participation, and
(when applicable) clearly differentiate between procedures performed as standard care and those being performed for the research.

For research involving clinical investigations of FDA-regulated products (drugs or devices), participants must also be given the name of a person to contact for answers to pertinent questions about the research and research participants’ rights, and in the event of a research-related injury to the participant. The University IRB may require an individual at the research site to serve as a local contact.

Securing Data and Protecting Participants' Privacy

Depending on the nature of the data to be collected and its sensitivity in the local culture, the principal investigator may need to implement a range of suggested data protection measures such as those described below. There are some restrictions on bringing identifiable data into/out of some countries. The European Union (EU), for example, has laws surrounding what kind of identifiable information can be taken out of Europe and brought to the US (this applies to electronic data that will be housed on a US server as well). Data export laws may also affect research in countries with which the US has embargoes or trade restrictions.

Location of Data Collection

Data collection sites should be chosen to protect participant privacy during all participant-researcher interactions (including recruitment, consent, and enrollment processes).
Investigators are encouraged to assess whether there may be participant risks related to a member of the community being seen speaking to the PI or the possibility of the discussion being overheard and plan the data collection procedures accordingly.

Paper Files

Data must be secured in the research field by means of a lock box or locking file cabinets whenever possible. In some remote sites, physically securing records may be difficult and alternate approaches such as maintaining records in English in an area where English is not understood can be effective.

Electronic Data

The collection of data must comply with local and applicable US law related to data privacy and security. Best practices under U.S. law suggest the use of password-protected computers, encrypted files or both and limiting access to necessary study personnel.
Researchers must exercise caution if they use insecure connections such as Internet cafes.
Politically sensitive information requires additional protections. For example, researchers may consider uploading encrypted data files to the University's servers and securely deleting the files from on-site electronic storage devices.

Local Research Assistants and Translator

When research data has the potential to cause social stigmatization, researchers are advised to exercise caution when selecting a local field assistant or translator to ensure that participant privacy will be maintained.
When members of the community are involved in recruitment, consent, or data collection, the researchers must train these individuals:
- to minimize the potential for undue influence,
- to ensure participants are allowed to refrain from answering questions or withdraw from the research without penalty, and
- to implement and follow the privacy and confidentiality requirements of the study.

US DHHS HIPAA Applicability

HIPAA regulations do not apply to health information obtained and held at international sites; however, researchers must comply with all applicable local privacy laws. If identifiable health information collected at an international site is stored within a University HIPAA-covered component, it becomes subject to HIPAA regulation.

Requirements for Continuing Review, Amendments, and Reporting Problems

University/Affiliate investigators conducting research in foreign countries must comply with the federal and IRB requirements for:

continuing review (i.e., renewal) whether by full-board or expedited review;
prior approval for amendments to approved research unless immediate changes are necessary to protect participants or others;
prompt reporting of complaints or problems (including unanticipated problems involving risks to participants or others) to the IRB, and sponsor as applicable; and
post-approval safety monitoring in accordance with 45 CFR 46.111, item (6); 21 CFR 56.111, item (a)(6); 21 CFR 312.32; 38 CFR 16.111, item (a)(6); and other federal regulations as applicable.
Complaints by individuals participating in transnational research, noncompliance, and unanticipated problems involving risk to participants or others will be handled in accordance with the IRB policy concerning assessment of complaints and problems in research.