280. For Investigators Conducting International Research
University and affiliate researchers involved in human subject 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.
Preliminary information about ethical and human research protection requirements for individual countries may be obtained from the USDHHS OHRP website, International pages by referencing the USDHHS 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 country's national policies may have implications for international research such as the availability of national health insurance, philosophically different legal systems, and socioeconomics.
Qualifications of Principal Investigators
University and affiliate 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.
Identification of Foreign Investigators
All foreign investigators collaborating in the research must be listed on the IRB protocol application and provide evidence of human research protection training.
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 non-exempt international 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 to 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.
Research that is complex or presents significant risk to subjects may require consultation with the University's or the external site's legal counsel to ensure that the rights of participating subjects are appropriately protected, and that the research is conducting in accordance with local law.
Understanding Local Context and Law
University and affiliate researchers conducting international research are advised to consider the following to enhance the research and protection of human subjects:
- 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.
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.
(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 subjects' rights, and in the event of a research-related injury to the subject. 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.
- Location of Data Collection
Data collection sites should be chosen to protect subject privacy during all subject-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 insure subjects 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.
USDHHS 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 Committee 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 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.