Any study that is intentionally designed to target individuals outside the United States in its stated procedures for participant recruitment, data collection, data analysis, or results dissemination.
There are no limitations on the Walden IRB’s capacity to review studies involving international research, provided that the primary investigator is fluent in English and completes the IRB application and all supporting materials in English.
The researcher must consult the international compilation of regulations provided by the USA federal Office of Human Research Protections (OHRP).
This list includes regulations, government infrastructures, and guidelines that are relevant to human subjects research, organized by country. Researchers are expected to be aware of all relevant regulations and to remain compliant with these regulations.
When any other country is involved in data collection, Walden applies the ethical standards of whichever country is more strict. The only time we relax the stricter county’s standards (such as age of consent) is when a local custom supporting one of the three main ethical principles articulated by the Belmont report (justice, beneficence, and respect for persons) dictates a different practice (such as asking for a father's consent for his adult daughter to participate in research).
All interpreters in the USA and partner countries are required to complete some sort of human subject protections training. Family Health International (FHI) shares a free, online module in English, French, Spanish, and Portuguese.
The content of these international trainings is not very different from the standard USA training in the National Institutes of Health (NIH) module because they are all based on Belmont Report principles, but this one does include some rich international examples. The IRB also will consider approving using other countries’ training programs that are custom-built by the researcher, provided that the Belmont Report principles and best practices in informed consent, voluntary participation in research, and research safety/confidentiality are covered.
The IRB only approves protocols in which informed consent can occur in a language/dialect in which the participants are fluent. In multilingual countries, it is acceptable to prepare consent documents in the official language of the country, but it is required that the person obtaining informed consent is fluent in at least one of the dialects/languages in which a participant is fluent. Participants may not be recruited if they are not fluent in at least one of the following:
Note that persons obtaining informed consent must also complete an IRB-approved training module regarding protection of human subjects. Either the NIH or FHI online modules are recommended but other training methods can be considered by the IRB and will be approved if they adequately train the research assistant regarding best practices of informed consent, research safety/confidentiality, voluntary research participation and the related Belmont Report principles of justice, beneficence, and respect for persons.
The IRB requires written translations of as many documents as possible at the time of IRB review, as opposed to plans to conduct on-the-fly interpreting. Any time that consent documents or other research materials are translated, the IRB requires (a) that backtranslation procedures confirm the accuracy of the translation, (b) that the qualifications of the translator(s) and backtranslator(s) are documented, (c) that translation and backtranslation procedures are documented.
Several organizations provide pamphlets or other materials to help researchers explain the purpose of research within developing countries. Language is not the only critical factor in bridging cultural differences in remote areas or areas with limited infrastructure. Researchers must remember that individuals in these areas are also likely to have different social and educational backgrounds as well. Study materials should explain the purpose of research activities without making cultural, social, and educational assumptions.
The IRB will seek the researcher’s assurance that s/he is familiar enough with the culture to authentically understand local norms of privacy, confidentiality and advocacy. It is not appropriate for any of us to apply American standards in these dimensions. The researcher should consult with qualified local experts to determine appropriate action plans to handle possible breaches in confidentiality (particularly when parents want access to a child’s data), situations that might indicate reporting abuse to authorities, and possible direct advocacy on behalf of a participant.
Researchers are responsible for their own safety and welfare while conducting research activities. In addition to acquiring the appropriate visas and access approvals, researchers are advised to link with non-governmental organizations (NGOs) for support in identifying a local research participant advocate, dealing with adverse events, pragmatic navigation of local government structures, and communication with local press.
In developing countries, it can be very difficult to distinguish the research activities from other types of educational, therapeutic, or aid efforts. International researchers are strongly discouraged from assuming dual roles. For example, an aid worker should not recruit participants in a community in which she is known as an aid worker since the community members would reasonably assume that the research activities are somehow linked to the broader aid effort. In order to ensure respect for persons (as per the Belmont Report), a researcher should not leverage pre-existing roles to encourage research participation, particularly when the vulnerable individual’s participation would result in personal gain (a doctoral degree) for the researcher. For more specific guidance on this topic, please review the online IRB Guidance for Research in Intervention or Treatment settings.
Below are the solutions to the most frequently occurring ethical challenges in doctoral research:
This is the simplest way to avoid pressuring subordinates, students, or other vulnerable individuals to participate in your doctoral research.
The IRB can only approve those specific components of data collection that show promise of effectively addressing the research question(s). Misalignment will cause approval delays.
Secondary data analysis (aka archival data analysis) is the most ethical way to study your own subordinates, students, clients, or any other vulnerable group because it does not ask them to do anything out of the ordinary for research purposes. Risks to these vulnerable individuals are managed by removing all identifiers from the dataset.
Unless the specific purpose of the doctoral research is the validation of a new measure, creating a new instrument is typically beyond the scope of a doctoral study.
The IRB does not review the entire proposal and can only approve the procedures that are listed in the IRB application itself. Thus, all participant recruitment and data collection procedures MUST be described in the IRB application. If an audit reveals that a student deviated from that specific list of IRB-approved procedures, then the data can be invalidated and the final doctoral study rejected.