International Human Subjects Research

When conducting research with participants outside the United States (U.S.), additional review and documentation will be necessary, if required, from the international site and country and the UMaine Office of Research Compliance (ORC) and Institutional Review Board (IRB). The principal investigator (PI) should start this process as soon as possible.

The PI must comply with U.S. regulations and local regulations at the study site and country. If possible, the investigator should work with local research collaborator(s) at the study site to help the PI better understand the local and country requirements (ethics reviews, permissions, etc.) at the international site. The PI should also be aware that human subjects research at an international site may greatly increase review time. All international studies are reviewed on a case-by-case basis and any requirement listed below may be waived depending on the study.

A. Minimal Risk Studies

Minimal risk studies are, according to the U.S. Health and Human Services Policy for Protection of Human Research Subjects, studies where “the probability and magnitude of harm or discomfort anticipated in the research (external link) are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR § 46.102).

For minimal risk studies, it is possible that a local ethics review is not required. The PI must obtain written documentation whether the site and country involved do or do not require an ethics review, as more fully described below. In addition, the PI should obtain a letter indicating and explaining the cultural and other local implications and how they will be addressed. This letter should be written by someone not associated with the study who is familiar with the local culture of the study site. The letter must be signed, dated, and should include the following:

  • Title of the study;
  • Description of the author’s experience with and knowledge of the culture of the foreign country and site;
  • Description of the study adequate to demonstrate the author understands the study; and
  • Confirmation that the study does not conflict with local and cultural norms.

The PI will also need to provide proof that neither a local ethics review nor government approval is needed. This information can be provided in one of the following ways:

  • Provide references in English to local regulations that indicate that an ethics review or government approval is not required. The PI must provide citations to the local laws and regulations.
    or
  • Provide a letter stating that neither an ethics review nor foreign government approval are required. The letter can be written by an IRB/Ethics Committee Chair, foreign University Attorney, or foreign Government official (such as the Ministry of Health, Ministry of Education, etc.). The letter is required to be on letterhead, signed, dated, and include the following:
    • Title of the author;
    • Title of the study;
    • Description of the study adequate to demonstrate the author understands the study; and
    • A statement that an ethics review is not required by the laws of the site or country.

The IRB requests that minimal risk studies be submitted at least 3 months before the PI intends to start the study, as review time may take considerably longer than a U.S. based study.

B. More Than Minimal Risk Studies

Written approval from a local ethics committee or foreign government is required; on letterhead, signed, dated and include the following:

  • Title of the study; and
  • A statement that the planned research was reviewed and approved by the local ethics committee and any necessary government agency (ex. Ministry of Health or Education) or official.

Greater than minimal risk international studies can take a long time to approve (6 months or more), so the PI should plan accordingly and submit the study as soon as possible.

C. Site Collaborator

Depending on the location, study risk, and any other factors the IRB deems relevant, the IRB will make a case-by-case determination of whether to require a local site collaborator.

Even if not required, the IRB strongly encourages the PI to engage a local site collaborator and enter into a written Memorandum of Understanding (MOU). The University of Maine (UMS) Office of General Counsel must review and approved the MOU prior to proceeding. Please contact the UMS Office of General Counsel for additional information and with any questions that may arise.

The PI may also need to seek a signed agreement with or signed written authorization from the site country’s government (examples include the Ministry of Health or Ministry of Education) that states that the PI is allowed to conduct the human subjects research project in that country.

D. The following should be included in all applications for international human subjects research (minimal or more than minimal risk):

  • Description of local context information including cultural implications and how they will be addressed.
    • Some examples include: current events that may increase risk to participants, rights to privacy in the host country, human rights conditions, legal autonomy of women and children, cultural beliefs, researcher’s knowledge of host country customs, language barriers, literacy rates of participants, etc.
    • The PI should also address any local political security concerns and any possible repercussions to or caused by the research. (An example of this could be risks related to colonialism or exploitation of vulnerable populations or nations.)
  • The consent form and all recruitment materials, initially submitted in English.
    • Once the materials are approved by the UMaine IRB, the documents should be submitted to a translator and then submitted to the local ethics committee and government (if applicable).
    • Once translated, these documents should be provided to the UMaine IRB along with a translation certification document. The translator must be certified and the certification must be attached with the translation. Exceptions to this requirement are possible and will be reviewed on a case-by-case basis.
  • The respective materials required in Section A or Section B above, as appropriate.
  • Description of how data will be kept secure at all times (in the host country, while traveling, etc.).
  • Description of how the faculty sponsor will oversee the international research conducted by students (when applicable).
  • Indication if participants will be paid and, if so, a description of the remuneration in terms of both U.S. and local currency. A description of the payment in relative terms (i.e., payment equates to a day’s work, hourly salary, and other local reference) should be included.
  • Any agreements or MOUs as required or recommended by Section C above.
  • All generally-required contents for all research applications, regardless of research location. Please visit the IRB website for additional guidance and information, or contact the Office of Research Compliance at umric@maine.edu for more information.

More Information on International Research

Please see International Research for more information on this topic as it relates to other research compliance areas.

References