International Research Resources

A foreign student goes home for the summer and while at home she wants to interview people about nutrition and their daily diet.  The student brought home her personal encrypted laptop to store the interview data for inclusion in her thesis, and a personal Smartphone so she can check email, use GPS to navigate and possibly record some interviews.

• Are the interview activities described in this case considered to be research?

Research is defined by regulation as a systematic investigation, including research and development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The activities described may be research.  The fact that the student plans to interact with people may constitute human subjects research.  Given the description of what information the student plans to obtain and what she plans to do with it, it is hard to determine whether the project would meet the regulatory definition of research.  In such circumstances, the student should contact the Yale IRB so that they may make the determination.  Visit  Human Research.

• Does the described activity require IRB approval?

If the activity in the foreign country is determined to be human subjects research, then it will require IRB approval by both the Yale IRB and a local IRB or ethics board in the foreign country. For the Yale IRB policy, guidance and an investigator checklist on international research, go to the Human Research section.

• When should IRB approval be sought?

IRB approval should be sought as soon as possible and is required prior to conducting any research activities involving human participants (e.g., recruitment or interviews).  The student needs to be aware that the entire IRB protocol submission and approval process can take up to several months so it is strongly recommended that IRB protocols be submitted to the IRB as soon as possible. Again, no research involving human participants can begin until the IRB reviews and approves the project.  It is a serious violation to conduct research involving human participants without IRB approval.

• What is local IRB approval?

Any human participant research conducted by a Yale faculty member, staff or student, must receive IRB approval from both the Yale IRB AND a local IRB or ethics board in the country in which the research is being conducted.  If there is no IRB in the country in which you’re planning to conduct the research, contact the Yale IRB for help with identifying an acceptable alternative (e.g., a local NGO).

• Are there restrictions regarding taking a laptop computer to a foreign country?

Export control laws restrict the export of certain data, information, or software to certain countries.  For example, bringing encryption software is prohibited for many countries.  In addition to what we typically think of as an export, carrying an item on a plane to another country, mailing something, or even faxing or emailing information is considered an export.  Many laptop computers at Yale have encryption software that could require an export control license if taking the laptop to a foreign country.  For some countries, the export rules are so strict that even blank computers may not be carried there without a license.  See below for additional information on Export Controls or see the Export Controls and Electronic Devices in International Travel memo.  

• Smartphone issues?

The rules are similar to those for computers (see previous question). 

• Are there restrictions on which airline the student can use? 

49 U.S.C. 40118, commonly referred to as the “Fly America Act,” requires that foreign air travel funded with Federal dollars be done on U.S. flag air carriers, with certain exceptions.  In this case, the student is flying home for the summer and there is no indication that Federal funds will be paying for her ticket, therefore the Fly America Act does not apply. 

• Could there be HIPAA or foreign country privacy issues?

The Health Insurance Portability and Accountability Act (HIPAA) regulations may apply.  Though foreign countries do not have HIPAA laws, if identifiable information about the human participants is brought back to Yale, HIPAA may apply.  If possible, investigators who are subject to HIPAA and who are conducting research abroad may want to consider de-identifying subject information prior to returning to Yale in order to avoid unintentional non-compliance with HIPPA regulations.  For more information about HIPAA and de-identifying information contact the HIPAA Office or the IRB.  It is also a good idea to check with the ethics board in the foreign country regarding any local privacy issues or concerns.  The EU, for example, has very strict data privacy laws.

A Yale PI receives a federal award to conduct her research and collaborates with a colleague in China by having a subaward issued to the collaborator’s home institution.  As part of the collaboration the PI in China is going to provide the Yale PI with coded biological samples obtained from human participants as part of the subaward’s scope of work.

• Is this collaboration considered to be research?

Yes, this collaboration is considered to be research.  In addition, this is considered human participant research and requires IRB review both at Yale and in China.  The colleague in China must be listed on the Yale IRB protocol and the country should be indicated in the location section of the protocol as well.  In addition, evidence of IRB approval from the institution in China is required.

• Would HIPAA requirements apply in this case?

It depends.  In general, coded biological samples means that a link exists and the samples could still be linked back to the identifiers or individuals who provided the samples.   If the samples do not contain any HIPAA identifiers and are not re-identified using the code then HIPAA’s requirements do not apply.  However, if the samples are later re-identified then HIPAA regulations will come into effect.  The PI must resubmit the protocol to the IRB for approval in order to re-identify the samples.  For additional information about HIPAA requirements see the Researcher’s Guide to HIPAA.

A faculty member plans to conduct an archeological dig in Iran. The dig is supported by a federal grant.  The PI will use some of the grant funds to pay for a plane ticket, room and board, purchase a vehicle while in Iran, pay a local individual to assist with translation and other tasks associated with the research.  Of course, the faculty member will bring his Yale laptop to record the research data and a GPS device to assist with the dig.

• Can research be conducted in a sanctioned/embargoed country?

Iran is a country that has a comprehensive embargo in place by the U.S. government Office of Foreign Asset Controls (OFAC). Travel to, transfer of information, and other interactions with embargoed countries may be restricted or require specific licenses. The countries with the most comprehensive embargoes include:  Cuba, Iran, Syria, North Korea, Republic of the Sudan (North Sudan) and Burma (Myanmar).  If your research involves interactions with any of these countries you should contact the Director of Corporate Contracts and Export Control Licensing (Donald.Deyo@yale.edu or call 203.785.3817) for guidance on how to proceed.

• Is the payment to a local individual okay?

Costs of professional and consultant services are generally allowable when reasonable in relation to the services rendered. This should be considered prior to proposal submission and planned into the budget.  In this case, because Iran is a country that currently has comprehensive embargoes against it, the transfer of money to that country from the U.S. to pay a local individual to work could be problematic or prohibited.  Contact the Director of Corporate Contracts and Export Control Licensing for guidance on how to proceed (Donald.Deyo@yale.edu or call 203.785.3817). 

• Is the purchase of a vehicle permissible? 

The purchase of a vehicle for research related purposes may be allowed provided that it was budgeted for in the proposal and complies with sponsor and University policies and appropriate OFAC licenses were obtained prior to the purchase.  If the purchase of a vehicle was appropriate, once the research is completed and the vehicle is no longer needed, it must be sold and the money returned to the award.  The Office of Grant and Contract Administration can assist with the proper procedures regarding the disposition of the funds received on the sale of the vehicle.

• Is the cost of travel to Iran appropriate to charge to a sponsored award?

Expenses for lodging and subsistence are generally an allowable expense so long as there is a direct benefit to the project. These expenses should be accounted for in the budget of the proposal and must comply with the sponsor’s terms and conditions and Yale’s policies.

• Are there specific laptop restrictions/issues to consider when taking a machine to a sanctioned/embargoed country?

Most standard laptops may be taken overseas without a license; however, many Yale laptops now have encryption software installed that may be considered controlled technology.  If your laptop contains encryption applications or software, contact IT or the Director of Corporate Contracts and Export Control Licensing or review the Export Controls and Electronic Devices in International Travel memo.  Also note, even without encryption software, taking a laptop to Iran generally requires a license. You should also be careful to prevent inadvertent releases of technology or information by using secure connections, a password to protect technical data and a firewall whenever possible. 

• Are there restrictions or issues related to taking a GPS devide to a sanctioned/embargoed country?

Similar to the question above, most GPS devices can be taken overseas without a license; however taking a GPS device to a sanctioned/emboargoed country will generally require a license. The Director of International Agreements and Export Control Licensing, in the Office of Research Administration, is available to assist Yale travelers in ascertaining compliance requirements. Contact: donald.deyo@yale.edu or 203-785-3817.

• Does Fly America apply?

In this case, the Fly America Act would come into play.  The faculty member is flying to another country using Federal funds and unless one of the specific exceptions applies, the faculty member must use a U.S. flag air carrier. If you have questions about whether the Fly America Act applies to you, contact your GCFA contact. For exceptions to the Act see: 3301 PR.01 Travel Arrangements for University Business

Yes. Because this activity involves the transfer of information from another country for research purposes certain restrictions and regulations apply. You should review this website for additional information on these restrictions and regulations.

If the research you are planning to conduct in a foreign country involves animals, animal samples, or interaction with human participants or human participants’ identifiable data, then IACUC and/or IRB approval is required. The investigators or collaborators from the other country and the location (country) must be listed on your Yale protocol and indicated in your sponsored proposal if funded by an external sponsor.

If you are conducting animal research in another country then you may need to comply with the host country’s laws on animal research. You can contact the IACUC office for assistance. (Email: iacuc@yale.edu or phone: 203-785-5992)

If you are conducting human participant research in another country then in most cases you need a local IRB approval. You are also required to educate yourself about and comply with the host country’s laws on human participant research.

Other types of committees or boards, such as an ethics board, may be an appropriate substitution for IRB review. Some countries, or areas within a country, may not have an IRB system or their ethics boards do not review the type of research you have planned, such as ethnographic research. In these cases the Yale IRB would likely accept sign off by a local NGO or other official body familiar with local culture. Consult with Yale’s Human Research Protection Program for assistance in identifying appropriate alternatives. (Email: hrpp@yale.edu or phone: 203-785-4688).

Costs of professional and consultant services are generally allowable on a sponsored award when reasonable in relation to the services rendered. This should be considered prior to proposal submission and planned into the budget.

Keep in mind, in embargoed or sanctioned countries such payments could be problematic or prohibited.  Contact the Director of Corporate Contracts and Export Control Licensing if you plan to engage in research in one of the embargoed countries.

Other issues to consider are what funds management will be required, and what currency will dominate?  How will exchange rate fluctuations be handled?  Are banking relationships needed?  If so, you should consult the Controller’s Office.

If you are conducting human subjects research you should make sure the person you hire is not also planning to be a participant in the study in order to avoid bias or any appearance of coercion. Additionally, family members are generally not permitted to serve as a translator for research participation so your translator should not recruit family members for the study unless you can use someone else to translate.

The Health Insurance Portability and Accountability Act (HIPAA) regulations may apply. Though foreign countries do not have HIPAA laws, if identifiable information about the human participants is brought back to Yale, HIPAA may apply. Additionally, some foreign countries or regions may have their own strict privacy laws (e.g., the European Union). 

If possible, investigators who are subject to HIPAA and who are conducting research abroad may want to consider de-identifying subject information prior to returning to Yale in order to avoid unintentional non-compliance with HIPPA regulations. See more information about HIPAA and de-identifying information or contact the IRB. It is also a good idea to check with the ethics board in the foreign country regarding any local privacy issues or concerns.