Transnational Research

Investigators and the IRB have responsibilities to ensure research conducted transnationally is afforded equivalent levels of protection to that which would be required if the research took place within the US, while taking into account local laws and cultural context. To gather information regarding transnational human subjects research, the IRB requires that the Transnational Research form in Kuali Protocols be completed for all Exempt, Expedited, and Full Board studies. Information collected in the Transnational Research form, includes:

• Local laws and regulations regarding human research protections,
• Social, cultural, economic, and/or political considerations which may impact the research or risks to subjects,
• Investigators’ knowledge and experience of the non-US location as it pertains to conduct of the research, as applicable, and
• Documentation of approval from a non-US location’s IRB, ethics committee, government agency, or other community group which reviews human subjects research, as applicable. When applicable, documentation of the approval must be provided prior to IU IRB approval.

The Office for Human Research Protections (OHRP) issues annually the International Compilation of Human Research Standards. The Compilation outlines laws, regulations, and guidelines that govern human subject protections around the world. This is to serve as a reference for investigators when conducting and the IU IRB when reviewing transnational research.

The IU HRPP/IRB’s review is typically limited to the human subjects research activities being conducted by IU or IU-affiliated investigators. Therefore, the level of review (Exempt, Expedited, or Full Board) provided by the IU HRPP/IRB may not align with the level of review provided by a local IRB or ethics committee, which may be reviewing different research procedures conducted by local investigators.

However, when IU is the prime awardee for non-exempt federally funded research, the IU IRB’s review will conform to the reviewing institution’s level of review. The IU IRB will also confirm that all sub-awardees conducting human subjects research activities have a Federalwide Assurance (FWA) and have obtained IRB approval for the research activities to be conducted at their institution. The IU IRB, at its discretion, may request additional documentation from the investigators to determine the scope of the other institution’s review. This may include the federal grant application, IRB application reviewed by another institution, and/or IRB approval documentation.

Consideration should be given to the most appropriate methods of obtaining and documenting informed consent in the non-US location(s). Conditions that may impact the method include local literacy levels, confidentiality considerations, and cultural norms. Additional considerations related to the consent process may include:

• Whether an interpreter outside of the research team is needed
• The legal age of majority for providing consent/the need for parental permission
• Circumstances where alternative consent processes should be used, such as use of a short form and witness, or use of photos or videos to aid subject understanding
• Alternative forms of consent documentation, like a fingerprint
• Whether elements of a traditional consent should be excluded. For example, email addresses or phone numbers in consent documents may not be realistic or feasible
• Considerations for words that may not translate from the English language (e.g., placebo or randomization)
• Some languages are not written or sometimes people speak a language but may not be able to read or write it.

General Data Protection Regulation (GDPR)

For research taking place in or targeting subjects residing in a European Economic Area (EEA), investigators may need to comply with the General Data Protection Regulation (GDPR) when collecting and analyzing research data. When studying information or data subject to GPDR, a consent addendum developed in collaboration with the Office of the Vice President & General Counsel is required to be used. Download the GDPR Consent Addendum Template.

Privacy Regulations in Other Countries

A number of countries have enacted or are considering enacting privacy regulations similar to GDPR.  While the IU IRB/HRPP attempts to stay abreast of changing regulations, it is the researcher’s responsibility to determine what privacy regulations may impact their conduct of transnational research and provide a summary of those local laws and regulations in the Transnational Research form in Kuali Protocols.

Travel arrangements

Research conducted outside of the US can pose some unique risks, specifically concerning the political, cultural, or economic conditions of the research site. Before making travel arrangements, investigators should review the Office of Overseas Study webpage regarding countries under travel advisories.

Foreign influence

IU has taken steps in response to federal and state concerns related to undue foreign influence. These steps are intended to help IU meet its obligation to comply with government requirements concerning undue foreign influence and to help inform investigators of these requirements and assist them to avoid legal liability resulting from failure to disclose certain foreign activities. These actions are outlined on the Foreign Influence webpage.