International Research

This section covers international research considerations.

Relevant toolkit materials:

Research studies are considered to have an international component when investigators travel abroad to collect data or investigators use or collect data from participants who are outside of the U.S. Examples include (1) a researcher traveling to China to conduct a survey with a Chinese population, (2) a researcher analyzing identifiable biological specimens that were collected in Kenya, or (3) researchers in the United States conducting an online survey targeting participants who live in other countries.

Depending on the country(ies), investigators may be required to obtain approval from the local IRB/ethics committee within the country in which they will be doing their research, in addition to UW IRB approval.

The researchers should clearly understand the host country's requirements for reviewing and approving human subject research. In addition, they should know the data laws as there are some restrictions on bringing identifiable data into/out of some countries.

Resource for identifying requirements by country:

Note: If documentation of local ethics approval is not available prior to IRB approval being granted, study teams can provide proof of approval via a change. IRB approval does not need to be held up until local ethics approval is obtained.

   

What if there is no ethics board?

Where there is no ethics board and ethics review is not required in the host country, researchers should work with local NGOs, researchers or community leaders to ensure that the project is consistent with cultural and legal expectations, and to secure support for the conduct of the research as appropriate. The IRB requires that there be good faith effort applied to secure local cooperation for the research and to document those efforts as part of the application. We may request a letter of support from an appropriate local body, organization or individual who will cooperate with and support the researcher.

For non-exempt studies, since UW-Madison will often not be able to serve as IRB of record for personnel in countries outside the US, the study team can work with RELIANT to identify appropriate training for the external personnel and to determine whether an Individual Investigator Agreement (IIA) or Collaborating Investigator Summary (CIS) is appropriate. See Reliance Manual: International Research.

When should you have an IRBM serve as a consultant?

Request a consultant when additional expertise or knowledge about culture, laws, or customs is needed.

For exempt or expedited reviews, request a consultant when there are questions about whether the cultural, economic, or political conditions of the country or countries in which the research will be conducted would alter the risk for participants compared to the same research conducted within the U.S. For example, research methods that have virtually no risk in the U.S. might have risk when conducted in other countries. Questions that may be innocuous in the U.S. could be offensive elsewhere. A breach of confidentiality may carry significant risks and assuring and maintaining confidentiality in other countries may be difficult. There could also be risks to the researcher. 

When does the EU’s or the UK’s Version of GDPR apply?

The GDPR applies to any research conducted in the European Economic Area (EEA) and the United Kingdom (UK) that involves the collection of identifiable data. GDPR does not apply to anonymized data. See the Investigator Manual GDPR section for GDPR requirements.

 



Keywords:
local IRB, ethics board, ethics committee, IIA, CIS 
Doc ID:
147944
Owned by:
Monica E. in Health Sciences Institutional Review Boards
Created:
2025-01-30
Updated:
2025-06-24
Sites:
HSIRBs-internal