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Human Subjects and Animal Research

Sagittal MRI image of a child's brainThe Human Research Protections Program (including the IRB) and Animal Care and Use Program (including IACUC) are run by the Vanderbilt University Medical Center. RDS serves as the University point of contact for these services. We provide resources to best serve the needs of university researchers. If you have questions about the IRB or IACUC, or if would benefit from specific guidance or training, please let us know.

 

 

 

International IRB FAQ

Please contact the IRB with specific questions about a study.

International research is any research that involves a collection site or collection of data outside of the United States. Since each local site has its own human protections expectations and regulations, additional approvals from the local community/country may be required for a study. The Vanderbilt IRB guidance on international human subjects research can be found here

Each study is unique, and requirements differ based on whether the international site is considered as “engaged” or “not engaged” based on the Vanderbilt HRPP policy X.H

Per the policy, if a international site is considered ‘engaged’ (i.e. a foreign institution is an active participant in the research), the requirements and responsibilities are as follows

  • The Vanderbilt IRB will review all international research utilizing human participants to assure adequate provisions are in place to protect the rights and welfare of the participants. 
  • Because Vanderbilt holds assurances with OHRP, the foreign institution or site must file an Assurance of compliance (FWA) with OHRP, if the study is federally funded.
  • Approval of research is permitted if the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46
  • The Vanderbilt IRB must receive and review the foreign institution or site’s IRB/IEC (Independent Ethics Committee) review and approval of each study prior to the commencement of the research at the foreign institution or site.

If the international site is considered ‘not engaged’ (i.e. a VU researcher would like to conduct research in a foreign country without a co-PI or institution located in the foreign country), the responisibilites are as follows

  • When the foreign institution or site has an established IRB/IEC, the Investigator must obtain approval to conduct the research at the "not engaged" site from the site’s IRB/IEC or provide documentation that the site’s IRB/IEC has determined that approval is not necessary for the Investigator to conduct the proposed research at the site. 
  • When the foreign institution or site does not have an established IRB/IEC, a letter of cooperation must be obtained demonstrating that the appropriate institutional or oversight officials are permitting the research to be conducted at the performance site. 
  • IRB approval to conduct research at the foreign institution or site is contingent upon receiving documentation of the performance site’s IRB/IEC determination, or letter of cooperation, as applicable. 
  • It is the responsibility of the VU Investigator and the foreign institution or site to assure that the resources and facilities are appropriate for the nature of the research. 
  • It is the responsibility of the VU Investigator and the foreign institution or site to notify the IRB promptly if a change in research activities alters the performance site’s engagement in the research (e.g., performance site “not engaged” begins consenting research participants, etc.). 

Finally, some international studies do not require international approval at all. For example, most web-based surveys do not require local approvals, as they are often minimal risk and tap into an established recruitment and consent methods.  However, if you are collecting data on foreign citizens, privacy rules may apply. See the IRB’s guidance on General Data Protection Regulation (GDPR) at www.vumc.org/irb/node/74.  Many countries are adopting policies similar to GDPR, OHRP includes a list of relative policies: https://www.hhs.gov/ohrp/international/gdpr/compilation-of-gdpr-guidances-tables/index.html

Please contact the IRB with specific questions about a study. 

When conducting research involving human subjects in a foreign country, the PI must consider the local context of the relevant country, including local customs and mores. Country wide regulations may dictate requirements for conducting human subjects research; or, in some cases, regulations may be relevant to only the local region. Vanderbilt’s IRB requires evidence of local approval, and it is the PI’s responsibility to fulfil this requirement. In some instances, one may forgo international approval if the study involves only the analysis of data, however this may present challenges should an academic journal require proof of IRB approval to publish results. 

The VU/VUMC procedure for international research requiring IRB approval and the responsibilities of the PI and IRB can be found in HRPP Procedure X.H.1. Researchers are advised to plan ahead when seeking approval for international studies, as additional time will be needed for obtaining approval from the international site, translating documents, and obtaining approval from Vanderbilt’s IRB.

When conducting human subjects research outside of the United States, a best practice is to work with a contact in the foreign country who has experience conducting similar research to help guide the process of obtaining any necessary approvals. If no local contact is available, researchers are encouraged to connect with others who have conducted international research in the same country for assistance in identifying the proper authorizing board, official, or equivalent ethics committee. A list of local IRB equivalents is provided annually by Health and Human Services - Office of Human Research Protections (OHRP) and can be found here, https://www.hhs.gov/ohrp/international. While these lists are predominately targeted toward clinical research, guidance for social and behavioral studies is provided for a number of countries.

Not all research sites have local ethics boards, however approval may be attained from an authorizing official. In this case, a letter of support is required from an individual in the host country who has the relevant expertise and authority to review the research. A best practice is to work with a contact in the foreign country to help identify this official and ensure that study design is suitable for the local context. 

The Vanderbilt IRB can assist in navigating all US federal regulations regarding human subjects research, however they are not experts in the requirements of all international sites nor do they have the language skills necessary to adequately research local regulations. Again, a local collaborator or contact is the best resource for understanding local laws, regulations, and approval processes.

If one country or site has a higher standard for conducting research with human participants, the research will need to meet the higher standard.

The Vanderbilt IRB requires translation certification to ensure that foreign-language consent and other documents used in a study are equivalent to those that were approved by the IRB. While many researchers are multilingual and able to translate documents, the IRB requires certification as evidence that the translation is accurate.