51²è¹Ý

51²è¹Ý IRB – International Research Policy

International research may pose special concerns for the IRB and for research teams. PIs are responsible for understanding and complying with the ethical and legal aspects of conducting human subjects research in an international setting. This often requires additional consideration for international participants’ rights and welfare within different cultural context and local regulations.

PIs should consider the following issues when evaluating local context and address them in their IRB protocol:

• Scientific/ethical justification for conducting research in an international setting, including whether and to what extent the research would burden and/or benefit the participant subjects and their communities
  
• Societal and cultural beliefs that may impact the research
• Role of women and children in the society and their autonomy to make decisions
• Literacy rate of the population
• Whether there are risks to participants that may be posed by the political, cultural, and economic context
  

The HHS Office for Human Research Protections maintains an of international laws and regulations pertaining to human research protections. Before submitting an IRB application, PIs should first consult this compilation to determine whether there is a specific local review process in the country where data collection will occur.

When No Local Review is Required:

If no local laws, regulations, or standards of practice require review by a local IRB or similar local review body, the PI must include with their IRB application a letter from someone with knowledge of the local context stating that:
a) there is no formal local review process in the country, and
b) that the individual has reviewed the protocol and can attest that the protocol will not put participants at risk.

The PI should also provide information describing the person’s qualification to comment on such matters.

Ideally, the person writing this letter should be a disinterested person. Collaborating researchers and faculty advisors would not typically be regarded as disinterested. However, if you do need to use a collaborator or faculty advisor to write this letter, please include a short rationale explaining why they are the best person to do so.

When Local Review is Required:

If a specific local review is required in the country of study, the approval from that local governing board must be included in the 51²è¹Ý IRB application. Please note that international approval processes often move slowly, so you should plan ahead and build potential delays into your timeline.  

For All International Studies:

Regardless of whether local review is required, research conducted at or in collaboration with a specific site, such as a school, university, hospital, or clinic, the PI must include with their submission a letter signed by an appropriately authorized representative of the site indicating the site’s support for the research to go forward.

The content, language, and method of consent should be carefully considered to ensure that it is culturally and contextually appropriate. Local contact information must be included on the consent form so that participants can reach out with concerns or questions. For example, if internet access is limited at the site, providing an email address would not be appropriate.

All personnel on the project, including those outside of the United States, must have human subjects training. Research assistants hired at the site are considered collaborators and must be included on the study protocol in most cases. If the 51²è¹Ý-required CITI training is not culturally appropriate for local research team members, please contact the IRB to determine another training method that will meet the team’s needs.