What consideration should a U.S. researcher keep in mind when obtaining informed consent in a non-U.S. setting?

When obtaining informed consent in a non-U.S. setting, it is crucial for a U.S. researcher to consider whether there are other individuals or groups whose permission must be sought. This reflects a fundamental aspect of ethical research practices, particularly in diverse cultural contexts where decision-making may not rest solely with the individual participant.

In non-U.S. settings, research can be influenced by cultural norms, community structure, and local laws, which may dictate that community leaders, family members, or specific societal groups play a role in granting consent. Engaging with these community stakeholders not only respects the local culture but also enhances the ethical integrity of the research process by ensuring that participants are supported and informed within their cultural context. This consideration fosters trust and collaboration between researchers and the communities involved, making the research more ethically sound and socially responsible.

Other options might focus on local IRB approval, public health standards, or participants’ comfort with study duration, but these do not capture the importance of community engagement and permission, which is critical in ensuring ethical practices in diverse settings.