Belmont Principles in International Research: Context Is Everything

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB


While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference. 


The Belmont principles serve as the foundation for ethical research conduct in the United States and provide institutional review boards (IRBs) with their mission to ensure that respect for persons, beneficence, and justice are present in any research projects conducted in the United States. Researchers in the rest of the world have similarly been encouraged to apply these principles to their local research activities. But how should we understand these principles within the unique context of each country’s values and culture?

In Panel IV: Applying the Belmont Principles Across Borders and Cultures, panelists presented examples of how human subjects research is evaluated and conducted in places like Romania, Russia, Tajikistan, Nigeria, Sudan, and Japan. The panelists emphasized the importance of the Belmont principles in conducting ethical, responsible research, but they also stressed the significance of culture in how the principles are interpreted and applied (or in some cases not applied).

The panel discussion emphasized the importance of cultural context in determining whether research is indeed conducted ethically. The Belmont principles were established within a culture that celebrates individualism and autonomy; in other cultures, community (and the individual’s role within that community) may be more highly valued. Clement Adebamowo provided a revealing example of this by describing how women in Nigeria choose to participate in a clinical trial; they indicate that they would discuss their participation with their husbands or heads of household in order to maintain harmony within their households. Similarly, Sara Lavinia Brair described how tribal chiefs and religious leaders in Sudan often make the decision of whether research should be allowed in their communities.

While gender politics may also play a part in these examples, we must remain keenly aware of the role that community plays in an individual’s decision. The decision is not necessarily “how will this affect me?” but rather “how will my decision affect the community?” As Dr. Adebamowo noted, cultural identity may not be defined as “I am because I am” but rather “I am because of we.”

It’s also important to note that economic and political elements within a culture that may influence research participation. In Japan, where health care is universally available, patients can access any health care provider, making research participation just one of many options. In some countries, low income levels can make research participation very appealing indeed. Additionally, the great respect given to medical professionals in some regions can contribute to therapeutic misconceptions regarding the research. Politics and corruption can also determine which research projects will proceed and which will be considered undesirable within the culture.

This panel emphasized for me that the Belmont principles were not designed to impose a specific culture’s ideals, but rather to safeguard the rights and welfare of people participating in clinical research. We must always consider a culture’s unique values and social structures. In considering the context in the Belmont principles are applied, we can discover how to best protect research participants within that society.