ABSTRACT
Informed consent is one of the cornerstones of ethical research with human subjects. Although most people living in Western countries are familiar with the concept of informed consent, in some parts of the world the idea that an individual has the right to give his or her informed consent for medical care or research participation is a foreign notion. In this chapter, we examine the ethical and legal basis of informed consent and review the published research on cultural variation in informed consent for clinical research participation. Our analysis of this literature identifies four different ways that culture may affect the informed consent process, including: 1) consent of community leaders may be sought prior to obtaining the individual consent of community members; 2) investigators may alter consent documents to better reflect the language and concepts used in the culture; 3) the consent procedure may be modified to reinforce the concept of opt-in participation and give participants more time to discuss their potential enrollment with others; and 4) instead of obtaining informed consent through written documents, researchers may use record consent verbally or through a fingerprint in cultures with an oral history or high rates of illiteracy.
