The Declaration of Helsinki, established in 1964, provides guidance on ethical issues in research; but provides minimal guidance to address specific issues that arise when conducting research in developing countries (Bhutta, 2002). This document tends to be very physician-oriented and suggests a portion of participants be assigned to a control group; therefore, these participants are not always afforded the best treatment. In relationship to informed consent, many challenges arise in diverse cultures (Igoumenidis & Zyga, 2011). All words are not completely translatable in another language. Low education levels often affect the participant’s full understanding of what research entails. Current cultural practices sometimes conflict with treatment and inventions. Patriarchal or matriarchal social structures may require non-research participants to give consent for others to participate. The age of consent varies dependent upon the host country. Information about voluntary withdrawal must be balanced with acknowledgement of their value to the research program and encouragement not to withdraw. Each of these challenges, that are more commonly encountered in developing countries, need pro-active conversation among nurses to promote ethical and culturally congruent research in order to fully protect every research participant.
This presentation supports and expands upon the three phases outlined by Woodsong and Abdool Karim (2005) with additional literature and recent research exemplars of the presenting authors. The authors, whose expertise is working in developing countries, make the following recommendations to conduct an ethical study. First, during a pre-enrollment phase, externally-sponsored research should be reviewed by an independent reviewer from the host country in addition to the sponsoring country (McMillan and Conlon, 2004). Advisory boards and focus groups should be established to represent the concerns of participants prior to enrollment (Woodsong & Abdool Karim, 2005). Community representatives need to be involved in the decision-making process to clarify the types of activities that participants will engage in during the research. It is critically important that researchers make an effort to learn what the community wants and expects from the study prior to the initiation of enrollment procedures. Anticipating common health problems that occur outside the parameters of the research protocol may prevent ethical scenarios associated with failure to provide treatment (Merritt, Taylor, & Mullany, 2010).
Second, during an enrollment phase, informed consent should be provided in a manner that allows for the whole family to be involved when appropriate to the culture (Woodsong & Abdool Karim, 2005). Most developed countries’ institutional review board policies are focused on the rights of the individual. This focus may conflict with the values of collectivistic cultures (Woodsong & Abdool Karim, 2005). Community-based research occurs in homes and villages where arrival is public and members of the community at-large may view the research participant as getting special privileges (Merritt, Taylor, & Mullany, 2010). It is essential to keep these cultural variations in mind when conducting research.
Finally, during the post-enrollment phase, researchers should continuously check for rumors or misconceptions that are occurring in the community that may affect enrollment (Woodsong & Abdool Karim, 2005). Participants may expect special privileges or incentives that were not anticipated by the researchers. Eventually, the products or knowledge gained from the research should be shared with the local community in addition to higher levels within the host country.
The focus of this presentation aligns with the mission of STTI to advance the scholarship of nursing through research as a global organization with the intent to improve the health of the world’s people. This session is meant to stimulate further discussion and thought about how international research should be conducted in an ethical manner within the cultural context of the host country.
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