Since the publication of seminal pneumonia etiology studies in the 1980s [1
], significant technological advances, particularly in the field of molecular diagnostics, have increased the potential to identify and characterize the roles of both existing and previously unrecognized pneumonia pathogens [4
]. These advances in laboratory diagnostics warrant renewed examination of the causes of pneumonia in both children and adults.
The Pneumonia Etiology Research for Child Health (PERCH) project is a multi country, case-control study of children <5 years of age who are hospitalized with severe pneumonia. PERCH is funded by The Bill & Melinda Gates Foundation and is designed to determine the etiology of and risk factors for severe childhood pneumonia in vulnerable populations at 7 stand-alone sites. During project planning (2009–2010), the investigators consulted a wide range of experts to help design an efficient, effective and ethically informed study.
The Johns Hopkins Bloomberg School of Public Health (JHSPH) serves as the coordinating center for all of the PERCH sites. The study protocol was designed to incorporate expert advice while being sensitive to the on-the-ground realities of 7 resource-limited country settings. Protocol and consent templates were initially reviewed and approved by the JHSPH institutional review board (IRB). These materials were subsequently modified with site specifications and requirements and the approved by local ethics committees. The JHSPH IRB then conducted a final review and approval of the materials.
A major potential benefit of PERCH is the planned biorepository of specimens from >12
000 children across the world in order to inform future research into the causes of pneumonia. Collection and storage of biological specimens from sick children across study sites in resource-limited countries in Africa and Asia represents a particularly complex aspect of the study. Addressing the ethical challenges associated with the biorepository included development of strategies for governance of the biorepository and informed consent for specimen donation. Expert advice was sought in this regard from colleagues at the Johns Hopkins Berman Institute of Bioethics.
In this paper, we describe this collaborative approach to developing a biorepository for PERCH, which may serve as a model to others engaged in similar endeavors. First, we provide a brief overview of the most significant ethical issues encountered with biorepositories, focusing on the issues associated with their structure and informed consent. Next, we describe the cultural challenges in the proposed research, highlighted by the perspectives of participating investigators. Finally, we outline the proposed approach to the PERCH biorepository, which was designed to be sensitive to the ethical, practical, and cultural challenges inherent to this research.