Cross-cultural and language barriers can be an impediment to the conduct of biomedical studies in developing nations. To assess the implementation of human-use procedures within a minimum-risk febrile illness surveillance study in Peru, personnel fluent in both English and Spanish conducted a review of 10 sites. Guideline adherence, consent procedures, and potential problems in the conduct of the trial were reviewed. Concerns cited by on-site investigators included patient follow-up, poor facilities, and power fluctuations that jeopardized samples before shipment to a central location. However, both local study coordinators and patients demonstrated a clear grasp of study enrollment and consent procedures and reported no significant problems in the conduct of the study. These findings suggest that significant planning is crucial before initiation of biomedical studies in developing nations to successfully overcome physical challenges and cultural dynamics that could otherwise adversely affect scientific outcomes.

Background

Infectious disease pathogens are among the leading causes of death in humans throughout Peru. These re-emerging and emerging diseases include typhoid, tuberculosis, pertussis, meningococcus, tetanus, measles, human immunodeficiency virus, dengue, malaria, and various other viral, bacterial, parasitic, and arthropod-borne pathogens.1 As a method of improving public health surveillance, the World Health Organization has proposed syndromic surveillance. This strategy is a counter to current surveillance techniques that are diagnosis driven but often lack the sensitivity to determine actual causes of illness. Syndromic surveillance depends on the passive collection of febrile samples from sentinel surveillance sites.2 In South America, where enormous potential exists for introduction of novel or altered pathogens, an opportunity exists for implementation of a public health surveillance program such as a febrile surveillance network that is sensitive to new and emerging causes of illness.

As such, the U.S. Naval Medical Research Center Detachment, Lima, Peru (NMRCD) uses syndromic surveillance, a technique that can Improve public health surveillance and early detection of outbreaks,3 to follow febrile illnesses throughout Peru. NMRCD works with the Peruvian government, Ministry of Health (MOH) officials, and local physicians. The Febrile Syndromic Surveillance (FSS) protocol of the NMRCD detects emerging pathogens so that preventive measures can be implemented. Here, we review a strategy by which FSS can be successfully established in a developing country and debate the utility of cross-cultural training for study coordinators.

Methods

This assessment was conducted at 10 remote sites to verify compliance, comprehension, and to overcome site-specific barriers. It included the following sites in Peru: Tumbes, Pampa Grande, Zarumilla, Piura, Chiclayito, Chulucanas, Sullana, Cuartel Miguel Cortes (Peruvian Army post), Querecotillo, and numerous locations in Iquitos (Fig. 1^sup 4^). Each visit entailed a forum with local personnel involved with the FSS study, including physicians, laboratory technicians, microbiologists, hospital directors, and regional directors of health.

The first portion of this assessment entailed a lecture in Spanish regarding informed consent, patient enrollment procedures, patient resolution, an explanation of NMRCD and U.S. requirements regarding patient interactions, and lessons learned. A paper copy of the Spanish language version of the NMRCD Office of Research Administration's slide presentation-"Protecting Human Subjects in Research"-and a concise summary of FSS procedures were provided to all sites for future reference. This was followed by an open forum with all personnel for any specific questions. All laboratory equipment was then tested to ensure proper function and to take steps to correct any deficiencies. Finally, a thorough review of patient enrollment and informed consent forms was conducted to account for proper documentation within the previous 30 days.

Results

The lecture and open forum generated numerous questions to clarify patient enrollment and informed consent protocol. The most common questions included treatment of minors without parents or legal guardians, compensation for patient participation, and how to deal with enrolled patients who no longer wish to continue participating in the study. Through discussions in Spanish, these topics were clarified.

All sites demonstrated minor shortcomings with regard to informed consent procedures usually due to misunderstandings. Most common, but relatively rare in comparison with the patient load, was improperly completed informed consent forms, including not filling in the patient name or writing the wrong name, the patient's failure to sign the informed consent form, and incomplete patient resolution. Rarely was it found that informed consent forms were not stored in well-locked rooms with access only available to participating investigators. If it did occur, it was usually due to a lack of space in the research facility. These discrepancies were identified and corrected with each site, when necessary.