When is it ethical to collect data on serious health conditions in developing countries in the absence of effective referral?

Researchers conducting large community-based studies in developing countries may have the occasion to collect data on serious health conditions (e.g. depression, cognitive disabilities) that are unrecognized or unacknowledged in the local setting, and for which there are few if any services to which participants in need of follow-up diagnosis and care could be referred. On the one hand, the collection of such data – in addition to directly serving the specific scientific aims of a particular research study – could constitute a broader public health benefit by helping to build up the evidence base needed to understand the magnitude of a public health problem, or by attracting needed attention and resources to the problem as manifested in the local setting. On the other hand, it appears ethically problematic for researchers to set out deliberately to collect data on serious health conditions to which they are not themselves equipped to respond, and for which they know in advance they can make no effective referral. We propose a set of guidelines to support researchers, research sponsors, and research ethics committees in making decisions about whether to collect data in low-resource settings on serious health conditions for which the possibility of effective referral is in doubt.