| Sumario: | Big Data is a term that refers to tremendously large data sets intended for computational analysis that can be used to advance research through revealing trends and associations. Innovative research that leverages Big Data can dramatically advance the fields of medicine and public health but can also raise new ethical challenges. This paper explores these challenges, and how they might be addressed such that individuals are optimally protected. Key ethical concerns raised by Big Data research include respecting patient's autonomy via provision of adequate consent, ensuring equity, and respecting participants' privacy. Examples of actions that could be taken to address these key concerns on a broader regulatory level, as well as on a case specific level, are presented. Big Data research offers enormous potential, but due to its widespread influence, it also introduces the potential for extensive harm. It is imperative to consider and account for the risks associated with this research.
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