Wastewater Monitoring and Informed Consent: Interrogating the Research/Surveillance Binary Under the Common Rule

Morgan Cole

According to the U.S. Centers for Disease Control and Prevention (“CDC”), “[s]urveillance systems can be either research or nonresearch, depending whether the purpose is to identify and control a health problem or to contribute to knowledge beyond the system’s participants, to society.” However, subpart A of the Federal Policy for the Protection of Human Subjects—otherwise known as the Common Rule—uniformly defines public health surveillance as nonresearch for the purpose of deciding when investigators must solicit informed consent from human research subjects.

Wastewater surveillance regimes share characteristics with both research and surveillance as defined under the Common Rule, and illustrate why treating those concepts as binary may be increasingly problematic. Though once a relatively straightforward way to anticipate and prevent infectious disease outbreaks, wastewater monitoring has evolved into a multifaceted surveillance tool aimed at a diverse suite of public health endpoints. The rapid growth of this technology during and after the height of the COVID-19 pandemic has made it an invaluable component of population-based disease prevention efforts, and, simultaneously, raised the following question: At what point does surveilling wastewater absent informed consent become unethical?