Vulnerability in research ethics: A call for assessing vulnerability and implementing protections.

ABSTRACT

Ethics standards reference the need for special consideration of vulnerable populations, such as pregnant women, incarcerated individuals, and minors. The concept of vulnerability is poorly conceptualized in the medical sciences where it originated, and its application to the social sciences is even more challenging. Social science researchers may unwittingly fail to appreciate preexisting vulnerabilities and indeed may be responsible for inducing new research-related vulnerability. In this paper, we present the first comprehensive coding of country-level vulnerability designations. Specifically, we coded all 355 official documents governing social/behavioral human subjects research for the 107 countries with such regulations and identified 68 distinct vulnerability categories. The data reveal substantial regional variation, overemphasis of categories derived from medical sciences, neglect of critical categories such as displacement, and likely heterogeneity within and across groups. The article provides a conceptual framework that shifts the problem away from static, enumerated categories toward emphasis on research-induced vulnerability. Based on our conceptualization and coding, we present a framework for assessing vulnerability and implementing appropriate protections.