Protecting and respecting the vulnerable: existing regulations or further protections?

Abstract

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.

The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines

“…Since 1979, the number of legal and non-legal research ethics policies and guidelines has increased tremendously and, with them, the use and scope of the concept of vulnerability or vulnerable populations [2, 3]. However, there is much scholarly disagreement over the appropriate meaning and application of this concept in research ethics, and policymakers are charged with the challenge of navigating this contentious landscape in the development and refinement of research guidelines and policies [4]. A growing body of literature critiques and aims to advance the way vulnerability is conceptualised and employed in research ethics, with major debates regarding foundational elements of this important ethical concept [5–10].…”

Understanding Ethical Issues of Research Participation From the Perspective of Participating Children and Adolescents: A Systematic Review

“…In the ensuing years, researchers have continued to recognize the need to balance the inherent vulnerability of children and adolescents with the necessity to research their unique needs and perspectives (Broome, Kodish, Geller, & Siminoff, 2003; Hurst, 2008; Levine et al, 2004; Solomon, 2013). There have been new research investigations with child and adolescent participants, outside of traditional clinical research settings and those using more novel designs.…”

Facts and Challenges Regarding Grounded Theory, the ICF and Ethical Issues

“…Discussions about ethics in research also involve the terminology of vulnerability and vulnerable groups. According to Solomon (2013), there are two groups of vulnerable research participants: the ones who are cognitively and the ones who are economically vulnerable. For this research it is especially the group of cognitively vulnerable participants, who are not able to decide deliberately if they want to participate in the study or not.…”