A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project

Am J Kidney Dis. 2022 Jul;80(1):132-138. doi: 10.1053/j.ajkd.2021.10.006. Epub 2021 Dec 4.

Abstract

An understanding of the ethical underpinnings of human subjects research that involves some risk to participants without anticipated direct clinical benefit-such as the kidney biopsy procedure as part of the Kidney Precision Medicine Project (KPMP)-requires a critical examination of the risks as well as the diverse set of countervailing potential benefits to participants. This kind of deliberation has been foundational to the development and conduct of the KPMP. Herein, we use illustrative features of this research paradigm to develop a more comprehensive conceptualization of the types of benefits that may be important to research participants, including respecting pluralistic values, supporting the opportunity to act altruistically, and enhancing benefits to a participant's community. This approach may serve as a model to help researchers, ethicists, and regulators to identify opportunities to better respect and support participants in future research that entails some risk to these participants as well as to improve the quality of research for people with kidney disease.

Keywords: Altruism; The Kidney Precision Medicine Project; autonomy; community engagement; human subjects; informed consent; institutional review boards; kidney biopsy; non-maleficence; precision medicine; research ethics; research participation; research risks and benefits; safety monitoring.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Humans
  • Informed Consent
  • Kidney
  • Precision Medicine*
  • Research Personnel*
  • Risk Assessment