Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice

PLOS: January 14, 2014

Three basic principles are key in assessing the ethics of any research conducted on humans: respect for persons (or autonomy), beneficence, and justice [1]. Respect for persons entails individuals being afforded the right to decide what should happen to them; this principle is fulfilled through a valid informed consent process. Research participants should expect investigators to make all efforts to secure their well-being, i.e., far beyond the “do not harm” Hippocratic maxim: beneficence refers to ensuring a favorable benefit/risk assessment of the proposed research. The principle of justice requires that research’s benefits and burdens be distributed fairly, and that research avoids the injustice resulting “when some benefit to which a person is entitled is denied without good reason” [1]. Initially understood as a principle to protect vulnerable people from the risks of clinical research, since the 1980s, when HIV/AIDS patients drew attention to the potential medical benefit of enrolling in clinical trials, this principle is understood also to encompass fair access to the potential benefits of research participation[2]. Thus, in addition to altruistic reasons, some participants enroll in clinical trials with the hope, or even expectation, that participation offers an opportunity to benefit through treatment, medical care, and disease monitoring to which, in some circumstances, the participants may otherwise lack access. Read More