Translational research—the need of a new bioethics approach

Abstract

Translational research tries to apply findings from basic science to enhance human health and well-being. Many phases of the translational research may include non-medical tasks (information technology, engineering, nanotechnology, biochemistry, animal research, economy, sociology, psychology, politics, and so on). Using common bioethics principles to these areas might sometimes be not feasible, or even impossible. However, the whole process must respect some fundamental, moral principles. The purpose of this paper is to argument the need for a different approach to the morality in translational bioethics, and to suggest some directions that might be followed when constructing such a bioethics. We will show that a new approach is needed and present a few ethical issues that are specific to the translational research.

Partnering with patients in translational oncology research: ethical approach

“…Our results are consistent with the opinion of some authors who stressed the need for a specific set of bioethical guidelines for TR and proposed the concept of “translational ethics” [7, 10–12]. The authors emphasize that this set should be developed according to the steps or phases identified in the process and to the entire translational research process.…”

“…Finally, they participated in elaborating two kinds of information leaflets, one for searching for genetic alterations in tumors with potential medical consequence for the patient and one concerning the future use of data or samples. This process agrees with recognizing that the legal and ethical frameworks in precision medicine and that TR must be built with a patient-centered approach, taking into account the individual concerns and expectations of patients [7, 13, 14, 32, 33]. …”

“…One of the main issues arising from the committee discussions and highlighted by patients was the primary dual intentionality of TR, bridging care and research pathways. Recently, Hostiuc et al [7] divided TR into a succession of six operating phases, starting with fundamental research and ending with the implementation of social policies, as a result of the whole translation process. Indeed, “translation” usually refers to how biomedical science should produce a return of investment by bridging the gap between the amount of knowledge produced and the expected benefit, the “bench-to-bedside” approach [30, 31].…”

“…This concept has been strengthened by many therapeutic and diagnostic advancements in oncology [1–5]. The challenge is both to accelerate the translation of biomedical research to therapeutic application [6]—from bench to bedside and to use patient samples and data and samples for research purposes in order to bring relevant clinical needs into the laboratory research environment—from bedside to bench to bedside [7]. …”

“…It also relies on the de-compartmentalization of data gathered at national, pan-national or disease levels [8, 9]. A growing body of literature highlights the need to rethink the current bioethical and regulatory frameworks [7, 10–14] and as Nicol et al [13] postulate, to reformulate in this context the classical tensions between community welfare and individual liberty, risk and benefit, and autonomy and paternalism. Indeed, on one hand, data and samples may be re-used in future unknown research and on the other, genetic or genomic analysis may result in a diagnostic or therapeutic application and in proposals to participate in a clinical trial of precision medicine [15–17].…”