Ethical considerations for modern molecular pathology.

Vos S1, van Diest PJ1, Ausems MGEM2, van Dijk MR1, de Leng WWJ1, Bredenoord AL3.

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Abstract

Molecular pathology is becoming an increasingly important discipline in oncology, as molecular tumor characteristics will increasingly determine targeted clinical cancer care. In recent years, many technological advances have taken place that contributed to the development of molecular pathology. However, attention to ethical aspects has been lagging behind, as illustrated by the lack of publications or professional guidelines. Existing guidelines or publications on ethical aspects of DNA sequencing are mostly aimed at germline or tumor sequencing in clinical genetics or biomedical research settings. As a result, large differences have been shown in the process of tumor sequencing analysis between laboratories. In this paper, we discuss the ethical issues to consider in molecular pathology by following the process of tumor DNA sequencing analysis from the pre-analytical to post-analytical phase. For a successful and responsible use of DNA sequencing in clinical cancer care, several moral requirements must be met; for example, those related to interpretation and returning of genetic results, informed consent, and the retrospective as well as future use of genetic data for biomedical research. Many ethical issues are new to pathology or more stringent than in current practice because DNA sequencing could yield sensitive and potentially relevant data, such as clinically-significant unsolicited findings. The context of molecular pathology is unique and complex, but many issues are similar to those applicable to clinical genetics. As such, existing scholarship in this discipline may be translated to molecular pathology with some adaptations and could serve as a basis for guideline development. For responsible use and further development of clinical cancer care, we recommend pathologists to take responsibility for the adequate use of molecular analyses and be fully aware and capable of dealing with the diverse, complex and challenging aspects of tumor DNA sequencing, including its ethical issues. This article is protected by copyright. All rights reserved.