Ethische und rechtliche Aspekte im Umgang mit genetischen Zufallsbefunden - Herausforderungen und Lösungsansätze

authored by

Sabine Rudnik-Schöneborn, Martin Langanke, Pia Erdmann, Jürgen Robienski

Abstract

Definition of the problem With an increasing number of genetic results obtained in whole genome analyses, the problem of incidental findings arises, i.e., findings that are discovered beyond the aims of the original investigation but have potential health or reproductive importance for patients or research participants. Since national or international guidelines have not been established, the authors discuss for Germany the current opinions about the management of incidental findings in clinical care and research. Arguments Following the German genetic diagnosis act ("Gendiagnostikgesetz", GenDG), it is mandatory to inform about the possibility of incidental findings. It is part of the informed consent which findings are communicated to the patient, taking the right not to know and the protection of minors into account. In the research context, the GenDG is not valid; however, the disclosure of possible incidental findings should be also included in the consent documents. There is agreement that results of high clinical utility should be returned to participants, even if there is no obligation to do so. The following aspects have to be considered when dealing with incidental findings: (1) information given in the consent documents, (2) interpretation of genetic results according to high, moderate, possible, questionable or unknown clinical meaning, (3) processing of returning results at the present and in the future, and (4) decision about resources to evaluate the clinical utility, to communicate results and to transfer them into clinical practice. Conclusion There is urgent need for empirical research and policy development in the context of incidental genetic results. In addition, it is important to study how patients and participants understand and utilize incidental findings and to develop educative and communicative strategies.

Organisation(s)

Centre for Ethics and Law in the Life Sciences

External Organisation(s)

RWTH Aachen University
Hannover Medical School (MHH)
German Center for Neurodegenerative Diseases (DZNE)
University of Greifswald

Type

Article

Journal

Ethik in der Medizin

Volume

26

Pages

105-119

No. of pages

15

ISSN

0935-7335

Publication date

06.2014

Publication status

Published

Peer reviewed

Yes

ASJC Scopus subject areas

Issues, ethics and legal aspects, Health(social science), Philosophy, Health Policy

Sustainable Development Goals

SDG 3 - Good Health and Well-being

Electronic version(s)

https://doi.org/10.1007/s00481-013-0244-x (Access: Closed)