Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction.

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberation about altering the genes of future generations.

Return and Disclosure of Research Results: Parental Attitudes and Needs Over Time in Pediatric Oncology.

Objectives: To explore parental attitudes regarding the return and disclosure of research findings in pediatric cancer trials over time.

Study Design: Two surveys were set up to evaluate the stability of parental attitudes. One survey was carried out among 581 parents whose child was diagnosed recently (response rate, 53.

Informed consent, biobank research, and locality: perceptions of breast cancer patients in three European countries.

Comparative studies are missing that explore how socio-cultural and institutional circumstances influence patient comprehension and expectations regarding informed consent for current and future research on their tissue and data. This study compares how breast cancer patients in three European countries (the United Kingdom, Belgium, and Germany) who have consented to participate in tumor banking assess the given consent and the accompanying local contextual factors influencing it. Our survey demonstrates that only 59% of the patients in the British survey, but about 90% in the German and Belgian surveys, correctly recalled tissue and data donation for study purposes.

Parental informed consent in pediatric cancer trials: a population-based survey in Germany.

Background: Ensuring adequate parental consent is a key issue of ethical practice in pediatric oncology. In Germany, however, knowledge about parental comprehension and satisfaction with the informed consent procedure is limited, and representative data on parents' perspectives are still missing. Based on data collected by means of a population-based survey, we evaluated the parental recall of the informed consent process for pediatric clinical trials, and how they rated the consent process retrospectively.

[Individualisation of medicine: medical philosophy and societal implications of an ambiguous guiding principle].

Based on genetic or other biomarkers, increasingly good predictions of individual disease dispositions and drug reactions as well as the characteristics of tumours and their response to treatment can be produced. Hopefully, preventive or therapeutic interventions may thus be better adapted to the individual's physical endowments to increase treatment efficiency and reduce unwanted drug reactions. These developments have been summarised under the conceptual umbrella of "individualised" or "personalised medicine".

Disclosure of individual research results in clinico-genomic trials: challenges, classification and criteria for decision-making.

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration.

Pharmacogenetics, adverse drug reactions and public health.

Adverse drug reactions (ADRs) are a major public health problem. Pharmacogenetic testing prior to drug treatment is supposed to considerably alleviate this problem. The state of pharmacogenetic development was assessed by a systematic literature review, supplemented by expert interviews.

Individualized pharmacogenetic therapy: a critical analysis.

Objective: Individualized, or personalized, therapy is highlighted as the declared goal of pharmacogenetics. In this paper, the content and significance of the individualization concept are analyzed.

Method: Our analysis is based on a systematic reading of the current literature pertinent to pharmacogenetics.

Prospects and limits of pharmacogenetics: the thiopurine methyl transferase (TPMT) experience.

Thiopurine drug metabolism is a quintessential case of pharmacogenetics. A wealth of experimental and clinical data on polymorphisms in the thiopurine metabolizing enzyme thiopurine methyl transferase (TPMT) has been generated in the past decade. Pharmacogenetic testing prior to thiopurine treatment is already being practiced to some extent in the clinical context, and it is likely that it will be among the first pharmacogenetic tests applied on a regular basis.

[Evaluation of genetic screening. The problem of hidden value judgements, conceptual arbitrary attitudes and methodological leeway in the so-called screening process].

Population-wide genetic screenings can multiply benefits, but may also increase risks and other adverse effects of genetic testing. Insofar, there is a particular need for legitimization of genetic screenings. Health economic calculus and the so-called "screening ratios" aim to relate information about potential costs to potential benefits.