Ethical management in the constitution of a European database for leukodystrophies rare diseases.

Background: The EU LeukoTreat program aims to connect, enlarge and improve existing national databases for leukodystrophies (LDs) and other genetic diseases affecting the white matter of the brain. Ethical issues have been placed high on the agenda by pairing the participating LD expert research teams with experts in medical ethics and LD patient families and associations. The overarching goal is to apply core ethics principles to specific project needs and ensure patient rights and protection in research addressing the context of these rare diseases.

Evaluation of biobank constitution and use: multicentre analysis in France and propositions for formalising the activities of research ethics committees.

Biobanks are collections of biological material and related files gathered and stored for clinical or research purposes. Here, we investigated the questions raised during the evaluation of biobanks by biomedical Research Ethics Committees (RECs), particularly in the context of genetic research. We sent a questionnaire to all RECs in France to survey their concerns and the ethical criteria used when evaluating research involving the storage of biological samples.

[Study over 10 years of 622 protocols receiving unfavourable reports from 19 research ethics committees].

Objective: The aim of this study was to analyse the nature of applications and the criteria for their negative evaluation by 19 ethics committees for the protection of human subjects participating in biomedical research, the French CCPPRB.

Methodology: The committees distinguished between negative opinions that were given from the start of the applications or after amendments were made, and between lost protocols (no answer within more than 1 year) or protocols that were outside of the framework of the Huriet-Sérusclat law. The opinions were analysed by an independent observer over a period of 10 years.

Communication of pharmacogenetic research results to HIV-infected treated patients: standpoints of professionals and patients.

The aim of pharmacogenetic studies is to adapt therapeutic strategies to individual genetic profiles, thus maximising their efficacy and minimising the likelihood of adverse side effects. Since the advent of personalised medicine, the issue of communicating research results to participants has become increasingly important. We addressed this question in the context of HIV infection, as patients and associations are particularly concerned by research and therapeutic advances.

Decisions concerning potentially life-sustaining treatments in paediatric nephrology: a multicentre study in French-speaking countries.

Background: Few studies have looked at how decisions are made to withhold or to withdraw potentially life-sustaining treatments (LST) in paediatric nephrology. The aim of this work was to evaluate such practices in all nephrology centres in French-speaking European countries, so that guidelines could be discussed and drawn up by professionals.

Methods: We used semi-directed interviews to question health care professionals prospectively.