Legal and ethical issues in integrating and sharing databases for translational medical research within the EU

Author(s):  
Iheanyi Nwankwo ◽  
Stefanie Hanold ◽  
Nikolaus Forgo
2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Saida Lhousni ◽  
Karam Yahya Belmokhtar ◽  
Ihab Belmokhtar ◽  
Mounia Elidrissi Errahhali ◽  
Manal Elidrissi Errahhali ◽  
...  

Background. Biobanks are highly organized infrastructures that allow the storage of human biological specimens associated with donors’ personal and clinical data. These infrastructures play a key role in the development of translational medical research. In this context, we launched, in November 2015, the first biobank in Morocco (BRO Biobank) in order to promote biomedical research and provide opportunities to include Moroccan and North African ethnic groups in international biomedical studies. Here, we present the setup and the sample characteristics of BRO Biobank. Methods. Patients were recruited at several departments of two major health-care centers in the city of Oujda. Healthy donors were enrolled during blood donation campaigns all over Eastern Morocco. From each participant, personal, clinical, and biomedical data were collected, and several biospecimens were stored. Standard operating procedures have been established in accordance with international guidelines on human biobanks. Results. Between November 2015 and July 2020, 2446 participants were recruited into the BRO Biobank, of whom 2013 were healthy donors, and 433 were patients. For healthy donors, the median age was 35 years with a range between 18 and 65 years and the consanguinity rate was 28.96%. For patients, the median age was 11 years with a range between 1 day and 83 years. Among these patients, 55% had rare diseases (hemoglobinopathies, intellectual disabilities, disorders of sex differentiation, myopathies, etc.), 13% had lung cancer, 4% suffered from hematological neoplasms, 3% were from the kidney transplantation project, and 25% had unknown diagnoses. The BRO Biobank has collected 5092 biospecimens, including blood, white blood cells, plasma, serum, urine, frozen tissue, FFPE tissue, and nucleic acids. A sample quality control has been implemented and suggested that samples of the BRO Biobank are of high quality and therefore suitable for high-throughput nucleic acid analysis. Conclusions. The BRO Biobank is the largest sample collection in Morocco, and it is ready to provide samples to national and international research projects. Therefore, the BRO Biobank is a valuable resource for advancing translational medical research.


2012 ◽  
Vol 38 (11) ◽  
pp. 694-696 ◽  
Author(s):  
Cecilia Mercieca ◽  
Kevin Aquilina ◽  
Richard Pullicino ◽  
Andrew A Borg

2020 ◽  
Vol 32 (2) ◽  
pp. 309-322
Author(s):  
Jessica Allen ◽  
David M Doyle ◽  
Shane McCorristine ◽  
Aisling McMahon

Abstract This analysis maps the key challenges posed by de-extinction to nature conservation law. The aim is to start a conversation about how such challenges should be framed and addressed if ongoing de-extinction projects in the United States of America (US) and the European Union (EU), the two jurisdictions examined, are successful. The analysis commences by providing a brief overview of existing debates in the conservation literature on the legal and ethical issues posed by de-extinction within the animal context. The article then proceeds to highlight two challenges animals created via de-extinction (de-extinctees) will likely pose for nature conservation law, namely: (1) to what extent taxonomies or definitions of ‘species’, and the methods for classifying these species under existing conservation frameworks, will be challenged by de-extinction; and (2) how existing conservation law frameworks in the US and the EU would likely apply to de-extinctees, and whether de-extinctees would be protected under these frameworks. It concludes by posing the broader question of whether and to what extent the law should facilitate de-extinction attempts in the same way that it has done for nature conservation.


2021 ◽  
pp. 211-218
Author(s):  
Anna Smajdor ◽  
Jonathan Herring ◽  
Robert Wheeler

This chapter discusses the legal and ethical issues related to medical research. It outlines international and national legal regulation. It discusses the important distinction between therapeutic and non-therapeutic research. The importance of consent and the protection of participants is highlighted.


2006 ◽  
Vol 13 (3) ◽  
pp. 209-217 ◽  
Author(s):  
Sjef Gevers

AbstractThe care for patients with dementia raises many legal (and ethical) issues. This article explores some of the more important topics, i.e. (early) diagnosis of the disease, the availability and provision of care, treatment and non treatment decisions, and medical research with dementia patients.


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