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The ethical framework for performing research with rare inherited neurometabolic disease patients

Giannuzzi, Viviana (author)
Fdn Ric Farmacol Gianni Benzi Onlus, Via Abate Eustasio 30, I-70010 Valenzano, BA, Italy.
Devlieger, Hugo (author)
Univ Leuven, Dept Dev & Regenerat, O&N 4 Herestr 49 Box 805, B-3000 Leuven, Belgium.
Margari, Lucia (author)
Aldo Moro Univ Bari, Dept Basic Med Sci Neurosci & Sense Organs, Piazza Giulio Cesare 11, I-70124 Bari, Italy.
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Odlind, Viveca Lena (author)
Uppsala universitet,Obstetrik & gynekologi
Ragab, Lamis (author)
Cairo Univ, Giza 12613, Egypt.
Bellettato, Cinzia Maria (author)
Brains Brain Fdn Onlus, Padua, Italy.
D'Avanzo, Francesca (author)
Brains Brain Fdn Onlus, Padua, Italy.
Lampe, Christina (author)
Brains Brain Fdn Onlus, Padua, Italy.;Horst Schmidt Klin Wiesbaden, Ctr Rare Dis, Dept Pediat & Adolescent Med, Wiesbaden, Germany.
Cassis, Linda (author)
IRP HSJD, Dept Neurol, Barcelona, Spain.;IRP HSJD, Dept Gastroenterol Pathol, Barcelona, Spain.;IRP HSJD, Dept Clin Biochem, Barcelona, Spain.;CIBERER, Barcelona, Spain.
Cortes-Saladelafont, Elisenda (author)
IRP HSJD, Dept Neurol, Barcelona, Spain.;IRP HSJD, Dept Gastroenterol Pathol, Barcelona, Spain.;IRP HSJD, Dept Clin Biochem, Barcelona, Spain.;CIBERER, Barcelona, Spain.
Cazorla, Angels Garcia (author)
IRP HSJD, Dept Neurol, Barcelona, Spain.;IRP HSJD, Dept Gastroenterol Pathol, Barcelona, Spain.;IRP HSJD, Dept Clin Biochem, Barcelona, Spain.;CIBERER, Barcelona, Spain.
Baric, Ivo (author)
Univ Hosp Ctr Zagreb, Zagreb, Croatia.;Univ Zagreb, Sch Med, Zagreb, Croatia.
Cvitanovic-Sojat, Ljerka (author)
Univ Zagreb, Sch Med, Zagreb, Croatia.
Fumic, Ksenija (author)
Univ Hosp Ctr Zagreb, Zagreb, Croatia.
Dali, Christine I. (author)
Copenhagen Univ Hosp, Dept Clin Genet, Rigshosp, Copenhagen, Denmark.
Bartoloni, Franco (author)
Fdn Ric Farmacol Gianni Benzi Onlus, Via Abate Eustasio 30, I-70010 Valenzano, BA, Italy.
Bonifazi, Fedele (author)
Fdn Ric Farmacol Gianni Benzi Onlus, Via Abate Eustasio 30, I-70010 Valenzano, BA, Italy.
Scarpa, Maurizio (author)
Brains Brain Fdn Onlus, Padua, Italy.;Horst Schmidt Klin Wiesbaden, Ctr Rare Dis, Dept Pediat & Adolescent Med, Wiesbaden, Germany.
Ceci, Adriana (author)
Fdn Ric Farmacol Gianni Benzi Onlus, Via Abate Eustasio 30, I-70010 Valenzano, BA, Italy.
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Fdn Ric Farmacol Gianni Benzi Onlus, Via Abate Eustasio 30, I-70010 Valenzano, BA, Italy Univ Leuven, Dept Dev & Regenerat, O&N 4 Herestr 49 Box 805, B-3000 Leuven, Belgium. (creator_code:org_t)
2017-01-16
2017
English.
In: European Journal of Pediatrics. - : SPRINGER. - 0340-6199 .- 1432-1076. ; 176:3, s. 395-405
Related links:
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https://doi.org/10.1...
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • The need for performing clinical trials to develop well-studied and appropriate medicines for inherited neurometabolic disease patients faces ethical concerns mainly raising from four aspects: the diseases are rare; include young and very young patients; the neurological impairment may compromise the capability to provide 'consent'; and the genetic nature of the disease leads to further ethical implications. This work is intended to identify the ethical provisions applicable to clinical research involving these patients and to evaluate if these cover the ethical issues. Three searches have been performed on the European regulatory/legal framework, the literature and European Union-funded projects. The European legal framework offers a number of ethical provisions ruling the clinical research on paediatric, rare, inherited diseases with neurological symptoms. In the literature, relevant publications deal with informed consent, newborn genetic screenings, gene therapy and rights/interests of research participants. Additional information raised from European projects on sharing patients' data from different countries, the need to fill the gap of the regulatory framework and to improve information to stakeholders and patients/families. Conclusion: Several recommendations and guidelines on ethical aspects are applicable to the inherited neurometabolic disease research in Europe, even though they suffer from the lack of a common ethical approach.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Pediatrik (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Pediatrics (hsv//eng)

Keyword

Paediatric
Rare
Genetic disease
Clinical research
Ethics

Publication and Content Type

ref (subject category)
art (subject category)

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