Consent procedures in pediatric biobanks

Giesbertz, Noor A. A.; Bredenoord, Annelien L.; Delden, Johannes J. M. van

doi:10.1038/ejhg.2014.267

Cited by 18 publications

(16 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The recommendations aim to strike this balance by including principles such as subsidiarity, the paediatric rule, the protection of minors and the minimisation of burden 22. Special considerations were given to the integration of minors in the consenting process 32. While consent is obtained from the legal guardian, minors have to be appropriately informed and have to have a voice in the decision-making process 33.…”

Section: Discussionmentioning

confidence: 99%

Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

et al. 2017

View full text Add to dashboard Cite

Innovative research in childhood rheumatic diseases mandates international collaborations. However, researchers struggle with significant regulatory heterogeneity; an enabling European Union (EU)-wide framework is missing. The aims of the study were to systematically review the evidence for best practice and to establish recommendations for collaborative research. The Paediatric Rheumatology European Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) project enabled a scoping review and expert discussion, which then informed the systematic literature review. Published evidence was synthesised; recommendations were drafted. An iterative review process and consultations with Ethics Committees and European experts for ethical and legal aspects of paediatric research refined the recommendations. SHARE experts and patient representatives vetted the proposed recommendations at a consensus meeting using Nominal Group Technique. Agreement of 80% was mandatory for inclusion. The systematic literature review returned 1319 records. A total of 223 full-text publications plus 22 international normative documents were reviewed; 85 publications and 16 normative documents were included. A total of 21 recommendations were established including general principles (1-3), ethics (4-7), paediatric principles (8 and 9), consent to paediatric research (10-14), paediatric databank and biobank (15 and 16), sharing of data and samples (17-19), and commercialisation and third parties (20 and 21). The refined recommendations resulted in an agreement of >80% for all recommendations. The SHARE initiative established the first recommendations for Paediatric Rheumatology collaborative research across borders in Europe. These provide strong support for an urgently needed European framework and evidence-based guidance for its implementation. Such changes will promote research in children with rheumatic diseases.

show abstract

Section: Discussionmentioning

confidence: 99%

Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

et al. 2017

View full text Add to dashboard Cite

show abstract

“…Hens et al 23 have been opposed to 'full broad consent to any possible future research', especially for more sensitive research with more privacy risks, due to the child's right to express his own values. Furthermore, Giesbertz et al 24 have concluded that different biobank characteristics lead to a different involvement of children in the consent process. The OECD-Guidelines leave a broader consent open to national regulations, provided that additional safeguards are at hand, such as oversight mechanisms.…”

Section: Informed Consent For Donationmentioning

confidence: 99%

Regulating biobanking with children’s tissue: a legal analysis and the experts’ view

2015

View full text Add to dashboard Cite

The OECD is a unique forum where the governments of 30 democracies work together to address the economic, social and environmental challenges of globalisation. The OECD is also at the forefront of efforts to understand and to help governments respond to new developments and concerns, such as corporate governance, the information economy and the challenges of an ageing population. The Organisation provides a setting where governments can compare policy experiences, seek answers to common problems, identify good practice and work to co-ordinate domestic and international policies.The OECD member countries are:

show abstract

“…In the current study, we collected rabbit blood specimens with EDTA tubes and stored split aliquots at 4 C for different preservation durations. As for the reason we used rabbit blood specimens instead of human blood specimens in this study, it's that previous reports had shown that our biobank was established to focus on pediatric diseases (Gao et al, 2015), and human blood specimens collected from children are very valuable in a biobank related to pediatric diseases (Giesbertz, Bredenoord & Van Delden, 2015). Therefore, to observe the effects of preservation durations at 4 C of blood specimens on the quality of RNA from the whole blood and the leukocytes, we examined the purity, the integrity and gene expression of whole blood RNA and leukocyte RNA, after rabbit blood specimens were stored at 4 C for different preservation durations.…”

Section: Introductionmentioning

confidence: 99%

Effects of preservation duration at 4 °C on the quality of RNA in rabbit blood specimens

Song

Zhou

2020

PeerJ

View full text Add to dashboard Cite

A prolonged preservation duration of blood specimens at 4 °C may occur due to the distance from collection points to storage facilities in many biobanks, especially for multicenter studies. This could lead to RNA degradation, affecting downstream analyses. However, effects of preservation durations at 4 °C on RNA quality in blood specimens need to be studied. We collected rabbit blood using EDTA tubes and stored them at 4 °C for different preservation durations. Then, we examined the quality of RNA from whole blood and leukocytes isolated from rabbit blood. Our results show that the purity of whole blood RNA and leukocyte RNA does not indicate significant change after rabbit blood is stored at 4 °C for different preservation durations (from 1 h to 7 days). The integrity of leukocyte RNA indicates the same result as above, but the integrity of whole blood RNA is significantly decreased after rabbit blood is stored at 4 °C for over 3 days. Moreover, expression of SMAD7, MKI67, FOS, TGFβ1 and HIF1α of whole blood RNA and leukocyte RNA remains basically stable, but PCNA expression of whole blood RNA or leukocyte RNA is significantly decreased after rabbit blood is stored at 4 °C for over 24 h or 7 days. Therefore, these results suggest that high-quality RNA is obtained from the fresher blood specimens and if blood specimens are stored for over 3 days at 4 °C, the quality of leukocyte RNA is more stable and of better quality than that of whole blood RNA.

show abstract

Consent procedures in pediatric biobanks

Cited by 18 publications

References 28 publications

Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

Regulating biobanking with children’s tissue: a legal analysis and the experts’ view

Effects of preservation duration at 4 °C on the quality of RNA in rabbit blood specimens

Contact Info

Product

Resources

About