The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials
Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data p...
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| Published in: | European journal of pediatrics Vol. 180; no. 5; pp. 1371 - 1379 |
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| Format: | Journal Article |
| Language: | English |
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Berlin/Heidelberg
Springer Berlin Heidelberg
01.05.2021
Springer Nature B.V |
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| ISSN: | 0340-6199, 1432-1076, 1432-1076 |
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| Abstract | Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.
Conclusion
: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols.
What is Known:
•
GDPR is applicable to clinical trials, including paediatric trials.
•
A number of challenges at the interface between the GDPR and CTR have been described.
What is New:
•
The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.
•
Three such situations are described and solutions offered. |
|---|---|
| AbstractList | Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.
Conclusion
: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols.
What is Known:
•
GDPR is applicable to clinical trials, including paediatric trials.
•
A number of challenges at the interface between the GDPR and CTR have been described.
What is New:
•
The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.
•
Three such situations are described and solutions offered. Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols.What is Known:•GDPR is applicable to clinical trials, including paediatric trials.•A number of challenges at the interface between the GDPR and CTR have been described.What is New:•The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.•Three such situations are described and solutions offered. Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols. What is Known: • GDPR is applicable to clinical trials, including paediatric trials. • A number of challenges at the interface between the GDPR and CTR have been described. What is New: • The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored. • Three such situations are described and solutions offered.Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols. What is Known: • GDPR is applicable to clinical trials, including paediatric trials. • A number of challenges at the interface between the GDPR and CTR have been described. What is New: • The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored. • Three such situations are described and solutions offered. Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected. Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols.What is Known:• GDPR is applicable to clinical trials, including paediatric trials.• A number of challenges at the interface between the GDPR and CTR have been described.What is New:• The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.• Three such situations are described and solutions offered. |
| Author | Dalrymple, H. W. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33462697$$D View this record in MEDLINE/PubMed |
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| References | European Union (2016). Regulation (EU) 2016/679, paragraph 58. European Union (2014). Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. European Commission Directorate-General for Health and Food Safety. (2019). Question and answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation, Question 3 (2). Available at https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf. Regulation (EU) No 536/2014, para 32. European Council Recommendation CM/Rec (2016)6 on research on biological materials of human origin, 2016, available at https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff, Art.12(5). European Union (2016). Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679 European Commission Directorate-General for Health and Food Safety. (2019). Question and answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation. Available at https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf. European Union (2016). Regulation (EU) 2016/679, Art. 8(1). Adapted from Heyd, D. Experimentation trial: why should one take part in medical research? In: Emanuel, E.J., Crouch, R.A., Arras, J.D., Moreno, J.D. Grady, C., es. Ethics and regulatory aspects of clinical research – readings and commentary. Baltimore: Johns Hopkins University Press; 2003. Chapter 23, p161-166. European Union (2014). Regulation (EU) No 536/2014, Art.10 (3); pregnant women are listed as one of the vulnerable populations. Although this Article addresses enrolment of subjects into clinical trials and the pregnancy was not in existence at that time, one might argue that the girl has become vulnerable by virtue of having become pregnant. Fovargue S (2013) Doctrinal incoherence or practical problem? Minor parents consenting to their offspring's medical treatment and involvement in research in England and Wales. C.F.L.Q., 25(1):1–18 ElckeJKranendonkEJPloemMCHennekamRCMRegulating biobanking with children’s tissue: a legal analysis and the experts’ viewEur.J.Human Gen.201624303610.1038/ejhg.2015.59 European Union (2016). Regulation (EU) 2016/679, para 166. For example, O’Donoghue, C. (2019). The interplay between the Clinical Trials Regulation and the GDPR. Privacy & Data Protection, 10 February 2019. Available at https://www.technologylawdispatch.com/2019/02/privacy-data-protection/the-interplay-between-the-clinical-trials-regulation-and-the-gdpr/; Anonymous (2018). The impact of the GDPR on clinical trial research. Norton Rose Fulbright Legal Update, October 2019. Available at https://www.nortonrosefulbright.com/en/knowledge/publications/9ba711e7/the-impact-of-the-gdpr-on-clinical-trial-research; Gogates, G. (2018). How does GDPR affect clinical trials? Applied Clinical Trials, Apr 06, 2018. Available at http://www.appliedclinicaltrialsonline.com/how-does-gdpr-affect-clinical-trials; Chassang, G. (2017). The impact of the EU general data protection regulation on scientific research. Ecancermedicalscience; 11: 709; Giannuzzi, V., Landi, A,, Bartoloni, F,, Ceci, A. (2018) A review on impact of general data protection regulation on clinical studies and informed consent. 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Question and answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation, Question 7. Available at https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf. European Union (2014). Regulation (EU) No 536/2014, Art 32(3); see also Clinical Trials Regulation (EU) No 536/2014 Draft questions & answers, Version 2.4, available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf. Amended Belgian Civil Code, Arts 375, 389, 405: http://www.juristax.be/Codes/CodeCivilB/CivilL1T10.html ; German Civil Code (Bürgerliche Gesetzbuch), ss 1627–1628, 1673, 1773, 1793: http://www.gesetze-im-internet.de/englisch_bgb/index.html#gl_p0020; Dutch Civil Code (Burgerlijk Wetboek), Book 1 Law of Persons and Family Law, Arts 1:246, 1:253b, 1:295, 1:336: http://www.dutchcivillaw.com/civilcodebook01.htm . 3933_CR20 3933_CR10 3933_CR21 3933_CR15 MA Ott (3933_CR22) 2018; 20 3933_CR16 3933_CR17 3933_CR2 3933_CR18 3933_CR5 3933_CR4 3933_CR7 3933_CR6 3933_CR14 3933_CR9 3933_CR8 3933_CR19 EJ Kranendonk (3933_CR12) 2017; 176 N Cannovo (3933_CR11) 2020; 21 cr-split#-3933_CR1.2 cr-split#-3933_CR1.1 cr-split#-3933_CR3.2 cr-split#-3933_CR3.1 J Elcke (3933_CR13) 2016; 24 |
| References_xml | – reference: 21st Century Cures Act,. An Act to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. Pub.L. 114 – 255, §3011. – reference: European Union (2014). Regulation (EU) No 536/2014, Art 32(3); see also Clinical Trials Regulation (EU) No 536/2014 Draft questions & answers, Version 2.4, available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf. – reference: Adapted from Heyd, D. Experimentation trial: why should one take part in medical research? In: Emanuel, E.J., Crouch, R.A., Arras, J.D., Moreno, J.D. Grady, C., es. Ethics and regulatory aspects of clinical research – readings and commentary. Baltimore: Johns Hopkins University Press; 2003. Chapter 23, p161-166. – reference: European Union (2016). Regulation (EU) 2016/679, paragraph 58. – reference: Amended Belgian Civil Code, Arts 375, 389, 405: http://www.juristax.be/Codes/CodeCivilB/CivilL1T10.html ; German Civil Code (Bürgerliche Gesetzbuch), ss 1627–1628, 1673, 1773, 1793: http://www.gesetze-im-internet.de/englisch_bgb/index.html#gl_p0020; Dutch Civil Code (Burgerlijk Wetboek), Book 1 Law of Persons and Family Law, Arts 1:246, 1:253b, 1:295, 1:336: http://www.dutchcivillaw.com/civilcodebook01.htm . – reference: European Union (2016). Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679 – reference: European Commission Directorate-General for Health and Food Safety. (2019). Question and answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation. Available at https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf. – reference: Regulation (EU) No 536/2014, para 32. – reference: KranendonkEJHennekamRCPloemMCPaediatric biobanking: Dutch experts reflecting on appropriate legal standards for practiceEur J Pediatr2017176758210.1007/s00431-016-2810-y – reference: European Union (2014). Regulation (EU) No 536/2014, Art 3(b). – reference: European Union (2014). Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. – reference: European Union (2016). Regulation (EU) 2016/679, para 166. – reference: European Union (2014). Regulation (EU) No 536/2014, Art.10 (3); pregnant women are listed as one of the vulnerable populations. 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J Clin Res Bioeth 9: 327. doi:10.4172/2155-9627.1000327 – reference: CannovoNGuarinoRFedeliPEthical and deontological aspects of pediatric biobanks: the situation in ItalyCell Tissue Bank20202146947710.1007/s10561-020-09833-4 – reference: Fovargue S (2013) Doctrinal incoherence or practical problem? Minor parents consenting to their offspring's medical treatment and involvement in research in England and Wales. C.F.L.Q., 25(1):1–18 – reference: ElckeJKranendonkEJPloemMCHennekamRCMRegulating biobanking with children’s tissue: a legal analysis and the experts’ viewEur.J.Human Gen.201624303610.1038/ejhg.2015.59 – reference: European Union (2016). Regulation (EU) 2016/679, Art. 8(1). – reference: European Council Recommendation CM/Rec (2016)6 on research on biological materials of human origin, 2016, available at https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff, Art.12(5). – reference: OttMACrawleyFPSa’ez-LlorensXOwusu-AgyeiSNeubauerDDubinGPoplazarovaTBeggNRosenthalSLEthical considerations for the participation of children of minor parents in clinical trialsPediatr Drugs20182021522210.1007/s40272-017-0280-y – ident: 3933_CR21 – volume: 176 start-page: 75 year: 2017 ident: 3933_CR12 publication-title: Eur J Pediatr doi: 10.1007/s00431-016-2810-y – ident: 3933_CR20 – ident: 3933_CR17 – ident: 3933_CR18 – volume: 21 start-page: 469 year: 2020 ident: 3933_CR11 publication-title: Cell Tissue Bank doi: 10.1007/s10561-020-09833-4 – ident: 3933_CR19 – ident: 3933_CR9 – ident: #cr-split#-3933_CR3.1 – ident: 3933_CR8 – ident: #cr-split#-3933_CR3.2 – ident: 3933_CR7 – ident: 3933_CR16 – ident: 3933_CR14 – ident: 3933_CR15 – ident: 3933_CR6 – ident: #cr-split#-3933_CR1.1 – ident: #cr-split#-3933_CR1.2 – ident: 3933_CR10 – ident: 3933_CR4 – ident: 3933_CR5 – ident: 3933_CR2 doi: 10.4172/2155-9627.1000327 – volume: 24 start-page: 30 year: 2016 ident: 3933_CR13 publication-title: Eur.J.Human Gen. doi: 10.1038/ejhg.2015.59 – volume: 20 start-page: 215 year: 2018 ident: 3933_CR22 publication-title: Pediatr Drugs doi: 10.1007/s40272-017-0280-y |
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| Title | The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials |
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