The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries
BackgroundThe lack of harmonization of evaluation criteria by Ethics Committees in the European Union (EU) has led to inconsistent ethics reviews received by research sites participating in multicenter non-interventional studies. The European General Data Protection Regulation (GDPR) appears to be i...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-04-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1384026/full |
| _version_ | 1827278997458780160 |
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| author | Annalisa Landi Yanis Mimouni Viviana Giannuzzi Franz Schaefer Annagrazia Altavilla Annagrazia Altavilla Spencer Gibson Daria Julkowska |
| author_facet | Annalisa Landi Yanis Mimouni Viviana Giannuzzi Franz Schaefer Annagrazia Altavilla Annagrazia Altavilla Spencer Gibson Daria Julkowska |
| author_sort | Annalisa Landi |
| collection | DOAJ |
| description | BackgroundThe lack of harmonization of evaluation criteria by Ethics Committees in the European Union (EU) has led to inconsistent ethics reviews received by research sites participating in multicenter non-interventional studies. The European General Data Protection Regulation (GDPR) appears to be implemented at national level with a substantial degree of variance in interpretation. The European Reference Networks (ERNs) were struggling in setting an Informed Consent Form (ICF) for registries, allowing reuse of data for research purposes. The aim of this work is to develop an adaptable ICF for research purposes to be used in ERN registries.MethodsTo work on this challenge, a team was established within the European Joint Programme on Rare Diseases (EJP RD) to develop a patients’ registry ICF template allowing easy adaptation to ERNs, country, and site-level specificities. ERN and patients’ representatives validated the choice of developing a GDPR-compliant template for research purposes. The feedback received from 34 Ethics Committees on the Clinical Patient Management System ICF, including the submission of patients’ data to the ERN registries and the EU consent regulatory framework were analyzed along with existing ontologies for data access and reuse. An adaptable ICF was developed following iterative cycles of consultation and review by clinicians, research experts, ethics and regulatory advisors, and patients’ representatives. The development of pediatric material for minor participants was also undertaken.Results and ConclusionResearch oriented ICF templates for adults and for parents/legal representatives of patients were released in 26 national languages. This adaptable ICF aims to foster, according to patients’ preferences, the reuse of registries data for research purposes in compliance with the applicable laws and standards. Pediatric material is being finalized to collect minors’ assent. ICF machine-readability is also progressing to enhance data discovery and facilitate its access and reuse conditions. |
| first_indexed | 2024-04-24T08:11:47Z |
| format | Article |
| id | doaj.art-70975e11dd4c4500b402471a602da30b |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-24T08:11:47Z |
| publishDate | 2024-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-70975e11dd4c4500b402471a602da30b2024-04-17T04:55:39ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2024-04-011110.3389/fmed.2024.13840261384026The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registriesAnnalisa Landi0Yanis Mimouni1Viviana Giannuzzi2Franz Schaefer3Annagrazia Altavilla4Annagrazia Altavilla5Spencer Gibson6Daria Julkowska7Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, ItalyEuropean Joint Programme on Rare Diseases Coordination, INSERM, Paris, FranceFondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, ItalyDivision of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, University of Heidelberg, Heidelberg, GermanyTeddy European Network of Excellence for Paediatric Research, Pavia, ItalyEspace Ethique PACA-Corse Assistance Publique - Hôpitaux de Marseille (AP-HM), Hôpital de la Timone, Marseille, FranceDepartment of Genetics and Genome Biology, University of Leicester, Leicester, United KingdomEuropean Joint Programme on Rare Diseases Coordination, INSERM, Paris, FranceBackgroundThe lack of harmonization of evaluation criteria by Ethics Committees in the European Union (EU) has led to inconsistent ethics reviews received by research sites participating in multicenter non-interventional studies. The European General Data Protection Regulation (GDPR) appears to be implemented at national level with a substantial degree of variance in interpretation. The European Reference Networks (ERNs) were struggling in setting an Informed Consent Form (ICF) for registries, allowing reuse of data for research purposes. The aim of this work is to develop an adaptable ICF for research purposes to be used in ERN registries.MethodsTo work on this challenge, a team was established within the European Joint Programme on Rare Diseases (EJP RD) to develop a patients’ registry ICF template allowing easy adaptation to ERNs, country, and site-level specificities. ERN and patients’ representatives validated the choice of developing a GDPR-compliant template for research purposes. The feedback received from 34 Ethics Committees on the Clinical Patient Management System ICF, including the submission of patients’ data to the ERN registries and the EU consent regulatory framework were analyzed along with existing ontologies for data access and reuse. An adaptable ICF was developed following iterative cycles of consultation and review by clinicians, research experts, ethics and regulatory advisors, and patients’ representatives. The development of pediatric material for minor participants was also undertaken.Results and ConclusionResearch oriented ICF templates for adults and for parents/legal representatives of patients were released in 26 national languages. This adaptable ICF aims to foster, according to patients’ preferences, the reuse of registries data for research purposes in compliance with the applicable laws and standards. Pediatric material is being finalized to collect minors’ assent. ICF machine-readability is also progressing to enhance data discovery and facilitate its access and reuse conditions.https://www.frontiersin.org/articles/10.3389/fmed.2024.1384026/fullinformed consentrare diseasesresearchethics reviewregistries |
| spellingShingle | Annalisa Landi Yanis Mimouni Viviana Giannuzzi Franz Schaefer Annagrazia Altavilla Annagrazia Altavilla Spencer Gibson Daria Julkowska The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries Frontiers in Medicine informed consent rare diseases research ethics review registries |
| title | The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries |
| title_full | The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries |
| title_fullStr | The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries |
| title_full_unstemmed | The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries |
| title_short | The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries |
| title_sort | creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review experience from rare disease registries |
| topic | informed consent rare diseases research ethics review registries |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1384026/full |
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