Research ethics systems, processes, and awareness across Europe: Radiography research ethics standards for Europe (RRESFE)

Bockhold, S.; McNulty, Jonathan P.; Abdurakman, Edwin; Bezzina, Paul; Drey, Nicholas; England, Andrew; Flinton, D.; Khine, Ricardo; McEntee, Mark F.; Mekiš, Nejc; Precht, Helle; Rainford, Louise; Reis, Cláudia Sà dos; Santos, A.; Syrgiamiotis, V.; Willis, S.; Woodley, J.; Beardmore, Charlotte; Harris, Rachel; O’Regan, Tracy; Malamateniou, Christina

doi:10.1016/j.radi.2022.07.002

Cited by 9 publications

(2 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As previously described, 18 the mixed methods survey consisted of 42 questions across six sections and comprised multiple choice, checkbox, rating scale, and open-ended question types. Voluntary submission of the survey was taken as implied consent.…”

Section: Methodsmentioning

confidence: 99%

Research ethics training, challenges, and suggested improvements across Europe: Radiography research ethics standards for Europe (RRESFE)

Bockhold¹,

McNulty²,

Abdurakman³

et al. 2022

Radiography

Self Cite

View full text Add to dashboard Cite

Section: Methodsmentioning

confidence: 99%

Research ethics training, challenges, and suggested improvements across Europe: Radiography research ethics standards for Europe (RRESFE)

Bockhold¹,

McNulty²,

Abdurakman³

et al. 2022

Radiography

Self Cite

View full text Add to dashboard Cite

“…This diversity arises also because each Ethics Committee may operate under its own set of rules and require different documents and contents for approval. This lack of harmonization in ethical evaluations across the European Union (EU) can lead to inconsistent ethical reviews for the same study at different research sites (13)(14)(15). The new European Clinical Trials Regulation introduces a streamlined process, allowing for a single study submission and review by one designated Ethics Committee per country (16).…”

mentioning

confidence: 99%

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

Landi,

Mimouni,

Giannuzzi

et al. 2024

Front. Med.

View full text Add to dashboard Cite

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.

show abstract

Unveiling scientific integrity in scholarly publications: a bibliometric approach

Nguyen,

Tuamsuk

2024

Int J Educ Integr

View full text Add to dashboard Cite

Research ethics systems, processes, and awareness across Europe: Radiography research ethics standards for Europe (RRESFE)

Cited by 9 publications

References 22 publications

Research ethics training, challenges, and suggested improvements across Europe: Radiography research ethics standards for Europe (RRESFE)

Research ethics training, challenges, and suggested improvements across Europe: Radiography research ethics standards for Europe (RRESFE)

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

Unveiling scientific integrity in scholarly publications: a bibliometric approach

Contact Info

Product

Resources

About