Research Themes
Ethics Review Equivalency
Multi-centre, multi-jurisdictional research, like all research with human participants, raises ethical issues. Projects are increasingly reviewed by research ethics committees (compulsory for clinical trials or research with animals, increasingly required by in social science or other research with human participants). However, the procedural and substantive rules surrounding ethics review, particularly reviews between different committees are not clear.
This research, particularly with colleagues in the Global Allicance for Genomics and Health (GA4GH) regulation and ethics working group, is developing approaches to harmonisation.
Data Protection and Medical Research
The European Union regulatory framework for data protection has recently undergone major reform; the Directive 95/46/EC will be replaced by the Regulation 2016/679 in May 2018.
I have worked on the potential for data protection as the basis for the regulation of research using biobanks and genomic data. My doctoral thesis concentrated on aspects of the Directive; my current work is on understanding the detail and potential of the new Law.
Animals in Research - ANIMPACT
This research is funded by the EU - under FP7. It concerns how the European Directive, and the domestic Law that implements it, on the use of animals in research.
This is intersting work. On its face, the Directive appears to produce a strong framework for the regulation of the use of animals, it also links to the 3Rs as the major substantive base of the Directive. However, it raises the question of how far there is consensus in the interpretation of the 3Rs, and in the operation of the procedures.
ENERIE / EURECNET - H2020 / EC FP7 Research Project
EURECNET has been a succesful networking project funded by the EC for a number of years. The purpose of the project is to develop links between EU Research Ethics Committees (RECs). By bringing together National REC representatives, EURECNET has facilitated capacity building in the EU REC community, and has opened new dialogues about good practice. ENERIE is a new project, starting under H2020 in October 2016, which will continue this work and open it up to include Research Integrity as well as Research Ethics.
My contribution, with my UM colleagues is to develop legal and ethics resources to assist the networking and the development of good practice. I am also very interested in finding out how RECs ensure they represent local sensitivities, and also how they perform as (quasi-)tribunals within expectations of natural justice.
PreMAX - CHAFEA (EC) Project
PreMAX looks at patient rights across the Member States of the EU (and EEA States). Particularly focusing on the impact of the Cross-border Patient Rights Directive (2011/24/EU), the project looks at the traditional and new, consumer-based rights in healthcare. The project has a small core consortium, but has drawn on a wide network of colleagues across the EU and EEA to give country-by-country expert assessment of the rights currently available.
My contribution was particularly in relation to the enforcement of patient rights, and the sanctions and systems in place to assist patients when their rights are breached. I also considered the Council of Europe contribution to patient rights.