scholarly journals Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape

2021 ◽  
pp. 397-419
Author(s):  
Olga Tzortzatou ◽  
Santa Slokenberga ◽  
Jane Reichel ◽  
Andreia da Costa Andrade ◽  
Carla Barbosa ◽  
...  
Keyword(s):  
Public Interest ◽  
Ethics Committees ◽  
Fragmented Landscape ◽  
Research Ethics Committees ◽  
Legal Basis ◽  
Member States ◽  
Legal And Ethical Requirements ◽  
Supranational Level ◽  
Insight Into

AbstractThis chapter seeks to provide insight into the ways in which Member States leveraged the regulatory discretion afforded to them by the GDPR. Specifically, it reviews the biobank regulatory environment; whether and how derogations under Article 89(2) GDPR are enabled; the legal basis for scientific research and the role of consent in biobanking post-GDPR; the balance between individual rights and public interest in national law; and finally, the GDPR’s impact and future possibilities for biobanking. In exercising self-determination, Member States can, to a certain extent, align data protection requirements with their values and aspirations. Such alignment, though, could jeopardize collaborative research. In light of the need to bridge divergent legal and ethical requirements at a national and supranational level, the role of Research Ethics Committees (RECs) might prove to be essential.

scholarly journals Philosophers in research ethics committees—what do they think they’re doing? An empirical-ethical analysis

2021 ◽  
Author(s):  
Charlotte Gauckler
Keyword(s):  
Research Ethics ◽  
Applied Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Structured Interviews ◽  
Discussion Section ◽  
Philosophical Perspective ◽  
Level 3 ◽  
Practical Level

AbstractResearch ethics committees in Germany usually don’t have philosophers as members and if so, only contingently, not provided for by statute. This is interesting from a philosophical perspective, assuming that ethics is a discipline of philosophy. It prompts the question what role philosophers play in those committees they can be found in. Eight qualitative semi-structured interviews were conducted to explore the self-perception of philosophers regarding their contribution to research ethics committees. The results show that the participants generally don’t view themselves as ethics experts. They are rather unanimous on the competencies they think they contribute to the committee but not as to whether those are philosophical competencies or applied ethical ones. In some cases they don’t see a big difference between their role and the role of the jurist member. In the discussion section of this paper I bring up three topics, prompted by the interviews, that need to be addressed: (1) I argue that the interviewees’ unwillingness to call themselves ethics experts might have to do with a too narrow understanding of ethics expertise. (2) I argue that the disagreement among the interviewees concerning the relationship between moral philosophy and applied ethics might be explained on a theoretical or on a practical level. (3) I argue that there is some lack of clarity concerning the relationship between ethics and law in research ethics committees and that further work needs to be done here. All three topics, I conclude, need further investigation.

Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

2005 ◽  
Vol 1 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Charles Warlow
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Public Interest ◽  
Ethics Committees ◽  
Unintended Consequences ◽  
Research Ethics Committees ◽  
Individual Interest ◽  
The Public ◽  
The Law ◽  
The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

scholarly journals III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

2019 ◽  
Vol 71 (5) ◽  
Author(s):  
Carlos A. Aguilar-Salinas ◽  
Virginia Pascual-Ramos ◽  
Juan G. Sierra-Madero ◽  
Alvar Loria-Acereto ◽  
Elena Zambrano-González ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees

In defence of a broad approach to public interest in health data research

2020 ◽  
pp. medethics-2020-106880
Author(s):  
Angela Ballantyne ◽  
G Owen Schaefer
Keyword(s):  
Research Ethics ◽  
Conceptual Understanding ◽  
Public Interest ◽  
Ethics Committees ◽  
Health Data ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Privacy Act ◽  
Institutional Review ◽  
Broad Approach

In their response to ‘Public interest in health data research: laying out the conceptual groundwork’, Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees (IRBs/RECs), we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current frameworks such as that found in the guidelines approved under Australia’s Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies.

Sign in / Sign up

Export Citation Format

Share Document