The Role of Ethics Committees in Relation to French Biomedical Research: Protection of the Person and Personal Data

2017 ◽  
pp. 55-71
Author(s):  
Brigitte Feuillet
Keyword(s):  
Biomedical Research ◽  
Personal Data ◽  
Ethics Committees

20. Biomedical Human Research and Experimentation

2019 ◽  
pp. 666-704
Author(s):  
G. T. Laurie ◽  
S. H. E. Harmon ◽  
E. S. Dove
Keyword(s):  
Biomedical Research ◽  
Randomised Controlled Trials ◽  
Personal Data ◽  
Experimental Treatment ◽  
Ethics Committees ◽  
Legal Aspects ◽  
Personal Injury ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Rule Making

This chapter discusses ethical and legal aspects of biomedical research. After highlighting the evolution and acceleration of rule-making in this setting, it differentiates between research and experimentation, and articulates a core regulatory concept, namely risk. It then covers ethical codes and legal instruments in human biomedical research, research ethics committees, randomised controlled trials, and experimental treatment, paying particular attention to informed consent and research involving people lacking capacity. It also addresses the unethical researcher, compensation for personal injury in research, research involving human tissue and personal data, and new approaches to research governance.

The Importance of National Laws in the Implementation of European Legislation of Biomedical Research

2005 ◽  
Vol 12 (3) ◽  
pp. 245-267 ◽  
Author(s):  
Andrulionis Gytis ◽  
Dominique Sprumont
Keyword(s):  
Clinical Trials ◽  
Biomedical Research ◽  
Ethics Committees ◽  
Research Community ◽  
Liability Insurance ◽  
Research Ethics Committees ◽  
International Level ◽  
European Perspective ◽  
International Regulation

AbstractThe industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation.

scholarly journals Biobank and Biomedical Research: Responsibilities of Controllers and Processors Under the EU General Data Protection Regulation

2021 ◽  
pp. 61-89
Author(s):  
Ana Nordberg
Keyword(s):  
Biomedical Research ◽  
Public Interest ◽  
Data Protection ◽  
Personal Data ◽  
Historical Research ◽  
General Data Protection Regulation ◽  
The Public ◽  
General Data ◽  
The Eu

AbstractBiobanks are essential infrastructures in current health and biomedical research. Advanced scientific research increasingly relies on processing and correlating large amounts of genetic, clinical and behavioural data. These data are particularly sensitive in nature and the risk of privacy invasion and misuse is high. The EU General Data Protection Regulation (GDPR) developed and increased harmonisation, resulting in a framework in which the specific duties and obligations of entities processing personal data—controllers and processors—were defined. Biobanks, in the exercise of their functions, assume the role of controllers and/or processors and as such need to comply with a number of complex rules. This chapter analyses these rules in the light of Article 89 GDPR, which creates safeguards and derogations relating to ‘processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes’. It identifies key compliance challenges faced by biobanks as data controllers and processors, such as determining whether the GDPR is applicable and its intersection with other regulations; when a biobank should be considered controller and processor; and what are the main duties of biobanks as data controllers and processors and options for compliance.

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.

scholarly journals Killing me Softly? Scrutinising the Role of Soft Law in Greece’s Response to COVID-19

2021 ◽  
Vol 12 (1) ◽  
pp. 59-76
Author(s):  
Evangelia (Lilian) TSOURDI ◽  
Niovi VAVOULA
Keyword(s):  
Asylum Seekers ◽  
Personal Data ◽  
Fundamental Rights ◽  
Soft Law ◽  
Freedom Of Movement ◽  
Hard Law ◽  
Primary Basis ◽  
Full Swing ◽  
Second Wave

Greece emerged as the EU’s poster child in the fight against COVID-19 during the first few months of the pandemic. In this contribution, we assess Greece’s use of soft regulation in its regulatory response to COVID-19. Using “acts of legislative content”, which can be broadly conceptualised as softly adopted hard law, the Greek government largely achieved flexibility and simplified adoption procedures without having to resort to soft law per se. The role of soft law was limited - it complemented hard law rather than constituting the primary basis of COVID-19 restrictions - but not completely negligible. Soft law instruments regulated the processing of personal data, and was also pivotal in clarifying the criminal sanctioning of COVID-related rule violations. Greece’s success in handling the first wave of the pandemic, while effective, was arguably unfair to asylum seekers who saw their right to apply for asylum curtailed, and their right to freedom of movement restricted when limitations on the rest of the population were lifted. With a second wave of infections currently in full swing, it is imperative to keep scrutinising regulatory responses to ensure that they place the health and dignity of every individual (whoever they might be) at their core and fully respect their fundamental rights.

Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

2019 ◽  
Vol 14 (2) ◽  
pp. 107-116 ◽  
Author(s):  
Blessing Silaigwana ◽  
Douglas Wassenaar
Keyword(s):  
South Africa ◽  
Research Ethics ◽  
South African ◽  
Biomedical Research ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Financial Contracts ◽  
Scientific Validity ◽  
Participant Selection ◽  
Education And Awareness

In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers’ CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs’ review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs.

Ethical and Social Issues in Medicine

2019 ◽  
Author(s):  
Roberta Springer Loewy ◽  
Erich H. Loewy ◽  
Faith T. Fitzgerald
Keyword(s):  
Ethical Issues ◽  
Social Issues ◽  
Ethics Committees ◽  
Daily Basis ◽  
Moral Authority ◽  
Health Care Ethics ◽  
Good Medicine ◽  
Personal Morality ◽  
Online Access

So rapidly has the field of health care ethics continued to grow that, when recently “googled,” the term produced 28.2 million hits. The challenge is to address the ethical and social issues in medicine in this very limited article space. It remains an impossible task to present more than a superficial discussion of these complex issues and the complicated cases in which they are to be found. Like good medicine, good ethics cannot be practiced by algorithm. The authors have opted to provide an operational guide to help clinicians sort through the ethical and social quandaries they must face on a daily basis. To that end, the authors have chosen to divide this chapter into the following sections: 1. A brief description of the biopsychosocial nature of ethics and how it differs from personal morality 2. A method for identifying and dealing with ethical issues 3. A discussion of the role of bioethicists and ethics committees 4. The professional fiduciary role of clinicians 5. Listings of some of the common key bioethical and legal terms (online access only) 6. A very brief discussion of the terms cited in the above listings (online access only) This reviews contains 4 tables, 8 references, 1 appendix, and 20 additional readings. Keywords: Ethical, social, right, wrong, good, bad, obligation, moral authority, critically reflective, and multiperspectival activity, Curiosity, Honesty, Patience, Open-mindedness

Ethical and Social Issues in Medicine

2019 ◽  
Author(s):  
Roberta Springer Loewy ◽  
Erich H. Loewy ◽  
Faith T. Fitzgerald
Keyword(s):  
Ethical Issues ◽  
Social Issues ◽  
Ethics Committees ◽  
Daily Basis ◽  
Moral Authority ◽  
Health Care Ethics ◽  
Good Medicine ◽  
Personal Morality ◽  
Online Access

So rapidly has the field of health care ethics continued to grow that, when recently “googled,” the term produced 28.2 million hits. The challenge is to address the ethical and social issues in medicine in this very limited article space. It remains an impossible task to present more than a superficial discussion of these complex issues and the complicated cases in which they are to be found. Like good medicine, good ethics cannot be practiced by algorithm. The authors have opted to provide an operational guide to help clinicians sort through the ethical and social quandaries they must face on a daily basis. To that end, the authors have chosen to divide this chapter into the following sections: 1. A brief description of the biopsychosocial nature of ethics and how it differs from personal morality 2. A method for identifying and dealing with ethical issues 3. A discussion of the role of bioethicists and ethics committees 4. The professional fiduciary role of clinicians 5. Listings of some of the common key bioethical and legal terms (online access only) 6. A very brief discussion of the terms cited in the above listings (online access only) This reviews contains 4 tables, 8 references, 1 appendix, and 20 additional readings. Keywords: Ethical, social, right, wrong, good, bad, obligation, moral authority, critically reflective, and multiperspectival activity, Curiosity, Honesty, Patience, Open-mindedness

scholarly journals Neuroactive steroids, their metabolites, and neuroinflammation

2012 ◽  
Vol 49 (3) ◽  
pp. R125-R134 ◽  
Author(s):  
Silvia Giatti ◽  
Mariaserena Boraso ◽  
Roberto Cosimo Melcangi ◽  
Barbara Viviani
Keyword(s):  
Nervous System ◽  
Biomedical Research ◽  
Experimental Models ◽  
Neuroactive Steroids ◽  
Steroid Metabolism ◽  
Neuroactive Steroid ◽  
Neuroprotective Strategy ◽  
Testosterone Metabolites ◽  
Inflammatory Effect

Neuroinflammation represents a common feature of many neurodegenerative diseases implicated both in their onset and progression. Neuroactive steroids act as physiological regulators and protective agents in the nervous system. Therefore, the attention of biomedical research has been recently addressed in evaluating whether neuroactive steroids, such as progestagens, androgens, and estrogens may also affect neuroinflammatory pathways. Observations so far obtained suggest a general anti-inflammatory effect with a beneficial relapse on several neurodegenerative experimental models, thus confirming the potentiality of a neuroprotective strategy based on neuroactive steroids. In this scenario, neuroactive steroid metabolism and the sophisticated machinery involved in their signaling are becoming especially attractive. In particular, because metabolism of neuroactive steroids as well as expression of their receptors is affected during the course of neurodegenerative events, a crucial role of progesterone and testosterone metabolites in modulating neuroinflammation and neurodegeneration may be proposed. In the present review, we will address this issue, providing evidence supporting the hypothesis that the efficacy of neuroactive steroids could be improved through the use of their metabolites.

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