Chapitre 3. Research ethics committees: a critical comparison between Argentina and the United States

2004 ◽  
Vol 15 (4) ◽  
pp. 49
Author(s):  
Florencia Luna
Keyword(s):  
United States ◽  
Research Ethics ◽  
Ethics Committees ◽  
The United States ◽  
Research Ethics Committees ◽  
Critical Comparison

scholarly journals Ethics Governance Outside the Box: Reimagining Blockchain as a Policy Tool to Facilitate Single Ethics Review and Data Sharing for the 'omics' Sciences

2018 ◽  
Author(s):  
Vaso Rahimzadeh
Keyword(s):  
United States ◽  
Research Ethics ◽  
Data Sharing ◽  
Ethics Committees ◽  
The United States ◽  
Research Ethics Committees ◽  
Common Rule ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Distributed Ledger

Clinical research and health information data sharing are but ripples in a growing wave of reimagined applications of distributed ledger technologies beyond the digital marketplace for which they were originally created. This paper explores the use of distributed ledger technologies to facilitate single institutional ethics review of multi-site, collaborative studies in the dataintensive sciences such as genetics and genomics. Immutable record-keeping, automatable protocol amendments and direct connectivity between stakeholders in the research enterprise (e.g., researchers, research ethics committees, institutions, funders and regulators) comprise several of the conceptual and technological advantages of distributed ledger technologies to research ethics review. This novel-use proposal dovetails recent policy reforms to research ethics review across North America that mandate a single ethics review for any study that takes place across more than one research site. Such reforms in the United States, Canada and Australia replace prior institution-by-institution approval mechanisms that contributed to significant research delays and duplicative procedures for collaborative research worldwide. While this paper centers on the Common Rule revision in the United States, the single ethics review mandate is a noteworthy example of regulation evolving in parallel with advances in the dataintensive sciences it governs. The informational exchange capacities of distributed ledger technologies align well with the procedural goals of streamlining the ethics review system under the new Common Rule ahead of its official implementation on January 19, 2020. The ethical, legal and social implications of applying such technologies to ethics review will be explored in this concept paper. Namely, the paper proposes how administrative data from research ethics committees (REC) could be protected and shared responsibly, as well as interinstitutional cooperation negotiated within a centralized network of research ethics committees using the blockchain. Keywords: Blockchain, Data Sharing, Ethics Review, Governance, IRB, Research, Single Mutual Recognition

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 Preventing ethics dumping: the challenges for Kenyan research ethics committees

2020 ◽  
pp. 174701612092506
Author(s):  
Kate Chatfield ◽  
Doris Schroeder ◽  
Anastasia Guantai ◽  
Kirana Bhatt ◽  
Elizabeth Bukusi ◽  
...  
Keyword(s):  
Research Ethics ◽  
Resource Constraints ◽  
Ethics Committees ◽  
Shared Responsibility ◽  
Standards Of Care ◽  
Primary Data ◽  
Research Ethics Committees ◽  
Governance System ◽  
Middle Income ◽  
System Resource

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping.

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

2011 ◽  
Vol 20 (1) ◽  
pp. 115-129 ◽  
Author(s):  
J. DEBORAH SHILOFF ◽  
BRYAN MAGWOOD ◽  
KRISZTINA L. MALISZA
Keyword(s):  
United States ◽  
Research Ethics ◽  
Gold Standard ◽  
The United States ◽  
Institutional Review Boards ◽  
Scientific Review ◽  
Initial Development ◽  
Institutional Review ◽  
Research Ethics Boards ◽  
A Current

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

Research ethics committees

BMJ ◽  
1990 ◽  
Vol 300 (6724) ◽  
pp. 608-608
Author(s):  
M. Drury
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees
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