scholarly journals Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

2019 ◽  
Vol 47 (2) ◽  
pp. 264-282 ◽  
Author(s):  
Edward S. Dove
Keyword(s):  
Research Ethics ◽  
Empirical Research ◽  
Regulatory Structure ◽  
Cooperative Research ◽  
Common Rule ◽  
Ethics Review ◽  
Research Ethics Review ◽  
General Support ◽  
The Us ◽  
The Uk

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

Cooperative Research Ethics Review Boards: A Win-Win Solution?

2005 ◽  
Vol 27 (3) ◽  
pp. 1 ◽  
Author(s):  
Greg Koski ◽  
Jessica Aungst ◽  
Joel Kupersmith ◽  
Kenneth Getz ◽  
David Rimoin
Keyword(s):  
Research Ethics ◽  
Cooperative Research ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Review Boards

scholarly journals A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review

PLoS ONE ◽  
2015 ◽  
Vol 10 (7) ◽  
pp. e0133639 ◽  
Author(s):  
Stuart G. Nicholls ◽  
Tavis P. Hayes ◽  
Jamie C. Brehaut ◽  
Michael McDonald ◽  
Charles Weijer ◽  
...  
Keyword(s):  
Research Ethics ◽  
Empirical Research ◽  
Scoping Review ◽  
Ethics Review ◽  
Research Ethics Review

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

A Novel Framework for Reflecting on the Functioning of Research Ethics Review Panels

2007 ◽  
Vol 14 (1) ◽  
pp. 99-116 ◽  
Author(s):  
Colin Macduff ◽  
Andrew McKie ◽  
Sheelagh Martindale ◽  
Anne Marie Rennie ◽  
Bernice West ◽  
...  
Keyword(s):  
Health Care ◽  
Nursing Education ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Rapid Change ◽  
Health Care Research ◽  
Ethical Review ◽  
Review Panel ◽  
Ethics Review ◽  
Research Ethics Review

In the past decade structures and processes for the ethical review of UK health care research have undergone rapid change. Although this has focused users' attention on the functioning of review committees, it remains rare to read a substantive view from the inside. This article presents details of processes and findings resulting from a novel structured reflective exercise undertaken by a newly formed research ethics review panel in a university school of nursing and midwifery. By adopting and adapting some of the knowledge to be found in the art and science of malt whisky tasting, a framework for critical reflection is presented and applied. This enables analysis of the main contemporary issues for a review panel that is primarily concerned with research into nursing education and practice. In addition to structuring the panel's own literary narrative, the framework also generates useful visual representation for further reflection. Both the analysis of issues and the framework itself are presented as of potential value to all nurses, health care professionals and educationalists with an interest in ethical review.

scholarly journals Bringing Ethics Review Home to Cowichan: Indigenizing Ethics Review in British Columbia, Canada

2021 ◽  
Vol 16 (2) ◽  
Author(s):  
Cowichan Tribes
Keyword(s):  
British Columbia ◽  
Research Ethics ◽  
First Nations ◽  
Indigenous Peoples ◽  
Preterm Births ◽  
High Rate ◽  
Community Members ◽  
Ethics Review ◽  
Research Ethics Review ◽  
United Nations Declaration

Cowichan Tribes’ territory, located in the Cowichan Valley on Vancouver Island, British Columbia, Canada, is experiencing an alarmingly high rate of preterm births compared to the national average of Indigenous Peoples in Canada. In response, and in partnership with the First Nations Health Authority (FNHA), Cowichan Tribes is in the first year of a 3-year study to investigate causes. Cowichan Tribes’ Elders and community members are guiding the study to ensure it follows Cowichan Tribes’ research processes and to support self- determination in research. Furthermore, as a way to enhance reconciliation, Elders and community members guided an on-site ethics review on Cowichan Tribes territory. This article outlines the collaborative, in-person research ethics review process that Cowichan Tribes, Island Health, and FNHA completed on August 21, 2019. The purpose of this article is to provide suggestions other First Nations could use when conducting a research ethics review, and to explain how this process aligns with the principles of ownership, control, access, and possession (OCAP®), the United Nations Declaration on the Rights of Indigenous Peoples, the Truth and Reconciliation Commission of Canada, and above all, the Cowichan snuw’uy’ulh (teachings from Elders).

scholarly journals Implementing a National Approach to Research Ethics Review during a Pandemic – the Irish Experience

2020 ◽  
Vol 3 ◽  
pp. 63
Author(s):  
Aileen Sheehy ◽  
Jennifer Ralph James ◽  
Mary Horgan
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Well Being ◽  
Lessons Learned ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Human Participants ◽  
High Standards ◽  
National Approach

The surge of coronavirus disease 2019 (COVID-19) research studies involving human participants in response to the pandemic has meant that research ethics committees across the world have been challenged to adapt their processes to meet demand while retaining high standards of review. Ethics review during this pandemic remains essential to ensure the safety, dignity and well-being of research participants, however research ethics committees are now faced with new, and often complex, ethics considerations and logistical challenges. This Open Letter looks specifically at the Irish experience of establishing a national approach to research ethics review amidst a global pandemic. This represents Ireland’s first National Research Ethics Committee, which provided the research community with an expedited and ‘single national opinion’ for ethics review for COVID-related research. The insights gleaned and lessons learned from the Irish experience may inform emergency responses to future pandemics or public health emergencies.

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