scholarly journals Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
David Atallah ◽  
Malak Moubarak ◽  
Nadine El Kassis ◽  
Sara Abboud
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Review Process ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Research Ethics Review

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.

Embracing qualitative research: a visual model for nuanced research ethics oversight

2016 ◽  
Vol 17 (1) ◽  
pp. 95-117 ◽  
Author(s):  
Elaine Doyle ◽  
Patrick Buckley
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Resource Constraints ◽  
Human Subjects ◽  
Qualitative Interviews ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Visual Model ◽  
Ethics Review ◽  
Research Ethics Review

The research ethics review systems within universities evolved from the positivist biomedical model but have expanded to include all non-clinical research involving human subjects. However, the application of the biomedical paradigm to qualitative research often creates significant problems. This article highlights the fundamental differences between biomedical and humanities and social science (HSS) research, illustrating that one size does not fit all when it comes to research ethics review. Recognising the resource constraints faced by many higher level education institutions, we develop a model which encompasses the traditional research ethics concepts without requiring separate oversight procedures. After its original construction based on extent research ethics literature, the model was evolved based on findings from qualitative interviews carried out with expert members of research ethics committees. The model can be adapted to multiple contexts through the application of different levels of tolerance in each domain. Our contribution is twofold: (1) to synthesise from the literature an explicit rationale for differentiating research contexts when it comes to research ethics oversight; and (2) to provide research ethics committees with a workable visual model that can be used to aid decision making in diverse research domains.

A University Wide Model for the Ethical Review of Human Subjects Research

2005 ◽  
Vol 1 (2) ◽  
pp. 39-44 ◽  
Author(s):  
Bryn Williams-Jones ◽  
Søren Holm
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Wide System ◽  
Tiered System ◽  
The University

In the United Kingdom (and elsewhere), there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of 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

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.

scholarly journals Research ethics by design: A collaborative research design proposal

2016 ◽  
Vol 13 (2) ◽  
pp. 84-91
Author(s):  
Donald S Borrett ◽  
Heather Sampson ◽  
Ann Cavoukian
Keyword(s):  
Research Ethics ◽  
Research Design ◽  
Collaborative Research ◽  
Review Process ◽  
Personal Data ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Regulatory Frameworks ◽  
Collective Benefit ◽  
Design Proposal

Privacy by Design, a globally accepted framework for personal data management and privacy protection, advances the view that privacy cannot be assured solely by compliance with regulatory frameworks but must become an organisation’s default mode of operation. We are proposing a similar template for the research ethics review process. The Research Ethics by Design framework involves research ethics committees engaging researchers during the design phase of the proposal so that ethical considerations may be directly embedded in the science as opposed to being viewed as addendums after the fact. This collaborative research design proposal results in the establishment of a culture of ethical research rather than research with ethical oversight. Both researchers and research ethics committees come to view the review process as one in which individual protection and collective benefit co-exist in a doubly-enabling positive-sum manner.

Sign in / Sign up

Export Citation Format

Share Document