scholarly journals International Coordination of Research Ethics Review: An Adequacy Model

Philosophies ◽  
2021 ◽  
Vol 6 (4) ◽  
pp. 93
Author(s):  
Adrian Thorogood ◽  
Michael J. S. Beauvais
Keyword(s):  
Research Ethics ◽  
Genomic Research ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Research Oversight ◽  
Genomics Research ◽  
Global Coordination ◽  
Protection Of Participants ◽  
Study Participants ◽  
Local Research

International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants’ rights and interests. For DTP genomic research, obtaining a review may in fact be impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing whether another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics-approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and which other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight.

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.

scholarly journals A call for a streamlined ethics review process for multijurisdictional, child health research studies

2019 ◽  
Vol 25 (7) ◽  
pp. 406-408
Author(s):  
Brigitte Lemyre ◽  
Jaya P Bodani ◽  
Stefani Doucette ◽  
Michael S Dunn ◽  
Deepak Louis ◽  
...  
Keyword(s):  
Research Ethics ◽  
Review Process ◽  
Standard Of Care ◽  
Youth Health ◽  
Administrative Costs ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Large Numbers ◽  
Preterm Born ◽  
Child Health Research

Abstract To be time and resource efficient in neonatal research and to answer clinically relevant questions with validity and generalizability, large numbers of infants from multiple hospitals need to be included. Multijurisdictional research in Canada is currently fraught with research ethics review process hurdles that lead to delays, administrative costs, and possibly termination of projects. We describe our experience applying for ethics review to 13 sites in 7 provinces for a project comparing two standard of care therapies for preterm born infants with respiratory distress syndrome. We welcome the current opportunity created by the Institute of Human Development Child and Youth Health and the Institute for Genetics, to collaboratively identify practical solutions that would benefit Canadian researchers, Research Ethics Boards, and children and families.

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