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

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          Abstract

          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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          Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel

          Background Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research “ethics preparedness” constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. Main text A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. Conclusion It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks.
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            Research Ethics and International Epidemic Response: The Case of Ebola and Marburg Hemorrhagic Fevers

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              Author and article information

              Contributors
              Role: ConceptualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
              Role: ConceptualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
              Role: ConceptualizationRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
              Journal
              HRB Open Res
              HRB Open Res
              HRB Open Res
              HRB Open Research
              F1000 Research Limited (London, UK )
              2515-4826
              16 November 2020
              2020
              16 November 2020
              : 3
              : 63
              Affiliations
              [1 ]National Office for Research Ethics Committees, Dublin, Ireland
              [2 ]Royal College of Physicians of Ireland, Dublin, Ireland
              [3 ]School of Medicine, University College Cork, Cork, Ireland
              [1 ]Central Committee for Research involving Human Subjects (CCMO), The Hague, The Netherlands
              [2 ]Leiden University Medical Center, Leiden, The Netherlands
              [3 ]Centre for Human Drug Research, Leiden, The Netherlands
              [4 ]Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities (PHM), Julius Center Research Program Methodology, University Medical Center Utrecht, Utrecht, The Netherlands
              [5 ]Julius Center for Health Sciences and Primary Care, Medical Humanities, University Medical Center Utrecht, Utrecht, The Netherlands
              [1 ]Department of Endocrinology, St Vincent's University Hospital, Dublin, Ireland
              [2 ]University College Dublin, Dublin, Ireland
              [1 ]Central Committee for Research involving Human Subjects (CCMO), The Hague, The Netherlands
              [2 ]Leiden University Medical Center, Leiden, The Netherlands
              [3 ]Centre for Human Drug Research, Leiden, The Netherlands
              [4 ]Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities (PHM), Julius Center Research Program Methodology, University Medical Center Utrecht, Utrecht, The Netherlands
              [5 ]Julius Center for Health Sciences and Primary Care, Medical Humanities, University Medical Center Utrecht, Utrecht, The Netherlands
              Health Research Board, Ireland
              [1 ]Department of Endocrinology, St Vincent's University Hospital, Dublin, Ireland
              [2 ]University College Dublin, Dublin, Ireland
              Health Research Board, Ireland
              Author notes

              No competing interests were disclosed.

              Competing interests: No competing interests were disclosed.

              Competing interests: No competing interests were disclosed.

              Competing interests: No competing interests were disclosed.

              Competing interests: No competing interests were disclosed.

              Competing interests: Have submitted a description of a local REC COVID response as part of a wider publication on COVID research ethics, under review. This intent was published in a protocol in this journal and discussed in the HRB TMRN Trials in a Pandemic Symposium, and thus is already open information.

              Competing interests: No competing interests were disclosed.

              Article
              10.12688/hrbopenres.13146.2
              7797935
              31893daf-0db6-471c-b78b-762b6265a4aa
              Copyright: © 2020 Sheehy A et al.

              This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

              History
              : 9 November 2020
              Funding
              Funded by: Health Research Board
              AS and JRJ are employees of the Health Research Board, Ireland.
              The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
              Categories
              Open Letter
              Articles

              research ethics,national research ethics committees,research integrity,covid-19

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