Author: Eva Pastor
Date: 06-08-10 17:53
Source: HSToday
URL: http://www.hstoday.us/content/view/13535/149/
Date published: June 8th 2010
Framework for Ethics Reviews During Public Emergencies Proposed
by Anthony L. Kimery
Tuesday, 08 June 2010
Emergency ethics review would be triggered by official declaration of public emergency
A new paper titled A Framework for Research Ethics Review During Public Emergencies, published in the Canadian Medical Association Journal (CMAJ), proposes a system “for emergency review of research protocols based on a combination of increased diligence and enhanced procedural flexibility in proportion to risks and circumstances” during serious pandemics and widespread outbreaks of potentially deadly viruses and other pathogens.
The intent is to expedite research while respecting the procedures of ethics reviews. “An emergency ethics review would be triggered by an official declaration of a public emergency,” the paper stated.
The authors of the paper noted that while the Novel H1N1 influenza pandemic highlighted the need for timely research, there are challenges to combining speed and flexibility with intense scrutiny in conventional research ethics reviews.
“Such emergencies have illuminated the challenges of combining speed and flexibility with intense scrutiny in conventional research ethics reviews,” the authors of the new paper stated, pointing out that “in response to requests for guidance from research ethics committees around the world, the World Health Organization (WHO) recently held a special technical consultation titled ‘Research ethics in international epidemic response.’”
“Emergency ethical review is a tool to help research ethics boards and institutions plan emergency procedures in ways that reconcile the procedures of research ethics review and special circumstances,” the authors of the paper wrote, adding that “public emergencies have illuminated the challenges of combining speed and flexibility with intense scrutiny in research ethics reviews.”
"We propose a new framework to guide departures from normal research ethics review during emergencies," wrote Catherine Tansey, University Health Network, Toronto General Hospital, with her coauthors. "It will be a combination of increased diligence with enhanced procedural flexibility in proportion to risks and circumstances."
“Emergency ethics review may also represent a useful model for general improvement of procedures in research ethics review,” the authors stated.
The authors wrote that “approaches that emphasize time-sensitive review have been adopted by the research ethics board of Health Canada,” and that “in response to the pandemic … in Canada the Public Health Agency of Canada has developed a pilot project titled Streamlining Ethics Review of Multi-Centre Pandemic Influenza Research,” but neither of these approaches “explicitly address the need for enhanced scrutiny during unusual circumstances, and may not be applicable to all public emergencies. Both approaches represent considerable departures from the procedures normally followed by institutionally based research ethics boards, making their widespread application doubtful.”
The authors of the paper further noted that a thorough literature search “did not reveal any publications with a primary focus on guidance for research ethics review in emergency circumstances.”
Anthony L. Kimery
About the author: Online Editor/Senior Reporter and HSToday eNewsletter Editor, is a respected award-wining editor and journalist who has covered national and global security, intelligence and defense issues for two decades.
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