Skip to main content

Main menu

  • Home
  • COVID-19
    • Articles & podcasts
    • Blog posts
    • Collection
    • News
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • Classified ads
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
    • Career Ad Discount
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • COVID-19
    • Articles & podcasts
    • Blog posts
    • Collection
    • News
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • Classified ads
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
    • Career Ad Discount
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Pinterest
  • Follow CMAJ on Youtube
  • Follow CMAJ on Instagram
Editorial

Research ethics review: Do it once and do it well

Paul Hébert and Raphael Saginur
CMAJ March 17, 2009 180 (6) 597; DOI: https://doi.org/10.1503/cmaj.090172
Paul Hébert
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Raphael Saginur
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

Research ethics boards are essential for protecting the rights and well-being of research participants. Currently, however, investigators, research institutes and funders are complaining that the system does not work. A chief complaint is that multicentre trials are over-reviewed and mired in bureaucracy because each centre performs its own independent reviews.

A simple calculation suggests that, for a 20-centre trial, some 300–500 person-hours in total may be required of the parties involved in the ethics review process. Given this significant opportunity cost, one would hope to find clear evidence that such a labour-intensive process protects patients effectively. Yet no such data exist. Getting input from a large number of committees may, in fact, adversely affect research participants by, for example, increasing the complexity of consent forms.1 Moreover, the need to conduct multiple independent reviews diminishes the time and expertise that can be allocated to the review and oversight of other studies. Time is also taken away from patient care, research and other valuable health care activities, in exchange for no proven benefit.

In North America, the ethics review process is generally dependent on local reviews, which are thought to be essential to ensure that ethical decisions reflect local conditions and culture. Although local conditions are important in multicentre trials, issues of local culture are less so. Costs and resource constraints in health care mean that research ethics boards are increasingly being asked “Do we have appropriate expertise and resources locally to undertake this study?” rather than “Is this study ethically sound?” More saliently, large national and international trials now often raise major issues related to liability, accountability and responsibility, as well as concerns about oversight once studies are underway. Although local research ethics boards can opine on these matters, without national guidance or the ability to speak as a collective, the voices of single committees often go unheard.

We need to overhaul the ethics review system from an autonomous local committee process into an interdependent collaboration of local committees working within a single national system. Although there are myriad rules and regulations governing research ethics in North America, all permit collaboration between ethics boards and would allow creation of a single decentralized review process. The new national system would replace totally independent multiple reviews with support of an interactive open review model at the local level. In such a redesign, we do not advocate that local institutions relinquish the right to approve studies; instead, we envision a streamlined and timely process that occurs locally once full ethics reviews have been conducted centrally. Our credo for research ethics review should become “do it once and do it well.”

To initiate theses changes, an early priority should be the harmonization of institutional standards across the country. Common forms could be developed to reduce the bureaucratic burden for multicentre trials. Once accepted standards are in place, institutions and ethics committees would be able to work together to review trials and share findings. Accountability would be further enhanced by adopting clear benchmarks to ensure timeliness and quality of reviews. The development of a national education program for new research ethics committee members and health researchers, as well as continuing education for more experienced members, could facilitate these changes and help streamline and enhance the function of all research ethics boards. Transparency, which is important for institutions that aim to protect the public and maintain public trust, would be served by posting all decisions on publicly accessible websites.

There has been some progress in Canada at the regional level. Quebec and Newfoundland and Labrador have adopted systems for centralized ethics review. The Ontario Cancer Research Ethics Board reviews cancer trials across that province. However, for improvements to occur across the entire system, we believe that a nationwide solution is both timely and necessary.

In Canada, none of this will happen without leadership from national institutions such as the Canadian Institutes of Health Research, the Panel on Research Ethics and other scientific councils. Leadership from the ethics and scientific communities will also be needed to build trust and a willingness to collaborate. Similar solutions should be sought in the United States. If all of Europe is envisioning collaborating on ethics reviews, there is no reason why we cannot do the same in Canada or even across North America.

Footnotes

  • With the Editorial-Writing Team (Matthew B. Stanbrook MD PhD, Ken Flegel MDCM MSc, Noni MacDonald MD MSc and Amir Attaran LLB DPhil)

    Competing interests: See www.cmaj.ca/misc/edboard.shtml for the Editorial-Writing Team's statements. Paul Hébert is an employee of the Canadian Institutes of Health Research. The opinions expressed in this article are those of the authors and not of the Canadian Institutes of Health Research. Raphael Saginur is a coinvestigator of the Canadian Network for the Governance of Ethical Health Research Involving Humans, funded by the Canadian Institutes of Health Research.

REFERENCE

  1. 1.↵
    Burman W, Breese P, Weis S, et al.; Tuberculosis Trials Consortium. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials 2003;24:245-55.
    OpenUrlCrossRefPubMed
PreviousNext
Back to top

In this issue

Canadian Medical Association Journal: 180 (6)
CMAJ
Vol. 180, Issue 6
17 Mar 2009
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Research ethics review: Do it once and do it well
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Research ethics review: Do it once and do it well
Paul Hébert, Raphael Saginur
CMAJ Mar 2009, 180 (6) 597; DOI: 10.1503/cmaj.090172

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
Research ethics review: Do it once and do it well
Paul Hébert, Raphael Saginur
CMAJ Mar 2009, 180 (6) 597; DOI: 10.1503/cmaj.090172
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Footnotes
    • REFERENCE
  • Responses
  • Metrics
  • PDF

Related Articles

  • Highlights
  • PubMed
  • Google Scholar

Cited By...

  • Impact of Clinical Study Regulatory Approval Delays in Brazil
  • Canada's new ethical guidelines for research with humans: a critique and comparison with the United States
  • Google Scholar

More in this TOC Section

  • Trouver, tester, « tracer » et isoler énergiquement pour battre la COVID-19
  • Intégration des essais randomisés dans les soins cliniques : comment le Canada peut faire mieux
  • Soins continus et COVID-19 : Qu’une telle tragédie ne se reproduise plus au Canada!
Show more Editorial

Similar Articles

Collections

  • Topics
    • Medical ethics

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions

Copyright 2021, Joule Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

Powered by HighWire