CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2001
The research ethics board is a social oversight mechanism to ensure that all human research subje... more The research ethics board is a social oversight mechanism to ensure that all human research subjects are protected. To achieve this end, research ethics boards must go beyond merely reviewing the paper protocols submitted by investigators. Continuing review of approved research is essential to
The use of charged-particle radiation therapy (CPRT) is an increasingly important development in ... more The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research.
The target article by Snyder, Miller, and Gray endorses a restricted use of the relative standard... more The target article by Snyder, Miller, and Gray endorses a restricted use of the relative standard as the morally appropriate interpretation of minimal risk. The relative standard identifies the referent for minimal risk as the population eligible for study participation. That is, minimal risk ...
Low response rates and inadequate question comprehension threaten the validity of survey results.... more Low response rates and inadequate question comprehension threaten the validity of survey results. We describe a simple procedure to implement personalized-as opposed to generically worded-questionnaires in the context of a complex web-based survey of corresponding authors of a random sample of 300 published cluster randomized trials. The purpose of the survey was to gather more detailed information about informed consent procedures used in the trial, over and above basic information provided in the trial report. We describe our approach-which allowed extensive personalization without the need for specialized computer technology-and discuss its potential application in similar settings. The mail merge feature of standard word processing software was used to generate unique, personalized questionnaires for each author by incorporating specific information from the article, including naming the randomization unit (e.g., family practice, school, worksite), and identifying specific indiv...
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 1997
BENJAMIN FREEDMAN, un des plus grands bioéthiciens du Canada et universitaire re- connu sur la s... more BENJAMIN FREEDMAN, un des plus grands bioéthiciens du Canada et universitaire re- connu sur la scène internationale, est mort le 20 mars 1997. Professeur de médecine à l’Université McGill de Montréal, Freedman a beaucoup contribué au domaine de la bioéthique, où il a fait notamment des travaux fondamentaux sur le consentement éclairé et la compétence. Dans le domaine de l’éthique de la recherche, Freedman est l’auteur du concept de l’équivalence clinique comme condition préalable à l’exécution éthique de recherches cliniques. Des travaux subséquents ont clarifié l’analyse éthique du risque et les limites du risque permis- sible en recherche sur les enfants. Parmi les travaux récents de Freedman, mention- nons un ouvrage d’analyse sur le judaïsme et la bioéthique.
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2001
The research ethics board is a social oversight mechanism to ensure that all human research subje... more The research ethics board is a social oversight mechanism to ensure that all human research subjects are protected. To achieve this end, research ethics boards must go beyond merely reviewing the paper protocols submitted by investigators. Continuing review of approved research is essential to
The use of charged-particle radiation therapy (CPRT) is an increasingly important development in ... more The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research.
The target article by Snyder, Miller, and Gray endorses a restricted use of the relative standard... more The target article by Snyder, Miller, and Gray endorses a restricted use of the relative standard as the morally appropriate interpretation of minimal risk. The relative standard identifies the referent for minimal risk as the population eligible for study participation. That is, minimal risk ...
Low response rates and inadequate question comprehension threaten the validity of survey results.... more Low response rates and inadequate question comprehension threaten the validity of survey results. We describe a simple procedure to implement personalized-as opposed to generically worded-questionnaires in the context of a complex web-based survey of corresponding authors of a random sample of 300 published cluster randomized trials. The purpose of the survey was to gather more detailed information about informed consent procedures used in the trial, over and above basic information provided in the trial report. We describe our approach-which allowed extensive personalization without the need for specialized computer technology-and discuss its potential application in similar settings. The mail merge feature of standard word processing software was used to generate unique, personalized questionnaires for each author by incorporating specific information from the article, including naming the randomization unit (e.g., family practice, school, worksite), and identifying specific indiv...
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 1997
BENJAMIN FREEDMAN, un des plus grands bioéthiciens du Canada et universitaire re- connu sur la s... more BENJAMIN FREEDMAN, un des plus grands bioéthiciens du Canada et universitaire re- connu sur la scène internationale, est mort le 20 mars 1997. Professeur de médecine à l’Université McGill de Montréal, Freedman a beaucoup contribué au domaine de la bioéthique, où il a fait notamment des travaux fondamentaux sur le consentement éclairé et la compétence. Dans le domaine de l’éthique de la recherche, Freedman est l’auteur du concept de l’équivalence clinique comme condition préalable à l’exécution éthique de recherches cliniques. Des travaux subséquents ont clarifié l’analyse éthique du risque et les limites du risque permis- sible en recherche sur les enfants. Parmi les travaux récents de Freedman, mention- nons un ouvrage d’analyse sur le judaïsme et la bioéthique.
Introduction: The quality of ethics review is often a bone of contention with trialists. Accredit... more Introduction: The quality of ethics review is often a bone of contention with trialists. Accreditation typically focuses on administrative requirements rather than assessing the quality of decisions. To date there are no established metrics of quality for research ethics review.
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.
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Papers by Charles Weijer
Aim: As a first stage we reviewed the empirical research regarding ethics review. We examined the range and nature of research activity in order to identify key themes, research foci, and research gaps to aid in the planning and commissioning of future research.
Methods: A scoping review of published studies. A study was eligible if it was empirical, considered the ethics review process, was focused on human subjects, and was published in English. Manuscript content was coded by two reviewers.
Results: 197 papers were included for data extraction. Few studies were from outside North America, Europe or Australasia. The most common research methodologies were surveys (N=93) and review of administrative data (N=79). Only two longitudinal studies and one systematic review were identified. The most common subject of study was the review process (N=148) and IRB member views (N=101). Only 7 studies included research participants and only one research sponsors. Main outcomes were: IRB structures (N=105), variation in decisions (N=62), IRB membership (N=61), delays in approvals (N=54). Least studied were participant views (N=4), IRB member knowledge (N=9), and post-approval outcomes (N=23).
Conclusion: To date studies have tended to focus on structure and timeliness of ethics review and there has been a lack of research around participant experiences, particularly in less developed countries or settings. A major limitation to date is the lack of longitudinal research which precludes any analyses of change or assessment of quality improvement in ethics review.