PubMed · 15685749
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2004. Editorial.. https://pubmed.ncbi.nlm.nih.gov/15685749/
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BACKGROUND: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. METHODS: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. RESULTS: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05). CONCLUSIONS: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.
BACKGROUND AND OBJECTIVE: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what extent a randomized consent design and a modification of this design is accepted by research ethics committees, in terms of ethics, health law, and methodology. METHODS: A postal survey was conducted among members of research ethics committees in the United Kingdom, and in The Netherlands, with professional competence in ethics, (health) law, methodology, or clinical practice. RESULTS: In both the UK and in The Netherlands, the modified randomized consent design appears to be statistically significantly more acceptable than the randomized consent design, with respect to ethical and judicial aspects. The overall rejection rate of the randomized consent design was 66% in the UK and 59% in The Netherlands. However, the modified randomized consent design was rejected by 47 and 41% in the two countries, respectively. CONCLUSION: the modified randomized consent design appears to be more acceptable than the randomized consent design. To increase consistency in the way research ethics committees handle study protocols, a discussion about the use of randomized consent designs appears necessary.