It is refreshing to see policy changes influenced by the evolution of science as opposed to crisis. The increased engagement of research participants in research coupled with increasing complexities in the research landscape have catalyzed revisions to the Common Rule. Inspired by the Belmont Report, the Common Rule was developed to ensure that research involving […]
A few weeks ago, Veritas IRB co-sponsored an ACRP Canada conference entitled Biobanking: Ethical, Regulatory and Practical Considerations for Clinical Trials. All of Montreal’s university research centres were represented as well as industry and private research sponsors highlighting the importance of biobanking for a variety of research disciplines. The conference kicked off with a passionate […]
Based on Canadian and American regulations, research sponsors must obtain the right to distribute and use an investigational drug for the purpose of a clinical trial. In both countries, sponsors of research must file an application to the applicable regulatory agency. This will exempt sponsors from the traditional approval requirements that are necessary to import […]
Based on Canadian and American regulations and guidelines, research sponsors and IRB/REBs must assess the qualifications of the investigator to conduct and supervise the proposed clinical trial. Steps may include, but are not limited to, the evaluation of the investigator’s resume, reviewing relevant publications, and assessing whether they have received the proper training on the […]
This weekend, the Society of Clinical Research Associates (SoCRA) will host its 25th annual conference in Montreal, Quebec. As part of the conference, Veritas IRB will be reflecting on the experiences and challenges researchers face when conducting clinical trials across borders. Very often researchers experience confusion, and even frustration, arising from the misinterpretation over how […]
Over the past month, we have written five posts in the series “Am I IRB Forum Shopping?”. Our first post was an Introduction to IRB Forum Shopping; the unethical practice of choosing an IRB based on the relative ease of the review and the perception that the review will result in a favourable decision. We presented […]
