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Central IRB, Clinical Trials, Research Participants, Uncategorised

IntegReview IRB and Veritas IRB announce partnership to provide accredited ethics review services in the U.S. and Canada

        Austin, Texas and Montreal, Canada – IntegReview IRB partnered with Canadian-based Veritas IRB Inc., to provide ethics review services and risk management consulting to sponsors of research and investigators in both the United States and Canada. Veritas IRB was the first Canadian organization ever to be accredited by the Association for […]

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Case Study, Clinical Trials, Crisis Management, Guidelines & Regulations, Informed Consent, Research Participants

A Tribute to Ellen Roche

In recognition of World Asthma Day, we wish to underline the importance of pursuing clinical research in order to improve the quality of life for the 300 million people affected by this disease. It is also important to remember those, like Ellen Roche, who participated in such clinical research. Ellen Roche was an employee at […]

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Clinical Trials, Guidelines & Regulations, Informed Consent

The Revised Common Rule:
Trans-border Research and Henrietta Lacks

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 […]

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Clinical Trials

Post-Conference Wrap Up

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 […]

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Uncategorised

Lost in Translation – What Does it Mean to Have “Regulatory Approval”?

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 […]

Medical professionals
Clinical Trials

Lost in Translation – What does it mean to be a “Qualified Investigator”?

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 […]