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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 […]

research ethics simplified
Case Study, en

Am I IRB Forum Shopping? Case Study #4 – IRB Forum Selling

The Montreal Tuberculosis Outbreak remains the most blatant case of IRB Forum Shopping in history. The events can be summarized as follows: The Montreal Tuberculosis Outbreak remains the most blatant case of IRB Forum Shopping in history. Why did SFBC Anapharm send their fourth study to IRB Services? Could it be that SFBC Anapharm had […]

Am I IRB Forum Shopping? Case Study #3: Threatening the IRB
Case Study, en

Risk Management is not Negotiable! – Case #3 of “Am I IRB Forum Shopping?”

In December 2015, a Canadian research sponsor submitted a Phase III, multicenter study to Veritas IRB for review. It involved women, 45 years of age and over. Veritas IRB approved the study with the condition that women of child-bearing potential must undergo routine urine pregnancy testing during their participation in the study and upon exiting […]

Veritas IRB Inc.
Case Study, en

Am I IRB Forum Shopping? Case Study #2: Promotion Disguised as Research

  Veritas IRB has received three submissions in the past five months of post-marketing observational trials from two research sponsors (the Canadian office of one of the top 20 pharmaceutical companies, and a Canadian-based pharmaceutical company). All three trials had one thing in common; they were old-fashioned seeding trials disguised as bona fide research studies. […]

silenced-doctort
Case Study, en

Am I IRB Forum Shopping? – Case Study #1: Gag Clauses

  Last month, Veritas IRB received a submission from a research sponsor (Canadian office of one of the top 20 pharmaceutical companies) for review of a Phase III, multicenter trial. Missing from the submission were the contracts (also referred to as clinical trial agreements) between the research sponsor and the Canadian investigators. Instead of providing […]