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. […]

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 […]

en, Guidelines & Regulations

Am I IRB Forum Shopping? – Introduction

We recently revisited the Montreal tuberculosis outbreak wherein we identified IRB Forum Shopping as the root cause of this tragedy. IRB Forum Shopping is an under-researched yet highly-relevant ethical issue in the context of the North American governance of clinical research. Essentially, it is the practice of choosing an IRB based on the relative ease […]


The Montreal Tuberculosis Outbreak Revisited.

Following our March 3, 2016 post entitled “Preventing your study from becoming the next tragedy.”, we received numerous requests for information regarding the Montreal tuberculosis outbreak. This avoidable tragedy was not covered – to any great extent – by English Canadian media, which may explain why few Canadians have ever heard of it. It wasn’t […]