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 […]
Tag Archives: TCPS2
19
May
May
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. […]
18
May
May
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, Regulatory Affairs
Hey Canada! Should you care about the U.S. modernization of the “Common Rule”?
15
Jan
Jan
The U.S. Department of Health and Human Services (hereinafter HHS), as well as fifteen other Federal Departments, have announced proposed revisions to their policies for the protection of human research participants, known as the “Common Rule”. The 131-page document (also referred to as “NPRM”) can be found here and the public was invited to comment before […]
13
Nov
Nov
As announced earlier this week in our email newsletter, we are all set to begin what should be an exciting conference over the upcoming weekend. Veritas IRB is once again at the PRIM&R AER 2015 conference in Boston. Like the previous years, the conference started with a pre-conference day dedicated to the in-depth exploration of […]
07
May
May
Clinical research is an increasingly complex enterprise, which requires knowledge and skills that are outside the traditional training of physicians and other healthcare professionals. The investigator must, for instance, understand what are the responsibilities of screening research participants, obtaining free and informed consent and supervising a trial. Although it is primarily the sponsor or CRO’s […]