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 […]

veritas irb ethics review
en, Regulatory Affairs

Hey Canada! Should you care about the U.S. modernization of the “Common Rule”?

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 […]

AER15, en

PRIM&R AER15 Conference Highlights – Day 2: Working Together

Working together is a challenge no matter what industry one finds themselves. This theme could not have been more at the forefront than at Day 2 at the PRIM&R Conference in Boston. Veritas IRB attended a series of fascinating presentations which ranged from genome editing, to communication of risks and benefits to participants, identifying major […]