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 […]
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 […]
This year, Veritas IRB will celebrate the 10th anniversary of its accreditation. At that time, our president, Janice Parente, saw in accreditation an opportunity for the entire research industry to move towards a participant-centric approach to research: “It is imperative to minimize the risks to clinical trial participants and maximize the benefits… Our industry has […]
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 […]
Part 2 of our TRMS 2015 Coverage When establishing trust in an organization, be it for the sake of protecting research participants or for maintaining the integrity of a research study, it is imperative that proper processes and procedures be in place for all parties involved. It is absolutely necessary for researchers and participants alike […]
November has no doubt been a month of interesting discussions and debates surrounding research and bioethics, as showcased recently at the 2015 PRIM&R Conference in Boston. (Editor’s note: for an in-depth look at our coverage from PRIM&R 2015, we welcome you to view our blog posts on PRIM&R Pre-Conference Highlights: From IRB 101 to Biobanking, […]
