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 […]

en

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 […]

research ethics simplified
Crisis Management

Preventing your study from becoming the next tragedy.

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 […]

clinical research technology, en

Leaving Las Vegas: Wearable Health Technologies in 2016

Every January, Las Vegas is home to the highly anticipated yearly conference called the Consumer Electronics Show. It’s difficult to believe that the CES is nearly 50 years old, as things have most certainly changed since 1967 on the technology front, and the conference has certainly been a substantial platform for many interesting consumers products, […]

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 […]