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 four Case Studies in this series to highlight instances of IRB Forum Shopping experienced by Veritas IRB in the last year. We also included the Montreal Tuberculosis Outbreak (Case Study #4 – IRB Forum Selling) as it remains the most blatant example of IRB Forum Shopping in history.

The IRB Forum Shopping Series

Case Study #1– Gag Clauses

Case Study #2– Promotion Disguised as Research

Case Study #3– Risk Management is Not Negotiable

Case Study #4– IRB Forum Selling

The IRB review, once considered a “necessary evil”, is increasingly perceived as a fundamental component to “patient-centric” research. Unique in its oversight, no research in humans can be conducted without it.

This series looked at certain elements in the IRB review such as the contract between the investigator and the research sponsor, scientific merit of the research, monitoring of research participant safety, and methods of screening research participants. It focussed on the harm that can be done (i) when an IRB intentionally disregards these elements in order to make its review more appealing (IRB Forum Selling), and (ii) when a research sponsor intentionally seeks out a lenient IRB to obtain a favourable decision (IRB Forum Shopping).

IRB Forum Shopping is not a victimless practice.

One can forum shop for an IRB based on the price of the review, the frequency of its meetings, the specialty of its boards, etc., but the public mandate of the IRB is not negotiable.

About the Authors

Martin Letendre

Martin Letendre is responsible for managing Veritas IRB's business operations and administering the activities of the Veritas IRB Boards. Martin is a member of the Quebec Bar and brings more than a decade of experience in health law and research ethics. His expert knowledge of, and ongoing activity and interest in research ethics have led to the publication of several reports and articles in peer-reviewed journals, and invitations as guest speaker at numerous conferences and scientific meetings. Martin was actively involved in the creation of an on-line tutorial for institutional research ethics boards in Quebec and was a member of Canada's three federal research agencies' Panel on Responsible Conduct of Research.

Janice E. Parente

Janice completed both her PhD and Post-Doctoral Fellowship in Molecular Pharmacology, and proceeded to develop her skills at the Director level within global pharma before founding her first contract research organization (CRO) in 1992. During the ensuing decade, Janice established her credentials as a successful and respected business leader and entrepreneur. In 2002, she sold her company in order to found ethica Clinical Research Inc., instilling in it her values and commitment to the protection of human research participants. This commitment led to ethica becoming the first Canadian entity and the first CRO in the world to earn full accreditation of its Human Research Protection Program (HRPP) in 2006. Janice's leadership and entrepreneurship have been recognized through numerous awards and nominations such as the prestigious Ernst & Young and Bank of Montreal Entrepreneur of the Year Awards and PROFIT Magazine's PROFIT W100 ranking of Canada's Top Women Entrepreneurs.
The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.