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 […]
Tag Archives: HRPP
16
Dec
Dec
Guest Blogger Andrew Milroy – HRPP and CQA Manager (Merita CQA) For 19 years ICH GCP E6 has not changed. Now, nearly two decades after its initial release, change is coming. Perhaps the biggest difference is the focus and preeminence of Quality Management. A modernized quality standard for clinical study processes is being espoused which […]
16
Nov
Nov
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 […]