The findings1 from the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial by Bilimoria et al1 were released in February 2016 to great fanfare and substantial controversy around the issues reviewed by Minami et al.2 Bilimoria et al1 make a strong case that this was a necessary trial with significant social benefit, both for the safety of surgical trainees and the safety of surgical patients. They also acknowledge the complexity of the ethical issues around the FIRST Trial and the fact that different perspectives can easily result in different conclusions regarding the need for additional scrutiny in terms of human subjects protection. A critical issue that is understated by Bilimoria et al1 is that research into quality and safety requires reframing ethical norms at a systemic level; the traditional model of human subjects protection is not equipped to provide ethical oversight at this level.
Cochran A. A Brave New World of Research Ethics. JAMA Surg. 2017;152(1):9. doi:10.1001/jamasurg.2016.3201