It would not be an overstatement to say that in 2018 the clinical research industry saw many changes, regulatory updates, and advances. As we move into 2019, take a brief moment to reflect on the past year with our top five most popular articles of 2018:
The prelude to the implementation of the new Common Rule was equally strewn with hints as much as long periods of silence. As the OHRP finalized their changes to the keystone regulation, those in the clinical research industry could only wait and speculate.
On January 17, 2018, the Common Rule was officially delayed until July 19, 2018, where it was promptly postponed again until January 21, 2019. Clinical research industry expert Jim Gearhart reported on the decision, and continued to update readers as events developed throughout the year.
The opioid crisis is staggering in the number of lives it has claimed, and experts fear that opioid deaths could top 500,000 over the next 10 years. Dr. Amanda Higley, IRB vice chair for Quorum, discussed the roots of the crisis, and what mitigating actions might be taken to address the issue.
In June of 2018, the Department of Health and Human Services and 15 other Federal Departments and Agencies issued another update on the status of the long-delayed Common Rule, introducing three burden-reducing provisions. These provisions aimed to streamline how regulated entities and their IRBs process, review, and approve human subject research. Among them: a new definition of “research,” a change in continuing review requirements, and the elimination of the requirement for grant documents.
Finally, the Common Rule actually seems like it will be implemented in the near future! In October of 2018, the FDA offered a final guidance document about how its regulations will align with the coming January’s changes to the Common Rule, detailing changes to expedited IRB review of minimal risk research, informed consent, and continuing review.
In a year clearly dominated by the interest in how the Common Rule delays would impact research, it was refreshing to see another important topic like the opioid crisis so widely read and appreciated by our clients and subscribers. What’s more, Quorum announced its readiness for Common Rule implementation recently. It will be interesting to see what topics 2019 bring. One thing is for sure: Quorum will be there to thoughtfully initiate conversations on new regulations and continue to drive research forward together.