Blog
Adoption of eConsent: When will it begin?
Rapid development of technology in the medical industry is forcing life science companies and research institutions to review and modify internal procedures to adapt. Electronic informed consent (eConsent), though still highly debated, is a prominent example of a...
Principle Investigators often struggle to follow their own protocol, FDA records reveal
According to recent records published by the U.S. Food and Drug Administration (FDA), the medical industry is experiencing an alarming rise in the number of failures to follow protocol. A report produced by FDA’s Bioresearch...
Reminder: The Common Rule revisions become effective January 21, 2019
Kind of like finishing the Indy 500 on a yellow flag – with the government shut down and no one available to postpone the changes, it appears the new Common Rule revisions will go into effect January 21st. After the 21st, the IRB will ask you to update your study...
The 5 biggest changes coming for researchers under the Revised Common Rule
Updates to the Common Rule, the principal rule which regulates human subjects research, are scheduled to go into effect this month on January 21, 2019 (after several delays). Studies approved or altered after January 21 will be governed by the new rule. If necessary,...
The world’s first gene-edited babies claim, 8 days later
In the latest example of regulations not keeping up with technology, on November 25, 2018, Marilynn Marchione of the AP published a report regarding He Jiankui’s claim that he had helped create the world’s first gene-edited babies using CRISPR-Cas9...