The revised Federal Policy for the Protection of Human Subjects (the “Common Rule”) collaborative (multi-site) research provision requires that U.S. institutions engaged in cooperative research conducted or supported by a Common Rule agency must rely on a single IRB...
The International Council for Harmonization (ICH) released an updated version of its guideline on general considerations for clinical trials, RAPS reports. ICH released the guideline, E8(R1), earlier this May for public consultation on the draft.The revised guideline...
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...
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 Monitoring Program (BIMO) states that of...
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...
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,...
