Experts say IRBs spend much of their time discussing informed consent issues and nuances, and yet this is the area cited most often in recent regulatory letters sent to research institutions.
The University of Alabama at Birmingham (UAB) was the most recent in a small list of institutions that received letters of determination from the Office for Human Research Protections (OHRP) of Rockville, MD, about allegations of noncompliance.
IRBs increasingly will have to adjust to collaborative approaches in research, including working with community partners and other stakeholders, experts say.
The Food and Drug Administration (FDA) has received many lengthy comments expressing concern about its recent draft guidance for IRBs, investigators, and sponsors regarding assessing the qualifications of investigators.
In June 2011, representatives from various IRBs and federal regulatory bodies met to discuss the development of a new model to improve the multisite study model.
The research oversight system, says a University of North Carolina at Chapel Hill researcher, has not evolved to keep up with the volume and complexity of the research it oversees.
The Food and Drug Administration (FDA) has now said that clinicians wishing to perform a fecal transplant for treatment of Clostridium difficile will have to obtain an investigational new drug (IND) application.
