Note: Pearl IRB updated this blog on August 9, 2021, and we will continue to update this in the future as necessary. Formal review procedures for human subject studies were established in reaction to unethical research practices in the 20th century. The Code of...
To date, manufacturers have had three choices when completing a clinical evaluation report (CER): 1) performing a clinical study, 2) performing a clinical literature review, or 3) a combination of performing a clinical study and literature review. However, with the...
Beginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB...
On January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common...
In January of 2016, a Phase I drug trial in France, conducted by the French contract research organization Biotrial, left one volunteer dead and five others hospitalized: four with permanent neurological damage. The drug, named BIA 10-2474, is under development, by...
