veritas irb ethics review
en, Regulatory Affairs

Hey Canada! Should you care about the U.S. modernization of the “Common Rule”?

The U.S. Department of Health and Human Services (hereinafter HHS), as well as fifteen other Federal Departments, have announced proposed revisions to their policies for the protection of human research participants, known as the “Common Rule”. The 131-page document (also referred to as “NPRM”) can be found here and the public was invited to comment before […]

en, Investigators

Why does the IRB/REB request Investigator qualification information?

Clinical research is an increasingly complex enterprise, which requires knowledge and skills that are outside the traditional training of physicians and other healthcare professionals. The investigator must, for instance, understand what are the responsibilities of screening research participants, obtaining free and informed consent and supervising a trial. Although it is primarily the sponsor or CRO’s […]