In clinical research, the purpose of institutional review board (IRB) review is to ensure the rights and welfare of human subjects are protected. Unnecessary delays in the IRB review process can prevent treatments from getting to patients and slow the improvement of...
Pearl Pathways’ own Director of RA/QA Services Becki Nowatzke was honored to serve on the planning committee for this compelling event featuring an outstanding slate of keynote speakers including Jonathan Blum (Principal Deputy Administrator & COO, U.S....
In Vitro Diagnostics (IVDs) are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, to cure, mitigate, treat, or prevent disease. Such products are intended for use in...
Independent or Institutional Review Board (IRB) review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to...
An institution that intends to conduct HHS-supported research involving prisoners as subjects must certify that an IRB has made the seven (7) findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible...
When an IRB reviews studies regarding data usage, risk is the primary consideration. When discussing exempt category reviews, issues surrounding the use of the DATA are key. The first issue often considered is what data are being used? What are the particulars of...
