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...
On June 30, 2020, OHRP posted new decision charts for the revised Common Rule (2018 Requirements) on their website. These charts are intended to help decision-makers determine if research is considered human subjects research, if exemption categories apply, if...
