The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

Many drug trials are vetted by companies with ties to the drugmakers, raising concerns about conflicts of interest and ...

A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

All submissions requiring IACUC review are assigned for review as they are received. Most protocols are reviewed and approved via designated member review (DMR), which allows approval once all review ...

Background: Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research ...

UConn Health has acknowledged that it had a lapse in an approved research protocol involving use of animals in the research process and that it was reported to federal regulators. A spokeswoman for ...