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 ...

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 ...

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 ...

Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...

Jin Jian, head of Huawei's Data Communication Protocol Development Department, delivered a keynote speech titled "Enterprise ...

There has been increasing concern in the biomedical community about the use of biological specimens obtained during clinical research. Current Federal regulations set out criteria for the use of ...

Borgonovo, Emanuele, Marco Pangallo, Jan Rivkin, Leonardo Rizzo, and Nicolaj Siggelkow. "Sensitivity Analysis of Agent-based Models: A New Protocol." Computational and Mathematical Organization Theory ...