TAG ARCHIVES FOR IRB

27
Sep2022

Research participants who discuss their research participation online may unintentionally disclose information that increases the risks of the research to themselves or others. These risks include unblinding study participants or the research team, communicating incorrect information, or inadvertently licensing participant behaviors that conflict with study requirements, each of which may potentially threaten study integrity and/or participant safety. Read more

25
Aug2022

Research noncompliance occurs when researchers (intentionally or unintentionally) fail to comply with established regulations, policies, and/or committee-approved research protocols. Noncompliance comes in many forms. It is study-specific and not always identified by IRBs and IACUCs in the same manner.  Some instances of noncompliance may be discovered through post-approval monitoring activities, while others come to the committees via whistleblowers, or reports submitted by the researchers themselves.  Whatever the case, committees must decide what happens after noncompliance has been identified. Read more

18
Aug2022

While the FDA and OHRP share a mission in protecting volunteers in research, the FDA has a unique responsibility as a public health and consumer protection agency. The dual mission is reflected in the purpose for Investigational New Drug and Investigational Device Exemption regulations which propose to assure safety and rights of subjects, permit evaluation of a drug’s safety and effectiveness, and encourage discovery and development of useful devices intended for human use.  Read more