This blog summarizes the major provisions of the second NPRM, which is focused primarily on harmonizing language, definitions, and informed consent requirements in 21 CFR 50—Protection of Human Subjects, and on harmonizing provisions around continuing review, IRB review generally, and IRB membership, in 21 CFR 56—Institutional Review Boards. Read more
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
The fact that IRBs are invisible to most human beings can make it feel impossible to meaningfully engage with the lay community. And yet, community engagement should be a valuable part of what we accomplish in the IRB's mission to serve the community. Read more
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
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
