Molly Greene

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Institutions are required by federal laws and regulations to oversee and evaluate their programs, facilities, and procedures for using animals in research, teaching, and/or testing activities. These responsibilities are specifically charged to an institutional official (IO) and an institutional animal care and use committee (IACUC). Initially, the(More)
The authors discuss the impact of regulatory burden on the research enterprise, with emphasis on animal care and use programs. They identify three sources of regulatory burden: specific requirements in law and regulation, interpretive requirements or "guidance" by regulatory agencies, and self-imposed regulatory burden resulting from institutional(More)
Every institution that is involved in research with animals is expected to have in place policies and procedures for the management of allegations of noncompliance with the Animal Welfare Act and the U.S. Public Health Service Policy on the Humane Care and Use of Laboratory Animals. We present here a model set of recommendations for institutional animal(More)
cedures to avoid future noncompliance. The IACUC may also wish to initiate a protocol review of the investigator’s other approved studies to determine whether the noncompliance is limited to the one protocol or extends to other protocols. Although the scenario did not mention funding, PHS Policy requires IACUC approval of those components of the proposal(s)(More)
With the ever-increasing call to reduce self-imposed regulatory and administrative burden in the animal research oversight process, knowledge of the regulations and a desire to streamline policies and procedures are needed to affect a change in culture. In this opinion piece, we provide details on why institutionally imposed regulatory burden can arise.
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