Future Oversight of Recombinant DNA Research: Recommendations of an Institute of Medicine Committee

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping regulatory authority and improved scientific understanding and social acceptance that the NIH commissioned the Institute of Medicine (IOM) to assess whether gene transfer research continues to warrant additional oversight. The overarching goal of the IOM was to ensure patient safety and the ethical conduct of research, while not subjecting scientists to unnecessary regulatory burdens, which can impede or delay scientific exploration and medical innovation. The IOM Committee recommended that the RAC should review individual protocols only if other regulatory authorities could not adequately do so, and the study meets one of the following criteria: (1) the protocol uses a new vector, genetic material, or delivery methodology representing a first-in-human experience; (2) the protocol relies on preclinical safety data obtained using a new preclinical model system of unknown and unconfirmed value; or (3) the protocol involves a vector, gene construct, or method of delivery associated with possible toxicities that are not widely known. Gene transfer research no longer stands alone as the only human application of an emerging technology that could benefit from additional oversight. Consequently, the IOM Committee recommended that the NIH Director charge a standing or new committee to examine the need for additional or different oversight for clinical applications of emerging novel technologies

A Framework for Catastrophic Disaster Response

The 3 critical components of catastrophic disaster preparedness are discuss: development of crisis standards of care, development of a “systems” approach that ensures integration among key stakeholders, and meaningful engagement with health professionals and the public

Crisis Standards of Care: A Systems Framework for Catastrophic Disaster Response

In 2011 alone, a tornado devastated Joplin, Missouri, and earthquakes rocked New Zealand and Japan, underscoring how quickly and completely health systems can be overwhelmed. Disasters can stress health care systems to the breaking point and disrupt delivery of vital medical services. At the request of the HHS, the IOM formed a committee in 2009, which developed guidance that health officials could use to establish and implement standards of care during disasters. In its first report, the committee defined “crisis standards of care” (CSC) as a state of being that indicates a substantial change in health care operations and the level of care that can be delivered in a public health emergency, justified by specific circumstances. During disasters, medical care must promote the use of limited resources to benefit the population as a whole. In this report, the IOM examines the effect of its 2009 report, and develops vital templates to guide the efforts of professionals and organizations responsible for CSC planning and implementations. Integrated planning for a coordinated response by state and local governments, EMS, health care organizations, and health care providers in the community is critical to successfully responding to disasters. The report provides a foundation of underlying principles, steps needed to achieve implementation, and the pillars of the emergency response system, each separate and yet together upholding the jurisdictions that have the overarching authority for ensuring that CSC planning and response occurs.https://www.inovaideas.org/emergency_books/1000/thumbnail.jp