Research Infrastructure

A sound research infrastructure is the foundation of science preparedness and is critical to employing disaster-related scientific research efforts in advance of, during and after disasters.  Some of the major components comprising a disaster scientific research infrastructure include:

How rapidly can your Institutional Review Board (IRB) respond to a researcher’s request to conduct emergency scientific research involving human subjects? The response to public health emergencies or disasters may require rapid research or clinical trials involving impacted individuals and populations. These studies often require compliance with federal human subjects protections, and approval by an IRB before they can begin. Rapid IRB evaluation and approval of scientific research involving human subjects plays a critical role in advancing research during a public health or medical emergency while ensuring the safety and protecting the health of people who volunteer to participate in the studies.

The Public Health Emergency Research Review Board (PHERRB) is a specialized IRB established under the auspices of the National Institutes of Health (NIH) as a network of NIH Institute and Center (IC) IRBs to carry out ethical review of research protocols involving human subjects that address public health emergencies. PHERRB reviewed protocols are conducted, supported, or regulated by the U.S. Department of Health and Human Services (DHHS) and subject to 45 CFR 46 and/or 21 CFR 50 and 56.

Where do agencies and communities turn to identify qualified and capable scientific researchers and institutions? Identifying a qualified and capable scientific research capability during a disaster or public health emergency can be challenging and complex. By establishing systems for pre-identified scientific research responders and research networks in advance of a public health emergency, our nation will have the infrastructure in place to provide data quickly for community leaders, members and responders. 

 In 2014, the Biomedical Advanced Research and Development Authority (BARDA) within DHHS/ASPR established a network of five clinical research organizations that will be available to developers of medical countermeasures – drugs, vaccines, and diagnostic tests needed in emergencies – to help these developers design and conduct the clinical studies needed to apply for approval from the Food and Drug Administration. The BARDA clinical studies network is one example of how the scientific community can work together to support our nation in preparing for and responding to emergencies.

How quickly can clinical and scientific research protocols be created in response to a major public health emergency or disaster? Clinical and scientific research protocols are often complex and require collaboration among multiple investigation sites and approval by regulatory compliance offices. These can be timely processes. The development of pre-scripted clinical and scientific research protocols can save critical time during a public health emergency.

How quickly can access to reliable data be granted, and to whom is access granted? Data sources may be developed in a timely manner, but providing access can be daunting. For this reason,  pre-established reliable and accessible data sources make up a vital component of the disaster scientific research infrastructure. Learn more about the White House Innovation for Disaster Response and Recovery at http://www.data.gov/disasters/.

How is scientific research funded prior to, during and after disasters? Ongoing scientific research is a critical function of public health emergency preparedness.  Since disasters are inherently unpredictable, and many new scientific research questions can emerge as a disaster unfolds, both static and dynamic funding streams are needed to sustain a disaster scientific research infrastructure.