Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. Methods: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. Results: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. Conclusion: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.

Academic Medical Centers (AMCs) offer patient care and perform research. Increasingly, AMCs advertise to the public in order to garner income that can support these dual missions. In what follows, we raise concerns about the ways that advertising blurs important distinctions between them. Such blurring is detrimental to AMC efforts to fulfill critically important ethical responsibilities pertaining both to science communication and clinical research, because marketing campaigns can employ hype that weakens research integrity and contributes to therapeutic misconception and misestimation, undermining the informed consent process that is essential to the ethical conduct of research. We offer ethical analysis of common advertising practices that justify these concerns. We also suggest the need for a deliberative body convened by the Association of American Medical Colleges and others to develop a set of voluntary guidelines that AMCs can use to avoid in the future, the problems found in many current AMC advertising practices.

On January 12, 2010, a major earthquake in Haiti resulted in approximately 212 000 deaths, 300 000 injuries, and more than 1.2 million internally displaced people, making it the most devastating disaster in Haiti's recorded history. Six academic medical centers from the city of Chicago established an interinstitutional collaborative initiative, the Chicago Medical Response, in partnership with nongovernmental organizations (NGOs) in Haiti that provided a sustainable response, sending medical teams to Haiti on a weekly basis for several months. More than 475 medical volunteers were identified, of whom 158 were deployed to Haiti by April 1, 2010. This article presents the shared experiences, observations, and lessons learned by all of the participating institutions. Specifically, it describes the factors that provided the framework for the collaborative initiative, the communication networks that contributed to the ongoing response, the operational aspects of deploying successive medical teams, and the benefits to the institutions as well as to the NGOs and Haitian medical system, along with the challenges facing those institutions individually and collectively. Academic medical institutions can provide a major reservoir of highly qualified volunteer medical personnel that complement the needs of NGOs in disasters for a sustainable medical response. Support of such collaborative initiatives is required to ensure generalizability and sustainability.

(Disaster Med Public Health Preparedness. 2010;4:169-173)

Agents of opportunity (AO) in academic medical centers (AMC) are defined as unregulated or lightly regulated substances used for medical research or patient care that can be used as “dual purpose” substances by terrorists to inflict damage upon populations. Most of these agents are used routinely throughout AMC either during research or for general clinical practice. To date, the lack of careful regulations for AOs creates uncertain security conditions and increased malicious potential. Using a consensus-based approach, we collected information and opinions from staff working in an AMC and 4 AMC-affiliated hospitals concerning identification of AO, AO attributes, and AMC risk and preparedness, focusing on AO security and dissemination mechanisms and likely hospital response. The goal was to develop a risk profile and framework for AO in the institution. Agents of opportunity in 4 classes were identified and an AO profile was developed, comprising 16 attributes denoting information critical to preparedness for AO misuse. Agents of opportunity found in AMC present a unique and vital gap in public health preparedness. Findings of this project may provide a foundation for a discussion and consensus efforts to determine a nationally accepted risk profile framework for AO. This foundation may further lead to the implementation of appropriate regulatory policies to improve public health preparedness. Agents of opportunity modeling of dissemination properties should be developed to better predict AO risk.

(Disaster Med Public Health Preparedness. 2010;4:318-325)

Objective: To describe the role of academic institutions in the community response to Federal Emergency Management Agency–declared disasters from September 11, 2001, to February 1, 2009.

Methods: We conducted a review of the published literature and Internet reports to identify academic institutions that participated in the community response to disaster events between September 11, 2001, to February 1, 2009, inclusive. From retrieved reports, we abstracted the identity of the academic institutions and the resources and services each provided. We characterized the resources and services in terms of their contribution to established constructs of community disaster resilience and disaster preparedness and response.

Results: Between September 11, 2001, and February 1, 2009, there were 98 published or Internet-accessible reports describing 106 instances in which academic institutions participated in the community response to 11 Federal Emergency Management Agency–declared disaster events that occurred between September 11, 2001, and February 1, 2009. Academic institutions included academic health centers and community teaching hospitals; schools of medicine, nursing, and public health; schools with graduate programs such as engineering and psychology; and 4-year programs. The services and resources provided by the academic institutions as part of the community disaster response could be categorized as contributing to community disaster resilience by reducing the consequences or likelihood of an event or to specific dimensions of public health preparedness and response, or both. The most common dimensions addressed by academic institutions (in order of occurrence) were resource management, enabling and sustaining a public health response, information capacity management, and performance evaluation.

Conclusions: Since September 11, 2001, the participation of academic institutions in community disaster response has contributed to community resilience and the achievement of specific dimensions of disaster preparedness and response.

(Disaster Med Public Health Preparedness. 2011;5:218–226)

Background: Agents of opportunity (AO) are potentially harmful biological, chemical, radiological, and pharmaceutical substances commonly used for health care delivery and research. AOs are present in all academic medical centers (AMC), creating vulnerability in the health care sector; AO attributes and dissemination methods likely predict risk; and AMCs are inadequately secured against a purposeful AO dissemination, with limited budgets and competing priorities. We explored health care workers' perceptions of AMC security and the impact of those perceptions on AO risk.

Methods: Qualitative methods (survey, interviews, and workshops) were used to collect opinions from staff working in a medical school and 4 AMC-affiliated hospitals concerning AOs and the risk to hospital infrastructure associated with their uncontrolled presence. Secondary to this goal, staff perception concerning security, or opinions about security behaviors of others, were extracted, analyzed, and grouped into themes.

Results: We provide a framework for depicting the interaction of staff behavior and access control engineering, including the tendency of staff to “defeat” inconvenient access controls. In addition, 8 security themes emerged: staff security behavior is a significant source of AO risk; the wide range of opinions about “open” front-door policies among AMC staff illustrates a disparity of perceptions about the need for security; interviewees expressed profound skepticism concerning the effectiveness of front-door access controls; an AO risk assessment requires reconsideration of the security levels historically assigned to areas such as the loading dock and central distribution sites, where many AOs are delivered and may remain unattended for substantial periods of time; researchers' view of AMC security is influenced by the ongoing debate within the scientific community about the wisdom of engaging in bioterrorism research; there was no agreement about which areas of the AMC should be subject to stronger access controls; security personnel play dual roles of security and customer service, creating the negative perception that neither role is done well; and budget was described as an important factor in explaining the state of security controls.

Conclusions: We determined that AMCs seeking to reduce AO risk should assess their institutionally unique AO risks, understand staff security perceptions, and install access controls that are responsive to the staff's tendency to defeat them. The development of AO attribute fact sheets is desirable for AO risk assessment; new funding and administrative or legislative tools to improve AMC security are required; and security practices and methods that are convenient and effective should be engineered.

(Disaster Med Public Health Preparedness. 2010;4:291-299)