Government and Regulations

Collaboration of the NIH and PHS Commissioned Corps in the International Ebola Clinical Research Response

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Challenges

In each instance, the partnership experience was not without a few problems. The match of skills between the officers who wanted to help and those needed for the research program did not always coincide. While the Corps has more than 1,200 pharmacy officers on active duty, only a fraction of those have experience conducting FDA-regulated clinical research.

Communication problems and time pressures were also constant companions to both the Corps and the NIH. The Corps was going through the largest international deployment in its history to staff multiple missions (including the primary MMU mission in Liberia). The addition of the NIH partnership, while consistent with the MMU staffing mission, provided even more work for a very limited resource. Communicating to the many Corps officers who wanted to volunteer and keeping deployment time lines on track were a challenge. Complicating the matter was the addition of stray e-mails from well-intentioned NIH and Corps staff who communicated directly with colleagues to encourage participation, not fully understanding the policies and protocol governing the deployment process.

Time was always an issue as the rotation schedules were relatively short and the number of activities to make an officer deployment ready were numerous. Obtaining official passports and visas was a challenge as that activity required coordination with the U.S. Department of State. Airline schedules changed with little or no notice, complicating deployments and returns. As the NIH added additional research studies for which support was required, time lines for studies to start became difficult to predict with certainty due to factors outside the control of the NIH. Recently, additional security training requirements for government workers traveling abroad were instituted, further complicating the process of deploying an officer.

The Corps officers taking part in this research response (which was not consistent with customary deployments from Corps headquarters) necessarily were volunteers from full-time assignments within DHHS, and as such, required the permission of their supervisory chain to volunteer. Regardless of this limitation, there was widespread support for these additional and specific research deployments. Although the use of short-term rotations was not ideal, in the end, the rotation plans worked, and the NIH was able to fulfill its research mission with the support of the Corps.

Lessons Learned/Preparing for the Future

Many lessons have been learned and continue to be learned throughout this research response and NIH/Corps partnership. Effective and frequent communication between the organization requesting Corps officers and the Corps headquarters is crucial. In the initial deployments, officers were deployed from the FDA with the assumption that they would be familiar with FDA-regulated clinical research. This was not always the case. The NIH and Corps headquarters later collaborated to develop a survey to send to Corps officers that was used to identify specific skill sets needed by officers who would be deploying to conduct clinical research. NIH personnel prescreened survey responses to identify and prioritize officers for deployment consideration by the deployment authority. This process resulted in the selection of officers who generally needed less training and guidance.

Effective training in clinical research principles for deployed officers and other staff needs to be developed and made available to all deploying individuals. All clinical research staff are required to have training on GCP, but most GCP training programs focus primarily on the ethical principles of research as outlined by the Declaration of Helsinki, Nuremberg Code, and other documents. Few GCP training programs present adequate information on the hands-on conduct of clinical research, especially research regulated by the FDA and other government bodies and therefore subject to certain strict requirements. Examples of crucial but often overlooked topics are source document retention, good documentation practices, cold-chain principles, and other issues related to the creation and retention of adequate trial records.21

The handoff between returning and deploying officers is crucial. Due to various issues with changing time lines, flights, and administrative processes, it is imperative to plan adequate overlap between returning and deploying officers. Delays in obtaining passports or visas, flight cancellations, and other unforeseen issues may unexpectedly shorten any planned overlap periods. A full workweek is desirable for overlap so that the new officer may experience tasks that occur throughout the week, be introduced to the various team members, and have help if unexpected events occur. A regular staff member should check periodically that proper procedures are being followed, as some information may be missed during each handoff, and consecutive unchecked handoffs could result in large deviations of important procedures. Onboarding and offboarding checklists should be developed and updated regularly to guide the handoff process.

On a larger scale, the respective agencies and other stakeholders involved in planning clinical research for public health emergencies need to be included in regular tabletop training exercises to better understand how to coordinate a response when needed. Additionally, although many of the Corps officers who took part in this deployment served as mentors for others preparing for deployment, establishing a formal roster of experienced officers to support specific roles of this type of response would help serve as a resource center for future deployments. Finally, coordination between any operating division (or agency) and the Corps should be through the established Corps command infrastructure to eliminate miscommunication and complicating deployment processes.22

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