NIH Clinical Center Offers Sabbatical in Clinical Research Management
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"The Clinical Center's new sabbatical is an innovative approach to assuring leadership in clinical research management, which will lead-in turn-to more rapidly moving advancements in medical science to improvements in health and health care for all,'' said Dr. John I. Gallin, Clinical Center director. "Our hope is that participants will go on to help lead major clinical research programs in the United States and abroad. We are pleased to be at the forefront of this endeavor."
The program is open to clinical investigators, health care managers and administrators, and others who oversee clinical trials, including international research studies. Participants can expect flexible and specialized education in this field and the opportunity to work and learn with the full complement of clinical research experts at NIH and components of the U.S. Department of Health and Human Services, including the Food and Drug Administration.
Re-engineering the clinical research enterprise - including training in the discipline - is one of the initiatives in the NIH Common Fund (formerly the NIH Roadmap for Medical Research), launched in 2004. The concept for the sabbatical program was also recommended by the NIH Director's Blue Ribbon Panel in 2004.
"The program will help demystify the complexities of governmental regulatory agencies while providing an opportunity to achieve excellence in clinical research management," Gallin said.
Sabbatical participants select electives from six core modules that offer exposure to all aspects of the clinical research environment: critical infrastructure, support services, legal and regulatory infrastructure, communications and outreach, strategic management, and funding opportunities.
"All have been structured to provide the training and hands-on experience required to manage a clinical research program of the highest quality," said Dr. Frederick P. Ognibene, Clinical Center deputy director for educational affairs and strategic partnerships and director of the Office of Clinical Research Training and Medical Education.
Electives within the modules include topics such as protocol writing and tracking, bioethics and human subjects' protections, international clinical research, informatics, research nursing, scientific review, patient recruitment, and budget management. Electives are primarily led by scientists and administrators in the Clinical Center, but participants also have the option of electives at the FDA, the HHS Office for Human Research Protections, and the Foundation for NIH.
"I am really glad that I had an opportunity to participate in the sabbatical program," said Dr. Roman Ivanov, a pilot participant and clinical researcher at the Pirogov National Medical-Surgical Center in Moscow. "It provided me with a unique opportunity to get a better understanding of infrastructure required for investigator-associated clinical trials and regulatory issues associated with them. I will do my best to share this knowledge with my colleagues and I hope that this will contribute to development of medical science in Russia."
There is no fee for participating in the program, and applications are accepted year-round. The Clinical Center expects to have approximately 10 participants per year. Stipends are not provided by the NIH for travel or living expenses, so it is expected that most individuals will be self-supported or supported by their home institution.