The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration (FDA) are educational and training programs designed to provide undergraduate and graduate students, post-master and post-doctoral, and faculty opportunities to participate in project-specific research and developmental activities at the National Center for Toxicological Research (NCTR). The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. The mission of NCTR is to conduct scientific research to develop and support innovative tools and evaluation of approaches that FDA uses to protect and promote individual and public health. To accomplish its mission, NCTR has established three strategic goals to ensure the conduct of innovative regulatory-science research vital to FDA. Regulatory Science-the science of developing and establishing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products-is the foundation of decision-making at FDA. The three strategic goals are:

• Advance scientific approaches and tools required to support public health
• Promote global interactions in regulatory science research
• Improve administrative management and develop new communication materials and methods to support HHS/FDA science goals

This is an open announcement to collect applicants for future research opportunities. The opportunities include full-time, part-time, and summer appointments at NCTR. Contact ORISE.FDA.NCTR@orau.org for more information.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. Appointments can vary from a few months to one year, but may be renewed for up to three years upon recommendation of FDA, contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

See https://orise.orau.gov/fda/ or http://www.fda.gov/ for more information.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.