What are the responsibilities and job description for the FDA-OSEL Research Fellowship in Autonomous Artificial Intelligence Device Evaluation position at Zintellect?
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available within the Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Food and Drug Administration (FDA), located at White Oak, Maryland.
Research Project: The selected fellow will collaborate closely with a multidisciplinary research group (engineers, physicists, mathematicians, clinicians, and statisticians) on developing regulatory science methods and tools to support regulatory evaluation of artificial intelligence (AI)-based computer aided rule-out devices. The research will involve extension of conventional Receiver operating characteristic (ROC) analysis to assess the safety and effectiveness of rule-out devices that identify and autonomously remove non-cancer cases from radiologists’ reading lists such that AI-negative cases are not reviewed by a radiologist. The selectee will be appointed as an ORISE Fellow at the DIDSR/OSEL/CDRH/FDA laboratories. Extensive opportunities for training and teaching in the metro DC area.
Learning Objectives: This research will facilitate learning about the assessment of image-based artificial intelligence (AI) devices used in radiology. The participant will gain extensive experience in ROC analysis and perform analytical estimation for the relevant evaluation metrics. The participant will also collaborate with DICOM medical images and open-source AI-enabled detection algorithms for mammograms. The participant will also analyze data to estimate the potential bias for different patient subgroups. The research effort will be summarized in conference and journal publications for which the ORISE fellow will get authorship recognition.
Anticipated Appointment Start Date: February 2025. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.
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. 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.
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.
