Health and Risk Communications Research

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Research Project: The project is in the Office of Communications (OCOMM).  This Health- and Risk-Communications Research Fellowship involves participation in a social and behavioral science research project whose objective is to provide data and evidence that can help inform the communications and regulatory activities of the FDA Center for Drug Evaluation and Research (CDER). Social Scientists in CDER’s Office of Communications (OCOMM) conduct applied qualitative, quantitative, and mixed-methods research studies to understand knowledge, attitudes, perceptions, needs, and behaviors related to a variety of topics, such as those associated with the U.S. opioid, substance use, and overdose crises. The participant will have the opportunity to conduct a qualitative study to obtain, analyze, and report on publicly available discussions occurring online and on social media about FDA-approved medications to treat opioid use disorder (MOUD).  Specific sub-populations may be investigated, such as users and/or prescribers of MOUD.

Learning Objectives: Under the guidance of the mentor, the participant will learn about, enhance skills in, and gain experience:

Conducting applied research on a topic of critical public health importance;
Designing and implementing a qualitative study from start to finish using online/social media data;
Engaging with OCOMM social scientists to use novel methods and platform(s) to collect online and social media data open to the general public or among sub-populations (e.g., a platform only open to licensed physicians);
Performing in-depth, systematic qualitative analysis and interpretation of large, unstructured, open-source text data consisting of online/social media conversations;
Synthesizing findings and writing a formal study report and updating it based on input from OCOMM social scientists;
Developing and making a presentation to OCOMM social science experts and possibly other internal CDER stakeholders;
Becoming knowledgeable about the nation’s opioid, substance use, and overdose crises, the impact they have on the public and health care system, and the FDA-approved medications used to treat these disorders; and
Collaborating with OCOMM social scientists.
Anticipated Appointment Start Date: 2024/2025.  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 part time.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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.
Qualifications
The qualified candidate should be currently pursuing a doctoral degree in the one of the relevant fields (e.g. health or science communication, public health, or related field with a focus on social and behavioral research).

Preferred skills:

An interest in conducting applied health and risk communication research after graduation is desired.
Experience conducting applied health-related systematic qualitative social science research, analysis, and interpretation of results is desired.
An interest in issues related to drug and substance use and experience conducting qualitative social media research is preferred.