*Applications will be reviewed on a rolling- basis.
HHS Office and Location: A fellowship opportunity is available in the Division of Compliance Oversight (DCO) within the Office for Human Research Protections (OHRP) (https://www.hhs.gov/ohrp/index.html), Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (HHS) located in Rockville, Maryland. Remote or hybrid flexibility will be considered.
OHRP provides leadership in the protection of the rights, welfare and wellbeing of subjects involved in research conducted or supported by HHS.
Research Project: OHRP's DCO has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46 at http://www.hhs.gov/ohrp/regulations- and-policy/regulations/45-cfr-46/index.html). In carrying out this responsibility, OHRP reviews allegations of noncompliance involving human subject research conducted or supported by HHS or that are otherwise subject to the regulations and determines whether to conduct a for-cause compliance investigation. DCO also conducts a program of not-for-cause evaluations of institutions and reviews and responds to incident reports from assured institutions.
The research participant will assist DCO in carrying out its broad responsibility for oversight of compliance with HHS Protection of Human Subjects Regulations at 45 CFR Part 46. This includes reviewing incident reports and complaints regarding allegations of noncompliance as well as and conducting site assessments and conducting research regarding compliance polices and procedures.
Under the guidance of a mentor, research activities may include:
Research and analyze HHS divisions approaches to compliance oversight procedures and prepare related reports for OHRP leadership. Research and assist OHRP's Division of Compliance Oversight in the development and implementation of recommendations made by the Government Accountability Offices report entitled Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness, GAO-23-104721, Published: Jan 17, 2023. Publicly Released: Feb 16, 2023. Research and collect data about research institutions that conduct HHS-supported human subject research and the IRBs that oversee that research. Research and assist in the development of OHRP compliance policies. Participate in internal and public presentations related to 2018 regulations (45 CFR 46) for the protection of human research subjects. Participate in Departmental or Agency committees and working groups on issues related to human subject protections. Collect, analyze, and evaluate information to develop and revise documents related to OHRP's compliance policies. Coordinate responses to requests for information, technical assistance and guidance related to human subject research policy. Learning Objectives: The research participant will learn about procedures DCO implements to carry out its mission to conduct oversight of compliance with HHS Protection of Human Subjects Regulations at 45 CFR Part 46.They will learn how to facilitate and engage cross-division collaboration regarding human subjects research protections within HHS. In addition, the research participant will learn processes and procedures for interacting with the Governmental Accountability Office (GAO). The research participant will learn how to evaluate incident reports and complaints regarding allegations of noncompliance as well as gain experience researching compliance polices and procedures.
Mentor(s): The mentor(s) for this opportunity are Lisa Buchanan (Iisa.firstname.lastname@example.org) and Amanda Sly (Amanda.Sly@hhs.gov). If you have questions about the nature of the research please contact the mentor.
Anticipated Appointment Start Date: 2023. 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 HHS and is contingent on the availability of funds.
Level of Participation: The appointment is full-time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens only.
ORISE Information: This program, administered by ORAU through its contract with the U.S. Department of Energy (DOE) to manage the Oak Ridge Institute for Science and Education (ORISE), was established through an interagency agreement between DOE and HHS. Participants do not become employees of HHS, DOE or the program administrator, and there are no employment-related benefits. Proof of health insurance is required for participation in this program. Health insurance can be obtained through ORISE.
The successful applicant(s) will be required to comply with Environmental, Safety and Health (ES&H) requirements of the hosting facility, including but not limited to, COVID-19 requirements (e.g. facial covering, physical distancing, testing, vaccination).
Questions: Please visit our Program Website. After reading, if you have additional questions about the application process please email HHSrpp@orau.org and include the reference code for this opportunity.