Special Requirements for Investigators on Research funded by the Public Health Service, the Department of Energy and certain other Foundations
The 2011 Public Health Service (PHS) regulations on “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (“the PHS COI regulations”) - 42 C.F.R. Part 50, Subpart F – overseen by the U.S. Department of Health and Human Services (HHS), impose special reporting requirements on investigators funded by PHS. The PHS COI regulation is federal law. As a recipient of federal research monies, Brown University must comply with these regulations.
In December 2021, the US Department of Energy (DoE) published their own Conflict of Interest Policy that closely aligns with the Public Health Service Regulations. FAL 2022-02, the Department of Energy Interim Conflict of Interest Policy Requirements for Financial Interest (“the DoE COI regulations), impose special reporting requirements on investigators funded by DoE. The DoE COI regulation is federal law. As a recipient of federal research monies, Brown University must comply with these regulations.
Do these special reporting requirements apply to me?
The special reporting requirements only apply to researchers who are Investigators participating in PHS funded research, DoE funded research, or research funded by a foundation that follows the PHS COI regulations.
Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, which may include, for example, postdoctoral fellows, collaborators, or consultants. As part of the proposal submission at Brown, the PI on a research grant is required to designate which research personnel is an Investigator. She will consider the role, rather than the title, of those involved in the research work.
Please note that under the DoE COI regulations, additional personnel can be designated as Investigators by DoE personnel.
If you are an Investigator on a research project funded by PHS, DoE or any of the foundations that follow the PHS COI regulations, the below requirements apply to you.
If you have questions or are unsure if this requirement applies to you, please contact the COI Administrator.
Special Requirements for PHS Investigators
1. FCOI Training
Investigators must complete FCOI training prior to engaging in new or continuing awards funded by PHS, DoE, and foundations that follow the PHS COI regulations. For more information, please visit the FCOI Training page.
2. Report new Significant Financial Interests within 30 days of acquisition or receipt
Investigators participating in PHS or DoE funded research are required to submit an updated disclosure of significant financial interests within 30 days of discovering or acquiring a new significant financial interest (SFI). This is a requirement under federal COI regulations and can be submitted via InfoEd.
What is a new significant financial interest (SFI)?
A “Significant Financial Interest” (SFI) is considered “new” if:
You have never previously reported it to the University;
It is a different type or nature of SFI (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source OR is the same type or nature of SFI (e.g., royalty payment) but from a different source (e.g., company A versus company B);
You previously reported the financial interest but it did not meet the minimum threshold to be considered an SFI (e.g. under $5,000).
3. Report Sponsored or Reimbursed Travel
Investigators who are participating in PHS or DoE funded research are required to report to the University the occurrence of any reimbursed or sponsored travel. Reimbursed travel is travel for which the investigator is directly reimbursed by the sponsoring entity. Sponsored travel is travel that is paid directly by the sponsoring entity and is not reimbursed to the investigator. For example, a professional organization in Switzerland pays directly for your flight and hotel expenses when you attend the organization’s conference as an invited speaker.
Please note that investigators on research projects funded by the Public Health Service (PHS), the Department of Energy (DoE) and certain foundations are required under federal law to report reimbursed or sponsored travel that is related to the investigator’s institutional responsibilities or professional expertise. The institution can establish internal thresholds for reporting and reviewing travel. At Brown, the threshold has been set to $5,000 for any 12 month period.
The $5,000 threshold does not mean that an investigator cannot have sponsored or reimbursed travel of more than $5,000. Rather, it means that any travel that exceeds this threshold must be reported.
EXCEPTIONS to this reporting requirement include when travel is reimbursed or sponsored by:
- a federal, state, or local government agency;
- an institution of higher education as defined at 20 U.S.C. 1001 (a) ;
- an academic teaching hospital;
- a medical center; or
- a research institution that is affiliated with an institution of higher education.
4. Public Accessibility
The Public Health Service (PHS) and the Department of Energy require that Brown University provide public access to certain information regarding financial conflicts of interest (FCOI) held by senior/key personnel on Brown research projects funded by PHS and DoE. Upon receiving a public access request, Brown will make available the following information regarding an investigator's financial conflict of interest (FCOI):
the investigator's name;
the investigator's title and role in the research project;
the name of the entity/entities in which the investigator holds the financial interest(s);
the nature of the financial interest(s);
the approximate value of the financial interest(s) (by ranges).
ORI will notify any investigator about whom a public access request has been made.
To make a public access request, please send an email to [email protected].