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.
The special reporting requirements only apply to researchers who are Investigators participating in PHS 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, collaborators or consultants. As part of the proposal submission at Brown, the PI on a research grant is required to determine which research personnel is an “Investigator”. He/she will consider the role, rather than the title, of those involved in the research work.
If you have been designated as an Investigator, you will be asked to complete the COI Assurance question as part of the proposal submission. If you are an investigator on a research project funded by PHS or any of the foundations that follow the PHS COI regulations, this requirement applies to you.
If you have questions or are unsure if this requirement applies to you, please contract Juliane Blyth.
Special Requirements for PHS Investigators
1. FCOI Training
As of August 24, 2012, investigators must complete FCOI training prior to engaging in new or continuing awards funded by PHS and foundations that follow the PHS COI regulations. Investigators have to be re-trained every four years and whenever there is a change to the institution's COI policy. The institution must also re-train any investigator who has been found to be not in compliance with the regulations and/or Brown's COI policy.
- Where can I take the FCOI training?
Brown’s on-line FCOI training module is available through Traincaster.
To take the training, click on the Traincaster link and log into the system. The FCOI training module should be assigned to you. If you do not have a Traincaster account OR if you cannot find the FCOI training module, please contact Juliane Blyth. If you have questions after you have taken the training, please contact Juliane Blyth.
2. Report new Significant Financial Interests within 30 days of acquisition or receipt
Investigators participating in PHS 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.
A “Significant Financial Interest” (SFI) is defined as the receipt by you, your spouse, or your dependent children of any of the following:
- Income that exceeds $5,000 from any outside entity, measured on a rolling 12‐month basis. This may be one payment from a particular company of more than $5000, or multiple payments from the same company that in the aggregate exceed $5000 and are received within the previous 12 months.
- Acquisition of equity in a public company that exceeds $5000 in value;
- Aggregated income and equity/ownership interest from a public company that exceeds $5,000, as measured on a rolling 12‐month basis;
- ANY equity/ownership interest in a privately‐held company;
- An income that exceeds $5,000 from rights in intellectual property , as measured on a rolling 12‐month basis;
- All reimbursed and “sponsored” travel that exceeds $5,000, as measured on a rolling 12‐month basis.
Excluded from this definition are:
- Payments (including travel) received from Brown University
- Income from investment vehicles over which you do not exercise control, such as mutual funds and retirement accounts
- Payments received from any of the following entities, provided these payments are received for teaching engagements, lectures, seminars, or services on advisory committees or review panels:
- Government agencies
- US institutions of higher education and research institutes affiliated with them
- Academic teaching hospitals
- Medical centers
An 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).
Investigators who are participating in PHS 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) and certain foundation (see list below), 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 (1) a federal, state, or local government agency; (2) an institution of higher education as defined at 20 U.S.C. 1001 (a) ; (3) an academic teaching hospital; (4) a medical center; or (5) a research institution that is affiliated with an institution of higher education.