Mandatory Conflict of Interest Rules for all PHS/NIH Funded Researchers
Argonne National Laboratory has updated its Conflict of Interest in Research policy to comply with the revised Public Health Service (PHS) regulations described below. The regulations apply only to PHS-funded grants and cooperative agreements, including noncompeting continuing awards.
The policydiffers from prior rules for disclosure and review of personal financial interests related to PHS-funded research in three key areas:
- Lower thresholds for disclosure
- Expanded scope of what must be disclosed
- Required COI training
The policy is available in an Argonne document.
Summary and FAQs
The U.S. Department of Health and Human Services and the PHS have issued new financial conflict of interest (FCOI) disclosure regulations. These FCOI regulations establish standards and thresholds for financial disclosures that must be followed by institutions that apply for or receive research support from PHS agencies, including the National Institutes of Health (NIH). The rules also apply to a handful of non-federal sponsors. Please consult the list of Federal and non-Federal sponsors that have adopted the PHS regulations. Please consult Argonne’s Sponsored Research Office for the most up-to-date list.
Mandatory financial disclosures
The FCOI regulations differ in several significant ways from the prior rules, including reduced disclosure thresholds and more expanded review and reporting obligations:
Who must disclose?
Any personnel on a PHS-funded project who are responsible for the design, conduct or reporting of the research. This would include senior and key personnel and all others who contribute to the scientific development or execution and reporting of a project in a substantive, measurable way, whether or not they request or receive salary or compensation. The requirement for disclosure extends to income and equity held by the spouse, registered domestic partner and dependent child(ren) of such personnel.
When must disclosure be made?
Personnel must disclose any Significant Financial Interests related to their Institutional Responsibilities at the time a proposal is submitted for PHS funding, at least annually throughout the period of any resulting award and within thirty (30) days of acquiring or discovering any new Significant Financial Interest.
What must be disclosed?
- Publicly traded equity owned or acquired in the previous 12 months in any Publicly Traded Entity, the value of which exceeds $5,000. Mutual funds or retirement funds over which you do not control investment decisions are excluded.
- Any equity interest owned or acquired in the previous 12 months in any non-Publicly Traded Entity, which exceeds $5,000. This includes any stock, stock option or other ownership interest.
- Any income or other payment for services received within the previous 12 months from any entity, which exceeded $5,000. Payments from Argonne, income from seminars, lectures or teaching engagements sponsored by a federal, state or local government, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with a U.S. institution of higher education are excluded.
- Any payments received within the past 12 months for any intellectual property rights and interests (e.g., patents, copyrights, assigned or licensed to a party other than Argonne), which exceed $5,000.
- Any travel reimbursement or payment totaling over $5000 per entity, within the past 12 months. Payments from federal, state or local governments, U.S. institutions of higher education, or a research institute, academic medical center or hospital affiliated with U.S. institution of higher education are excluded.
The FCOI regulations also include new requirements for mandatory and ongoing education and training. Argonne presently uses CITI Program Conflict of Interest training. All PHS investigators, as defined by the rule, must complete this training prior to beginning work on a PHS-funded project. Please retain a copy of completion for your records.
Pursuant to PHS requirements, Argonne will provide to any member of the public information about the significant financial interests of Senior/Key investigators funded by Public Health Service (PHS) funds, if the financial interest relates to the PHS-funded research project and Argonne has determined that the financial interest creates a conflict of interest under PHS regulations. To obtain conflict of interest information, please complete this form and submit it as instructed.
If you need assistance in identifying the sponsor’s award number and/or precise spelling of the Senior/Key investigator’s name, please access the National Institutes of Health’s RePORT tool for assistance here or here.
Please complete one form for each individual investigator regarding whom information is requested. Please submit this form to SPP@anl.gov with the subject line “PHS FCOI Information Request.” Argonne will endeavor to respond within five business days, beginning the business day following the request.
Please note that you will receive specific information regarding the Investigator only if Argonne has determined that an FCOI exists In that case, the report will contain the following information:
- Investigator’s name
- Investigator’s title and role with respect to the research project
- Name of the entity in which the significant financial interest is held
- Nature of the financial interest
- Approximate dollar value (in ranges) of the significant financial interest, or a statement that the interest is one that cannot be readily determined through reference to public prices or other reasonable measures of fair market value
The information provided will be current as of the date of the correspondence and is subject to updates, on at least an annual basis. Updated information will not be reported to you. You must submit a new request to seek updated information.
The regulations and updated FAQs prepared by the NIH can be accessed at the NIH Financial Conflict of Interest webpage.