PHS COI Requirements
In response to the Department of Health and Human Services (HHS) Responsibility of Applications for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors Final Rule, WSU has revised Executive Policy #27, Ethics, Conflict of Interest, and Technology Transfer.
The intent of the revised HHS regulation is to increase accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators' financial conflicts of interest, and strengthen HHS's compliance oversight. The primary goal is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under HHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest.
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Services (HIS)
- National Institutes of Health (NIH)
- Substance Abuse & Mental Health Services Administration (SAMHSA)
Non PHS Sponsors (Adopted PHS FCOI Regulations):
- Alliance for Lupus Research
- American Cancer Society
- American Heart Association
- American Lung Association
- Arthritis Foundation
- California Breast Cancer Research Program (CBCRP)
- California HIV/AIDS Research Program (CHRP)
- Juvenile Diabetes Research Foundation
- Lupus Foundation of America
- Susan G. Komen Foundation
Significant Financial Interests
For PHS funding (or for non-PHS sponsors who have adopted PHS regulation), a SFI is a financial interest of the Investigator and of the Investigator's family which reasonably appears to be related to the Investigator's WSU Responsibilities. An SFI must be disclosed if:
- The value of remuneration received from a publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
- The value of remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator and his/her Family holds any equity interest in a non-publicly traded entity;
- The values above should include any intellectual property rights and interests (e.g., patents, copyrights), held by the Investigator and his/her Family upon receipt of income related to those rights and interests;
- Any Travel reimbursed or sponsored (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigators WSU Responsibilities; except travel that is reimbursed or sponsored by a nonconflicting institution.
Investigator means the project director or principal investigator, the co-principle investigators and any other person, regardless of title or position, including the PD/PI and Senior/Key personnel as defined in this policy, who is responsible for the design, conduct, or reporting of a research project, funding or proposal.
Family means the Investigator's or Research Employee's spouse/domestic partner, dependent children and other dependent relatives living in his or her household (Investigator's/Research Employee's financial interest includes the aggregate financial interest of the family).
Significant Financial Interest (SFI) means a financial interest of the Investigator and his/her Family that is the amount and type which must be disclosed to the University or which creates a COI for the Investigator or Research Employee. The University and most federal sponsors have specific provisions establishing what constitutes SFI.
Investigator's WSU Responsibilities means an Investigator's professional responsibilities on behalf of the University, which may include for example: activities such as research, research consultation, teaching, professional practice, and institutional committee memberships.
- 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 institute that is affiliated with an Institution of higher education.
Investigators must disclose their Significant Financial Interests (SFI's) at the following times:
- When submitting a proposal related to HHS funding (direct or flow-through funding)
- When a new SFI is discovered or acquired (e.g., through purchase, marriage, or inheritance)
- When travel is reimbursed or sponsored (i.e., travel expense paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to the Investigator's WSU Responsibilities, with some exceptions (see non-conflicting institution definition below).
The University's Financial Conflict of Interest Committee, supported by the Office of Research Assurances, will review the SFI's and contact the Investigators if necessary.
Each Investigator (PI's, Co-I's, and Key Personnel) must complete training prior to engaging in HHS-funded research and at least every four years. The training is located online on MyResearch.
The information below is intended to help WSU faculty, researchers, staff, and students interpret and comply with Federal, State, and WSU regulations and policies on conflict of interest (COI). If there is any question about a specific situation please call Sheri Glaesman (firstname.lastname@example.org, 509-335-0039) or Michael Kluzik (email@example.com, (509) 335-9553).
What has changed in 2012?
The Department of Health and Human Services (HHS) passed new regulations which became effective August 24, 2012 for all Public Health Service (PHS) funding. These new regulations require any WSU Investigator that is funded by HHS to comply (Significant Financial Interest disclosure, travel disclosure, training, etc.) with the new regulations.
What if I do not have any HHS funding?
WSU employees must report financial conflict of interests via the financial Conflict of Interest and Outside Activity Request and Approval form http://www.coi.wsu.edu/forms.asp.
However, if you do not have HHS funding, you are not required to complete the significant financial interest disclosure, travel disclosure, and training.
Where can I find the WSU conflict of interest policy?
The WSU conflict of interest policy is found in Executive Policy #27, Washington State University Ethics, Conflict of Interest, and Technology Transfer http://public.wsu.edu/~forms/HTML/EPM/EP27_Ethics_Conflict_of_Interest_and_Technology_Transfer.htm.
Where can I find more information?
HHS website http://grants.nih.gov/grants/policy/coi/index.htm.
HHS FAQ's http://grants.nih.gov/grants/policy/coi/coi_faqs.htm.
National Science Foundation (NSF) conflict of interest information http://www.nsf.gov/pubs/policydocs/pappguide/nsf11001/aag_4.jsp#IVA.
Will my information be kept confidential?
Information submitted will be kept confidential to the extent allowed by the regulations and Federal and State laws. Under the HHS regulations, if WSU determines there is a Financial Conflict of Interest AND receives a request for disclosure, the following will be disclosed:
- 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 Significant Financial Interest; and
- Approximate dollar value of the Significant Financial Interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Who is required to complete the SFI disclosure?
All Investigators listed in the "Credit" section of the eREX for HHS funding are required to complete the SFI disclosure form. The HHS regulations define the term investigator to mean 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 funded by the HHS, or proposed for such funding, which may include, for example collaborators or consultants. Principal Investigators may list post-docs, graduate students, technicians, etc. on the eREX (for credit or no-credit), if they meet the definition of Investigator.
Where do I access the SFI form?
The SFI disclosure form is found in MyResearch, under the "Compliance" tab, under the "CoI" tab, within the SFI tab.
How often must I complete and submit the SFI disclosure form?
The SFI disclosure form must be completed and submitted prior to the submission of any HHS funding proposal. Even if applying for a second (or 3rd, or 4th, ...) HHS funding opportunity, you will be asked to certify that your SFI disclosure is current and accurate.
The SFI disclosure form must be amended/updated/resubmitted prior to the acceptance of an HHS funded award.
The SFI disclosure form must be amended/updated/resubmitted within 30 days of any new SFI. If a new SFI is not disclosed within 30 days, and is found to be a conflict of interest, the regulations require that a "retrospective review" be conducted. The retrospective review must look at all research activities conducted during the period the COI was not disclosed and determine whether there is the potential for bias.
The SFI disclosure form must be updated at least annually.
What does "salary and payment for services" include?
Remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship). Not including: income from seminars, lectures, or teaching engagements 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 institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for 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 institute that is affiliated with an Institution of higher education.
The HHS regulations use the term "'Investigator's institutional responsibilities" (and did not use the term Investigator's research responsibilities because they wanted the broader tie to the Investigator's roles). Thus Investigators must disclose salary and payment for services that could reasonably appear to be related to their WSU responsibilities. For example, an Investigator on the board of a pharmaceutical company should disclose the income assuming they have been appointed to the board for their expertise.
What is the disclosure period?
The previous 12 months.
What is the dollar threshold for reporting?
$5,000, when aggregated from any source.
Must I report social security income?
Should I include salary, royalties, or other remuneration paid by WSU if I am currently employed or appointed to WSU?
Should I include intellectual property rights assigned to the Institution and agreements I have made to share in royalties related to such rights?
Should I include income from investment vehicles, such as mutual funds and retirement accounts?
No, unless you directly control the investment decisions made by the vehicles.
Disclosure of "Equity Interests"
What does equity interests include?
Any stock, stock option, or other ownership interest in any entity that reasonably appears to be related to the Investigator's WSU responsibilities.
The HHS regulations use the term "Investigator's institutional responsibilities" (and did not use the term Investigator's research responsibilities because they wanted the broader tie to the Investigator's roles). Thus Investigator's must disclose equity interests that could reasonably appear to be related to their WSU responsibilities.
What is the disclosure period?
The previous 12 months.
What is the dollar value threshold?
$5,000, when aggregated from any source.
Disclosure of "reimbursed travel"
What travel must be reported?
For any Investigator with HHS funding - Any reimbursed travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that 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 institute that is affiliated with an Institution of higher education.
How do I report such travel?
If submitting a WSU Travel Authority (TA), it will capture the required information and it should be routed to the Office of Research Assurances.