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Disclosing Financial Interests: Public Health Service Sponsored Research

See financial interest reporting requirements for Public Health Service (PHS) sponsored research.

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Overview

The Public Health Service (PHS) regulations on Objectivity in Research (revised in August 2011) are designed to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of PHS Research Activities will be free from bias resulting from an Investigators’ Financial Conflicts of Interest (FCOIs).   New rules for FCOI in all research sponsored by PHS, including the National Institutes of Health (NIH), require disclosure of significant financial interests by Investigators who participate in PHS-funded research either directly or through a subaward.  The new rules also apply to a handful of non-federal sponsors who have adopted the PHS requirements. 

The new regulations apply only to grants and cooperative agreements awarded on or after August 24, 2012, including noncompeting continuing awards.  The University of California has issued a new policy on Disclosure of Financial Interests & Management of Conflicts of Interest – Public Health Service Research Awards as mandated by PHS.

What types of awards require disclosure?

Disclosure is required for any award for which research funding is available from PHS, including research contracts, research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects or research resources awards and conference grants.

When is disclosure required?

All PHS-funded Investigators planning to participate on a proposed PHS Research Activity will be required to disclose any Significant Financial Interest (SFI) related to their Institutional Responsibilities at the following times: 
  • At the time of the initial proposal submission, continuation, renewal or supplemental funding, and at least annually.
  • Whenever new personnel are added.
  • Within 30 days if there is any new or change in SFIs occurring prior to or during the period of an award.
  • When a project is awarded through a subaward and the awarding agency is PHS or another agency who has adopted the PHS financial disclosure requirements.
  • When the University is the prime contractor and subawards a portion of the research with another entity. The receiving entity is required to supply assurances that will allow the University to comply with the PHS regulations.

Who is required to disclose?

All PHS-funded Investigators (i.e., the Project Director/Principal Investigator, any other person identified as Senior/Key personnel in a grant application, progress report, or other report submitted to the PHS, and others who direct or can materially influence the research, or who are responsible for the design, conduct, and reporting of such research) will be required to disclose any Significant Financial interests related to their Institutional Responsibilities.

What is a significant financial interest related to Institutional Responsibilities?

A financial interest is anything of monetary value, whether that value can be easily determined or not, that is held by you, your spouse or registered domestic partner, and dependent children.  Under the PHS definitions, a financial interest becomes significant when it:
  1. Reasonably appears to be related to or is in the same field of expertise as your Institutional Responsibilities. Institutional Responsibilities include the teaching/education, research, outreach, clinical services, training and University and public service performed on behalf of the University and directly related to those credentials, expertise and achievements upon which your University appointment/employment is based, AND
  2. Meets any of the PHS reporting categories and thresholds.

What significant financial interests must be disclosed?

Significant financial interests (SFI) related to the Investigator’s Institutional Responsibilities consisting of one or more of the following interests of the Investigator or the Investigator's spouse or registered domestic partner and dependent children.  Note: Travel SFI applies only to the Investigator.

Investigators must disclose SFIs related to their Institutional Responsibilities that meet the following thresholds:

  • Publicly-Traded Entity: Any income received from an entity during the 12 months prior to disclosure which, when combined with the value of any equity interest you hold in the entity, exceeds $5,000 from a single entity, which is any for-profit entity or non-profit organization.

This may include salary, consultant payments, honoraria, royalty payments, dividend, loan, or any other payments or consideration with value, including payments made to the University of California Health Sciences Compensation Plans during the prior twelve months. These activities include providing consulting services, serving on a board of directors, scientific advisory board, committee, panel or commission sponsored by a for-profit or non-profit organization, including professional or scholarly societies; acting in an editorial capacity for a professional  journal; reviewing journal manuscripts, book manuscripts, or grant or contract proposals for a non-profit or for-profit organization. Equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

  • Non-Publicly Traded Entity: Any compensation received from an entity during the 12 months prior to disclosure that exceeds $5,000 OR an equity interest of any amount you hold in that entity.

This may include stock or stock options in a company that is developing, manufacturing or selling products or providing services used in your clinical practice, teaching, research, administrative or committee responsibilities.

  • Intellectual property rights and interests: Income (e.g. royalties or licensing fees) received from an entity, other than UC, during the 12 months prior to disclosure that exceeds $5,000. 

This may include receipt of income such as royalties or licensing fees from an organization other than The UC Regents for use or sale of patented or copyrighted intellectual property (e.g. software, textbooks, or other scholarly works).

  • Travel: Sponsored travel or reimbursements made to or on behalf of, the Investigator, exceeding $5,000 during the twelve months preceding disclosure, from a for-profit or non-profit entity related to the Investigator's Institutional Responsibilities.

    This includes travel paid for or reimbursed by a professional society, a company for which you are consulting, or any other for-profit or non-profit organization.

What significant financial interests do not need to be disclosed?

Significant Financial Interests (SFIs) do not include:
  1. Mutual funds or other investment vehicles such as retirement funds as long as you do not directly control the investment decisions.
  2. Payment made to you by UC for salary, stipends, royalties, honoraria, reimbursement of expenses or any other remuneration received from the University.
  3. Income for seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with a US institution of higher education.
  4. Travel paid for or reimbursed by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with a US institution of higher education.

How do I disclose significant financial interests related to Institutional Responsibilities?

Investigators must complete and submit the Financial Interest Disclosure for PHS-Funded Research form with the proposal package to:
  • Health Sciences Sponsored Projects Pre-Award Office (HSSPPO) for NIH Grant proposals only 
  • Office of Contract and Grant Administration (OCGA) for General Campus and Health Sciences  proposals
  • Scripps Institution of Oceanography OCGA Office for SIO proposals

What are the new processes and procedures for conflict of interest disclosure and review for PHS-funded research activity?

The Conflict of Interest Office has developed a three-step process to implement the disclosure, review, and reporting requirements of the revised PHS financial disclosure regulations.

This new process, which is effective August 24, 2012, has been designed to reduce an Investigator’s financial reporting requirements at the initial proposal submission stage for new and competing continuation/renewal proposals. More detailed financial information will not be collected from Investigators unless it is determined that a proposal is likely to be funded, generally when a Just-in-Time (JIT) or similar request is received. This will allow Investigators and the Independent Review Committee (IRC) on Conflict of Interest to concentrate efforts on disclosure and review associated with projects that are likely to be funded and reduce the administrative burden on Investigators at the time a new or competing continuation/renewal proposal is submitted.

The requirement in the 2011 PHS regulations for annual disclosure, however, means that significant financial interests (SFIs) must be re-disclosed on or before the due date of the progress report/non-competing continuation proposal. While this does represent an additional burden, the revised disclosure process should still minimize that for most investigators.

New or Competing Continuation/Renewal Proposals

Step 1: At the Time of Proposal Submission:

At the time a PHS proposal is submitted, any individual on the proposed project who meets the definition of Investigator is required to provide basic identifying information and responses to an initial set of four screening questions pertinent to the new federal regulations for disclosure of significant financial interests on the Financial Interest Disclosure for PHS-Funded Research.  This form must accompany the proposal when it is submitted to HSSPPO/OCGA/SIO-OCGA.

Unless a proposal is likely to be funded, this is the extent of the financial disclosure requirement for most investigators.

Step 2: After Notice of Award is Received:

If and when a proposal receives a Notice of Award or some other notification from PHS that indicates it is likely to be funded and when the Financial Interest Disclosure for PHS-Funded Research has a “Yes” response, only those individual(s) with a “Yes” response will be contacted by the Conflict of Interest (COI) Office to complete and submit the PHS Financial Conflict of Interest Disclosure Supplement. The Supplement contains a set of questions, the answers to which will be used to determine whether or not a disclosed SFI is related to the PHS research project to be funded.

Note: At this time the Principal Investigator should make sure that he/she and all other Investigators participating in the project complete the required UC Conflict of Interest Training for Public Health Service Investigators.

Only those investigators for whom relatedness has been established will move to Step 3.

Step 3:
Any Investigator with a related SFI as determined by their responses on the PHS Financial Conflict of Interest Disclosure Supplement will be reviewed by the IRC.

The IRC will review the proposal, the PHS Financial Disclosure and Supplement forms and any other pertinent information which may be needed to determine whether the related SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research.  If so, a management plan will be put in place in order to provide reasonable expectation that the PHS-funded research will be conducted free of bias. This review will occur at the regularly scheduled monthly meetings of the IRC.

Non-Competing Continuation Proposals/Progress Reports, No Cost Time Extensions, Requests for Supplements that also Extend the Period of Performance

The regulations require that annual financial disclosure of SFI be made by all investigators, including those of any subrecipient who is relying on the University of California’s PHS-compliant policy. The three-stage process to be followed is described below:

Step 1:

On or before the due date of a Progress Report/Non-Competing Continuation Proposal, at the time a no-cost extension is requested or a supplement that extends the period of performance of the award is requested, the Financial Interest Disclosure for PHS-Funded Research must be completed by all investigators and submitted to the Conflict of Interest Office. Any investigators with a “Yes” response to any of the questions on the Financial Interest Disclosure for PHS-Funded Research must complete and submit the PHS Financial Conflict of Interest Disclosure Supplement at this time, as well. These disclosure documents will serve as the required annual disclosure for investigators who have disclosed previously and the initial disclosure for any new investigators being added to the project.

Step 2:

The Supplement contains a set of questions, the answers to which will be used by to determine whether or not a disclosed SFI is related to the continuation research project to be funded. Note: At this time the Principal Investigator should make sure that he/she and all other investigators participating in the project complete the required UC Conflict of Interest Training for Public Health Service Investigators.

Step 3:

Any Investigator with a related SFI as determined by their responses on the PHS Financial Conflict of Interest Disclosure Supplement will be reviewed by the IRC.

The IRC will review the proposal, the PHS Financial Disclosure and Supplement forms and any other pertinent information which may be needed to determine whether the related SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research. If so, a management plan will be put in place in order to provide reasonable expectation that the PHS-funded research will be conducted free of bias. This review will occur at the regularly scheduled monthly meetings of the IRC.

What are the new disclosure requirements for Subrecipients?

Collaborators from other institutions who share responsibility for the design, conduct or reporting of research results, and who will be conducting research under a sub-grant or subcontract from the University are expected to comply with the policies and procedures for disclosure and review of significant financial interests (SFIs) at the institution at which they are employed, or, if their institution does not have a conflict of interest policy that complies with the PHS regulations, they must comply with the University’s policies and procedures for disclosure and review of SFIs related to PHS sponsored awards.

Subawards issued by the University will ask the subrecipient institution to certify that its policy is in compliance with PHS conflict of interest regulations, and unless the subrecipient does not have a PHS-compliant policy, will indicate that the recipient organization is responsible for reviewing the disclosures submitted by its Investigators and, if a Financial Conflict of Interest is identified, for sending the University notification of the conflict and of the subrecipient institution’s plan to manage, reduce or eliminate the identified conflicts, in accordance with PHS reporting requirements.

In most cases, a subrecipient will be an educational institution or non-profit entity, which will have a PHS-compliant policy in place as of August 24, 2012. However, in those rare instances where this is not the case, the subrecipient must agree to rely on the UC policy, including submission of the UC San Diego financial disclosure forms and adherence to the procedures and processes put in place by the campus for review, management and reporting of financial conflicts of interest.

For those subrecipients without a PHS-compliant policy, each subrecipient Investigator must complete the UC San Diego Financial Disclosure for PHS-Funded Subrecipients. If the proposal is selected for funding, then Steps 2 and 3 (as described above in the new processes and procedures for conflict of interest disclosure and review for PHS-funded research activity) will apply equally to disclosures from subrecipient Investigators.

Those subrecipients with a PHS-compliant policy will be expected to rely on that subrecipients policy and report FCOIs to the COI Office in accordance with the PHS requirements; they will not have the option of relying on the UC policy.

What is the PHS training requirement?

All Investigators are required to take PHS-compliant training prior to engaging in PHS-funded research for new awards and at least every four years while engaging in PHS-funded research. Training is also required immediately if an Investigator is new to the institution, if the UC policies change in a way that affects Investigator requirements or if UC finds that an Investigator is noncompliant with any policy or management plan. This training requirement applies equally for those funding agencies that have adopted the PHS regulations. The institution must be able to verify that training has been completed.

  • UC San Diego employees should complete this training via the UC Learning Center (to access the UC Learning Center, go to blink.ucsd.edu, select "personal tools" and then the UC Learning Center link). In the search field, enter "Compliance & Conflict of Interest for Researchers Briefing (COIR)." 
    1. Go through the training slides to complete the course.
    2. Follow the directions provided on the last slide of the course to submit confirmation of completion to the COI Office.

What additional resources are available to assist Investigators?

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