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Conflict of Interest

PHS Financial Disclosure

The Public Health Service (PHS) requires disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or via subaward. The American Cancer Society, American Heart Association, Alliance for Lupus Research, Arthritis Foundation, Susan G. Komen for the Cure and other non-PHS agencies have also adopted the PHS requirements.

The RAC Conflict of Interest Office has developed a three-stage process to implement the disclosure, review and reporting requirements of the revised PHS financial disclosure regulations, which are effective August 24, 2012.

This new process, with new PHS financial disclosure forms, has been designed to reduce and simplify the administrative burden associated with financial disclosure and review at the initial proposal submission stage for new and competing continuation/renewal proposals. More detailed financial information will not be collected unless and until a proposal is likely to be funded, generally when a Just-in-Time (JIT) or similar request is received. This will allow the COI Committee to concentrate its efforts on review associated only with projects that are likely to be funded and reduce the administrative burden on both investigators and COI Committee staff 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 SFI 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 a proposal is submitted, whether UCB will be the prime awardee or the subawardee to another entity, any individual on the proposed project who has been named by the UCB Principal Investigator as an investigator (as defined by the regulations) is required to complete and sign the PHS Financial Disclosure (Form 1), which contains four questions pertinent to the requirement for disclosure of Significant Financial Interests (SFI). This form must accompany the proposal when it is submitted to the Sponsored Projects Office. The UC Berkeley PI must also provide SPO with a signed PHS FCOI Policy: Principal Investigator Certification, or, in lieu of a signed/dated form, the PI may directly send email to SPO with the certification language included. A proposal will not be considered complete and cannot be submitted to the funding agency by the Sponsored Projects Office unless required financial disclosures are in place.

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

Step 2

If and when a proposal receives a JIT request or some other indication from the funding agency that indicates it is likely to be funded and when the PHS Financial Disclosure (Form 1) has “yes” responses, only those investigators with “yes” responses will be contacted by the Conflict of Interest (COI) Coordinator to request completion and submission of the PHS Financial Disclosure (Form 2). The PHS Financial Disclosure (Form 2) contains a set of questions, the answers to which will be used by the campus Designated Official (in consultation with the Principal Investigator, investigator and others, as necessary) to determine whether or not a disclosed SFI is related to the 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 PHS-compliant training.

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

Step 3

  • Any investigator who is notified by the COI Coordinator that s/he has a related SFI will complete a PHS Financial Disclosure (Form 3), which contains a set of questions developed to determine the extent to which the identified SFI may directly and significantly affect the design, conduct or reporting of the PHS-funded research project.
  • The COI Committee will review the PHS Financial Disclosure (Forms 1 - 3) in conjunction with the proposal and any other information, which may have been provided or requested, to decide whether the related SFI constitutes a financial conflict of interest (FCOI) under the regulations. If it is determined that an FCOI exists, then the COI Committee will develop an appropriate management plan with the purpose of providing reasonable expectation that the FCOI of the investigator(s) will not bias the research results of the PHS-funded research. That management plan requires the signed concurrence of the investigator(s) with the FCOI. The COI Coordinator will then report required details of the FCOI to the NIH (or the prime awardee if UCB is a subrecipient.) FCOI’s must be reported to NIH prior to the expenditure of funds. PIs and investigators must plan for sufficient processing and review time, as review by the COI Committee will take place at its regularly scheduled monthly meetings.

A Special Note about Subrecipients:

Each subrecipient must complete a UCB Subrecipient Commitment Form (dated 9/2012 or later), which has questions pertinent to the new PHS financial disclosure regulations to determine if a subrecipient has a PHS-compliant policy in place. If the subrecipient has completed and signed a previous version of the UCB Subrecipient Commitment Form (earlier than 9/2012), then each subrecipient must complete a UCB Subrecipient Commitment Form: FCOI Addendum, so that the new information is provided.

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 Berkeley 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 investigator of the subrecipient must complete the UCB PHS Financial Disclosure (Form 5) before UCB submits its proposal to PHS. A proposal will not be considered complete and cannot be submitted by the Sponsored Projects Office unless PHS Financial Disclosure (Form 5) has been submitted by all investigators of the subrecipient. If the proposal is selected for funding, then Steps 2 and 3 (as described above) 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 UCB in accordance with the PHS requirements; they will not have the option of relying on the UC policy.

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

The regulations now require that annual financial disclosure of SFI be made by all investigators, including those of any subrecipient who is relying on UC Berkeley’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 a PHS Financial Disclosure (Form 1) must be completed by all investigators and provided to the Sponsored Projects Office. Any investigators with a “yes” response to any of the questions on Form 1 must complete and submit PHS Financial Disclosure (Form 2) 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. The UC Berkeley PI must also provide SPO with a signed PHS FCOI Policy: Principal Investigator Certification, or, in lieu of a signed/dated form, the PI may directly send email to SPO with the certification language included.

Step 2

The campus Designated Official (in consultation with the Principal Investigator and others, as necessary) will 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 PHS-compliant training.

Step 3

  • Any investigator with a related SFI will be notified by the COI Coordinator and requested to complete a PHS Financial Disclosure (Form 3), which contains a set of questions developed to determine the extent to which the related SFI may directly and significantly affect the design, conduct or reporting of the continuing PHS-funded research project.
  • The COI Committee will review the PHS Financial Disclosure (Form 3) in conjunction with the proposal, the PHS Financial Disclosure (Forms 1 and 2) and any other information, which may have been provided or requested, to decide whether the related SFI constitutes a financial conflict of interest (FCOI). If it is determined that an FCOI exists, then the COI Committee will develop the appropriate management plan for the conflicted investigator, and the COI Coordinator will report to the NIH (or the prime awardee if UCB is a subrecipient), as required by the regulations.

NOTE: The Sponsored Projects Office will not release an award until all investigator financial disclosures have been received, reviewed and approved and the PI has certified that all investigators on the project have completed the PHS-compliant training.

Forms

NOTE: Please use Adobe Acrobat or Reader to fill out PDF forms.

Training

All Investigators are required to take PHS-compliant training prior to engaging in PHS-funded research for new awards or no later than the due date of the next subsequent progress report/non-competing continuation proposal for ongoing projects, whether receiving remuneration or not, 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. The training requirement must be met as follows:

  • University of California Conflict of Interest Training for Researchers (COIR) is available for UC Berkeley researchers with a Calnet ID through the UC Learning Center on the campus Blu portal. Note that UC extramurally funded researchers (PHS and non-PHS funded) must complete this COIR training (whether or not they have also completed other PHS-specific training) to satisfy Regentally mandated COI training if included in the August 8, 2012 COIR rollout audience. The mandatory completion date for this training is September 30, 2012.
    • Go to Blu, login with your Calnet ID, click UC Learning (near bottom left), and search for COIR.
    • Go through the training slides to complete the course.
    • After you have completed the training, you will receive a certification email. Keep this email for your records.
  • PHS researchers should complete the training by August 24, 2012 or take an additional stand-alone COI-PHS course if they meet certain conditions, i.e., a Notice of Award or continuation dated on or after August 24, 2012.
    • Go to Blu, login with your Calnet ID, click UC Learning (near bottom left), and search for COI-PHS.
    • Go through the training slides to complete the course.
    • After you have completed the training, you will receive a certification email. Keep this email for your records.
  • Only those investigators (including those of subrecipients who are relying on the UC PHS-compliant policy) who do not have a Calnet ID must complete the COI-PHS training course on the COI Committee web site.
    • Go through the training slides to complete the course.
    • After you have completed the training, print and sign the certification form provided. Keep this for your records.

UC Policy

UC Berkeley Information

PHS Policy