August 30, 2012

PHS FCOI Requirements: Impact on New Proposals and Awards

Revised Public Health Service (PHS) financial disclosure regulations, effective August 24, 2012, require the Sponsored Projects Office to change the way it processes various types of transactions for PHS sponsors as well as several other non-PHS sponsors who also have adopted these same PHS FCOI requirements.

The following guidance is effective as of August 24, 2012 and describes what is required of UC Berkeley principal investigators (PIs) who plan to submit research proposals and/or receive research funding from any of the PHS funding agencies and non-PHS agencies that have adopted the PHS Financial Conflict of Interest (FCOI) regulations. A current list of these sponsors is provided at the end of this notice.

Please note: This guidance applies to all PHS funded research grants and cooperative agreements including research grants, career development grants, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects, or research resources awards. It does not apply to NSF or any other non-PHS sponsor except those listed at the end of this announcement. Also, it does not apply to Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) applications, but it does apply to Phase II SBIR/STTR applications/awards.

Proposal Submission to Sponsors with PHS FCOI Policy

Before any new research proposal can be submitted by SPO to any sponsor that has adopted the PHS FCOI policy, the UC Berkeley PI must provide SPO with:
  1. A faxed or scanned PI certification form signed and dated by the UC Berkeley PI. This is a new form entitled, “PHS FCOI Policy: Principal Investigator Certification.” In lieu of a signed/dated form, SPO also will accept an email directly from the PI with the certification language included.
  2. A faxed or scanned PHS Financial Disclosure (Form 1) for each UC Berkeley investigator named in the proposal.
  3. A faxed or scanned PHS Financial Disclosure (Form 5) for each subrecipient investigator named in the proposal, but only if the subrecipient does not have a PHS-compliant FCOI policy.
Note: UC Berkeley PIs who are notified after August 24, 2012 that they will be funded by a PHS sponsor or a non-PHS sponsor that has adopted the PHS FCOI policy must provide items 1-3 above to SPO if these were not provided at the proposal stage. The award will not be set up by SPO until these items are received and all positive disclosures have been approved by the UC Berkeley COI committee.

Determining if a Subrecipient has a PHS-Compliant FCOI Policy

The UC Berkeley PI should take these steps:
  • First consult the FDP FCOI Clearinghouse to see if the subrecipient is listed. If the subrecipient is listed on the FDP FCOI Clearinghouse website, nothing more is required of the UC Berkeley PI for the subrecipient’s investigators.
  • Each subrecipient must complete a UCB Subrecipient Commitment Form. The current version of the form, dated 9/2012, 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), and if the subrecipient is not listed on the FDP FCOI Clearinghouse website, the UC Berkeley PI must ask the subrecipient to complete and submit a UCB “Subrecipient Commitment Form: FCOI Addendum,” so that the new information is provided.
  • If the subrecipient’s authorized official indicates on the Subrecipient Commitment Form or on the Addendum that it DOES NOT have a PHS-compliant FCOI policy, the UC Berkeley PI will need to submit to SPO a faxed or scanned PHS Financial Disclosure (Form 5) signed and dated for each of the subrecipient’s investigators named in the proposal.

PHS Non-Competing Continuation Applications (Progress Reports)

For a non-competing continuation application/progress report submitted to any PHS sponsor, the UC Berkeley PI must submit to SPO items 1-3 listed above on or before the date the non-competing continuation application/progress report is due to the PHS sponsor. Failure to do this will violate PHS FCOI regulations.

Other Covered Transactions

PHS FCOI regulations also require SPO to collect from the UC Berkley PI items 1-3 listed above prior to submitting a request for a no-cost extension or any supplement that extends the end date of the award.

PHS Sponsors

National Institutes of Health (NIH)
Food and Drug Administration (FDA)
Centers for Disease Control (CDC)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Health Resources and Services Administration (HRSA)
Indian Health Services (IHS) Substance Abuse and Mental Health Services Admin (SAMHSA)

Non-PHS Sponsors adopting PHS FCOI Regulations

Alliance for Lupus Research
American Cancer Society
American Heart Association
Arthritis Foundation
Susan G. Komen for the Cure

For more detailed information about PHS financial disclosure requirements consult PHS Financial Disclosure on the RAC Conflict of Interest web site.