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Financial Disclosure and Requirements for PHS Investigators

Financial Disclosure and Requirements for PHS Investigators

Health and Human Services (HHS) issued a regulation, 42 CFR Part 50 Subpart F, on financial disclosure for Public Health Service (PHS)-funded investigators. Effective August 24, 2012, this regulation requires additional financial disclosure and training for anyone involved in the design, conduct and analysis of PHS-funded research, including PIs, co-PIs, academic professional research staff, postdoctoral research associates, and graduate research assistants.

If your research or employment is funded by the PHS (list of agencies), this regulation will affect you. Training and disclosure are required.

 

Watch a brief video on PHS Travel Disclosure

Required Training for PHS Investigators

Health and Human Services has issued a new regulation, 42 CFR Part 50 Subpart F, on financial disclosure for Public Health Service (PHS)-funded investigators. Effective August 24, 2012, this regulation requires training for anyone involved in the design, conduct and analysis of PHS-funded research, including PIs, co-PIs, academic professional research staff, postdoctoral research associates, and graduate research assistants.

  • Training must be completed by all new investigators before engaging in PHS funded research.
  • Training must be completed by all investigators currently involved in PHS projects prior to renewal or continuation.

Online Training through the OVCR Portal

Illinois Investigators: Login using Bluestem, and browse for PHS Financial COI Training.

Non-Illinois Investigators: Send an email to phsdisclosure@illinois.edu containing the following information:

  • Subject: Non-UIUC PHS investigator requesting training portal access

  • Body: Full Name

  • Phone Number(s)

  • Email Address

  • Desired Username

OVCR staff will contact non-Illinois investigators with login information. Once you receive those instructions Login and browse for PHS Financial COI Training.

Instructions for accessing the PHS Investigator Training in the Portal

To arrange training for your College, Department, or Research group; contact Linda Lee Drozt, phsdisclosure@illinois.edu, 333-0034.

Disclosure Processes for PHS Investigators

Financial Disclosure Processes for PHS Investigators

All PHS investigators are required to disclose their Significant Financial Interests (SFI) (and those of the Investigator's spouse and dependent children) that reasonably appear to be related to the Investigator's institutional responsibilities:

  1. no later than at the time of application for NIH-funded research;
  2. within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
  3. at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.

Pre-Award Financial Disclosure

At the time of PHS proposal submission, renewal, or continuation Principal Investigators and Co-Investigators will be asked to certify that financial disclosures and travel disclosures are up to date for all investigators expected to participate in the project.

Use the Sponsor Specific Disclosure within the START myDisclosures system to disclose significant financial interests and reportable sponsored travel.

If activities are disclosed that require review, the investigator and the unit head will be consulted.
Investigators must submit this form even if no significant financial interest is disclosed.

Disclosures will be reviewed in the Office of the Vice Chancellor for Research (OVCR), to determine if there are potential financial conflicts of interest (FCOI) relating to the individual's institutional responsibilities. OVCR will consult with the unit head(s) on the identification of FCOI as needed, and will work with the unit head(s) to manage any FCOI that are identified.

"Just in Time" Disclosure, FCOI Management and Training for Awards and Renewals

Prior to initial award, renewal, or continuation, Principal Investigators will be asked to certify that financial disclosures, travel disclosures and training are up to date for all investigators participating in the project: Certification Forms

If between the time of proposal and the time of award an investigator has acquiried a significant financial interest, he or she should use the Sponsor Specific Disclosure within the START myDisclosures system to disclose the unreported interests.

Subawards

Information regarding subawards is available at http://www.ospra.uiuc.edu/subawardadmin.html

Forms

Subrecipient PHS Investigator Financial Interest Disclosure Form
Subrecipient Certification of Financial Disclosure and Training for PHS Investigators

Ongoing Disclosures and Training

  • All PHS investigators must be trained concerning the HHS requirements and the University of Illinois Policy on Conflicts of Commitment and Interest prior to initiating work on a PHS-funded project.
  • PHS investigators must continue to disclose significant financial interests on an ongoing basis, within 30 days of acquiring a new interest.
  • New PHS investigators who join a project must disclose significant financial interests upon joining the project and then continue to disclose significant financial interests on an ongoing basis.
  • Any financial conflicts of interest that are identified must be managed or eliminated within 60 days.
  • Externally sponsored or reimbursed travel must be disclosed by PHS investigators within 30 days.
     

Travel Disclosure for PHS Investigators

PHS investigators are required to disclose the occurrence of any reimbursed or sponsored 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. This disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources as provided in the HHS regulation.

The travel disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

  • a federal, state, or local government agency,
  • a U.S. 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 a U.S. institution of higher education.

Please note that reimbursement of travel by other non-profit agencies must be disclosed, e.g. American Heart Association, American Cancer Society, Nature Conservancy, etc.

The Sponsor Specific Disclosure within the START myDisclosures system should be used to disclose reimbursed travel, in cases where no payment for services is also being made to the individual, e.g. travel to give presentations, travel associated with job interviews, travel to review proposals for non-profit agencies.

Travel disclosures entered on this web page will be reviewed in the Office of the Vice Chancellor for Research. PHS investigators and their unit heads will be contacted if questions arise.

Travel associated with significant financial interests such as consulting, paid service on a Board of Directors or Advisory Committee, or other paid outside activities should generally be reported in conjunction with disclosure of the financial interest or paid outside activity. Please use the Sponsor Specific Disclosure within the START myDisclosures system for this purpose.

Watch a brief video to determine whether disclosure of travel is required.

If activities are disclosed that require review, the form will be routed to your unit head for signature.

OSP Processes for PHS-funded Investigators

Proposal submission

At the time of proposal submission, the principal investigator and co-principal investigators will be asked to sign a transmittal form confirming that all disclosures are up to date for researchers named in the PHS proposal.  PHS transmittals cannot be accepted without all named PI and co-PI signatures.

To avoid delays, it is recommended that all researchers who are expected to be involved in the design, conduct and reporting of PHS-funded research complete training and assure they are up to date on disclosures of significant financial interests.

Data on completion of training and disclosure for faculty, staff and students is available from OVCR through Box.  Please contact phsdisclosure@illinois.edu to request access.

“Just in Time” stage

OSPRA will provide notification of the JIT request and a reminder to complete the disclosure form, required trainings, and the Certification Form.

  1. Please list the names of anyone who will be involved in the design, conduct or analysis of research on the funded project.  Make sure that each person has completed (1) PHS Investigator Training and is up to date with (2a) PHS Investigator Financial Disclosure and (2b) Travel Disclosure. Note this for each investigator in columns 1 and 2 of the form.
  2. Ensure the Principal Investigator signs the certification form.
  3. Submit the form electronically to phsdisclosure@illinois.edu.  Staff in the Office of the Vice Chancellor for Research will check the status of any conflicts of interest and return the form to OSPRA or contact the principal investigator for more information.

Award Stage

OSPRA will confirm with OVCR that a signed certification form is on file prior to forwarding the award to Grants and Contracts.  Funds cannot be expended until all PHS investigators on the project are trained and up to date with their disclosures.  Therefore, no anticipation accounts will be granted, or award funds created until OSPRA has received an approved certification form from the OVCR.

Subawards

Information regarding subawards is available at http://www.ospra.uiuc.edu/subawardadmin.html

HHS Regulation Requirements Information

Please familiarize yourself with the requirements of the new HHS regulation by reviewing the information below.

FCOI Tutorial on the HHS Regulation - You may document completion of this to satisfy your training requirement.
FCOI Presentation for NIH Grantees
Frequently Asked Questions about the Regulation

PHS FCOI Compliance Instructions (PDF)

If you have questions about the regulation or the University's Policy on Conflicts of Commitment and Interest, or suggestions regarding the implementation of the HHS regulation, please contact Linda Lee Drozt, phsdisclosure@illinois.edu, 333-0034.

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