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Public Health Service (PHS) Regulations

Effective: August 24, 2012 

The Department of Health and Human Services issued a final rule that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).   These changes apply to all PHS-funded contracts and grants, subcontracts with PHS as the prime sponsor, and other research grants and contracts from entities that adopt the PHS regulations (see Agencies and Organizations Following PHS Regulations).  The University of California policy does not exceed but closely mirrors the federal regulations to meet the minimum disclosure requirements. 

When to Disclose:

  • Initial proposal
  • New personnel added
  • New significant financial interest (within 30 days of discovering or acquiring new SFI)
    • Per the NIH FAQs, a new SFI is a different type or nature of SFI (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source that meets or exceeds the threshold.  In addition, a “new” SFI is also considered to be the same type or nature of SFI (e.g., royalty payment) from a different source (e.g., company A versus company B).
  • Non-competing continuation
  • Renewal proposal
  • Supplemental funding
  • No cost time extension
Disclosures are required at least annually for the duration of the award.

Definitions:

  • Investigator(s) include 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 PHS, or proposed for such funding, which may include, for example, collaborators or consultants.  For more clarification, please visit Identifying PHS Investigators.
    • For non-UCI Investigators on the UCI's award/proposal and any subrecipients following UCI's PHS COI Policy, all individuals that meet the definition of an Investigator must submit the Form 800SR.
  • Institutional Responsibilities include an Investigator’s teaching/education, research, outreach, clinical service, and University and public service on behalf of the University of California and directly related to those credentials, expertise and achievements upon which the Investigator’s University of California campus position is based.

Per these revised PHS regulations, principal investigators and all other investigators responsible for the “design, conduct or reporting” of the PHS-funded research project are required to disclose all significant financial interests related their institutional responsibilities.  Investigators must also disclose the financial interests of their spouses/registered domestic partners and/or dependent children. 

Determining Significant Financial Interests

All UCI Investigators need to complete the Annual Disclosure in KC COI which includes the following question:

Do you, your spouse/registered domestic partner, and/or dependent children have any of the following financial interests related to your institutional responsibilities?

  • Total income or payment of services received over the past 12 months and/or equity interest in a publicly traded entity exceeding $5,000 when aggregated
  • Total income or payment of services received over the past 12 months from a non-publicly traded entity exceeding $5,000
  • Any equity interest in a non-publicly traded entity
  • Total payments received over the past 12 months for any intellectual property rights and interests (e.g., patent, copyright, assigned or licensed to a party other than the Regents) exceeding $5,000

If an Investigator has one of the above financial interests, they will need to complete the Annual Form 810 to be reviewed by the COI staff and/or COIOC member to determine whether the SFIs are related to the PHS-funded project.   If the SFI is determined to be related, then the COI staff will notify the investigator that he/she will need to also submit the PHS Addendum (Form 820) for COIOC review.

Travel Disclosure Process

All reimbursed or sponsored travel related to Investigator’s institutional responsibilities should be disclosed in the PHS Travel Log in KC COI (excluding travel that is reimbursed or sponsored by a Federal, state, local government agency, an Institution of higher education as defined by 20 U.S.C. 1001(a), an academic teach hospital, a medical center, or a research institute affiliated with an Institution of higher education).  

New Significant Financial Interest (30 day update requirement)

Each Investigator is required to disclose within 30 days of acquiring or discovering a new significant financial interest (SFI).  A "new SFI" is a different type of SFI (e.g., royalty payment versus income) than what had previously been disclosed from the same source/entity that meets or exceeds the threshold.  In addition, a "new SFI" is also considered to be the same type or nature of SFI (e.g. royalty payment) from a different source/entity (e.g., company A versus company B).  
  • Travel Only Significant Financial Interests: If the new significant financial interest only includes sponsored or reimbursed travel, then the Investigator enters the travel information in the PHS Travel Log in KC COI 
  • Non-Travel Significant Financial Interests: For all other types of significant financial interests (excluding travel), the Investigator updates their Annual Disclosure and selects "Yes" to Question 1 indicating they are reporting a new SFI.  COI Staff will contact the Investigator directly if additional forms are required through email.  

Training

Each Investigator must also complete training prior to engaging in research related to any PHS-funded grant or contract and at least every 4 years and under designated circumstances:

  • UCI’s FCOI policies change in a manner that affects Investigator requirements
  • Investigator is new to UCI
  • UCI finds an Investigator noncompliant with UCI’s FCOI policy or management plan

UCI Investigator

Please go to The UC Learning Center to access training and search “COIR.” The training is titled Compliance & Conflict of Interest Training for Researchers Briefing (COIR).

Non-UCI Investigator

Please contact COI Staff at coioc@research.uci.edu to obtain access to the training module.

Public Accessibility

Certain information concerning identified FCOIs of senior/key personnel will be available upon written request to any requestor within 5 business days.  Please contact the COI Administrator or the Public Records Office, http://www.pro.uci.edu/.

Retrospective Review

In cases of non-compliance, UCI is required to conduct a retrospective review for later determined financial conflicts of interest but not required to report the review to the PHS Awarding Component unless bias is found.

other active PHS awards

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