PHS COI Policy Update

Grace Park, COIOC AdministratorOffice of Research

June 2012

Objectives

• Highlight Revisions to the PHS Regulations on Financial Conflict of Interest

• Implementation Plans• Contact Information• Questions

Background

• In 1995, the Public Health Service (PHS) published regulations to promote objectivity in research

• The final rule revising the 1995 PHS regulations were issued on August 25, 2011

• Implementation deadline is August 24, 2012

PHS COI Revisions

Definition of Significant Financial Interest (SFI) - Threshold

1995 Regulations• Must disclose if

aggregate payments or equity interests are greater than $10,000

2011 Regulations• Must disclose if

aggregate payments or equity interests are greater than $5,000

• Any equity in non-publicly traded entities

• Any travel payments and/or reimbursements

Travel

• Investigators must disclose any reimbursed or sponsored travel – Purpose of the trip– Identity of sponsor/organizer– Destination– Duration

Exclusions

1995 Regulations• Income from seminars, lectures,

or teaching, and service on advisory committees or review panels, for public or nonprofit entities

2011 Regulations• Income from seminars, lectures,

or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an 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 an institution of higher education

What Must Be Disclosed

1995 Regulations• Only Significant

Financial Interests (SFI) the Investigator deems related to PHS-funded research

2011 Regulations• All SFIs related to

Investigator’s institutional responsibilities

Definition of Institutional Responsibilities

• “Institutional Responsibilities” is defined as teaching/education, research, outreach, clinical service, and University and public service on behalf of the UC which are in the course and scope of the Investigator’s UC employment.

Determination of Relatedness

1995 Regulations• Investigator bore the

responsibility for determining the relatedness of a SFI to the PHS funded research as part of the disclosure process

2011 Regulations• The Institution has the

responsibility for determining whether an Investigator’s SFI is related to the PHS funded research

2011 Regulations• Disclosures of SFI related

to institutional responsibilities disclosed at time of proposal

• Within 30 days of discovering or acquiring a new SFI

• Annually during the period of award

1995 Regulations•Disclosures of SFI were submitted at time of award

Timing of the Disclosures

Review Procedure

1. Disclosure at time of proposal – SFI related to institutional responsibilities

2. Review of relatedness3. At time of award - submission of addendum

for SFI related to PHS funded research4. COIOC Review

Going Forward

UCI’s Preparations

• Coordinating with other UC campuses• Updating UCI’s policy, procedures, and forms• Promoting awareness of the PHS revisions and

UCI’s procedural changes

Campus Awareness

• Educating and informing the campus is essential:– To prevent delays in the release of PHS funding– To minimize the administrative burden on

researchers and staff– To facilitate the transition to complying with the

new regulations

Contact Information

Grace Park, COI Administrator• parkgj@uci.edu (949) 824-7218Nadia Wong, COI Analyst• nadiaw@uci.edu (949) 824-0012

Questions?