new phs financial conflict of interest (fcoi) regulatory requirements investigator responsibilities...

PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 1

New PHS Financial Conflict of Interest (FCOI) Regulatory Requirements

Investigator ResponsibilitiesCampus-Wide Overview

2012

PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 2

INTRODUCTIONSection 1

August 24, 2012


Note!!!

• This presentation applies only to Public Health Service (PHS) regulations. All definitions & requirements are for OUHSC faculty/staff who have or are applying for a Public Health Service (PHS) award.

• Other Conflict of Interest policies also apply to all faculty, staff, and students. Those policies may be found at this site. http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/regents-poli

cy-conflict-of-interest/

It is the responsibility of al faculty, staff, and students to be familiar with and in compliance with all applicable state law and University policies

August 24, 2012

http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/regents-policy-conflict-of-interest/




Purpose of the Updated Regulation

• The regulation is aimed at ensuring that the design, conduct, or reporting of research funded under PHS grants and cooperative agreements will not be biased by any conflicting financial interest of the investigators responsible for the research.

August 24, 2012


Summary of Regulatory Changes: Key ChangesBlue indicates change from 1995 regulations • Requirement that institution determines if a disclosed

financial interest is related to the employee’s institutional responsibilities (change from study responsibilities only) OUHSC PHS Investigator discloses all Significant Financial Interests

(SFIs)

• PHS definition: de minimis threshold for disclosure is lowered (to $5K), includes any equity, and scope of outside compensation subject to disclosure is broadened (now includes non-profit organizations)

• Disclosure for financial interests in the previous 12 months (new timetable)

August 24, 2012


Summary of Regulatory Changes: Key Changes , cont.Blue indicates change from 1995 regulations

• Travel, reimbursed or covered, must be disclosed to institution regardless of dollar amount (new)

• Paid authorship, royalties, copyrights, textbooks, must be disclosed to institution (new)

• Mandatory training requirement every 4 years for investigators (new)

• Timely disclosure of any changes in significant financial interest must occur within 30 days (new)

August 24, 2012


KEY DEFINITIONSSection 2

August 24, 2012


Key Definitions: Public Health Service (PHS)

• Includes National Institutes of Health (NIH) Centers for Disease Control & Prevention (CDC) Food & Drug Administration (FDA) Agency for Healthcare Research & Quality (AHRQ) Health Resources & Services Administration (HRSA) Indian Health Service (IHS) Substance Abuse & Mental Health Services Administration (SAMHSA) Agency for Toxic Substances & Disease Registry (ATSDR) Administration for Children and Families (ACF) Centers for Medicare & Medicaid Services (CMS) Federal Occupational Health (FOH)

August 24, 2012


Key Definitions: Investigator

• “Project Director/Principal Investigator (PD/PI) as well as any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or proposed for such funding Applies to sub-investigators, sub-recipients, sub-grantees,

collaborators, subcontractors, or consortium members Includes state flow-through if originating source is a PHS agency

PD/PI is responsible for identifying all individuals who might be considered an Investigator on a PHS award

August 24, 2012


Key Definitions: Investigator, cont.You are considered an Investigator if you are:

• A Principal Investigator (PI)/Project Director (PD)• Senior/Key Personnel• All significant contributors or collaborators if responsible for design,

conduct or reporting of research• Designated by the PI/PD as responsible for design, conduct or

reporting of research This could include administrative staff if the PD/PI determines that they could

influence the design, conduct, or reporting of research

It is the PI’s responsibility to identify all Investigators as defined by the PHS regulationsAugust 24, 2012


Key Definitions: Institutional Responsibilities• An Investigator’s “professional responsibilities on behalf of the institution”• Examples include but are not limited to

Research Research consultation Teaching Professional practice Speaking Engagements Institutional committee memberships Service on panels such as Institutional Review Boards or Data and Safety

Monitoring Boards

Only disclose Significant Financial Interests related to an Investigator’s institutional responsibilities

August 24, 2012


Definition: Significant Financial Interest (SFI) Blue indicates change from 1995 regulations

• Payments from a publicly traded entity over the 12 months preceding the disclosure that, when aggregated, exceeds $5,000 as of the date of the disclosure Includes salary and any payment for services not otherwise identified

as salary such as• Equity interest includes any stock, stock option, or other ownership

interest, as determined through reference to public prices or other reasonable measures of fair market value;

• Intellectual Property rights and interests and any payment for services, salary, consulting fees, honoraria, paid authorship

Includes spouse and dependent children!!!


Definition: Significant Financial Interest (SFI) cont.Blue indicates change from 1995 regulations

• Payments from a non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000 Investigator holds any equity interest (e.g., stock, stock option, or

other ownership interest) Includes non-profits (such as foundations)

• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests

• Investigators also must disclose the occurrence of any reimbursed or sponsored travel regardless of amount

August 24, 2012


Key Definitions: SFI – Excluded Sources – No disclosure Required

You do NOT have to disclose if the SFI comes from the following sources:• Salary, royalties, or other remuneration from current institution• Agreements to share in royalties related to Intellectual Property

Rights assigned to OUHSC• Mutual funds and retirement accounts with no investigator control

of investment• Income from teaching engagements sponsored by a federal, state,

or local government agency, an institution of higher education, an academic teaching hospital, a medical center or an academic research institute

• Income from service on committees or review panels for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, a medical center, or an academic research institute.

If your SFI comes from any other source, you must disclose

August 24, 2012


Key Definitions: Financial Conflict of Interest (FCOI)

• An interest that could directly and significantly affect the design, conduct or reporting of the research

• Conflict of interest is a situation in which financial or other personal considerations: may compromise, may involve the potential for compromising may have the appearance of compromising

an employee’s objectivity in meeting University duties or responsibilities, including research activities

• Determined by OUHSC The Investigator does NOT determine FCOI, only discloses SFI

August 24, 2012


Key Definitions: SFI vs. FCOI

• A significant financial interest (SFI) is defined by the PHS criteria on slides 12 & 13 All PHS Investigators must disclose all SFIs

• A Significant Financial Interest (SFI) is not always an FCOI• The designated Institutional official* determines if an FCOI

exists when a SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research

* Designated Institutional Official is the OUHSC Vice President for Research

August 24, 2012


DISCLOSURE PROCESSSection 3

August 24, 2012


SFI Disclosure Process

An Investigator must disclose to the institution all significant financial interests (SFIs) (and those of his/her spouse and

dependent children)RELATED TO HIS/HER INSTITUTIONAL RESPONSIBILITIES at the time the research proposal is submitted to the grant awarding

agency

August 24, 2012

19

SFI Disclosure Process

PHS Financial Conflict of Interest (FCOI) Regulatory Requirements


Significant Financial Interest (SFI) Disclosure Process1. Project Director/Principal Investigator (PD/PI) is responsible for

his/her own SFI disclosure and determines who meets the definition of “Investigator” on their project The PD/PI identifies all other individuals, regardless of title or position, who

he/she identifies as responsible for the design, conduct, or reporting of research or proposed for such funding

It is the PD/PI’s responsibility, in conjunction with department assistance, to notify and secure disclosures from the identified Investigators

2. The designated Investigators complete the Significant Financial Interests Form (SFIF) Project-based form – one form for each project for each designated Investigator

(completed form may be duplicated for multiple projects) If the Investigator has no SFIs, no further action is required If the Investigator has one or more SFIs, he/she completes the SFI Attachment (1

per SFI entity)August 24, 2012


SFI Disclosure Process, cont.

3. The identified Investigators send the completed SFIF and, if applicable, the SFI attachments to ORA ([email protected])

All disclosures must be received by ORA before an application can be approved for submission

4. A copy of the SFIF is forwarded to the Vice President for Research (OUHSC Institutional Official) for review Institutional Official evaluates every PHS-research-related SFI in the

context of each PHS project to determine if the interest creates a Financial Conflict of Interest (FCOI)

May involve the Investigator in that review process

5. If the Institutional Official determines there is no FCOI, the process is completeAugust 24, 2012

mailto:[email protected]


SFI Disclosure Process, cont.

6. If the Institutional Official determines there is an FCOI, then he will work with the investigator to create a FCOI management plan. Within 60 days of receipt of disclosure Application may be submitted without management plan as long as

all SFIs for all designated Investigators have been disclosed The original disclosure along with the decision is kept in the proposal

file and will be used to verify at the Just-in-Time (JIT) and award stages

7. The Institutional Official reports details of FCOI and management plan to funding agency

August 24, 2012


SFI Disclosure Process: When to Disclose SFI?

• No later than at the time of application for PHS-funded research

• Within thirty days of discovering or acquiring a new Significant Financial Interest

• At least annually, in accordance with the specific time period during the period of award.

Disclosure includes spouse and dependent children

August 24, 2012


TRAINING, TRAVEL, PAID AUTHORSHIP & PUBLIC DISCLOSURE

Section 4

August 24, 2012


Training

• Funding cannot be released until all designated Investigators have successfully completed the OUHSC FCOI training The PD/PI must designate all Investigators on ORA Routing Form, or notify ORA of personnel changes ORA verifies completion of training prior to award set-up

• All Investigator(s)designated by the PD/PI should take the mandatory training as soon as possible Must repeat training every 4 years Or immediately if designated an Investigator by a PD/PI.

August 24, 2012


Travel Disclosure

• All Investigators must complete Travel Supplemental Disclosure Form (TSDF) for any reimbursed travel or any sponsored travel

• i.e. paid on behalf of the Investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available

• One form per travel event• Disclosure must occur within 30 days of reimbursement or

travel event if sponsored travel

Exclusions! It’s not as bad as you think. Remember the SFI Excluded Sources

August 24, 2012


Paid Authorship

• All Investigators must disclose paid authorship not covered in the SFI exclusion list as part of the Significant Financial Interest Disclosure. Within 30 days of occurrence (if greater than >$5,000)OR When the aggregate from a single entity exceeds >5,000

Exclusions! It’s not as bad as you think. Remember the SFI Excluded Sources

August 24, 2012


Public Accessibility of FCOI Information

OUHSC must make publicly available certain information about FCOIs that were identified involving investigators by responding

to requests within 5 business days.

Remember! An FCOI is not an SFI. OUHSC is not obligated to disclose SFIs

August 24, 2012


DETAILED REGULATION CHANGESFor Reference Only


Definition of Investigator

1995• Anyone involved in the design,

conduct, and reporting of the research

2012• Project Director/Principal

Investigator as well as any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which includes subawardees and may include collaborators or consultants

Significant Financial Interests (SFI) Threshold

1995• De minimis threshold of

$10,000 for disclosure generally applies to payments aggregated for the Investigator and the Investigator’s spouse and dependent children

• Equity: An equity interest that exceeds $10,000 in value or more than a 5% ownership interest in any single entity

2012• De minimis threshold of

$5,000 for disclosure applies to any remuneration received from the entity aggregated together with the value of any equity interest.

• Includes any equity interest in

non-publically traded entities

• OUHSC may apply higher standards for what constitutes an SFI

31PHS Financial Conflict of Interest (FCOI) Regulatory

Requirements


SFI Reporting Period

1995• In the next 12 months

2012• In the previous 12 months


Which SFIs Need to be Disclosed Once Threshold is Met?

1995• Only those SFI the Investigator

deems related to the PHS-funded research

• OSR-100

2012• All SFI related to the Investigator’s

institutional responsibilities• Annual disclosure• Updates required within 30 days of

change or occurrence (travel/paid authorship)


Excluded from Disclosure Requirement

1995• Income from seminars, lectures, or

teaching engagements sponsored by public or nonprofit entities; income from service on advisory committees or review panels for public or nonprofit entities

• An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children meets both of the following tests: does not exceed $10,000 in value and does not represent more than a 5% ownership interest in any single entity.

2012• Income from seminars, lectures, or

teaching engagements, or service on advisory committees or review panels sponsored by a Federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

• Income or service for any other type of organization must be reported.


Types of SFI Excluded

1995• Excludes income from investment

vehicles such as mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles

2012• Same


SBIR/STTR Phase I

1995• Excluded

2012• Excluded• Phase II is included


Intellectual Property (IP)

1995• Royalties are included among the

“payments” subject to the $10,000 threshold.

2012• The threshold of $5,000 applies to

licensed IP rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to licensed intellectual property rights.

• Excluded Unlicensed IP that doesn’t generate

income IP rights assigned to the Institution and

agreements to share in royalties related to such rights


Paid Authorship*

1995• Not included

2012• Included• Doesn’t include academic

textbooks, etc.

Remember – SFI disclosure doesn’t necessarily mean FCOI


Travel Reimbursements and Sponsored Travel

1995• Not included

2012• Disclose the occurrence of ANY

reimbursed travel or sponsored travel related to institutional responsibilities

• NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.


Sub-recipients and Reporting of Identified FCOIs

1995• Institutions must take reasonable

steps to ensure that Investigators working for sub-recipients comply with the regulations by requiring those Investigators to comply with the institution’s policy, or by requiring the entities to provide assurances to the institution that will enable the institution to comply

2012• Incorporate as part of a written

agreement terms that establish whether the FCOI policy of the awardee Institution or that of the sub-recipient will apply to sub-recipient Investigators, and include time periods to meet disclosure and/or FCOI reporting requirements

• Sub-recipient Institutions who rely on their FCOI policy must report identified FCOIs to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to NIH to meet reporting obligations.


FCOI Training1995

• No requirement

2012• Each Investigator must complete

training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the following circumstances: If institutional FCOI policies

change in a manner that affects Investigator requirements

An Investigator is new to an Institution

An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan.


Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to NIH

1995• Grant/Contract number, PI, name

of Investigator with FCOI, whether FCOI was managed, reduced, or eliminated

2012

Requirements in 1995 regulations, plus:

• Name of the entity with which the Investigator has a FCOI;

• Nature of FCOI, e.g., equity, consulting fees, travel reimbursement, honoraria;

• Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amts between $20K-$100K by increments of $20K; amts above $100K by increments of $50K or statement that a value cannot be readily determined


Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to NIH, con’t2012

A description how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research

• Role and principal duties of the conflicted Investigator in the research project

• Conditions of the management plan• How the management plan is designed to safeguard objectivity in the

research project• Confirmation of the Investigator’s agreement to the management plan• How the management plan will be monitored to ensure Investigator

compliance• Other information as needed.

Annual Report with status of the FCOI and changes to the management plan


Public Accessibility

1995• No requirement

2011• Make information available concerning

identified FCOIs held by senior/key personnel via a publicly accessible Web site or by a written response to any requestor within 5 business days of a request, and update such information as specified in the rule.

• This information will include at a minimum the Investigators name, title, and role; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.


FAQs and ResourcesNIH• 42 CFR 50 Subpart F

http://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm

• NIH FCOI Page http://grants.nih.gov/grants/policy/coi/index.htm

• NIH FAQs – New and Updated (3/21/2012) http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

OUHSC• Office of Research FCOI Page

http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest- fcoi/

• Board of Regents Policy http

://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/regents-policy-conflict-of-interest/August 24, 2012




http://grants.nih.gov/grants/policy/coi/index.htm

http://grants.nih.gov/grants/policy/coi/index.htm

http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/









Contact Information

Office of Research AdministrationPhone: (405)271-2090

Email: [email protected]: http://research.ouhsc.edu

http://research.ouhsc.edu/

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