new phs financial conflict of interest (fcoi) regulatory requirements investigator responsibilities...
TRANSCRIPT
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 3
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 4
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 5
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 6
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 7
KEY DEFINITIONSSection 2
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 8
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 9
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 10
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 11
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 12
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!!!
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 13
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 14
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 15
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 16
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 17
DISCLOSURE PROCESSSection 3
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 18
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 20
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 21
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 22
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 23
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 24
TRAINING, TRAVEL, PAID AUTHORSHIP & PUBLIC DISCLOSURE
Section 4
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 25
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 26
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 27
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 28
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 29
DETAILED REGULATION CHANGESFor Reference Only
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 30
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 32
SFI Reporting Period
1995• In the next 12 months
2012• In the previous 12 months
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 33
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)
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 34
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.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 35
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 36
SBIR/STTR Phase I
1995• Excluded
2012• Excluded• Phase II is included
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 37
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 38
Paid Authorship*
1995• Not included
2012• Included• Doesn’t include academic
textbooks, etc.
Remember – SFI disclosure doesn’t necessarily mean FCOI
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 39
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.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 40
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.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 41
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.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 42
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 43
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 44
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.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training 45
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
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements 46
Contact Information
Office of Research AdministrationPhone: (405)271-2090
Email: [email protected]: http://research.ouhsc.edu