Policy – Conflict Of Interest In Federally Funded Research

PURPOSE

Federal regulations were promulgated in 1995 to ensure that Public Health Service (PHS) [including the National Institutes of Health (NIH) and National Science Foundation (NSF)-funded research (grants, collaborative agreements and contracts) would not be biased by conflicting financial interests of investigators. Briefly, these regulations place specific requirements upon investigator to disclose financial interests and upon The Institute to identify conflicts; to arrange for conflicts to be managed, reduced or eliminated; to maintain records of financial disclosures; and to inform personnel of these Federal regulations and of The Institute’s Conflicts of lnterest Policy for Federally Funded Research which, together with The Institute’s general Corporate Compliance Policy on Conflicts of lnterest, provides the framework for Institute employees to conduct The Institute’s business ethically and honestly, encourages self disclosure and sets out procedures for the identification, investigation and resolution of possible conflicts.

The purpose of these regulations is to promote “objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants and cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.” The PHS amended its Financial Conflict of Interest Regulation effective August 24, 2012. ln order to fully comply with the PHS’s new regulation, The Rogosin Institute has revised its Conflict of Interest in Federally Funded Research Policy effective August 24, 2012 and created a new Financial Disclosure Form for PHS Funded Awards. lnvestigators planning to apply for funding from a PHS agency (directly or flowing thru another agency) or have current PHS funding or plan to ask for no cost extension of an existing PHS award must comply with the new FCOI Regulations.

This policy promotes compliance with all applicable federal and state laws and regulations regarding Financial Conflict of Interest including the National Institutes of Health (NIH), the National Science Foundation, the Food and Drug Administration (FDA), and other agencies that are part of the Public Health Service (PHS).

Before a Principal Investigator can submit a proposal to any ofthe PHS agencies, all investigators must have a completed Disclosure Form on file and have completed the Conflict of Interest training.

The amended regulation requires that all persons applying for, receiving or being supported on PHS funds must be compliant with PHS rules on training, disclosure, and establishment of conflict of interest management plans prior to the awarding of funds. The rules apply to current interests and interests in the 12 months preceding the disclosure, rather than interests that are anticipated in the future.

The major changes to the PHS Financial Conllict of lnterest Policy include:

Lower financial disclosure thresholds
Increased transparency for travel reimbursement
New conflict of interest training
New public accessibility requirements

DEFINITIONS

HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

Investigator means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. The term “Investigator” includes the Investigator’s spouse and dependent children.

PHS means the Public Health Service, an operating division of the u.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated.

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject 6 this subpart. Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

Research means a systematic investigation designed to develop or contribute to knowledge which can be generalized and which relates broadly to public health. The term encompasses basic and applied research and product development and includes any such activity for which research funding is available from a PHS grant or cooperative agreement whether authorized under the PHS Act or other statutory authority.

Significant Financial Interest (SFI) means:

1. A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:

(i) With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e g, consulting fees, honoraria, paid authorship); 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;

(ii) With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g, stock, stock option, or other ownership interest); or

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

2. Investigators also must 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; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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. The Institute will determine if any travel requires further investigation, including determination or disclosure of the monetary value.

The term SFI does not include the following types of financial interests:

Salary, royalties, or other remuneration paid by the Institution to the investigator if the investigator is currently employed or otherwise appointed by The Institute, including intellectual property rights assigned to The Institute and agreements to share in royalties related to such rights.
Any ownership interest in The lnstitution held by the investigator, if the Institution is a commercial or for profit organization;
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;
Income from seminars, lectures, or teaching engagements sponsored by 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; or
Income from service on advisory committees 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.

POLICY

RI ANNUAL DISCLOSURE

1. The Institute has established a Corporate Compliance Plan to ensure that all of its employees perform at highest level of personal and professional ethics and in legal compliance with all federal rules and regulations. A Corporate Compliance Officer who reports to the Corporate Compliance Committee and the Board of Directors oversees the Compliance Plan.

2. The Institute’s Corporate Compliance Manual also contains a policy entitled “Gifts & Business Courtesies”, which details what is and what is not acceptable relating to the acceptance or giving of gifts and business courtesies.

3. The Institute’s Compliance Manual also contains a “Conflict of Interest” policy which defines a conflict of interest and sets out procedures for board members, officers and key employees to follow in disclosing actual or potential conflicts of interest in the corporate compliance officer, or his or her designee. Such disclosure includes the annual completion of a Conflict of Interest Questionnaire and its forwarding to the Compliance Officer for review.

CONFLICT OF INTEREST IN RESEARCH SUPPORTED BY FEDERAL FUNDS

This policy is designed specifically to address possible conflicts of interest pertaining to Federally Funded research and applies to all investigators involved in federally funded research studies.

In accordance with federal regulations, The Institute has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator (as defined in this policy). Thus, The Institute requires that all investigators disclose any SFI (as defined in this policy) that could reasonably appear to affect or be affected by a PHS project. A potential financial Conflict Of Interest (fCOI) exists when an individual’s personal or private interests might lead an independent observer to reasonably question whether the individual’s professional actions or decisions are determined by considerations of significant personal interest, financial or otherwise.

COMPLIANCE

All persons subject to this policy are expected to comply with it fully. Whenever an investigator has violated this policy, the Corporate Compliance Officer, or his or her designee, shall report such violation to the Clinical Research Director and, where appropriate and in consultation with the President of The Institute, sanctions may be imposed.

In addition, The Institute shall follow federal regulations regarding the notification of the sponsoring agency in the event an investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the investigator until the matter is resolved.

TRAINING

Research personnel funded under PHS awards/cooperative agreements issued on or after August 24, 2012 must complete training on their responsibilities for disclosure of external interests and other aspects of the NIH regulations under 42 CFR 50 (Subpart F) as follows:

1. Prior to an investigator’s engagement in research related to any PHS funded project;
2. Every four years; and
3. Immediately under the following circumstances:

a. The Institute’s fCOI policies change in a manner that affects the requirements for research personnel; b. The Institute finds that the key personnel is not in compliance with The Institute’s fCOI policy or management plan.

Training requirements include being familiar with this policy and completing the online NIH tutorial at (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm)

The principal investigator will be responsible for identifying all investigators who should have undergone the required training prior to their engagement in the covered research.

A Certificate of Training must be provided to the Clinical Research Manager.

PROCEDURES

1 . Investigators engaged in PHS sponsored activity must, in accordance with federal and Institute policies, disclose to the Clinical Research Manager, a listing of his/her known SFIs (and those of his/her spouse and dependent children):

a) That would reasonably appear to be affected by the research for which PHS funding is sought; and

b) In entities whose financial interests would reasonably appear to be affected by the research.

Investigators may choose to disclose any other financial or related interest that could present an actual or perceived conflict of interest. Any disclosure of a SFI or any other financial or related interest should provide sufficient detail to permit an accurate and objective evaluation.

2. Investigators must complete and send The Rogosin Institute Financial Disclosure Form for PHS Funded Awards to the Clinical Research Manager prior to submission to a funding agency. Note that the required financial disclosure under 42 CFR Part 50 is specific for the particular grant application. Therefore, a financial disclosure form must be completed for each grant applicant. This financial disclosure is thus distinct from the annual disclosure required by The Institute.

3. The principal investigator for each proposed activity is responsible for determining who meets the definition of investigator as set forth in this policy and for ensuring and certifying that each investigator provides a completed Financial Disclosure Form along with the proposal. Such disclosure forms must be completed and submitted to the Clinical Research Manager before a proposal is endorsed by The Institute and forwarded to the federal funding agency.

4. All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable SFIs are obtained.

5. The Research Director and/or Clinical Research Manager will review the responses to The Rogosin Institute Financial Disclosure Form for PHS Funded Awards and determine the following:

The reported financial interests will not directly and significantly affect the design, conduct or reporting of the research, and therefore no conflict of interest exists; or
The reported financial interests could directly and significantly affect the design, conduct or reporting of the research, and thus represents a conflict of interest; or
No significant financial interests are reported; and
What, if any, further investigation or action might be necessary for any individual disclosure of a possible conflict.

6. If a potential fCOI is determined, the Research Director and/or Clinical Research Manager shall present the potential conflict to the Corporate Compliance Officer and/or Committee.

7. The disclosure must be reviewed to determine if further action is required before The Institute expends any awarded funds or issues a purchase order or subcontracts for the acquisition of goods and services related to any award that may result from the proposal.

8. If after reviewing the disclosure form and other available information, it is determined that a SFI could affect the design, conduct, or reporting of research activities, the Director, Clinical Research Manager and/or Corporate Compliance Officer will determine which conditions or restrictions are imposed so that the conflict will be managed, reduced, or eliminated.

The following are examples of possible conditions or restrictions:

a) Public disclosure of SFIs
b) Monitoring of research by independent reviewers
c) Modification of the research plan
d) Disqualification from participation in the portion of the sponsored funded research project that would be affected by the SFIs
e) Divestiture of SFIs
f) Severance of relationships that create actual or potential conflicts
g) Refuse the proposed sponsored project.

9. If the investigator is dissatisfied with the determinations, the investigator may, within ten (10) calendar days of such recommendation, submit a written appeal to the President of The Institute. In reviewing the matter and determining whether a conflict of interest exists and/or what actions should be taken to manage, reduce or eliminate a potential conflict, the President will make the final decision.

10. The required disclosure form must be updated if new reportable information is obtained during the period of an award. Records of investigator financial disclosures, and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Clinical Research Manager and The Institute’s Corporate Compliance Officer, or designee, in accordance with standard Institute policies and procedures governing the retention of its records and shall determine the retention period, but same shall be no less than three years after the termination or completion of the award to which they relate, or the resolution of any government action involving those records, whichever is later.

ll. For collaborators/sub-recipients/subcontractors from other institutions involved in externally sponsored projects of The Institute, The Institute will take reasonable steps to ensure that any sub-recipient investigator complies with 42CFR 50 subpart F, by incorporating in the certificate of commitment and in the contract, terms that establish whether The Institute’s or the sub-recipient’s own Financial Conflict Of Interest policy will apply to its investigators, and include time periods to meet disclosure and/or Financial Conflict Of Interest policy reporting requirements.

Sub-recipient institutions that rely on their Financial Conflict Of Interest policy must report identified fCOI to The Institute in sufficient time to allow The Institute to report it to the PSH funding agency to meet its reporting obligations.

REPORTING

For research personnel funded under a PHS award or cooperative agreement awarded on or after August 24, 2012, The Institute will provide to the NIH a fCOI report regarding any investigator SFI found to be a fCOI as follows:

Prior to the expenditure of funds
During the period of award
Within 60 days of identifying a new fCOI
At same time, as when grantee submits annual progress report, including multiyear progress: report annually for the duration of the project period (including extensions with or without funds), addressing the status of the financial interest and any changes to the management plan and whether the fCOI is still being managed or explain why the fCOI no longer exists.

All fCOI reports will include the following information:

A project/grant/contract number
A PD,PI or contact PD/PI if a multiple PD/PI model is used
The name of investigator with fCOI
The name of the external entity with which the investigator has a fCOI
The nature of the fCOI (equity, consulting fees, travel reimbursement, honoraria, etc.)
The value of the financial interest (dollar ranges are permissible: $0-4,999; $5,000-9,999; $10,000-19,999; amounts between $20,000-$ 100,000 by increments of$20,000; amounts above $100,000 by increments of $50,000), or a statement that a value cannot be readily determined.
A description how the financial interest relates to PHS-funded research and the basis for The Institute’s determination that the financial interest conflicts with such research.
A description of the key elements of The Institute’s management plan, including:a. The role and principal duties of the conflicted investigator in the research project
b. The conditions of the management plan
c. How the management plan is designed to safeguard objectivity in the research project
d. A confirmation of the investigator’s agreement to the management plan
e, How the management plan will be monitored to ensure investigator compliance
f. Other information. as needed

Annual Report

The status of the fCOI
Any changes to the management plan

Public Accessibility

To ensure public accessibility, The Institute will make information available concerning identified fCOIs held by key personnel via a publicly accessible Web site, (if applicable), or will provide a written response to any requestor within five (5) business days of a request regarding any SFI disclosed to The Institute that meets the following three (3) criteria:

1 . The SFI was disclosed and is still held by the key personnel for the NlH-funded research project identified by The Institute in the grant application, progress report, or any other required report submitted to the NIH.
2. The Institute determines that the SFI is related to the NlH-funded research
3. The Institute determines that the SFI is a fCOI.

This information will include at a minimum:

The investigator’s name
The investigator’s title and role with respect to the research project
The name of the entity in which the SFI is held
The nature of the SFI
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.

The information will be updated as required.

RETROSPECTIVE REVIEW, MITIGATION PLANS, AND REPORTING TO NIH

For research personnel funded under a PHS award or cooperative agreement awarded on or after August 24,2012:

Whenever an fCOI is not identified or managed in a timely manner, including failure by the investigator to disclose a SFI, failure by the institution to review or manage a fCOI, or noncompliance with the management plan, The Institute will, within 120 days of the determination of noncompliance, complete a retrospective review of the investigator’s activities and the project to determine bias in the design, conduct, or reporting of such research. The retrospective review will include the following:

1. A project number
2. A project title
3. The PD/PI or contact PD/PI if a multiple PD/PI model is used
4. The name of the investigator with the fCOI
5. The name of the entity with which the investigator has a fCOI
6. The reason(s) for the retrospective review
7. The detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
8. The findings and conclusions of the review

When bias is found, The Institute will notify the PHS funding agency promptly and submit a mitigation report with the following pieces of information required under the regulations: