PURPOSE

The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of Tiba Biotech (Company) research and to comply with federal regulations.

This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F). This regulation was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. An electronic version of the regulation is found at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.

.

SUMMARY OF PROCESS

Significant Financial Interests (SFI) (as defined below) shall be disclosed on the Significant Financial Interest Disclosure Form by an Investigator requesting government-sponsored or company-sponsored funds for a research project or by an Investigator when a Significant Financial Interest arises during the course of research. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a Significant Financial Interest Disclosure Form annually.

It is the Principal Investigator’s responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal or application for human subjects’ approval.

The Significant Financial Disclosure Form and supporting materials are forwarded to the Company’s designated administrator of this FCOI Policy (“Financial Administrator”) for review. The Finance Department will be responsible for evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy.

Advance approval by the Financial Administrator is required prior to engaging in government-sponsored research. A SFI review must be completed before any expenses are incurred under an award.

Annual updates are required of all Investigators. Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately to the Financial Administrator. Annual updates and newly acquired interests are reported using the Significant Financial Interest Disclosure Form. This process is meant to inform each Investigator of the (i) Institution policy; (ii) Investigator’s disclosure responsibilities; and (iii) the Regulations (42 CFR 50.604(b)).

.

TRAINING

The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes financial conflict of interest. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Tiba Biotech engaged in NIH-funded research or its compliance.

The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the training, a certificate of completion must be turned into the Financial Administrator. You should retain a copy for your records. This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by the Company due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or new to the Company. At a minimum, the FCOI training shall be taken every three (3) years.

This process is designed to require each PHS-supported Investigator to complete FCOI training: (i) prior to engaging in research related to any PHS-funded grant; (ii) at least every three (3) years; and (iii) immediately if (a) Institution revises its FCOI policy that affects requirements of Investigators; (b) an Investigator is new to the Institution; and (c) an Investigator is not in compliance with the policy or management plan (42 CFR 50.604(b)).

.

KEY DEFINITIONS

The following definitions are provided as a reference and are considered key definitions in understanding the federal regulations of FCOI. A complete list of official definitions can be found at 42 CFR 50.603.

Institution – means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for, or receiving NIH research funding.

Investigator – means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, which may include, for example, collaborators or consultants.

Institutional responsibilities – means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Financial interest – means anything of monetary value, whether or not the value is readily ascertainable.

Financial conflict of interest (FCOI) – means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.

Manage – means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

Senior/Key Personnel – means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the regulation.

Significant Financial Interest (SFI) –

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 significant financial interest 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 (ii) With regard to any non-publicly traded entity, a significant financial interest 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) Upon receipt of income related to intellectual property rights and interests (e.g. patents, copyrights) that exceeds $5000.
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 excluded sources provided in regulation. For example, if the PI travels to a scientific seminar but does not pay or receive reimbursement by the Company directly (i.e. the travel was paid for by a third party/sponsor), the PI is required to disclose basic information to the Company relating to the trip, such as purpose of the trip, identify of the payer/sponsor, destination and duration. The Company is required to determine if additional information is required (e.g. monetary value) and whether the travel constitutes a FCI with NIH-funded research.
3. The term significant financial interest does not include the following types of financial interests:

(i) salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution; (ii) intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; (iii) any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; (iv) 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; (v) 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 (vi) income from service on advisory committees or review panels for a federal, state or local government agency, Institution of higher education as defied 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.

.

PROCEDURES

A. Identification of Persons Required to Disclose a Significant Financial Interest – It shall be the responsibility of the Principal Investigator of a Research project to identify all Investigators who have a SFI requiring disclosure under this policy and to ensure that a SFI Disclosure Form is prepared and submitted. In addition, the Principal Investigator shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed.

B. Submission and Review of Significant Financial Interest Disclosure Form – Every individual having a SFI requiring disclosure under this policy shall prepare a fully-completed SFI Disclosure Form that shall be submitted to the Financial Administrator. An initial review of the SFI Disclosure Form will be conducted by the Financial Administrator to determine whether a potential for conflict of interest exists. If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the SFI Disclosure Form. A management plan may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy. The management plan may require one or more of the following actions (but not limited to) to be taken in order to manage, reduce or eliminate any actual or potential conflict of interest:

• Public disclosure of significant financial interests;
• Review of research protocols by independent reviewers;
• Monitoring of research by independent reviewers;
• Modification of research plan;
• Disqualification from participation in all or a portion of the research funded;
• Divesture of significant financial interests;
• Severance of relationships that create actual or potential conflicts

All management plans are required to be signed by the Investigator and the Financial Administrator (in consultation with the Company’s CEO). Compliance of the management plan shall be monitored by the Financial Administrator and implemented within 60 days of identified FCOI.

C. Annual Reporting and After-Acquired Significant Financial Interests – All Investigators shall provide annual SFI Disclosure reports or more frequently if required by the management plan. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI Disclosure Form within 30 days of discovering or acquiring the new SFI. It is the Principal Investigator’s responsibility to ensure that any newly acquired Investigator on a research project submits the required SFI report to the Financial Administrator.

D. Violations of Conflict of Interest Policy – Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of a management plan, the Financial Administrator shall make recommendations to the CEO regarding the impositions of sanctions or disciplinary proceedings against the violating individual. In addition, the Company shall follow Federal regulations regarding the notification of the sponsoring agency (e.g. NIH) in the event an Investigator has failed to comply with this policy. The federal agency may take its own action as it deems appropriate, including the suspension of the funding for the Investigator until the matter is resolved.

Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:

• failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
• failure by the Institution to review or manage such a Financial Conflict of Interest; or
• failure by the Investigator to comply with a Financial Conflict of Interest management plan;

the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. The Institution shall document the retrospective review, including: the project number; project title; the PD/PI or contact PD/PI if a multiple PD/PI model is used; the name of the Investigator with the FCOI; the name of the entity with which the Investigator has a financial conflict of interest; the reason(s) for the retrospective review; the detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.); the findings of the review; and the conclusions of the review.

If bias is found, the Institution must notify NIH promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually as prescribed above

E. Record Keeping – Records of Investigator SFI Disclosure Forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Finance Administrator for three (3) years from the date the final expenditure report is submitted to the sponsoring agency (e.g. NIH), as required by 45 C.F.R. 75.361. This includes all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review.

F. Sub-recipient Requirements – Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies. If a SFI is identified by the sub-award recipient, they are required to notify the Financial Administrator of the existence of the conflicting interest within 30 days of the identification of the interest. In addition, the sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations.

G. Federal Reporting – The Finance Department is responsible for the reporting disposition of matters involving disclosures of SFI in accordance with applicable federal requirements. The following reports are required by the NIH:

i. Initial report – prior to the Company’s expenditure of any funds under a NIH-funded research project, the Company must provide to the NIH an FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation.

ii. During on-going NIH-funded research projects – the Company shall submit an FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, the Company shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance.

iii. Annual FCOI report – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.