NIH requires grantees and investigators to comply with the requirements of 42 CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is sought.” This subpart promotes objectivity in research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will not be biased by any conflicting financial interest of an investigator. The signature of the Authorized Organizational Representative on the face page of the application serves as certification of compliance with the requirements of 42 CFR Part 50, Subpart F. Under the requirements, PDX Pharmaceutical or “Institution” will do the following:

–  Maintain an up-to-date, written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which NIH funding is sought.
–  Shall promote and enforce Investigator compliance with the regulations.
–  Shall manage FCOI and provide initial and ongoing FCOI reports.
–  Agree to make FCOI and SFI information available to HHS, promptly, upon request.
–  Per 42 CFR 50.605, prior to the Institution’s expenditure of any funds under a NIH-funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response within five business days of a request, of information concerning any Significant Financial Interest disclosed to the Institution that meets the following three criteria:
                (A) The SFI was disclosed and is still held by the Senior/Key Personnel for the NIH-funded research project identified by the Institution in the grant application, progress report, or any other required report submitted to the NIH;
                (B) The Institution determines that the SFI is related to the NIH-funded research; and
                (C) The Institution determines that the SFI is an FCOI.
–  Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them.
–  Make additional information available to NIH, upon request, as to how it handled conflicting interests in accordance with the regulations.

Training Requirements
Each Investigator will be informed, through the distribution of PDX Pharma’s FCOI policy as well as the Investigator’s disclosure responsibilities, which follow the Federal regulation (42 CFR 50.604 (b)). FCOI training will be required for all Investigators 1) prior to engaging in research related to any PHS-funded grant, 2) at least every four years or 3) immediately, if PDX Pharma revises its FCOI policy that affects the Investigator requirements, investigator is new to the Institution, or if an Investigator is not in compliance with the plan. To complete the training, each Investigator will review this document along with the following webinars and tutorials provided through the US Dept. of Health & Human Services OER

–  Financial Conflict of Interest Presentation with Case Studies (06/26/2012)
https://grants.nih.gov/grants/policy/coi/FCOI_NIH_Regional_Seminar-June_22_2012.ppt

–  Web based tutorial
https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
https://grants.nih.gov/grants/policy/coi/fcoi_web-based_tutorial.pdf

–  Other resources listed on NIH’s FCOI page
https://grants.nih.gov/grants/policy/coi/index.htm

All Investigators at PDX Pharma must sign a letter stating that they have reviewed and agree to abide by all FCOI requirements.

Disclosure, Review, and Monitoring Requirements

The FCOI regulation covers all financial interests of monetary value, whether or not the value is readily ascertainable. Investigators are required to disclose their SFIs (and those of the Investigator’s spouse and dependent children) that reasonably appear to be Investigator’s institutional responsibilities
(1) No later than at the time of application for NIH-funded research;
(2) Within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI; and
(3) At least annually during the period of award.
PDX Pharmaceuticals’ definition of “Significant Financial Interest (SFI)” is the same as that defined in the NIH’s 2011 revised FCOI regulation as follows:

(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. 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 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) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests, when aggregated, exceeds $5,000 .

(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 Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(3) The term significant financial interest 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 Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution 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.

The designated institutional official will solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to an Investigator’s institutional responsibilities. The institutional official will determine, using the above guidelines, whether an Investigator’s SFI is related to PHS-funded research and, if so related, whether the SFI is an FCOI. The designated official will review all Investigator SFI disclosures, determine if any SFIs relate to PHS-funded research, determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research), develop and implement management plans, as needed to manage FCOIs. The designated official will review disclosures of SFIs, make determination of FCOIs, and implement a management plan when required for an Investigator who is new to participating in the research project or for an existing Investigator who discloses a new SFI. The designated official will review disclosures of SFIs, make determination of FCOIs, and implement a management plan within sixty days whenever an Institution identifies an SFI that was not disclosed timely by an Investigator or not previously reviewed by the Institution. The designated official will take such actions as necessary to manage FCOIs, including any financial conflicts of a sub-recipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project.
The President is currently designated as the institutional official, and is responsible for ensuring the proper collection and reporting of all FCOIs according to the above guidelines.

Reporting Requirements to NIH

The designated institutional official will send initial, annual, and revised FCOI reports, including all reporting elements required by the regulation, to the NIH for the Institution and its subrecipients, if applicable, as required by the regulation: 1) prior to the expenditure of funds, 2) within 60 days of identification for an Investigator who is newly participating in the project, 3) within 60 days for new, or newly identified , FCOIs for existing Investigators, 4) at least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project, 5) following a retrospective review to update a previously submitted report, if appropriate. The designated institutional official will notify NIH promptly if bias is found with the design, conduct or reporting of NIH-funded research and to include the requirement to submit a Mitigation Report in accordance with and including all reporting elements as required by the regulation 42 CFR 50.605(a)(3)(iii). The designated institutional official will notify NIH promptly if an Investigator fails to comply with the Institution’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research. PDX Pharmaceuticals will notify NIH promptly and take corrective action for noncompliance with the policy or the management plan.

All FCOI reports will be reported to the NIH through electronic Research Administration (eRA) commons FCOI module and will contain the followings

1) Project number;
2) PD/PI or Contact PD/PI if a multiple PD/PI model is used;
3) Name of the Investigator with the FCOI;
4) Name of the entity with which the Investigator has an FCOI;
5) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
6) 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 the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
7) A description of how the financial interest relates to the NIH-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research;
8) A description of the key elements of PDX Pharma’s management plan including the following:
(A) Roles and principal duties of the conflicted Investigator in the research project;
(B) Conditions of the management plan;
(C) How the management plan is designed to safeguard objectivity in the research project;
(D) Confirmation of the Investigator’s agreement to the management plan;
(E) How the management plan will be monitored to ensure Investigator compliance; and
(F) Other information as needed.

New FCOI Report (Initial submission Grant Number, PI, Name of Entity with FCOI, Nature of FCOI, Value of financial interest (in increments), Description of how SFI relates to research, Key Elements of Management Plan.

Annual FCOI Report addresses the status of FCOI (i.e., whether FCOI is still being managed or no longer exists) and Changes to Management Plan, if applicable. Annual report due at the same time as when the Institution is required to submit annual progress report, multi-year progress report, or at time of extension.

Revised FCOI Report. If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward or make changes to originally submitted FCOI report. Following the completion of a retrospective review when there is noncompliance with the regulation, if needed.

Mitigation Report. Project Number, Project Title, Contact PI/PD, Name of Investigator with FCOI, Name of Entity with FCOI, Reason for review, Detail Methodology, Findings and Conclusion. When bias is found as a result of a retrospective review.

Maintenance of Records
PDX Pharmaceuticals will maintain all FCOI-related records for at least 3 years from the date the final expenditures report is submitted to the PHS (NIH).

Enforcement Mechanisms and Remedies and Noncompliance

Sanctions or other administrative actions to ensure Investigator compliance will be fully implemented depending on the nature and severity of the noncompliance. These sanctions may include anything from a written warning to termination of employment. The designated institutional official will complete and document retrospective reviews within 120 days of the Institution’s determination of noncompliance for SFIs not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner and to document the reviews consistent with the regulation. In any case in which the Department of Health and Human Services determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required by the regulation, the Institution shall require the Investigator involved to: 1) Disclose the FCOI in each public presentation of the results of the research, and 2) to request an addendum to previously published presentations.

Subrecipient Requirements

When applicable, a written agreement will be implemented that states the subrecipient will follow the FCOI policy of the awardee Institution. If applicable, PDX Pharma will obtain a certification from subrecipient(s) that its FCOI policy complies with the regulation. If applicable, this will include a written subrecipient agreement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows the awardee Institution to report identified FCOIs to the NIH as required by the regulation. Alternatively, if applicable, included in the written agreement will be a requirement to solicit and review subrecipient Investigator disclosures so as to enable the awardee Institution to identify, manage and report identified FCOIs to the NIH.

Public Accessibility Requirements

PDX Pharmaceuticals agrees to post this FCOI policy on its public Web site.
PDX Pharmaceuticals will also make available information concerning identified FCOIs held by senior/key personnel (as defined by the regulation), publicly accessible prior to the expenditure of funds. The information will: 1) Include the minimum elements as provided in the regulation, 2) Be posted on a Public Website or made available within 5 calendar days of a written request, 3) Be updated, at least annually, 4) Be updated, within 60 days of a newly identified FCOI, 5) Remain available for three years from the date the information was most recently updated.

The information that the Institution makes available via a publicly accessible Web site or written response shall include, at a minimum, the following:
1) Investigator’s name;
2) Investigator’s title and role with respect to the research project;
3) Name of the entity in which the Significant Financial Interest is held;
4) Nature of the Significant Financial Interest; and
5) Approximate dollar value of the Significant 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 the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.