Financial Conflict of Interest Policy

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Biopeptides Corp is a for profit company that primarily develops immunodiagnostic assays and vaccines for various infectious diseases affecting human health. Objective research is of the upmost importance to Biopeptides Corp(as well as our subgrantees and vendors), to ensure public trust and meet the scientific, programmatic, and ethical goals of our National Institutes Health (NIH) grant efforts. The Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) has published their final rules to address the increasing complexities related to financial interests held by biomedical and behavioral researchers. Biopeptides Corp has made efforts to put in place a Financial Conflict of Interest (FCOI) Policy that fully addresses these requirements (including those of our sub-level vendors).  As needed, we will continue to review and update this policy to address changes in personnel FCOI issues or DHHS guidance.

Biopeptides Corp’s policy requires that each investigator, subrecipient, subgrantee and collaborator affiliated with Biopeptides Corp, through NIH or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). These directives highlight NIH’s commitment to preserving the public’s trust that the research they support is conducted without bias and with the highest scientific and ethical standards. Biopeptides Corp anticipates using this FCOI as the standard for all Federal agency grant and contract efforts.

The following are key term definitions and Biopeptides Corp’s policy guidance for principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Biopeptides Corp. This policy and all FCOI Biopeptides Corpguidance are also available at Biopeptides web site (or this document, the Financial Conflict of Interest (FCOI) Policy, updated June 21, 2021 (Addendum A, Biopeptides Corp’s Employee Handbook) so that all interested parties, including the general public have access to this Company policy.

Investigator

An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct, or reporting of research funded by PHS.

Training Requirement

Biopeptides Corp and all defined sub-level vendors are required to complete training related to Financial Conflict of Interest (FCOI). If any conflicts of interest are found or known, they must be disclosed. The training must be updated no-less than every four years or as designated based on grant or role circumstances. Information and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site. (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm).

Significant Financial Interest (SFI)

Significant Financial Interest is defined by the regulations as:

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 reasonable appears to be related to the investigators institutional responsibilities: 
   1. With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from that 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 the 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 in stock, stock options or       other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value.
   2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remunerations 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 interests (e.g. stock, stock options, or other ownership interest) or
   3. 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, medical center, or 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 a FCOI with the PHS-funded research.
3. The term significant financial interest does not include the following types of financial interests: salaries, 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 retirements 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, 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.

Financial Conflict of Interest (FCOI)

A Financial conflict of interest exists when Biopeptides Corp  logically determines that a Significant Financial Interest (defined above) might directly and significantly affect the design, conduct or reporting of PHS-funded research.

Management of a FCOI

If an FCOI is identified, action will be taken to address the FCOI. That action will include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

PHS Awarding Component

The PHS awarding component is any sub-agency of the Public Health Service or Department of Health and Human Services.

Disclosures/Reporting Process

Biopeptides Corp ‘s designated official, the institution signing official, will solicit and review all “disclosure forms” and evaluate whether they contain any FCOI. If no FCOI is found the “disclosure forms” will be filed in an SFI binder. If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds. Disclosures will occur on an annual basis. Any new conflicting interests that are identified subsequent to the initial disclosure must be reported to Biopeptides Corp within 30 days. Biopeptides Corp will then report it to the PHS awarding component within 60 days. Each investigator must submit an updated disclosure of an SFI not less than annually. If a PHS-funded project is conducted by an investigator or SO with a conflict that was not disclosed or managed, Biopeptides, Corp. is required to disclose the conflict in each public presentation related to the results of the research.

Records Management

The records of all financial disclosures and all actions taken by Biopeptides Corp will be maintained for at least three years from the date of submission of the final expenditures report.

Research

PHS research is any project governed by PHS regulation, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

Compliance and Penalties for Non-Performance

If an investigator fails to comply with Biopeptides Corp’s FCOI policy within 120 days, Biopeptides Corp will complete a retrospective review of the Investigator’s activities to determine bias and fully define the FCOI. If a bias is found, Biopeptides Corp shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. Biopeptides Corp will work with the Investigator to set up an FCOI management plan to mitigate the situation., Biopeptides Corp recognizes that it is required to mandate that the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.

Point of Contact

If you have questions about this policy, or would like to discuss or report a potential conflict of interest, pleas contact Biopeptides, Corp. signing official, Raymond Dattwyler at rdattwyler@mac.com