Reference # AY20APR23

Updated On: 21-Apr-2023

Next Review Date: 19-Apr, 2026

Approval Date: 24-Apr-2023

Approved By: Christian Faul

SCOPE: Company Wide. The Government Awards Compliance Program (Program) covers all projects

conducted with government funds in Alpha Young LLC and is applicable to all employees, sub recipients,

consultants, or any other covered organizations or persons involved in governmental awards.

PURPOSE: Under this policy, Alpha Young LLC strives to ensure that all work performed under

Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts

of interest that could harm patients, the reputation of Alpha Young LLC, the governmental agency

providing the funding, and/or external partners. As Alpha Young LLC must comply with government

regulations when making expenditures with Government Awards, this policy governs the disclosure of

individual financial interests and the management and reporting of individual financial conflicts of

interest in Governmental Awards. It is intended to comply with the requirements of federal regulations,

including , but not limited to, the conflict of interest regulations of the U.S. Department of Health and

Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (titled

Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and

the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of

Interest Rules”).

DEFINITIONS:

Conflict Management Plan: the document specifying the actions to be taken to manage a Financial

Conflict of Interest.

External Partner: a consultant, subcontractor, or sub-recipient performing work under a Government

Award who is not employed by Alpha Young LLC

Government Award: government grants and cost reimbursement contracts including research grants or

contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan

guarantees, property, donated supplies, and direct appropriations) that Alpha Young LLC receives

directly from government agencies or indirectly from pass through entities. (At Alpha Young LLC,

Government Awards are commonly referred to as “Sponsored Projects.”) Government Awards do not

include procurement contracts, payments for health care services provided under government health

care programs (e.g., Medicare, Medicaid) or Medical Education and Research Costs (MERC)).

Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly

affect the design, conduct, or reporting of a research study or other government funded project.

Immediate Family Member: a spouse, domestic partner, child or step-child, parent or step-parent, or

sibling or step-sibling.

Investigator:

(1) For PHS-funded research: the project director or principal Investigator and 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 may include, for example, collaborators or

consultants.

(2) For other Government Awards: project staff directly involved in management of the project or

who hold key responsibilities on the Government Award. Typically, these would be individuals

specifically named to a Government Award or whose participation is key to the success of the project.

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Alpha Young

LLC, which may include, but is not limited to: research, research consultation, teaching, professional

practice, institutional committee memberships, and service on panels such as Institutional Review

Boards or Data and Safety Monitoring Boards.

Public Health Service (PHS): a division of the Department of Health and Human Services, consisting of

the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic

Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and

Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service

(IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services

Administration (SAMHSA).

Research: a systematic investigation, study, or experiment designed to develop or contribute to

generalizable knowledge relating broadly to public health, including behavioral and social-sciences

research.

Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting

fees, honoraria, paid authorships).

Significant Financial Interest:

(1) A financial interest consisting of one or more of the following interests of the Investigator or their

Immediate Family Member that reasonably appears to be related to the Investigator’s Institutional

Responsibilities:

(i) the value of any remuneration received from a public 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; or

(ii) the value of any remuneration received from a non-publicly traded entity in the twelve months

preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their

immediate family) 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 must disclose the occurrence of any reimbursed or sponsored travel related to their

Institutional Responsibilities. The disclosure will include, at a minimum, the following details: (i) the

purpose of the trip; (ii) the identity of the sponsor/organizer; (iii) the destination; and (iv) the trip

duration. (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, an academic teaching

hospital, a medical center, or a research institute that is affiliated with an Institution of higher

education.)

(3) A significant financial interest does not include the following:

Salary, royalties, or other remuneration paid by Alpha Young LLC to the Investigator if the Investigator is

currently employed or otherwise appointed by Alpha Young LLC;

Intellectual property rights assigned to Alpha Young LLC and agreements to share in royalties related to

such rights;

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 in 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; and

Income from service on advisory committees or review panels for a federal, state, or local government

agency, or 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:

It is the policy of Alpha Young LLC to comply with the Financial Conflict of Interest Rules (“FCOI Rules”)

to ensure that the work performed under Government Awards is carried out in a manner that is free

from any bias which may result from financial conflicts of interest. All Investigators for Government

Awards must disclose any Significant Financial Interests (SFI) to Alpha Young LLC. Investigators must

complete or update a disclosure survey at least annually during the period of the award and must

disclose any new SFI’s within thirty days of discovering or acquiring the SFI. Investigators also must

ensure that the disclosure survey is completed or updated no later than the time of application for a

Government Award.

If Alpha Young LLC determines that a SFI constitutes a Financial Conflict of Interest (“FCOI”), Alpha Young

LLC will establish and monitor a Conflict Management Plan (“CMP”) to manage or eliminate the conflict

of interest. The manager of Sponsored Projects Administration (SPA) will be the conflict of interest

official responsible for managing the conflict of interest process for Government Awards. No

Government Award funds may be expended unless the SPA Manager has determined that no FCOI exists

or that any FCOI is manageable in accordance with the terms of a CMP that has been adopted and

implemented in accordance with the procedures set forth in this policy.

Duty to Cooperate

If the conflict of interest official requests additional information from an Investigator to assess whether

a SFI constitutes a Financial Conflict of Interest, (including but not limited to documents relating to the

SFI), the Investigator must cooperate with the request. If a CMP is implemented in connection with a

SFI, the Investigator must comply with the CMP. Compliance with the requirements of this policy is a

condition of employment with Alpha Young LLC for employed Investigators and a condition of

participating in Government Award projects as an External Partner. Failure to comply may result in

appropriate sanctions.

Education

Investigators must complete training regarding this policy and the applicable regulations at the following

times: (i) upon becoming an Investigator for Alpha Young LLC; (ii) before performing work under a

Government Award; (iii) when this policy is revised to alter the responsibilities of an Investigator;(iv) and

at least every four years.

Public Posting of Policy

This policy will be posted on a publicly accessible Internet site for Alpha Young LLC.

Reporting of Financial Conflicts of Interest for PHS-Funded Projects

Before the expenditure of any funds under a PHS-funded project and within sixty days of subsequently

identifying a Financial Conflict of Interest, the SPA Manager will report all Financial Conflicts of Interest

that have not been eliminated to the PHS awarding component and will ensure that an appropriate

Conflict Management Plan has been implemented. The report will include the elements required under

the PHS FCOI Rules. For subsequently identified FCOI’s, the SPA Manager will conduct a retrospective

review to determine whether the PHS-funded project was affected by the financial conflict of interest,

and if bias is found, will submit a mitigation report to the PHS awarding component. The SPA Manager

also will provide an annual FCOI report that addresses the status of any previously reported FCOI’s and

CMP’s related to an ongoing PHS-funded project.

External Partners

Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”)

to Alpha Young LLC on a PHS-funded award must either: (1) have a FCOI policy that meets the

requirements of the PHS FCOI Rules or (2) follow this policy.

Organizations with their own policy will certify that the policy meets the requirements of the PHS FCOI

Rules by submitting an External Partner Financial Conflict of Interest Disclosure form or registering with

the FDP Clearinghouse [insert link] before submission of the Government Award. The SPA Manager will

verify registration with the FDP Clearinghouse before submission. The contract with Alpha Young LLC

will contain language requiring compliance with the organization’s FCOI Policy.

Individuals and organizations without their own FCOI policy are required to follow this policy. The

contract with Alpha Young LLC will contain language requiring compliance with Alpha Young LLC’s

Government Awards FCOI Policy.

Procedure

This procedure is for use by Alpha Young LLC employees and External Partners that do not have their

own FCOI policy.

Before the expenditure of funds under a Government Award, Investigators must complete the training

on Alpha Young LLC’s Government Awards FCOI Policy. All external investigators must complete FCOI

training required under the policy. Training can either be completed using the NIH FCOI tutorial found

at: https://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or CITI COI training found at:

https://about.citiprogram.org/en/homepage/ .

Training must be documented by submitting the Government Award FCOI Training Certification form to

Alpha Young LLC Sponsored Projects Administration. The required training is valid for four years;

however, Investigators are required to certify annually that they understand and have complied with

their responsibilities under Alpha Young LLC’s Government Awards FCOI Policy.

After the training is completed, the Investigator will complete the Government Award FCOI

Questionnaire. This survey must be completed no later than the time of application for a Government

Award and before any funds are expended. It also must be updated as required by the policy.

The principal investigator/project director will complete the Government Award Approval form, which

requires verification that those meeting the definition of Investigator and External Partners have been

informed of the requirement to comply with this policy.

The Investigator must report and update their Government Award FCOI Questionnaire when he/she is a

recipient of sponsored travel. The Investigator will disclose: the purpose of the trip; the name of the

entity that paid for the travel; the travel destination; the duration of the trip; the dates of the travel; and

if known, the approximate value of the Sponsored Travel.

If the SPA Manager determines a FCOI exists, he/she will create a draft CMP. The draft CMP will be

presented to the Research Compliance Oversight Committee (RCOC) for consideration and approval. The

RCOC will act as the Conflict of Interest Committee for purposes of Government Awards.

The actions taken by the RCOC will be documented in the RCOC meeting minutes. The SPA Manager will

ensure that CMP’s are properly implemented and will monitor compliance with CMP’s on an ongoing

basis. The RCOC will review the status of established CMP’s at intervals determined by the RCOC and

indicated in the CMP, and will have oversight responsibility for the enforcement of CMPs and

compliance with this policy.

Each Investigator under a CMP must comply fully and promptly with the CMP, and each person

identified in the CMP as having responsibility for monitoring compliance with the CMP must carefully

and fully monitor that compliance.

For PHS-funded projects, SPA will disclose the FCOI and CMP to the PHS awarding component before the

expenditure of any federal funds.

For PHS-funded projects, Alpha Young LLC will be make FCOI information available to those who submit

a request by sending an email to Chris@alpha-young.com or by writing SPA at the address below.

Responses will be sent within five business days.

Alpha Young LLC will keep records related to FCOI and the related CMP for the longer of at least three

years after:

the date of creation;

the date of termination or completion of the Government Award and submission of the final

expenditure report for the Government Award identified in the disclosure statement;

the date of final resolution of any investigation, audit, or similar action involving the records; or

the date required to be in compliance with Alpha Young LLC’s Record Retention policies.

RCOC will regularly evaluate compliance with this policy and will review the effectiveness of SPA’s

conflict of interest management program, including a review of the implementation and effectiveness of

these procedures.

SPA Procedure for External Partners with their own PHS Rule policy

The principal investigator/project director will complete the Government Award Approval form, which

requires them to inform any External Partner if they need to comply with FCOI Rules.

Prior to any application submitted by Alpha Young LLC for a Government Award, SPA must receive

confirmation the External Partner has a FCOI policy that meets the PHS FCOI Rules.

The External Partner will have two options to verify they have a FCOI:

Submit the External Partner Financial Conflict of Interest Disclosure.

Contact information:

Christopher Yanucil

Alpha Young LLC

Email: Chris@alpha-young.com