MALCOVA, Inc. is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest.

This policy is presented here in order to comply with the federal regulations issued by the Department of Health and Human Services entitled “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Serve Funding is Sought” (42 CFR Part 50, Subpart F, and 45 CFR Part 94).

Any Investigator within MALCOVA, Inc. must understand and comply with this policy. If a situation arises in which there is question or concern regarding a Financial Conflict of Interest, the Investigator should discuss the situation with the Designated Official.

DEFINITIONS

Specific to this policy, the following definitions apply:

Designated Official is the individual designated by MALCOVA, Inc. to oversee the financial conflicts of interest process and review any disclosures of significant financial interests.

Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.

Financial conflict of interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research as determined by MALCOVA, Inc. through the Designated Official.

Financial Interest means anything of monetary value received or held by an Investigator or his or her or their immediate family, whether or not the specific value is readily ascertainable.

Immediate family refers to an Investigator’s spouse and dependent children.

Investigator means the project director/principal investigator and any other person who is responsible for the design, conduct, or reporting of the research or proposed research.

Key personnel includes the research project director, principal investigator, and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to the sponsor by or on behalf of MALCOVA, Inc.

PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.

PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.

Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

Research means 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. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.

SIGNIFICANT FINANCIAL INTEREST

1.       Significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s responsibilities surrounding projects within MALCOVA, Inc., including:

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 the disclosure, when aggregated, exceeds $5,000. Remuneration includes any 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.

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 spouse, partner, dependent children) owns any equity interest, regardless of dollar value. For purposes of this paragraph, the terms remuneration and equity interest shall have the same meanings as set forth above.

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

Any occurrence of third-party reimbursed or sponsored travel related to the Investigator's institutional responsibilities, with the exception of any travel 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 center affiliated with an institution of higher education.

2.   The term Significant Financial Interest does not include:

Salary, royalties, or other remuneration from MALCOVA, Inc.;

Any ownership interest in MALCOVA, Inc. (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);

Income from investment vehicles such as mutual funds or 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, a medical center, or a research institute 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.

PROCEDURES

Designated Official Responsibilities 

The Designated Official or his/her designee shall be responsible for the following:

Informing MALCOVA, Inc. Investigators of their obligations under this policy and any related regulations;

Reviewing disclosures of significant financial interest to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest;

Screening and managing potential financial conflicts of interest;

Maintaining all records relating to disclosures of financial interests, MALCOVA, Inc.’s review of and response to such disclosures, and any related actions under this policy;

Ensuring inclusion of any required certifications in applications for funding or contract proposals;

And Reporting and disclosure as required under this policy and applicable regulations.

Investigator Responsibilities

Disclosure of Significant Financial Interests

Prior to the submission of a proposal for funding, each Investigator shall complete a Public Health Service Significant Financial Interest Disclosure Form ("disclosure form") and attach all required supporting documentation, if any. An Investigator must submit a disclosure form prior to the time a proposal is submitted even if he or she does not have any Significant Financial Interests. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential and accompany the disclosure form.

All financial disclosures must be updated by Investigators during the period of the award on an annual basis and on an ad hoc basis. Ad hoc disclosure to the Designated Official should occur within 30 days of discovering or acquiring a Significant Financial Interest.

The Investigator must disclose any reimbursed or sponsored travel related to their research within 30 days of the travel.

All disclosure forms and supporting documentation shall be submitted to the Designated Official.

Review and Decision Process of the Designated Official

The Designated Official shall promptly review each disclosure of a Significant Financial Interest to determine whether it constitutes a Financial Conflict of Interest. A Financial Conflict of Interest exists when the Designated Official determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting research funded by a sponsor covered by this policy, or is in an entity whose financial interest could be affected by the research.

If the Designated Official determines that a Financial Conflict of Interest exists, the Designated Official shall take action to eliminate, reduce, or manage the Financial Conflict of Interest, within 60 days of the disclosure.

If the Designated Official determines that there is a Financial Conflict of Interest that can be managed, they shall require and approve a written management plan before any related research goes forward. The affected Investigator, in consultation with the Designated Official, is responsible for developing and submitting a proposed management plan.

Reporting to Sponsors

The Designated Official shall provide initial and ongoing reports relating to an Investigator's Financial Conflicts of Interest to the sponsor in accordance with applicable federal regulations and the sponsor's policies. If the funding for the research is a sub-award from a prime awardee, reports shall be made to the prime awardee to permit the prime awardee to fulfill his or her reporting obligations to the sponsor.

Confidentiality

MALCOVA, Inc., will, to the extent possible, protect the confidentiality of disclosures. In every instance, MALCOVA, Inc. will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to staff only on a need-to-know basis and will not be disclosed outside of MALCOVA, Inc. unless necessary to comply with contractual, legal, or regulatory requirements.

Investigator Noncompliance

If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential financial conflict of interest), MALCOVA, Inc. may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research. For PHS-funded research, failure to comply with this policy or the applicable regulations shall result in prompt notification of the PHS Awarding Component of the corrective action taken or to be taken as well as making available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts.

Retention of Records

The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information consistent with MALCOVA, Inc.’s Record Retention policy. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by MALCOVA, Inc. with respect to each financial conflict of interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 74.53(b) or 48 CFR Part 4, Subpart 4.7.

Regulatory Authority

This policy is intended to comply with the requirements of the PHS regulations. Where there are substantive differences between this policy and the regulations, the regulations shall take precedence.

Point of Contact

If you have a conflict of interest or if you have a question to discuss, contact FCOI at MALCOVA.com.