The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take to promote objectivity in research. The regulations apply to all PHS-funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is PHS. This policy is designed to ensure that MagIC Lifescience Inc (hereafter, “MagIC”) is in full compliance with federal regulations when applying for or receiving PHS funding. This policy applies to all Investigators (as defined by the policy) who are involved with PHS-funded research by means of a grant or cooperative agreement, including research funded by NIH.

Definitions:

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

Financial interest: anything of monetary value, whether or not the value is readily convertible.

Institutional Official: the individual within MagIC who has been designated to solicit and review disclosures from Investigators of significant financial interests related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Institutional Official will be the CFO of MagIC.

Institutional responsibilities: an Investigator’s professional responsibilities on behalf of MagIC, and as defined by MagIC in its policy on financial conflicts of interest, which may include for example: activities such as externally sponsored research or scholarly activities.

Investigator: the project director or the 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.

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

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. 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).

Significant financial interest:

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:

   1. 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;

   2. 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

   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, and 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 and Institution of higher education. This disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with this policy, the Institutional Official 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.

Significant financial interest does NOT include the following types of financial interests:

1. Salary, royalties, or other remuneration paid by MagIC to the Investigator if the Investigator is currently employed or otherwise appointed by MagIC, including intellectual property rights assigned to MagIC and agreements to share in royalties related to such rights;

2. 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;

3. 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

4. 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.

Disclosure of Significant Financial Interests

All investigators are required to disclose to MagIC’s Institutional Official the Investigator’s Significant Financial Interests (and those of the Investigator’s spouse and dependent children) on an annual and ad hoc basis, using the Significant Financial Interest Disclosure Form.

If a Significant Financial Interest is reported on the form, Investigators should submit the completed form together with supporting documentation in a sealed envelope marked confidential to MagIC’s Institutional Official. If no Significant Financial Interests are reported, the form should also be submitted to the Institutional Official.

All Investigators who are participating in PHS-funded research are required to submit an updated disclosure of significant financial interests at least annually, to MagIC’s institutional Official, during the period of the award.

In addition to the annual disclosure, Investigators must make disclosures in the following situations:

• New applications for funding: All Investigators who are planning to participate in the PHS-funded research must disclose to MagIC’s Institutional Official the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) before the application is submitted.

• New significant financial interests: All investigators must submit an updated disclosure of significant financial interests to MagIC’s Institutional Official within thirty days of acquiring (e.g.., through purchase, marriage, or inheritance) a new significant financial interest.

• Travel: Investigators must disclose the occurrence of any reimbursed or sponsored travel, as defined above under the term “Significant financial interest.” This disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. MagIC’s Institutional Official 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.

Review of Financial Disclosures

If a Significant Financial Interest Disclosure Form reveals a Significant Financial Interest, as defined above, MagIC’s Institutional Official shall promptly review the form, together with supporting documentation, to make a determination of whether it constitutes an FCOI. An FCOI exists when the Institutional Official reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. MagIC may involve the Investigator in the Institutional Official’s determination of whether a significant financial interest is related to the PHS-funded research.

Management of FCOI

If the Institutional Official determines that an FCOI exists, he or she must require the creation of and approve a written plan for the management of the FCOI before related research may proceed. The Investigator, in cooperation with MagIC, shall develop and present to the Institutional Official a Conflict of Interest Management Plan that details proposed steps that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by the Significant Financial Interest.

Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:

• Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

• For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;

• Modification of the research plan;

• Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;

• Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

• Severance of the relationships that create financial conflicts.

No expenditures on PHS awards will be permitted until the Investigator has complied with the disclosure and training requirements (see below) of this policy and has agreed, in writing, to comply with any plan(s) determined to be necessary for the management of the FCOI.

MagIC shall monitor Investigator compliance with the FCOI management plan on an ongoing basis until the completion of the PHS-funded research project.

If MagIC identifies an FCOI and eliminates it prior to the expenditure of any PHDS-awarded funds, MagIC is not required to submit an FCOI report to the respective agency.

Reporting Financial Conflicts of Interest

1. Sponsoring Agency

If the Institutional Official determines that any Significant Financial Interest is an FCOI, the Institutional Official shall provide to the PHS sponsoring agency an FCOI report regarding the FCOI and ensure that MagIC has implemented a management plan in accordance with this policy. The FCOI report must be provided to the PHS sponsoring agency in accordance with its specific requirements within 60 days of the original disclosure and before any funds are expended under a PHS-funded research project, and it must include sufficient information to enable the PHS awarding agency to understand the nature and extent of the financial conflict and assess the appropriateness of MagIC’s management plan.

If PHS funding for the project comes via a subaward agreement, the FCOI report shall be made available to the prime awardee such that they may fulfill their reporting obligations to the PHS sponsoring agency.

2. Public Request

As required by sponsoring agency regulations, information on Financial Conflicts of Interest will be made available to members of the public in response to inquiries to the Institutional Official within 5 business days of receipt of such requests.

Subrecipients

If any part of PHS-funded research is conducted through a subrecipient (e.g., subcontractors or consortium members), MagIC (i.e., awardee Institution) will take reasonable steps to ensure that any subrecipient Investigator complies with applicable federal regulations. To this end, MagIC shall enter into a written agreement with each subrecipient that 1) includes a statement indicating whether MagIC’s or subrecipient’s institutional FCOI policy shall apply; and 2) specifies the timing for reporting of FCOIs by subrecipients to MagIC to enable the timely review and reporting of such FCOIs in compliance with PHS requirements.

Training

All Investigators must complete training on this policy prior to engaging in research related to any PHS-funded grant and at least every four years.

In addition, Investigators must complete training on this policy within a reasonable amount of time determined by the Institutional Official in any of the following circumstances:

• MagIC revises its FCOI policies or procedures in a way that affects the requirements of Investigators;

• An Investigator is new to MagIC

• MagIC finds that an Investigator is not in compliance with this policy or an approved FCOI management plan.

Investigators should contact the Institutional Official to schedule training.

Investigator Non-Compliance

1. Sanctions: MagIC requires Investigators to comply fully with this policy. Instances of deliberate breach of policy, including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms, violation of guidelines, or failure to comply with prescribed monitoring procedures may result in sanctions being imposed upon the violating individual.

2. Retrospective Review: In addition, if the Institutional Official determines that an FCOI was not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by MagIC to constitute an FCOI; failure by MagIC to review or manage such an FCOI; or failure by the Investigator to comply with an FCOI management plan, MagIC shall, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS–funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

MagIC is required to document the retrospective review; such documentation shall include the following key elements: project number; project title; name of PI; name of the Investigator with the FCOI; name of the entity with which the Investigator has an FCOI; reason(s) for the retrospective review; detailed methodology used for the retrospective review; findings of the review; and conclusions of the review.

Based on the results of the retrospective review, if appropriate, the Institutional Official shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, MagIC is required to notify the PHS sponsoring agency promptly and submit a mitigation report to the PHS sponsoring agency. 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 MagIC’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

Record Maintenance

MagIC will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the sponsor. Access to such records will be limited to the faculty member, authorized institutional officials and others who have the legal right to review the records.

Regulatory Authority

This policy implements the requirements of 42 C.F.R. 50, Subpart F and 45 C.F.R. 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.

Public Accessibility

This PHS Policy is available on a publicly accessible website and has been made available to PHS via NIH eRA Commons.