I. Purpose and Scope

This policy is designed to promote objectivity in research, to assist in the identification of individual and organizational potential and actual financial conflicts of interest related to the design, conduct or reporting of research and sponsored programs, and to support compliance with government regulations applicable to financial or beneficial conflicts of interest.

 

The policy implements the requirements of certain federal regulations, as defined herein, and applies to all projects funded directly or indirectly, through a subaward from another organization, by the Public Health Service of the U.S. Department of Health and Human Services (PHS), including all PHS agencies, other than Phase I SBIR or STTR awards (collectively the “PHS Regulations”).

 

It also applies to research funded by other federal funding agencies (e.g. NASA) or other non-federal funding agencies (e.g., American Cancer Society) that follow PHS regulations as well as other federal funding agencies, including but not limited NSF, DOD, DOE, NIJ, or non-federal agencies that include Financial Conflict of Interest terms as a condition of award. This policy does not apply to awards where the funding agency has specifically exempted the award from financial conflicts of interest requirements.

 

II. Definitions

A. Aggregate: The total of all remuneration, sponsored travel, any equity interests and all other monies from a single source in a 12-month period.

 

B. Conflict of Commitment: A situation in which an employee engages in an outside professional activity, paid or unpaid, that involves a commitment of time that may interfere, or appear to interfere, with fulfillment of the employee’s obligations to the company, even if the outside activity is valuable to the company or contributes to the employee’s professional development and competence. Conflicts of Commitment may also arise when an external entity attempts to impose an obligation to improperly share information with or withhold information from the company.

 

C. Designated Official: The CEO or their designee who is ultimately responsible for the review of disclosures of Significant Financial Interests, the design of a management plan related to any relevant Financial Conflicts of Interest and reporting of the interest in accordance with applicable federal agency requirements.

 

D. Equity Interests: Refer to stock, stock options, warrants, and other existing or contingent ownership interests.

 

E. Family: Means an Investigator’s spouse or domestic partner, and dependent children.

 

F. Financial Conflict of Interest: A Significant Financial Interest, as defined below, that pacDNA reasonably determines could directly and significantly affect the design, conduct, or reporting of research.

 

G. Responsibilities: The Investigator’s responsibilities associated with his or her pacDNA appointment or position.

 

H. Investigator: Includes, but is not limited to, the project director (PD), principal investigator (PI), any co-PI, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or proposed for such funding, which may include, for example, collaborators or consultants.

 

I. Outside Professional Activities: Means compensated and uncompensated activities undertaken outside of an Investigator’s responsibilities at pacDNA, relate to the Investigator’s area of professional expertise.

 

J. PHS Regulations: Refers to the Public Health Agency’s (PHS) regulations entitled “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R. Part 50, Subpart F) and “Responsible Prospective Contractors” (45 C.F.R. Part 94). The National Aeronautics and Space Administration (NASA) has implemented and follows the PHS regulations.

 

K. Remuneration: Includes salary and payments for services, such as consulting fees, Honoria or paid authorship.

 

L. Significant Financial Interest:

A financial interest or income received or held by an Investigator, alone or in combination with their Family (and not expressly excluded below) that reasonably appears to be related to the Investigator’s Institutional Responsibilities. Examples of Significant Financial Interests that must be disclosed are:

a. Interest or income in or from a publicly traded entity where:

• The aggregate value of the remuneration and the value of any equity interest as of the date of disclosure exceeds the funding agency’s threshold. For example, the PHS threshold is $5,000. This includes any remuneration received during the 12-month period preceding the disclosure, or expected to be received in the 12 months after the disclosure; or

• The entity is sponsoring any of the Investigator’s research.

• Interest or income in or from a non-publicly traded entity where the aggregate value of remuneration exceeds the funding agency’s threshold. For example, the PHS threshold is $5,000. This includes when any equity interests are held.

b. Interest in the form of income related to intellectual property rights and interests paid by an entity other than pacDNA.

c. Sponsored Travel related to Institutional responsibilities not reimbursed or sponsored by pacDNA, as defined below; or

d. As specifically defined by the funding agency.

 

M. Sponsored Travel: Travel expenses paid to or on behalf of an Investigator by a single external entity in a 12-month period; including travel imbursed or paid on behalf of an Investigator’s Family member by a single external entity within a 12-month period if such travel reasonably appears to be related to the Investigator’s responsibilities at pacDNA.

 

III. Policy

A. GENERAL DISCLOSURE REQUIREMENTS

Full and prompt disclosure is critical to pacDNA’s ability to identify, manage, and eliminate financial conflicts of interest. There are three types of disclosures:

1. Annual Disclosure. Investigators, as defined above, must disclose their significant financial interests and commitments to pacDNA on an annual basis.

2. Proposal-related Disclosures. Prior to submitting a proposal for funding, any investigators identified in the proposal and other project personnel, if requested by the Designated Official or designee, must disclose whether any Investigator holds any Significant Financial Interest and if so, how they may be related to the Investigator’s responsibilities at pacDNA. If there is a potential relationship, the Investigator must file a full disclosure with additional information regarding the relationship of the project to the Significant Financial Interest prior to the submission of the proposal to the funding agency.

3. Ad Hoc Disclosures. An Investigator must disclose, on an ad hoc basis, any newly acquired or discovered Significant Financial Interest or commitment:

a. Within 30 days following the date on which the Significant Financial Interest is acquired or arises;

b. Prior to the Investigator commencing participation in any research project the Investigator is joining; or

c. Within 30 days of being hired by the pacDNA.

 

B. TRAVEL DISCLOSURE REQUIREMENTS

The PHS Regulations require Investigators to disclose to pacDNA, any Sponsored Travel undertaken by the Investigator related to his or her responsibilities at pacDNA, as defined above. Such Sponsored Travel must be included in the aggregate value when calculating an Investigator’s financial interests, in order to determine whether the Sponsored Travel rises to the level of Significant Financial Interest.

 

Travel disclosures must be made if travel is reimbursed or sponsored by an organization other than:

a. pacDNA;

b. Federal, state or local governmental agencies;

c. U.S. institutions of higher education;

d. U.S. research institutes affiliated with institutes of higher education; and

e. U.S. academic teaching hospitals and medical centers.

 

All travel reimbursed or sponsored by a non-U.S. entity must be reported, and may be reported to any relevant federal funding agency as required by their regulatory requirements. Such disclosures must be made by the Investigator within 30 days following reimbursement or within 30 days following the completion of the trip if the organization or entity funds the travel directly.

 

The travel disclosure must include at a minimum, the purpose of the trip, the identity of the organization or entity funding the travel, the destination, and the duration of the trip (usually measured in days).

 

C. REVIEW AND MANAGEMENT OF DISCLOSURES

The Financial Conflict of Interest regulations in this policy require pacDNA to evaluate all Investigator disclosures against the scope of the award to determine if any interests could influence the design, conduct or reporting of the research (i.e. SFI determinations or other reportable financial or beneficial interests).

 

If a SFI or other reportable conflict is reported by the Designated Official, pacDNA will work with the Designated Official to craft a project management plan and report the conflict to the funding agency in accordance with their specific procedures. The project management plan is designed to ensure the objectivity of results relative to a specific, externally funded project.

 

D. REQUIRED PUBLIC DISCLOSURES

Funding agency regulations include a requirement for pacDNA to respond to public requests for information regarding Financial Conflicts of Interests related to awards subject to the funding agency’s regulations. pacDNA must respond to any public request for information within five (5) business days.

 

E. SUBAWARDS ISSUED BY PACDNA

When pacDNA issues a subaward to another organization to carry out a portion of a funded project that has implemented requirements for evaluating and managing conflicts of interest, pacDNA is required by regulation to include those requirements in all subawards at any tier.

a. When issuing subawards under such awards, pacDNA will require subrecipient organizations have a financial conflict of interest policy that complies with the relevant regulations or the subrecipient must be willing to comply with the pacDNA policy and procedures as it relates to the specific subaward.

b. This requirement will be set forth in the pacDNA subaward.

c. Exceptions to this policy must be approved by the Designated Official.

 

If a subrecipient Investigator has a Financial Conflict of Interest, pacDNA is responsible for reporting the Financial Conflict of Interest to the funding agency on behalf of the subrecipient.

a. Subrecipients must report Financial Conflicts of Interest to pacDNA within 45 days of discovering the Financial Conflict of Interest so that pacDNA may report it to the funding agency in a timely manner.

b. pacDNA may be required by the relevant regulations to make information regarding subrecipient Financial Conflict of Interest available to the public in the same manner that pacDNA uses to with respect to its own Financial Conflict of Interest disclosures.

c. pacDNA will notify the subrecipient of any requests for information.

d. Questions regarding the specifics of a subrecipient’s Financial Conflict of Interest will be directed to the subrecipient.

 

F. SUBAWARDS ISSUED TO PACDNA

When pacDNA makes a proposal for or receives a subaward from a Pass-Through Entity (PTE) to carry out a portion of a project subject to conflict of interest regulations, pacDNA must comply with the relevant regulations regarding Financial Conflicts of Interest.

a. This Policy, which covers the obligations set forth under such regulations applies to these proposals and awards rather than the policies of the Pass-Through Entity.

b. In the event a Financial Conflict of Interest is identified under a subaward, pacDNA will provide the Pass-Through Entity with the project management plan described above.

c. Reports are provided in the same form and format as pacDNA uses in connection with its direct awards.

d. The Pass-Through Entity is also responsible for any public accessibility reporting as required by any applicable regulation.

e. The Pass-Through Entity may also be subject to state-specific disclosure requirements.

 

G. RESTROSPECTIVE REVIEW

Retrospective reviews will be conducted in cases where a Financial Conflict of Interest is not identified or managed in a timely manner due to any of the following:

a. Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;

b. Failure by PacDNA to review or manage such a Financial Conflict of Interest; or

c. Failure by the Investigator to comply with a Financial Conflict of Interest management plan.

 

pacDNA must, within 60 days of its determination of non-compliance, complete a retrospective review of the Investigator’s activities and the funded research to determine whether the design, conduct, or reporting of the funded research, or any portion thereof, conducted during the period of non-compliance, was biased. Retrospective reviews will be conducted by the CEO together with an independent third-party reviewer.

 

H. TRAINING

pacDNA must provide training regarding this policy and the PHS Regulations to Investigators. pacDNA uses the NIH FCOI Training Module freely available on NIH website.

a. Investigators must complete the training prior to engaging in research related to any project subject to the PHS Regulations, and

b. At least every four (4) years thereafter.

 

Investigators must also complete training immediately when:

a. The Financial Conflict of Interest Policy is substantively amended in a manner that affects the requirements of Investigators;

b. pacDNA determines that the Investigator has not complied with this Policy or with a management plan related to his or her research; or

c. An Investigator is new to pacDNA.

 

I. RECORD RETENTION

As it pertains to the requirements of this policy, on behalf of the Designated Official, pacDNA will retain all disclosures, conflict management plans, and related documents for a period of at least seven (7) years following submission of the final expenditure report for the applicable project to the funding agency or Pass Through Entity, unless any litigation, claim or negotiation, audit, or other action involving the records is commenced before expiration of the seven-year period, in which case, records will be retained until completion of the action and resolution of all issues.