Why We Have This Policy
Posit Science is built upon objective analysis of facts – our science, the way we build our programs, and the ways we market and support them. It is crucial to the trust that our users, investors, and government research funders place in us that our actions are based on our goals, our values, and the facts we observe in the world. If our actions are instead influenced by a conflict of interest – a financial or non-financial interest or obligation that serves one of us as an individual rather than all of us as a company, then we have let those stakeholders down and we have let our company down.
Posit Science also receives research funding, and as a result, we comply with the federal Public Health Service’s (PHS) requirements for institutions that seek research funding. The PHS has implemented regulations (Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought) (referred to in this policy as the “FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest. The FCOI Regulations are applicable to institutions that apply for or receive PHS grants or cooperative agreements for research and to each investigator planning to participate in or participating in such research.
We have implemented this policy to fulfill Posit Science’s obligation under the FCOI Regulations to maintain an up-to-date, written, enforced policy and process on investigator conflicts of interest.
A Few Key Definitions
A financial conflict of interest (FCOI) is a situation where an investigator has a significant financial interest (SFI) that Posit Science reasonably determines could directly and significantly affect the design, conduct, or reporting of federally sponsored research.
What is a financial interest?
A financial interest is anything of monetary value received or held by an investigator (including their direct family members). The definition of a financial interest includes
- Salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works)
- Equity interests (e.g., stocks, stock options, or other ownership interests)
- Intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests
- Reimbursement or sponsored travel and/or entertainment from an entity that is not Posit Science.
Note that a financial interest includes situations where the value is – and is not – readily ascertainable.
For example, financial interests include
- A salary from the spouse of a principal investigator who works at the San Francisco Zoo.
- Equity in a blockchain startup that is owned by the adult child of a clinical trial manager.
- Income from a book published by a research associate.
- A trip paid for by a pharmaceutical company to attend a scientific meeting.
As you can see, many things are correctly defined as financial interests.
What is a significant financial interest (SFI)?
A financial interest becomes a significant financial interest (SFI) when one or more of the following interests of the investigator (including family members) reasonably appears to be related to the investigator’s responsibilities at Posit Science and meets one or more of the below thresholds:
- With regard to any publicly traded entity, an SFI 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;
- With regard to any non-publicly traded entity, an SFI 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 (including their family) holds any equity interest
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- 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 the investigator’s institutional responsibilities
For clarity, SFIs do not include
- Salary, royalties, or other remuneration paid by Posit Science to the investigator when the investigator is a Posit Science employee.
- Equity in Posit Science when the investigator is a Posit Science employee.
- Income from investments (like 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 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
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
The Director of Sponsored Projects is responsible for training investigators on this policy, including
- The specifics of this policy
- Investigator’s disclosure responsibilities
- Relevant federal regulation
Training should occur
- Prior to engaging in research related to any funded grant
- At least every 4 years
- Immediately, if
- we revise its policy in a way that affects requirements of investigators
- an Investigator is new to Posit Science
- an investigator is not in compliance with the policy or an existing FCOI management plan
Specifically, all Investigators will complete conflict of interest training at the Collaborative Institutional Training Initiative (CITI Program). The Director of Sponsored Research will maintain copies and record of all CITI training certificates.
Disclosure, Review, and Monitoring Requirements
When and How Should Disclosures Be Made To Posit Science?
All Investigators are required to disclose their potential conflicts (including those of their spouses and dependent children) to the Director of Sponsored Research on an annual and on an ad hoc basis, as described below.
On an annual basis, the Director of Sponsored Research Programs will require each investigator to complete the financial interest screening form. Any investigator answering “yes” to the relevant screening questions will complete the full financial disclosure form, which will include full detail on all SFIs.
Ad Hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure.
- Beginning Work: Investigators must disclose their SFIs within 30 days of their initial employment, or when their work responsibilities change such that they meet the definition of an investigator.
- New Issues: Investigators must provide an ad hoc disclosure of any SFI they acquire or discover during the course of the year within 30 days of discovering or acquiring the SFI.
- Before Grant Proposal Submission and Again Before Expenditure of Grant Funds: Each relevant investigator must confirm that their annual disclosure is current, or provide an ad hoc updated disclosure of their SFIs. We will not submit a research proposal unless the relevant investigators have provided such confirmations/ad hoc disclosures.
- Sponsored Travel: Investigators must disclose reimbursed or sponsored travel related to their institutional responsibilities before such travel occurs because such travel is an SFI. Such disclosures should include the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value; as well as any other information requested by the Director of Sponsored Research.
Evaluating Disclosures and Determining that Financial Conflicts of Interest Exist
The Director of Sponsored Research will review the financial interest screening forms on an annual basis, and the full financial disclosure firms on an annual and ad hoc basis, and will evaluate each disclosed issue in light of the work performed by the disclosing investigator.
For any disclosed issue that could directly and significantly affect the design, conduct, or reporting of federally sponsored research, the Director of Sponsored Research will make a formal finding of a financial conflict of interest (FCOI).
If an FCOI is determined to exist, the Director of Sponsored Research will develop and implement a FCOI management plan within 60 days of receipt of the disclosure.
Managing Disclosed Financial Conflicts of Interest
An FCOI management plan may include any or all of a variety of features, potentially including (but not limited to)
- full public disclosure
- appointment of an independent monitor
- modification of the research plan
- Other actions as described in the relevant NIH FAQ
The affected investigator must formally agree to the proposed management strategies and sign the written management plan before any related federally sponsored research goes forward.
The Director of Sponsored Research will periodically review and monitor the ongoing activity to oversee compliance with the management plan.
The Director of Sponsored Research will report initial, annual, and revised reports regarding FCOIs or non-compliance to the appropriate federal agency in accordance with agency regulations.
Reports will be made
- Prior to the expenditure of funds
- Within 60 days of identification for an investigator who is newly participating in the project
- Within 60 days for new, or newly identified, FCOIs for existing investigators
- At least annually (at the same time as when we are required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
- After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.
We will notify the relevant funding agency promptly if bias is found with the design, conduct or reporting of funded research. We will include a mitigation report to explain the actions we are taking to mitigate the effects of the bias, and include the required information in our reports (e.g., entity name, name of the investigator with the FCOI, nature of SFI, value of the SFI).
We will notify the relevant funding agency promptly if an investigator fails to comply with the policy, or if a FCOI management plan appears to have biased the design, conduct, or reporting of the research. We will take corrective action for an investigator’s noncompliance with our policy or any FCOI management plan assigned to them.
Maintenance of Records
The Director of Sponsored Research will retain all disclosure forms, FCOI management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the federal agency or to the prime federal awardee.
If relevant action (e.g., litigation, claim, financial management review, or audit) is started before the expiration of the three year period, we will retain the records until such action has been resolved.
Enforcement Mechanisms and Remedies and Noncompliance
If an investigator fails to comply with this policy, the Director of Sponsored Research may take various actions including restriction on use of funds or suspension of all relevant activities until the matter is resolved.
The Director of Sponsored Research will complete a retrospective review if they determine that an SFI was not disclosed in a timeline manner, or an FCOI was not identified or managed in a timely manner, including
- Failure by the investigator to disclose a SFI that we determine is an FCOI
- Failure by us to review or manage such an FCOI
- Failure by the investigator to comply with the FCOI management plan
Documentation of the retrospective review will include the project number, project title, PI, name of Investigator with the FCOI, name of the entity with which the Investigator has the FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The Director of Sponsored Research Projects will update any previously submitted report to the funder relating to the research, specifying the actions that will be taken to manage the FCOI going forward. This retrospective review will be completed in the manner and within 120 days.
In any case in which the Department of Health and Human Services determines that a PHS/NIH-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required by the regulation, the Institution shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research, and to request an addendum to previously published presentations.
We commonly work with subrecipients on funded research studies (e.g., academic institutions carrying out clinical trial activities).
If a subrecipient carries out a portion of the work, we will establish, via a written agreement, the governing FCOI policy to ensure that they (as an institution, and their relevant investigators) comply with the applicable FCOI regulation.
Generally, we expect that the subrecipient will certify that their FCOI policy complies with the respective regulations and, further, that the subrecipient will report identified FCOIs for its investigators in a time frame that allows us to report identified FCOIs to the awarding agency.
In the rare event that a subrecipient lacks a compliant FCOI policy, the subrecipient will be governed by our FCOI policy. In this situation, we will solicit and review subrecipient investigator disclosures and identify, manage, and report FCOIs to the sponsor.
In the event that a subrecipient notifies us of an FCOI for subrecipient investigators for which we are the prime awardee, we will promptly notify the sponsor.
Keeping FCOI Data Confidential
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, we may be required to make such information available to the federal Awarding Component and/or federal government, to a requester of information concerning financial conflict of interest related to federal funding, or to the primary entity who made the funding available to the Institution.
If we are requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the relevant investigator will be informed of this disclosure.
Public Accessibility Requirements
This policy will be made publicly available on the institution’s website at www.brainhq.com/coi.
Prior to the expenditure of funds, we respond to any requestor within five business days of the request with information concerning any SFI that meets the following criteria:
- The SFI was disclosed and is still held by the senior and key personnel;
- A determination has been made that the SFI is related to the federally funded research; and
- A determination has been made that the SFI is a FCOI
- The information made available is consistent with the requirements of the federal regulation (e.g., investigator’s name, title and role with respect to the research project, name of the entity in which the SFI is held, nature of the SFI, and approximate dollar value of the SFI)
This policy implements the requirements described in the “Checklist for Policy Development Related to the 2011 Revised Financial Conflict of Interest (FCOI) Regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F)” as described here.