PHS Financial Conflict of Interest Policy

1) Introduction

The purpose of this policy is to ensure that research funded by the National Institutes of Health (NIH) is designed, conducted and reported objectively, without bias resulting from Investigator financial conflicts of interest (FCOI). The 2011 revised regulations, 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research”, and 45 CFR Part 94, “Responsible Prospective Contractors”, set the requirements for promoting objectivity in Public Health Service (PHS)-funded research under grants and cooperative agreements, and under research contracts, respectively. The regulations and this policy do not apply to Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Phase I applications or awards.

This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements under 42 CFR Part 50 Subpart F and NIH’s guidance. BTC Media Labs LLC (“BTC Media Labs”, “the Institution”) adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research. It establishes processes to identify, disclose and manage Investigator financial conflicts of interest, in order to:

protect research integrity;
ensure the safety of human research participants;
maintain public trust in PHS/NIH-supported research.

2) Applicability

This policy applies to grants and cooperative agreements from Public Health Service (PHS) agencies, such as the NIH, the FDA and AHRQ, that are subject to 42 CFR Part 50 Subpart F. It does not apply to SBIR or STTR Phase I applications or awards. It applies to individuals who meet the regulatory definition of “Investigator” (below) and who plan to take part, or take part, in PHS/NIH-funded research.

Awards from funders that are not PHS agencies are covered by BTC Media Labs’ separate conflict-of-interest policy for that funder and by the terms of that award. Awards from the National Science Foundation (NSF), for example, are covered by BTC Media Labs’ NSF Conflict of Interest Policy.

3) Definitions

Financial Conflict of Interest (FCOI): a significant financial interest that meets both of these conditions:

the Institution’s designated official determines that it is related to the PHS/NIH-funded research (the SFI could be affected by the research, or the SFI is in an entity whose financial interest could be affected by the research);
it could directly and significantly affect the design, conduct or reporting of the PHS-funded research.

Financial Interest: anything of monetary value, whether or not its value is readily ascertainable.

Institutional Responsibilities: the professional responsibilities an Investigator carries out on behalf of BTC Media Labs. They include:

research and research consultation, including collaboration with university and clinical partners;
design, development, testing and validation of the Institution’s software products, including accessibility apps for iPhone, iPad, Apple Watch and Mac;
studies with users, including people who are Deaf or hard of hearing;
development of datasets, speech and sound-recognition models and related systems;
publication and presentation of research results;
grant writing and fundraising;
business development and partnerships;
service on committees, advisory boards or panels (such as Institutional Review Boards or Data and Safety Monitoring Boards) on behalf of the Institution.

Designated Official (DO): the individual appointed by BTC Media Labs to:

solicit and review disclosures of significant financial interests;
determine FCOIs in accordance with 42 CFR 50.604(f) and this policy;
develop management plans for identified FCOIs.

Institution: any public or private organization, domestic or foreign (excluding a federal agency), that is applying for or receives PHS/NIH research funding.

Investigator: the Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by PHS/NIH or proposed for such funding. This may include collaborators or consultants. The Institution decides who is responsible for the design, conduct or reporting of the research. It considers the individual’s role, rather than their title, and the degree of independence with which they carry out the work.

Manage: taking action to address a financial conflict of interest, which can include reducing or eliminating it, to ensure, to the extent possible, that the design, conduct and reporting of the research will be free from bias.

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);
includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.

PHS-Funded Research: any activity supported by a PHS Awarding Component through a grant or cooperative agreement, whether funded under the PHS Act or other statutory authority.

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

Senior/Key Personnel: the PD/PI and any other individual the Institution identifies as senior/key personnel in a grant application, progress report or other submission to PHS/NIH. In this policy, the term applies to the public accessibility requirement in Section 9.

Significant Financial Interest (SFI):

A domestic or foreign (non-United States) financial interest of the Investigator (and of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and that is one or more of the following:
- 1. Publicly traded entity: the value of any remuneration received from the entity in the twelve months before the disclosure, plus the value of any equity interest in the entity on the date of disclosure, together exceeds $5,000.
  - 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.
- 1. Non-publicly traded entity: either of these:
  - the value of any remuneration received from the entity in the twelve months before the disclosure exceeds $5,000; or
  - the Investigator (or spouse or dependent child) holds any equity interest in the entity (e.g., stock, stock option or other ownership interest).
- 1. Intellectual property (IP) rights and interests (e.g., patents, copyrights): income greater than $5,000 received in the twelve months before the disclosure that is related to such rights and interests. This includes royalties and agreements to share in royalties related to licensed IP rights.
Travel: Investigators disclose reimbursed or sponsored travel related to their Institutional Responsibilities in excess of $5,000 over the previous 12 months.
- This includes trips paid on the Investigator’s behalf rather than reimbursed directly, where the exact cost may not be known.
- The disclosure includes, at minimum, the purpose, the sponsor or organizer, the destination and the duration of each trip.
- It does not apply to travel reimbursed or sponsored by:
  - a federal, state or local government agency located in the United States;
  - a United States institution of higher education;
  - an academic teaching hospital;
  - a medical center;
  - a research institute affiliated with a United States institution of higher education.
Not an SFI. Investigators are not required to disclose:
- salary, royalties or other remuneration paid by BTC Media Labs to the Investigator while the Investigator is employed or otherwise appointed by BTC Media Labs, including IP rights assigned to BTC Media Labs and any agreements to share royalties related to those rights;
- any equity interest in BTC Media Labs, since BTC Media Labs is a commercial, for-profit organization;
- income from investment vehicles such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions for them;
- income from seminars, lectures or teaching engagements sponsored by, or from service on advisory committees or review panels for, any of the following:
  - a U.S. federal, state or local government agency;
  - a U.S. institution of higher education;
  - an academic teaching hospital;
  - a medical center;
  - a research institute affiliated with a U.S. institution of higher education.

Foreign financial interests: Investigators must disclose all foreign financial interests received from any foreign entity when the income meets the disclosure threshold (e.g., over $5,000). This includes:

income from seminars, lectures or teaching engagements;
income from service on advisory committees or review panels;
reimbursed or sponsored travel.

Foreign entities include foreign institutions of higher education and foreign governments, including local, provincial or equivalent governments of another country.

4) Significant Financial Interest (SFI) Disclosure Requirements

Investigators disclose their SFIs related to their Institutional Responsibilities as defined in this policy. The disclosure is not limited to the Investigator’s research responsibilities or funded research. The Institution, not the Investigator, determines whether an SFI is related to the PHS/NIH-funded research. Disclosures are made on the Institution’s SFI Disclosure Form, available on this policy’s web page or from contact@btcmedialabs.com, and retained under Section 15.

Investigators disclose SFIs at these times:

A. At the time of application:
- The PI and every other Investigator disclose their SFIs to the DO.
- An Investigator who joins the project after the application is submitted, or during the research, discloses promptly and before taking part.
B. Annually during the award: each Investigator on an NIH award submits an updated disclosure at least annually, on or before January 31 each year. It includes:
- 1. any information not previously disclosed, including SFIs associated with NIH-funded projects transferred from another institution;
- 1. updated details of previously disclosed SFIs, such as changes in the value of an equity interest.
C. Ad hoc during the award:
- Investigators disclose a new SFI within 30 days of discovering or acquiring it (e.g., through purchase, marriage or inheritance).
- Investigators disclose reimbursed or sponsored travel within 30 days of each occurrence.

5) Review of SFI Disclosures

Designated Official(s): The Designated Official (DO) is BTC Media Labs’ Chief Executive Officer or any other senior officer designated by the Chief Executive Officer. Because BTC Media Labs is a small company, the DO solicits and reviews all SFI disclosures, including the DO’s own, and makes all determinations of FCOI. The DO records the reasoning for each determination in the FCOI records.

As BTC Media Labs grows, it may designate additional or different DOs from among its officers, such as a Chief Operating Officer or a Chief Research Officer. Any such designation is made in writing, kept in the FCOI records, and reflected in an update to this policy.

When more than one DO is designated, they review disclosures and make determinations together. A DO steps aside from a review and determination in either of these cases:

the DO has a disclosed SFI related to the research under review;
more independence is warranted.

The remaining DO(s) then serve as DO for that matter, and the recusal is documented.

Each SFI is evaluated against every PHS/NIH application or award for which the Investigator is responsible for the design, conduct or reporting of research. The evaluation determines whether the SFI is related to that research and, if so, whether it is an FCOI. Each review, and its outcome, is documented whether or not an FCOI is found.

Disclosures are reviewed as follows:

A. Before a new award is issued or any awarded funds are spent (e.g., at the Just-in-Time stage):
- The DO reviews the Investigator’s SFIs before NIH issues the award.
- If an FCOI is identified, an FCOI report is submitted to NIH through the eRA Commons FCOI Module before any funds are spent.
B. Annual disclosure: the DO reviews updates to previously disclosed SFIs and decides whether any management plan needs to change. Changes are reflected in the next annual FCOI report to NIH, if applicable.
C. Ad hoc during the award: when a new Investigator joins a project, or an Investigator acquires or discovers a new SFI, the DO, within 60 days:
- 1. reviews the disclosure;
- 1. determines whether the SFI is related to the PHS/NIH-funded research;
- 1. determines whether an FCOI exists;
- 1. if so, implements a management plan, at least on an interim basis.
An FCOI report is submitted to NIH within 60 days of identifying the FCOI.

6) Relatedness of SFIs to PHS/NIH-Funded Research and FCOI (42 CFR 50.604(f))

The DO assesses whether SFIs relate to the NIH-funded research and whether they are an FCOI, using the criteria in 42 CFR 50.604(f).

Relatedness test: an SFI is related to the research when the DO reasonably determines either of these:

the SFI could be affected by the PHS/NIH-funded research; or
the SFI is in an entity whose financial interest could be affected by the PHS/NIH-funded research.

The DO may consult the Investigator when assessing relatedness.

FCOI determination: an FCOI exists when the DO reasonably determines that the related SFI could directly and significantly affect the design, conduct or reporting of the PHS/NIH-funded research. “Significantly” means that the financial interest would have a material effect on the research.

7) Management of SFIs that Pose an FCOI

When an FCOI is identified, the DO determines and implements management strategies to ensure the research is conducted objectively. Examples include, but are not limited to:

Public disclosure of the FCOI (e.g., in publications or presentations, to study personnel, or to the IRB or Data and Safety Monitoring Board).
For human subjects research, disclosure of the FCOI to participants in the informed consent document.
Appointment of an independent monitor to protect against bias in the design, conduct and reporting of the research.
Modification of the research plan.
Change of personnel roles, or removal from portions of the research.
Reduction or elimination of the financial interest (e.g., divesting equity).
Severance of relationships that create financial conflicts.

The DO:

communicates the determination and the management plan to the Investigator in writing;
requires the Investigator to certify compliance with the plan;
submits an FCOI report to NIH through the eRA Commons FCOI Module.

No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan.

The DO records each management plan on BTC Media Labs’ internal FCOI Management Plan template. The template captures the elements NIH requires in an FCOI report (42 CFR 50.605(b)(3)): the Investigator’s role and principal duties, the conditions of the plan, how the plan safeguards objectivity, the Investigator’s agreement, and how the plan is monitored.

8) Monitoring Investigator Compliance

BTC Media Labs monitors Investigator compliance with each management plan for the duration of the NIH award. It does the same for subrecipient Investigators when this policy applies to them.

The DO may request and review documentation showing that the required FCOI disclosures were made, for example:

publications;
presentation materials, abstracts and posters;
written communications to study personnel.

Investigators provide copies of such materials to the DO. These records are kept to document compliance and to support review and audit.

9) Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

FCOI policy: as required by Section 4.1.10 of the NIH Grants Policy Statement, BTC Media Labs makes this policy publicly available on its website at https://btcmedialabs.com/policies/phs-fcoi/.

Identified FCOIs held by Senior/Key Personnel: before any funds are spent under an NIH award, BTC Media Labs ensures public accessibility. It gives a written response within five business days to any request for information about an SFI that meets all three of these conditions:

the SFI was disclosed and is still held by Senior/Key Personnel;
BTC Media Labs has determined that the SFI is related to the NIH-funded research;
BTC Media Labs has determined that the SFI is an FCOI.

The response includes at least:

the Investigator’s name;
the Investigator’s title and role in the research project;
the name of the entity in which the SFI is held;
the nature of the SFI;
the approximate dollar value of the SFI, in these ranges:
- $0–$4,999; $5,000–$9,999; $10,000–$19,999;
- $20,000 to $100,000 in increments of $20,000;
- above $100,000 in increments of $50,000;
- or a statement that the value cannot be readily determined through public prices or other reasonable measures of fair market value.

The response notes that the information is current as of the date of the correspondence. It is subject to updates:

at least annually;
within 60 days of the Institution identifying a new FCOI.

The requestor may ask again later for the updated information.

If BTC Media Labs uses a publicly accessible website to meet this requirement, it updates the information at least annually. It also updates it within 60 days of either of these:

receiving or identifying an additional SFI of Senior/Key Personnel related to the NIH-funded research that was not previously disclosed;
a new SFI being disclosed by Senior/Key Personnel joining the project and determined by the DO to be related and an FCOI.

Information on SFIs subject to public accessibility remains available for at least three years from the most recent update.

10) Reporting Identified Financial Conflicts of Interest

Before spending any funds under an NIH award, BTC Media Labs submits an FCOI report to NIH for any Investigator SFI determined to be an FCOI. It also ensures the Investigator has agreed to, and begun, the management plan.

FCOI Signing Official: BTC Media Labs designates an institutional official, currently the Chief Executive Officer, to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH.

FCOI reports are submitted only when an award is active and an FCOI has been identified: no award means no report, and no FCOI means no report. The NIH eRA Commons FCOI Module User Guide explains how to prepare and submit reports.

A. Initial (original) FCOI reports: these include all information required by 42 CFR 50.605(b)(3) (NIH FAQ H.5). They are submitted:
- before any funds are spent, if an FCOI is identified when a new award is issued;
- within 60 days of identifying a new FCOI during the award, for example after a new SFI disclosure or when a new Investigator joins.
B. Annual FCOI reports: submitted for the duration of the award, including extensions with or without funds.
- They state whether each reported FCOI is still being managed or no longer exists, and describe any changes to the management plan.
- They are submitted with the Research Performance Progress Report (RPPR) or multi-year progress report, or at the time of an extension.
- NIH opens the annual report for submission 75 days before the next budget period start date for continuation awards, and notifies the Institution by email when it is due (see NIH: elements of an FCOI report).
- They are not required at closeout.
C. Revision or mitigation reports: after a retrospective review (Section 12), BTC Media Labs submits:
- a revision report, if new information is found;
- a mitigation report, if bias is found.

Report	Content	When
New FCOI report	Grant number; PI; entity; nature of the FCOI; value (in the required ranges); how the interest relates to the research; key elements of the management plan	Before funds are spent on a new award, or within 60 days of identifying a new FCOI
Annual FCOI report	Status of the FCOI and any changes to the management plan	With the annual or multi-year progress report, or at an extension
Revised FCOI report	Updates to a previously submitted report	After a retrospective review, if applicable
Mitigation report	Project number and title; contact PD/PI; Investigator; entity; reason for review; methodology, findings and conclusions	After a retrospective review that finds bias

11) Training Requirements for Investigators

Each Investigator is informed of this policy and trained on their responsibility to disclose foreign and domestic SFIs under this policy and 42 CFR Part 50 Subpart F.

Training is completed:

before engaging in PHS/NIH-funded research;
at least every four years;
promptly when any of these occur:
- BTC Media Labs revises this policy in a way that affects Investigator requirements;
- an Investigator is new to BTC Media Labs research under an NIH award (training before taking part);
- BTC Media Labs finds that an Investigator has not complied with this policy or a management plan (training within 30 days, as the DO directs).

Investigators complete either:

the NIH FCOI training module, keeping the completion certificate and sharing it with the DO; or
NIH’s virtual seminar presentation on FCOI compliance, sending the DO the completion date by email for audit purposes.

12) Noncompliance With FCOI Policy and Corrective Actions

Late-identified SFI. If BTC Media Labs identifies an SFI that was not disclosed, reviewed or managed in a timely manner, the DO, within 60 days:

reviews the SFI;
determines whether it is related to NIH-funded research;
determines whether it is an FCOI;
if so, implements an interim management plan and submits an FCOI report to NIH through the eRA Commons FCOI Module.

Noncompliance. Noncompliance means an FCOI was not identified or managed in a timely manner, including:

an Investigator’s failure to disclose an SFI later determined to be an FCOI;
the Institution’s failure to review or manage an FCOI;
an Investigator’s failure to comply with a management plan.

In any of these cases, BTC Media Labs, within 120 days of identifying the noncompliance:

completes a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether any part of the research was biased in its design, conduct or reporting;
documents the review in accordance with 42 CFR 50.605(a)(3)(ii)(B) (NIH FAQ I.2) and, where appropriate, updates the FCOI report with the actions that will be taken to manage the FCOI going forward.

If bias is found:

BTC Media Labs promptly notifies NIH and submits a mitigation report through the FCOI Module, in accordance with 42 CFR 50.605(a)(3)(iii) (NIH FAQ I.3).
The report includes the impact of the bias on the research project and the plan of action to eliminate or mitigate its effect.
BTC Media Labs then continues to submit annual FCOI reports as required.
It may take interim measures on the Investigator’s participation until the review is complete.

If no bias is found: no further action is taken unless new information arises. Where applicable, BTC Media Labs updates the existing FCOI report.

If a failure to comply appears to have biased the research:

BTC Media Labs promptly notifies the PHS/NIH Awarding Component of the corrective action taken or to be taken.
The Awarding Component may take appropriate action, or refer the matter back to the Institution with directions on how to maintain objectivity.
PHS may, for example, require an Institution employing such an Investigator to enforce any applicable corrective actions before a PHS/NIH award, or when a PHS/NIH grant involving such an Investigator is transferred.

13) Clinical Research Requirements

This section applies if HHS determines that a PHS-funded clinical research project was designed, conducted or reported by an Investigator with an FCOI that was not managed or reported as required. The project must be one evaluating the safety or effectiveness of a drug, medical device or treatment. In that case, BTC Media Labs requires the Investigator to:

disclose the FCOI in each public presentation of the research results;
request an addendum to previously published presentations.

14) Subrecipient Requirements

A subrecipient relationship exists when federal funds flow from or through BTC Media Labs to another individual or entity (for example, a university research partner under an STTR award) that:

carries out a substantive portion of the PHS-funded research; and
is accountable to BTC Media Labs for programmatic outcomes and compliance.

BTC Media Labs takes reasonable steps to ensure that subrecipient Investigators comply with 42 CFR Part 50 Subpart F. Each written subaward agreement states whether BTC Media Labs’ policy or the subrecipient’s own policy applies (NIH Grants Policy Statement 15.2.1).

If the subrecipient’s policy applies:
- The subrecipient certifies in the agreement that its policy complies with the regulation.
- The subrecipient reports identified FCOIs to BTC Media Labs in time for BTC Media Labs to meet NIH deadlines: before funds are spent, and typically within 50–55 days of identifying an FCOI, so that BTC Media Labs can meet NIH’s 60-day deadline.
- BTC Media Labs’ DO then submits the report to NIH through the FCOI Module.
If the subrecipient cannot certify compliance:
- The agreement states that BTC Media Labs’ policy applies.
- Subrecipient Investigators disclose to BTC Media Labs their SFIs related to the subrecipient’s work for BTC Media Labs.
- BTC Media Labs reviews those SFIs, manages any FCOIs, monitors compliance and reports to NIH.

15) Maintenance of Records

BTC Media Labs keeps records of:

all Investigator disclosures;
its review of, and response to, each disclosure, whether or not an FCOI was found;
all actions taken under this policy or a retrospective review.

Records are kept for at least three years from the date the final expenditure report is submitted, or longer where 2 CFR 200.334 requires, for each competitive segment. Management plans are kept in these records and are not submitted to NIH.

16) Enforcement Actions for Investigator Noncompliance and Remedies

Compliance with this policy is a condition of employment, engagement (for consultants and collaborators) or subaward for every Investigator. Failure to comply with this policy may result in corrective or disciplinary action. Failures include:

failure to disclose an SFI;
failure to follow a management plan;
failure to complete required training.

At the Institution’s discretion, and depending on the seriousness of the failure, actions may include:

formal written notification and required retraining;
restrictions on participation in the research or on use of research funds;
removal from the project;
suspension or termination of employment, a consulting agreement or a subaward;
disqualification from future work on federally funded research at BTC Media Labs.

BTC Media Labs also takes all actions required by federal regulations and award terms, including:

retrospective review;
mitigation;
notifying NIH when required.

The PHS/NIH Awarding Component and HHS may inquire at any time, before, during or after an award, into any Investigator disclosure and the Institution’s review of and response to it (including any retrospective review), whether or not an FCOI was found. BTC Media Labs will submit, or permit on-site review of, all relevant records. To the extent permitted by law, HHS keeps records of financial interests confidential.

Based on that review, the Awarding Component may decide either of these:

that an FCOI will bias the objectivity of the research to such an extent that further corrective action is needed;
that the Institution has not managed the FCOI in accordance with the regulation or this policy.

It may then impose:

specific award conditions (2 CFR 200.208);
suspension of funding or other enforcement action (2 CFR 200.339) until the matter is resolved.

17) Useful FCOI and NIH Resources

BTC Media Labs SFI Disclosure Form, for Investigators’ disclosures under Section 4.
NIH email for FCOI inquiries: fcoicompliance@mail.nih.gov
The regulation: 42 CFR Part 50 Subpart F, Promoting Objectivity in Research
NIH Financial Conflict of Interest
NIH FCOI Frequently Asked Questions
NIH FCOI Policy Development Checklist
NIH Grants Policy Statement, Section 4.1.10: Financial Conflict of Interest
NIH eRA Commons FCOI Module User Guide
NIH FCOI Training and NIH virtual seminar on FCOI compliance

18) Point of Contact

Questions about this policy, and disclosures of financial interests:

BTC Media Labs LLC
contact@btcmedialabs.com