Calm Science Conflict of Interest Policy

Formally Approved by Calm legal team effective January 18, 2022

A. Introduction

The Calm Science personnel, Scientific Advisory Board (SAB), and external research partners, seek to promote objectivity in research by establishing standards for the design, conduct and reporting of research at Calm (i.e., Institution). This policy governing financial conflict of interest applies to all federally sponsored Investigators of the Institution. The Institutional Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until any financial conflict of interests are resolved or other action deemed appropriate by the Institutional Official is implemented. Violation of any part of this policy may result in disciplinary action.  

B. Definitions

Calm (i.e., Institution): A for-profit organization based in San Francisco, California. Calm is a meditation, sleep and relaxation app available in both the Apple and Google Play Store. Calm comprises a number of departments that contribute to its innovation and growth including business to business (B2B), content, engineering, growth (Calm Science), legal, marketing, operations, people and product. 

Calm Science: A department of Calm composed of a team of investigators, overseen by the Director of Science, who receive compensation by Calm to conduct scientific research related to the use of the Calm app. The Calm Science team are paid employees of Calm or independent contractors. 

Scientific Advisory Board (SAB): A committee composed of PhD-level investigators with expertise in a variety of public health domains and complementary health approaches (e.g., yoga, mindfulness, meditation). The purpose of the SAB is to provide external oversight that ensures the rigor and objectivity of Calm's scientific research. The committee provides feedback on study design, manuscripts and grant applications, evaluates the strength of research proposals from external investigators, and provides high-level feedback for scientific foundation of product and content.

Investigator: Investigator includes anyone responsible for the design, conduct, or reporting of research, regardless of title or position, and their immediate family members. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students.  The definition may also include collaborators or consultants as appropriate.

Family: Any member of the Investigator’s immediate family, specifically, any dependent children and spouse.

Institutional Official: This individual is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities.  For the purposes of this policy, the Institutional Official is designated as Legal Operations Lead.

Financial Conflict of Interest: A Significant Financial Interest that the Institution reasonably determines could directly and significantly affect the design, conduct, or reporting of federally sponsored research.

Financial Interest: Anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any 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; and reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities.

Research means a systematic investigation, study, or experiment development designed to contribute to knowledge in science, history, and other fields. This includes basic research to produce published articles, books, or book chapters. The term also encompasses tasks related to the development of new experiments and instruments.

Significant Financial Interest means:

  1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's Family) 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 Family) 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, 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.
  3. Investigators also must disclose any potential conflicts of interest with the selection, award and administration of contracts (i.e., vendor and/or consultant agreements). No employee, officer, or agent may participate in the selection, award, or administration of a contract supported by a federal award if he or she has a real or apparent conflict of interest. Such a conflict of interest would arise when the employee, officer, or agent, any member of his or her immediate family, his or her partner, or an organization which employs or is about to employ any of the parties indicated herein, has a financial or other interest in or a tangible personal benefit from a firm considered for a contract. Investigators or designees may neither solicit nor accept gratuities, favors, or anything of monetary value from contractors.
  4. The term significant financial interest does not include the following types of financial interests: 
    1. salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
    2. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
    3. 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
    4. 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
    5. 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.

C. Conflict of Interest

This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest and must respond appropriately when conflicts of interest arise. To that end, this policy informs Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and the Institution to manage those conflicts of interest that arise, and describes situations that are prohibited.  Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Institutional Official.  

1. Training Requirements

Each Investigator must complete training on this Policy, the investigator’s responsibilities regarding disclosure and the federal regulations prior to engaging in research funded by federal agencies, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. The Director of Science will be responsible for training Investigators on this policy. 

Specifically, all Investigators will have completed appropriate ethics/human subjects and conflict of interest training at the Collaborative Institutional Training Initiative (CITI Program) before engaging in research and will maintain this training every four years thereafter. The Calm Science team will maintain copies and record of all CITI training certificates.

2. Disclosure of Financial Interests

All Investigators (and the Investigator’s spouse and dependent children) are required to disclose their outside financial interests as defined above to the Institution on an annual and on an ad hoc basis, as described below.  The Institutional Official is responsible for the distribution, receipt, processing, review and retention of disclosure notifications.

a. Annual Disclosures

All Investigators must disclose their Significant Financial Interests that are related to the investigator’s institutional responsibilities to the Institution, through the Institutional Official, on an annual basis during the period of award. All disclosure notifications should be submitted to the Institutional Official. 

b. Ad hoc Disclosures

In addition to annual disclosure, certain situations require ad hoc disclosure.  All Investigators must disclose their Significant Financial Interests to the Institution, through the Institutional Official, within 30 days of their initial appointment or employment.  

Prior to entering into federally sponsored projects or applications for federally sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirm the currency of the annual disclosure or submit to the Institutional Official an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity.  The Institution will not submit a research proposal unless the Investigator(s) have submitted such ad hoc disclosures.  

In addition, all Investigators must submit to the Institutional Official an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.

c. Travel

Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest.  Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.  The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes Financial Conflict of Interest with the Investigator’s research.  

3. Review and Monitoring by the Institutional Official

The Institutional Official will review all disclosures, determine whether a Financial Conflict of Interest exists and develop/implement a management plan within 60 days of receipt of the disclosure. If the disclosure notification reveals a Significant Financial Interest, the Institutional Official or designee will determine whether it constitutes a Financial Conflict of Interest.  If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the financial conflict of interest including the reduction or elimination of the conflict, as appropriate. 

A Financial Conflict of Interest will exist when the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of federally sponsored research.  If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must develop and implement a written management plan. 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 Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.  

4. Reporting to Federal Agencies

The Institutional Official or designee will report initial, annual (i.e., ongoing) and revised financial conflicts of interest or non-compliance to the appropriate federal agency in accordance with agency regulations.  Annual reports will provide a status of the financial conflict of interest and any changes to the management plan, if applicable, until the completion of the project. If the funding for the research is made available from a prime federal awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified financial conflict of interest such that the prime awardee may fulfill their reporting obligations to the federal agency. 

5. Investigator Non-Compliance

Failure to Comply: In the event of an Investigator’s failure to comply with this Policy, the Institutional Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented. The Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional Official, will be described in a written explanation of the decision to the Investigator and, where applicable, the Institutional Review Board (IRB), and will notify the individual of the right to appeal the decision.  

Retrospective Review: If the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, will complete a retrospective review of the Investigator’s activities and the federally-sponsored research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.  

Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.  The Institutional Official will update any previously submitted report to the federally funded or the prime federal awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and within the time frame established in federal regulations. 

6. Maintenance of Records

The Institutional Official 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 federal agency or to the prime federal awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.

7. Subrecipient Requirements

If a subrecipient carries out a portion of the work, Calm shall take reasonable steps to ensure that any subrecipient and subrecipient Investigator complies with the applicable FCOI regulation.

Calm will establish, via a written agreement, the governing FCOI policy.

  1. Subrecipient will certify that its FCOI policy complies with the respective regulations and, further, subrecipient will report identified FCOIs for its investigators in a time frame that allows Calm to report identified FCOIs to the awarding agency.
  2. Alternatively, if a subrecipient lacks a compliant FCOI policy, the subrecipient will be governed by the Calm’s FCOI policy; Calm will solicit and review subrecipient Investigator disclosures and identify, manage and report FCOIs to the sponsor.

In the event that a subrecipient notifies Calm of an FCOI for subrecipient Investigators for which Calm is the prime awardee, Calm will promptly notify the sponsor.

8. Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential.  However, the Institution may be required to make such information available to the federal Awarding Component and/or federal government, to a requestor 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 requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure. 

9. Public Accessibility

a. Conflict of Interest Policy

Per the requirements of 42 CFR 50 Subpart F, this Conflict of Interest policy will be made publicly available on the institution’s website.

b. Significant Financial Interests

Per the requirements of 42 CFR Part 50 Subpart F, prior to the expenditure of funds, the Institution will respond to any requestor within five business days of the request with information concerning any Significant Financial Interest that meets the following criteria:

      1. The Significant Financial Interest was disclosed and is still held by the senior and key personnel;
      2. A determination has been made that the Significant Financial Interest is related to the federally funded research; and
      3. A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.

The information to be made available shall be consistent with the requirements of the federal regulation.  

10. Regulatory Authority

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