Corporate Policies

The TSC Alliance will enter into corporate relationships for the sole purpose of providing mission related benefits to its members and the TSC community. The TSC Alliance will not accept any corporate donation or enter into any corporate relationship that would create a conflict of interest, or even its appearance, with the TSC Alliance’s mission, sound science, or board-approved policies. All procedures and formal agreements with corporate donors will be designed to prevent any undue influence upon the TSC Alliance.

The TSC Alliance will perform appropriate and adequate due diligence, with respect to all corporate donors, to insure that the company’s activities, affiliations and business practices do not compromise the TSC Alliance’s mission.

In all relations with external organizations, the TSC Alliance will act in ways that will only enhance the credibility and professional recognition of the TSC Alliance. In order to insure that all corporate donations are in alignment with the TSC Alliance’s mission and are always for the sole benefit of the TSC community, the TSC Alliance’s Board of Directors has approved the following guidelines and principles in regard to corporate support.

Types of Corporate Support

• Financial and/or in-kind support in the form of grants and/or sponsorships for educational and communications vehicles (i.e., conferences, videos, podcasts, publications and Community Alliance initiatives).
• Financial and/or in-kind support in the form of grants and/or sponsorships for fundraising purposes.
• Strategic alliances that provide improved services for constituents.
• Cause-related marketing.
• Health message promotion.
• Financial grants and/or professional support for clinical trials and research.

Vested Corporate Interactions to Avoid

A vested corporation is one that either makes or offers products/services used by an individual with TSC.

• TSC Alliance will not endorse any other corporation’s product, service or program.
• TSC Alliance will not lend its name to license products, services or programs of other organizations.
• TSC Alliance will not recognize or certify the quality or standards of a particular company, including its products and services.
• TSC Alliance’s name and logo should not be associated with a specific branded product of an external company.  References to the TSC Alliance website, phone number and address for the purposes of referral information are an exception to the above.

General Principles

• TSC Alliance will not endorse any corporation or product nor will it allow a corporation’s interest to factor into its decision-making process.  All unrestricted educational grants received by the TSC Alliance will acknowledge and recognize the contributing corporate donor, not the company’s product (i.e. specific drug).
• In exchange for contributions, the TSC Alliance will allow standard recognition to include, but not be limited to, items such as signage and acknowledgement in TSC Alliance publications.  Additional types of recognition will be considered on a case by case basis, based on the type of funding or opportunity presented.
• TSC Alliance will not accept grants that may adversely affect its nonprofit status.
• Revenue generated through corporations will be used to advance the mission of the TSC Alliance in accordance with the strategic plan.
• The TSC Alliance will maintain complete control of the development and implementation of all content and materials related to educational conferences and materials and all research and clinical trials conducted by the TSC Alliance.
• Corporations providing sponsorships for advocacy and research conferences or symposia will not influence conference content or selection of speakers.
• TSC Alliance will maintain control and discretion over all corporate funds received and will ensure compliance with related grant agreements.

Adopted January 7, 2009.

The Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) to 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 an Investigator’s financial conflicts of interest. The regulations apply to all National Institutes of Health (NIH)-funded grants, cooperative agreements, research contracts, and subawards except Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants.

This policy is written in the context of NIH-funded research; however, if an Investigator is applying for funding from any other PHS agency this policy will apply as if the name of the PHS agency were substituted for “NIH” throughout.

Definitions

“Investigator” means the project director or 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 NIH, or proposed for such funding, which may include, for example, collaborators or consultants. TSC Alliance’s Chief Scientific Officer, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

“Institutional Responsibilities” means an Investigator’s professional activities on behalf of TSC Alliance (for example, administration, research, or consulting).

“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 spouse and dependent children that reasonably appear to be related to the Investigator’s institutional responsibilities on behalf of TSC Alliance.
   1. With regard to any foreign or domestic 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 for the investigator, investigator’s spouse and dependent children, 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 foreign or domestic 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. With regard to foreign or domestic intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests.
2. Third-party reimbursed or sponsored foreign or domestic travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children) of greater than $5,000 that is related to the Investigator’s Institutional Responsibilities must be disclosed to TSC Alliance. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor, the destination, and the duration. This disclosure requirement excludes travel paid for by TSC Alliance and does not apply to travel that is reimbursed or sponsored by an U.S. federal, state, or local government agency, an U.S. 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. The term “Significant Financial Interest” does not include the following types of financial interests: (i). Salary, royalties, or other remuneration paid by TSC Alliance to the Investigator if the Investigator is currently employed or otherwise appointed by TSC Alliance, including intellectual property rights assigned to TSC Alliance and agreements to share in royalties related to such rights; 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; income from seminars, lectures, or teaching engagements sponsored by an U.S. 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 income from service on advisory committees or review panels for an U.S. 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.

A “Financial Conflict of Interest” exists when the designated official (identified below) reasonably determines that the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

Disclosure

Prior to the submission of an application to the NIH for funding, all Investigators must have disclosed to TSC Alliance’s designated official an up-to-date listing of their Significant Financial Interests (SFIs). Any new Investigator, who, subsequent to the submission of an application to NIH for funding from NIH, or during the course of the research project plans to participate in the project, must similarly disclose their SFI to the designated official promptly and prior to participation in the project.

Each Investigator who is participating in research under an award from NIH must submit an updated disclosure of SFI at least annually during the period of the award and must submit an updated disclosure of SFI within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.

Review by TSC Alliance’s Designated Official

The designated official at TSC Alliance is the Chair of the Governance Committee. The designated official will solicit (using a financial disclosure form for Investigators) and review disclosures of SFI of Investigators. Prior to expenditure of funds received from NIH by TSC Alliance, the designated official will (a) review any SFI that has been identified in a disclosure; (b) determine if the SFI is related to NIH-funded research by comparing the SFI to each research award on which the Investigator is identified; (c) determine if a “Financial Conflict of Interest” (FCOI) exists (see guidelines below); and (d) develop and implement a management plan to manage any FCOI. The designated official may ask for input from the Governance Committee, Science and Medical Committee, and/or Executive Committee.

The designated official will review (as described in the previous paragraph) within sixty (60) days (a) any disclosures of an Investigator who is newly participating in the project, or (b) any new or newly identified FCOIs for existing Investigators.

Guidelines for Determining “Relatedness” and Financial Conflict of Interest

The designated official will determine whether an Investigator’s SFI is related to the research under a NIH award and, if so, whether the SFI is a Financial Conflict of Interest (FCOI). An Investigator’s SFI is related to the research under the award when the designated official reasonably determines that the SFI (a) could be affected by the research conducted under the award or (b) is in an entity whose financial interest could be affected by the research. The designated official may involve the Investigator in the determination of whether a SFI is related to the research supported by the award.

In determining if an Investigator’s SFI is related to the research under a NIH award and, if so, whether the relationship creates a FCOI, the designated official considers the role of the Investigator and the magnitude of the opportunity to bias the results, the nature of the research being proposed, and the value of the SFI in relation to the size and value of the entity.

Management of Financial Conflict(s) of Interest

If a FCOI exists, the designated official will determine by what means the conflict should be avoided or managed in order to mitigate undue bias. These means may include but are not limited to full public disclosure of the FCOI, the Investigator’s recusal from decisions affecting the conflicting entity, modification of the activity, and/or appointment of an independent monitor. In making the determination, the designated official will be guided by the principles discussed in this policy.

If a FCOI exists, the designated official will communicate the determination and the means identified for eliminating or managing the conflict, in writing, to the Investigator, to the relevant Principal Investigator/Project Director (if different from the Investigator), and the Investigator’s direct supervisor. The designated official will keep a record of the disclosure and other relevant information for at least three years. If the designated official prescribes monitoring of the activity, the written communication will describe what monitoring shall be performed and what records are to be kept.

The designated official will keep a record of Investigator disclosures of financial interests and the designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the award and, where applicable, other relevant NIH Regulations.

No expenditures on a NIH award will be permitted until the Investigator has complied with the disclosure requirements of this policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the FCOI. The designated official will notify, in writing, TSC Alliance’s Signing Official for NIH awards (currently the President and CEO) of the existence and the nature of a FCOI and how the conflict has been managed, reduced, or eliminated. No expenditures can be incurred until information on the FCOI is made publicly accessible and the Signing Official has reported the FCOI to NIH.

Public Accessibility to Information Related to Financial Conflicts of Interest

Prior to the expenditure of any funds under a NIH award, TSC Alliance will ensure public accessibility by providing a written response to any requestor within five (5) business days of a request, of information concerning any SFI disclosed to the Institution that meets the following three criteria:

1. The SFI was disclosed and is still held by the senior/key personnel for the NIH-funded research project identified by TSC Alliance in the grant application, progress report, or any other required report submitted to the NIH;
2. The TSC Alliance determines that the SFI is related to the NIH-funded research; and
3. The TSC Alliance determines that the SFI is a FCOI.

The information that TSC Alliance will make publicly available will include, at a minimum, the following: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the Significant Financial Interest in the following ranges: $0- $4,999; $5,000-9,999; $10,000 – $19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

When TSC Alliance responds to written requests for the purposes of public accessibility, it will ascertain from the Investigator that the information provided is current as of the date of the correspondence and will note in its written response that the information is subject to updates, on at least an annual basis and within 60 days of TSC Alliance’s identification of a new FCOI, which should be requested subsequently by the requestor.

Information concerning a FCOI will remain available for responses to written requests for at least three years from the date that the information was most recently updated.

Reporting of Financial Conflicts of Interest to NIH

TSC Alliance will provide to NIH via the eRA Commons FCOI Module a FCOI report compliant with NIH regulations regarding any Investigator’s or any subrecipient Investigator’s SFI found to be a FCOI and will ensure that the Investigator has agreed to and implemented the corresponding management plan (a) prior to the expenditure of funds, (b) within sixty (60) days of identification of an Investigator who is newly participating in the project, (c) within sixty (60) days for new or newly identified FCOIs for existing Investigators, and (d) at least annually in conjunction with annual progress reports, and (e) if a retrospective review reveals new information relevant to a FCOI.

Training Requirements

Each Investigator must complete training on TSC Alliance’s Financial Conflict of Interest Policy for PHS-Funded Research prior to engaging in research related to any NIH-funded award and at least every four (4) years, and immediately (within ten business days) if (a) TSC Alliance revises this policy in any manner that affects the requirements of Investigators, (b) an Investigator is new to TSC Alliance and will be working under an NIH award, or (c) an Investigator is not in compliance with this policy or a management plan issued under this policy.

Training will inform the Investigator of this policy, the Investigator’s disclosure responsibilities of all foreign and domestic SFI per the SFI definition, and the relevant federal regulation. Training will utilize resources available on NIH’s FCOI Training Webpage as specified by TSC Alliance’s Chief Scientific Officer and approved by the designated official.

Failure to Comply with This Policy

When a FCOI is not identified or managed in a timely manner for any reason (for example, because the underlying SFI is not disclosed timely by an Investigator, or because a FCOI was not timely reviewed or reported by TSC Alliance, or because an Investigator failed to comply with a management plan), TSC Alliance will, within 90 days of determining noncompliance, complete a retrospective review of the Investigator’s activities and the research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Depending on the nature of the FCOI, TSC Alliance may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date the noncompliance is identified and the completion of the retrospective review.

TSC Alliance will document the retrospective review including all key elements required by the 42 CFR 50.605(a)(3)(ii)(B), including but not limited to the project title, name of the Investigator, name of the entity with whom the Investigator has a FCOI, reasons and detailed methodology of the review, and the findings and conclusions as to whether any NIH-funded research was biased as described above.

If bias is found, TSC Alliance shall take corrective action for noncompliance with this policy or the management plan and will notify NIH promptly and submit a mitigation report to NIH. 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 TSC Alliance’s plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, TSC Alliance will submit FCOI reports annually. TSC Alliance may also provide sanctions or other administrative actions to ensure Investigator compliance with this policy.

Clinical Research

In any case in which the Department of Health and Human Services determines that an NIH-funded 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 TSC Alliance as required by the regulation, the TSC Alliance will 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.

Subrecipient COI Compliance

A subrecipient relationship is established when federal funds flow through TSC Alliance to another individual or entity, the subrecipient will be conducting a substantive portion of an NIH-funded research project, and the subrecipient is accountable to TSC Alliance for programmatic outcomes and compliance matters. Subrecipients (who include but are not limited to collaborators at other institutions, consortium members, consultants, contractors, subcontractors, and subawardees) are subject to TSC Alliance’s terms and conditions, and as such, TSC Alliance will take reasonable steps to ensure that any subrecipient’s Investigator is in compliance with the federal FCOI regulation. TSC Alliance will incorporate, as part of a written agreement with the subrecipient, terms that establish whether TSC Alliance’s FCOI Policy or that of the subrecipient will apply to the subrecipient’s Investigator.

If the subrecipient’s FCOI policy applies to the subrecipient Investigator, the subrecipient will certify as part of the agreement with TSC Alliance that it is in compliance with the federal FCOI regulation and the subrecipient institution’s portion of the project is in compliance with the federal financial conflict of interest policy. If the subrecipient cannot provide the certification, the agreement shall state that the subrecipient Investigator is subject to TSC Alliance’s FCOI Policy for disclosing SFI that are directly related to the subrecipient’s work for TSC Alliance. TSC Alliance will, if applicable, submit a FCOI report to the NIH for any FCOIs identified for a subrecipient Investigator. The agreement shall also specify the sufficient time period for the subrecipient to report all identified FCOIs to TSC Alliance to enable TSC Alliance to provide timely FCOI reports to the NIH.

If the subrecipient’s Investigator is subject to the TSC Alliance’s FCOI Policy, the agreement shall specify the time period for the subrecipient to submit all Investigator disclosures of SFI to TSC Alliance. Such time period must be sufficient to enable TSC Alliance to comply with its review, management, and reporting obligations under the regulation. TSC Alliance will submit any FCOI reports for a subrecipient Investigator to NIH.

Maintenance of Records

Records relating to FCOI matters covered under this policy must be maintained for a minimum of three years after any applicable research project’s final financial report is submitted to NIH, or until three years after the final action has been taken on any audit, litigation, or claim, whichever is longer.

Failure to Comply with This Policy

No expenditures of funds on an award supported by NIH will be permitted unless the Investigator has complied with the disclosure requirements of this policy and has agreed, in writing, to comply with any designated officially-approved FCOI management plan.

Approved by the Executive Committee:  August 17, 2023.

The following information details the TSC Alliance official policy on organizational participation in Food and Drug Administration (FDA) hearings and meetings regarding the regulatory approval of drugs, biological products, and medical devices in accordance with its Corporate Relations Policy:

• The TSC Alliance will not generally provide testimony or submissions in its name in direct support for or against any drug, biological product, or medical device approval application. However, the TSC Alliance may on occasion provide testimony, submissions, or participate in open or closed FDA meetings in its name to provide information about, or relevant to, tuberous sclerosis complex (TSC) or related diseases, including information (e.g. evidence of community need, what constitutes evidence of clinical benefit, endpoints, etc.), which may be relevant to regulatory decisions regarding an application under FDA review or a product under development.
• Any request for the TSC Alliance to provide testimony, statements, or opinions either supporting or opposing specific drugs, biological products, or devices in FDA or regulatory approval proceedings shall be reviewed by the Science and Medical Committee, the Government Relations Committee, and the Executive Committee of the TSC Alliance Board of Directors.  These Committees shall make a recommendation to the Board of Directors regarding whether the TSC Alliance should testify or take similar action.  In the event that the Committees recommend that the TSC Alliance should provide testimony, statements, or opinions either supporting or opposing specific drugs, biological products, or devices in FDA or regulatory approval proceedings, final determination of the course of action to be taken by the TSC Alliance in an official capacity shall be made by the Board of Directors.  If a representative of the TSC Alliance testifies before the FDA, that person will clearly disclose any conflict of interest prior to testimony or submission as is required at all FDA meetings and hearings.  Nothing in this section prohibits the CEO or Chief Science Officer from representing the interests of the TSC community in a manner that is non-specific to individual drugs, biological products, or medical devices.
• TSC Alliance staff will monitor the development of drugs, biological products and devices relevant to TSC, including the pendency of applications for FDA or other regulatory approval of such treatments, and provide this information to its members and the general public.
• In the dissemination of information concerning the development of treatments, officers and staff of the TSC Alliance will comply with the Corporate Relations Policy and refrain from taking any action that can be seen as endorsing any corporation’s product, service, or program, except as provided above.
• The Chief Executive Officer, together with the Executive Committee of the TSC Alliance Board of Directors, will maintain complete control of the development and use of all content and materials produced or used by the TSC Alliance related to the dissemination of information concerning the development and regulatory approval of drugs, biological products, medical devices, or programs for the treatment of individuals with TSC.
• Nothing in this policy impedes or discourages individual members of the TSC Alliance, or its Professional or Corporate Advisory Boards from participating in or testifying before the FDA or other regulatory panels, provided they make clear that they are not acting as a representative of the TSC Alliance.

Approved by the Board of Directors on June 16, 2011.