Principles and Policies: Conflict of Interest

The Sentinel System Principles and Policies are currently under review by Collaborating Institutions.

 In this section:

Conflict of Interest

It is important to maintain public confidence in the integrity and credibility of the Sentinel Initiative and its findings. Participants, both individuals and institutions, must avoid actions and engagements that may cause a reasonable person to question the impartiality of either the FDA or Sentinel or to question the scientific integrity of Sentinel activities.

“Conflicts of interest are defined in terms of the risk of undue influence and not actual bias or misconduct. Whether they are at the individual or the institutional level, conflict of interest policies seek to prevent compromised decision-making rather than to try to remedy its consequences.”[1] In Sentinel, conflicts of interest (COI) are determined in the context of specific project activities. In general, COI exist in any of the following situations:

  • activities or relationships with other persons or organizations affect a participant’s ability, or potential ability, to render impartial assistance or advice, or give the appearance of doing so
  • the participant’s objectivity is or might be impaired
  • the participant has or might acquire an unfair competitive advantage

COI may arise not only from financial interests, but also from non-financial engagements with or commitments to other organizations and associations with interests related to the subject matter being addressed by specific Sentinel activities.

In this COI policy, COI Policy for Protocol-Based Assessments applies to protocol-based assessments of FDA-regulated medical products. COI Policy for Routine Analytic Framework Inferential Assessments applies to both protocol-based assessments and inferential assessments of FDA-regulated medical products that use the Sentinel Routine Analytic Framework (RAF) tools. These inferential tools currently include modular program Level 2 and Level 3 assessments based on the RAF nomenclature. Descriptive RAF assessments, including summary table, and modular program Level 1 assessments, are not included in the COI policy.

COI Policy for Protocol-Based Assessments

COI Policy for Protocol-Based Assessments applies to protocol-based assessments of FDA-regulated medical products. The FDA reserves the right to extend this policy to additional Sentinel projects as deemed appropriate by the Agency. The COI policies applicable to RAF assessments delineated in COI Policy for Routine Analytic Framework Inferential Assessments (below) also apply to protocol-based assessments.

For all Sentinel protocol-based assessments, the SOC will prepare a Cover Memorandum that FDA will verify after the statement of work is approved and before workgroup participants are selected. The Cover Memorandum will provide a project-specific list of products and firms for which individual financial and non-financial interests must be disclosed.

The Sentinel COI Committee will evaluate individual disclosures before individuals can participate in these projects. The COI Committee is described in Sentinel System Principles and Policies. Members of the committee are chosen by the Sentinel Principal Investigator[2] and approved by the FDA. Committee members must have no other vested connections to Sentinel.

Disclosure

Required disclosures do not necessarily constitute conflicts and, for the purposes of this policy, interests that do not meet the threshold for disclosure will not be considered conflicts. Disclosures will be evaluated by the COI Committee in consultation with others as described in COI Policy for Protocol-Based Assessments: Evaluation.

Who Is Required to Disclose

Individuals who have, or propose to have, substantive roles related to Sentinel protocol-based assessments are required to disclose financial and other interests that are significant as defined by this policy and related to their engagement, or potential engagement, in work on these specific projects.

Substantive roles include those in which individuals have decision-making authority[3] or provide advice to those who have decision-making authority with respect to any of the following:

  • The design of projects
  • The conduct of the work
  • The reporting of results

For the purposes of this policy, such individuals are also referred to as investigators.

What is Required to Be Disclosed

Required disclosures include significant financial and non-financial interests held at the onset of potential engagement in a Sentinel protocol-based assessment or during the twelve months preceding the disclosure that are related to the project-specific list of products and/or firms named in the relevant Cover Memorandum.

Significant Financial Interests

Significant financial interests include anything of monetary value or potential monetary value (whether or not the value is readily ascertainable) that meets the reporting thresholds specified in the regulations issued by the U.S. Department of Health and Human Services (HHS) in August 2011 (42 CFR Part 50 and 45 CFR Part 94) and is related to the project-specific list of products and/or firms named in the relevant Cover Memorandum. The precise details of the HHS financial conflict of interest regulations that are being applied to Sentinel are provided in the Sample Conflict of Interest Cover Memorandum, Part VII. More generally, significant financial interests include any of the following types of assets held currently or during the previous 12-month period:

  • investments, options, contracts, grants, gifts, employment, fees, intellectual property, and patents and patent applications
  • interests in publicly traded and non-publicly traded entities, both domestic and foreign
  • financial interests related to the participant’s institutional responsibilities[4]
  • financial interests held by spouses/domestic partners[5] and dependent children
  • reimbursed or sponsored travel that is not reimbursed or sponsored by a government agency or an institution of higher education

Significant Leadership Interests

Significant leadership interests include any relationship or role in which the individual (and/or the individual’s spouse/domestic partner and/or dependent children) participates with decision-making authority on boards, committees, professional societies or associations, or in processes that are related to the project-specific list of products and/or firms named in the relevant Cover Memorandum. This includes institutional responsibilities that relate to the subject matter of the Sentinel activity in which the participant proposes to become involved, such as participation with decision-making authority on committees that oversee purchases of medical products.

Significant Other Interests

Significant other interests include any relationship or role in which the individual (and/or the individual’s spouse/domestic partner and/or dependent children) is engaged that might pose a significant conflict of interest, or appearance of a conflict, such as a pending lawsuit that is related to the project-specific list of products and/or firms named in the relevant Cover Memorandum. If an individual is aware that his or her institution has a significant conflict of interest with respect to the products and/or firms named in the Cover Memorandum, that conflict should be reported under this heading.

How Interests Are Disclosed

A Cover Memorandum will be provided to the FDA by the SOC that describes project-specific products and firms for which individual financial and non-financial interests must be disclosed. FDA will approve the Cover Memorandum after the statement of work is approved and before workgroup participants are selected.

If the individual is required to file a disclosure form based on his/her proposed role in the Sentinel protocol-based assessments but has no interests related to the products and/or firms listed in the Cover Memorandum, then the individual may submit an Absence of Individual Conflicts of Interest Attestation (“Individual Attestation”) in lieu of a Sentinel Confidential Disclosure Form for Project Specific Individual Interests (“Individual Disclosure Form”).

If the individual is required to file a disclosure form based on his/her proposed role in the Sentinel protocol-based assessments and has interests related to the products and/or firms listed in the Cover Memorandum, then the individual must submit a Sentinel Confidential Disclosure Form for Project Specific Individual Interests (“Individual Disclosure Form”) with the SOC for review by the COI Committee. This form covers required disclosures of both financial and non-financial interests.

When Interests Are Disclosed

The appropriate Sentinel COI form must be submitted:

  1. Upon initial engagement, or proposed engagement, with the project prior to participation in the project
  2. Annually thereafter for the duration of the period of participation in the project
  3. Within 30 days of acquisition of any new and reportable interests related to any of the products and/or firms noted in the relevant Cover Memorandum

Individual Disclosure Forms and Individual Attestations will be stored by the SOC for at least three years from the time that the final project report is accepted by the FDA.

To Whom Interests Are Disclosed

Individual Disclosure Forms and Individual Attestations are submitted to and collected by the SOC. Alternatively, an individual may elect to submit an Individual Disclosure Form directly to the COI Committee. The SOC forwards all Individual Disclosure Forms and Individual Attestations to the COI Committee along with background information concerning the activity in which the individual proposes to participate.

When payments for an investigator’s participation in a workgroup are made to the institution that employs him/her rather than directly to the individual, in addition to the Sentinel review and disposition, the institution may impose its own policies governing institutional access to information disclosed by the investigator to the Sentinel COI Committee, as well as to information about the conflict assessment, management plan, and other actions taken by the Sentinel COI Committee. Institutions are required to advise the SOC of such policies.

Evaluation

Individual Disclosure Forms are reviewed by the full COI Committee for potential conflicts in keeping with the COI Committee Guidelines. The COI Committee determines whether a conflict exists and, in consultation with the Sentinel Principal Investigator and the FDA, whether the individual may or may not participate if one is determined to exist. The COI Committee may request additional information concerning potential conflicts if the information is materially relevant to determining whether a conflict exists. If an individual with a recognized conflict is allowed to participate, s/he must submit to the COI Committee a proposed plan for management of the conflict.

The COI Committee may discuss concerns about potential conflicts with the disclosing individual, the Sentinel Principal Investigator, the FDA, and Sentinel legal counsel. The COI Committee may also discuss such concerns with outside experts and individuals whom the Sentinel Principal Investigator, the FDA, and the COI Committee believe are able to provide qualified advice and a “reasonable person” perspective, provided that no confidential information is revealed during the discussions. The COI Committee may consult:

  1. Individuals pre-approved by the Sentinel Principal Investigator and FDA whenever it believes that obtaining their perspectives will provide valuable input. These individuals will serve as an ad hoc advisory committee for the COI Committee. This group may include other individuals known to have expertise related to COI, the patient representatives to the Planning Board, and other "reasonable person" outsiders. The names of these individuals will be made publicly available. No confidential information may be revealed in such discussions.
  2. Additional outside experts with the express approval of the Sentinel Principal Investigator and FDA. The names of these individuals will be known to the Sentinel Principal Investigator and FDA but not made publicly available. No confidential information may be revealed in such discussions.

The Sentinel Principal Investigator and the FDA reserve the right to require that an individual with an actual or apparent conflict refrain from participation in the proposed activity based on the COI Committee’s recommendation. If this occurs, the SOC will assist the workgroup in locating another qualified individual to perform the function at issue.

The COI Committee will prepare a written report regarding its assessment and disposition of each submitted disclosure form. Keeping such records should improve comparability of decisions over time and facilitate transitions among Committees. These reports will be stored for at least three years from the time that the final project report is accepted by the FDA.

Management

Constraints on Participation

Individuals who have conflicts, as determined by the COI Committee, may be allowed to participate in Sentinel activities related to the topics areas in which they have conflicts under certain circumstances and in certain capacities. The following constraints apply:

  1. Individuals with conflicts may not be decision-makers on matters related to the subject of the conflict. For example, an individual with a COI may not be selected as the leader of a task order workgroup related to the subject of the conflict. Further, an individual with a COI may not participate as a voting member in any committee or workgroup involving the subject of the conflict.
  2. Individuals with conflicts may participate as advisers, including as members of task order workgroups, in limited circumstances. Whether such an individual will be permitted to participate will be decided by the COI Committee after it has examined the submitted COI management plan (described below) with respect to the issue that poses the conflict. Participation will be permitted under circumstances in which:
    1. The individual has important expertise that is needed for the project and cannot be easily duplicated by another readily available individual who has no conflict or a lesser conflict
    2. The existence and nature of the conflict is disclosed to anyone who may consider or make decisions on the basis of the advice provided by that individual, including other workgroup participants
    3. A plan for managing the conflict has been agreed to and implemented by the individual and the Sentinel COI Committee

For example, an individual with necessary expertise may be permitted to participate in an advisory, non-voting role as a resource if a reasonable person would not expect the conflict to result in bias. Where the potential for or appearance of bias is determined to be great enough to compromise the scientific integrity of the results, participation is not allowed. For example, an individual who has been retained by an interested party to support the party's position on the issue being considered, or who may substantially gain, financially or otherwise, from a particular outcome with respect to that issue, would not be permitted to participate.

  1. Individuals with conflicts may be permitted to participate in situations in which that participation only involves implementation of decisions that have been made and where the outcome cannot be expected to be influenced by the conflicted individual’s discretionary decision-making.

Management Plans

If it is determined that an actual or apparent COI exists, and also that the individual may be allowed to participate in the related Sentinel activity nonetheless, then the participating individual must submit to the COI Committee a proposed COI management plan that outlines procedures to manage, reduce, or eliminate the conflict, whether actual or apparent, throughout the duration of the contract and any applicable post-contract restriction period as defined by the FDA in the Cover Memorandum. The proposed COI management plan must address, in detail, the checks and balances in place to oversee the COI and describe the process of reporting on the status of the COI to the COI Committee, the Sentinel Principal Investigator, and the FDA. Further, the COI management plan must contain a statement of consent for the FDA to inspect all records, correspondence, and other documentation related to the COI. The COI management plan must be reviewed and accepted by the COI Committee, the Sentinel Principal Investigator, and the FDA. If, after discussion and negotiation, the COI management plan is deemed unacceptable by the COI Committee, the Sentinel Principal Investigator, or the FDA, then participation in the proposed activity may not occur. COI management plans will be incorporated by reference into all subcontracts. COI management plans must be renewed annually and within 30 days of any changes in the COI for the duration of participation in the relevant Sentinel activity. These updates must be reviewed and reported on by the COI Committee to the Sentinel Principal Investigator within 60 days of receipt.

Mitigation

If a significant financial or non-financial interest was not disclosed and was not previously reviewed by the COI Committee, then the COI Committee and Sentinel Principal Investigator will, within 60 days of being made aware of such interest, evaluate and report on whether any portion of the project done prior to the identification and management of the interest was biased in design, conduct, and/or reporting. Their findings and information about corrective actions taken, or to be taken, will be reported to the FDA and on the Sentinel website, and, if warranted, a COI management plan will be instituted from that point forward.

If a significant interest was not disclosed and is upon review determined to be a conflict, then the COI Committee and Sentinel Principal Investigator will, within 120 days of this determination, complete a retrospective review consistent with the NIH regulations delineated at 42 CFR § 50.605.

Confidentiality, Reporting, and Posting

Confidentiality

All information disclosed by individuals during the disclosure and review process will be held as confidential, except as necessary to implement this policy or as otherwise required by law. Only individuals who have signed the FDA’s Non-Public Information (NPI) form and the Sentinel Confidentiality Agreement[6] and are charged with collecting COI-related disclosures, evaluating potential COI, or overseeing COI management plans will have access to disclosure forms and management plans.

All disclosure forms and related documentation will be retained by the SOC and/or the COI Committee for at least three years from the date of acceptance of the final project report by the FDA.

Reporting to FDA

COI management plans must include:

  • steps for notifying the FDA of the existence of an actual or apparent COI
  • the actions that have been or will be taken to manage, reduce, or eliminate the COI

Updates must be provided annually. All communications to the FDA will be done through the COI Committee and/or the SOC.

Posting Regarding Individual Conflicts of Interest on the Sentinel Website

When it is determined that an individual has a conflict and the individual is nonetheless allowed to participate in a Sentinel activity related to that conflict, the project description on the Sentinel website will include:

  1. The individual’s name
  2. The individual’s position with respect to the Sentinel project
  3. A brief description of the conflict consistent with FDA’s Public Availability of Advisory Committee Members' Financial Interest Information and Waivers  
  4. A statement that a conflict exists and a management plan is in place, including a notice stating (a) that the individual is not a decision-maker on matters related to that specific Sentinel project, nor is s/he participating as a voting member in any committee or workgroup related to the project and (b) whether the individual is either participating as a non-voting adviser because his/her expertise is both needed and otherwise unavailable from other individuals with no or more limited conflicts, or the individual’s participation only involves implementation of decisions that have been made and where the outcome cannot be expected to be influenced by discretionary decision-making

All publications and presentations related to the activity must include information concerning the existence of the conflict in keeping with these requirements, consistent with the rules of the journal or conference.

Postings concerning individuals will be updated within 60 days of the time at which the SOC becomes aware of new information and will remain posted on the Sentinel website for at least 3 years from the time of the last update or acceptance of the final project report by the FDA, whichever is later.

Information posted regarding participating individuals who have been determined to have conflicts may be reviewed by the individual prior to posting. If the individual and the COI Committee cannot agree concerning the content of the posting, the individual may elect to withdraw from the project.

Penalties for Non-Compliance

Individuals will not be permitted to participate in work on Sentinel projects until they have submitted attestations or disclosure forms for review by the COI Committee. Individuals who fail to comply with the requirements of COI Policy for Protocol-Based Assessments may be banned from continued engagement in Sentinel activities related to the area of conflict if the COI Committee, the Sentinel Principal Investigator, or the FDA deems suspension or termination of engagement to be appropriate. Individuals who repeatedly fail to comply with the requirements of COI Policy for Protocol-Based Assessments may be banned by the Sentinel Principal Investigator or the FDA from further engagement with Sentinel. Deliberate failure to report relevant interests may be subject to additional penalties under the law.

COI Policy for Routine Analytic Framework Inferential Assessments

COI Policy for Routine Analytic Framework Inferential Assessments applies to inferential assessments of FDA-regulated medical products that use the Sentinel Routine Analytic Framework (RAF) tools. These inferential tools currently include modular program Level 2 and Level 3 assessments based on the RAF nomenclature. This section also applies to protocol-based assessments, as described in COI Policy for Protocol-Based Assessments. Descriptive RAF assessments, including summary table and modular program Level 1 assessments, are not included in the COI policy.

Investigators, including epidemiologists, biostatisticians, clinicians, pharmacologists, and any others who participate as decision-makers in assessments covered under COI Policy for Routine Analytic Framework Inferential Assessments may also participate in activities funded by the following sources: U.S. Federal,  state or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; the Reagan-Udall Foundation for the Food and Drug Administration (RUF-FDA); the Patient-Centered Outcomes Research Institute (PCORI); and/or the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC). Investigators funded by sources not listed in the prior sentence or who have significant financial or non-financial interests as defined in COI Policy for Protocol-Based Assessments held currently or during the previous 6-month period must file disclosures as defined in COI Policy for Protocol-Based Assessments: Disclosure. All disclosures must be evaluated by the COI Committee based on project-specific Cover Memoranda developed by the SOC and approved by FDA. Any activities, either paid or voluntary, with organizations in categories not listed above should be discussed with the FDA Project Lead on the contract prior to initiation.

Additional Information about Select Funding Organizations That Do Not Pose Conflicts

The Reagan-Udall Foundation for the Food and Drug Administration (RUF-FDA)

The RUF-FDA is an independent 501(c)(3) not-for-profit organization created in the Food and Drug Administration Amendments Act (FDAAA) of 2007. It is the only organization specifically established by the United States Congress to provide a framework for public-private partnerships intended to advance regulatory science on behalf of the Agency. As a result, it can be expected to receive funding from groups other than U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, or academic teaching hospitals or medical centers. Investigators who participate as decision-makers in assessments covered under COI Policy for Routine Analytic Framework Inferential Assessments may participate in activities funded by the RUF-FDA’s Innovation in Medical Evidence Development and Surveillance (IMEDS) Program. The Foundation has established governance procedures for IMEDS that address scientific and technical issues, stakeholder access, and appropriate reporting, and these governance procedures have been endorsed by FDA.

The Patient-Centered Outcomes Research Institute (PCORI)

The PCORI is an independent 501(c)(1) not-for-profit organization created by Congress in 2010 to fund research that can help patients and those who care for them make better-informed decisions about healthcare choices. PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCORTF), which was established by Congress through the Patient Protection and Affordable Care Act of 2010. The PCORTF receives income from three funding streams: appropriations from the general fund of the Treasury, transfers from the Centers for Medicare and Medicaid trust funds, and a fee assessed on private insurance and self-insured health plans (the PCOR fee). Investigators who participate as decision-makers in in assessments covered under Section 8.2 may participate in activities funded by PCORI.

The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)

The BBCIC, affiliated with the Academy of Managed Care Pharmacy (AMCP), is a not-for-profit, scientific public service initiative established in 2015 to monitor and generate post-market evidence for novel biologics, their corresponding biosimilars, and other related products regarding effectiveness and safety. The BBCIC is the only research network dedicated to monitoring biosimilars, draws on large sets of de-identified medical and pharmacy data (100 million lives), and harnesses cutting-edge distributed research network and surveillance methods. Managed care and integrated delivery organizations have devoted significant resources to develop an infrastructure that makes possible active surveillance of biosimilars and novel in distributed research networks (DRNs). The BBCIC marshals these resources for the important public health benefit inherent in monitoring biosimilar safety and effectiveness, using ongoing sequential analyses to compare biosimilars to their innovator product. Projects are jointly funded by pharmaceutical companies and overseen by independent scientific committees. An FDA liaison sits on the BBCIC Planning Board. The BBCIC requires that BBCIC Research Reports be submitted for publication within six months after the completion of the Research Report. When published, the publication will be posted on the BBCIC.org site. If six months have elapsed after the publication submission and the publication does not give a publication date or a release, the BBCIC Science Committee may release such results at its discretion on the BBCIC.org site.[7] Investigators who participate as decision-makers in assessments covered under COI Policy for Routine Analytic Framework Inferential Assessments may participate in activities funded by BBCIC.

Attestations

Investigators interested in participating as decision-makers in assessments covered under COI Policy for Routine Analytic Framework Inferential Assessments must submit Absence of Individual Conflicts of Interest Attestations to the SOC. Forms must be submitted:

  1. Upon initial engagement, or proposed engagement, with the project
  2. Annually thereafter for the duration of the period of participation

Investigators are required to notify the SOC within 30 days of acquisition of any new interests funded by organizations not allowed in COI Policy for Routine Analytic Framework Inferential Assessments. Individual Disclosure Forms and Individual Attestations will be stored by the SOC for at least three years.

Penalties for Non-Compliance

Individuals who fail to comply with the requirements of COI Policy for Routine Analytic Framework Inferential Assessments may be banned from continued engagement in Sentinel activities related to the area of conflict if the Sentinel Principal Investigator or the FDA deems suspension or termination of engagement to be appropriate. Individuals who repeatedly fail to comply with the requirements of COI Policy for Routine Analytic Framework Inferential Assessments may be banned by the Sentinel Principal Investigator or the FDA from further engagement with Sentinel. Deliberate failure to report relevant interests may be subject to additional penalties under the law.

Conflict of Interest Training

The SOC will provide instruction concerning the current Sentinel COI policy to all site Principal Investigators at Collaborating Institutions, as well as other investigators and personnel, as warranted.

Sample Conflict of Interest Cover Memorandum 

Cover Memorandum

For Confidential Disclosure Forms and Attestations        

This memorandum lists the specific products and firms for which potential individual conflicts of interest related to a specific Sentinel System project must be disclosed and evaluated prior to participation in the design, conduct, or reporting of that project. The memorandum also describes what constitute required disclosures for the purposes of determining the existence of individual conflicts of interest.

I. NAME OF SENTINEL PROJECT

To be filled in by the SOC.

II. BRIEF DESCRIPTION OF PLANNED ASSESSMENT

To be filled in by the SOC.

III. NAME OF FDA WORKGROUP LEAD

To be filled in by the SOC.

IV. DATE FDA APPROVED THIS FORM

To be filled in by the SOC.

V. LIST OF RELEVANT PRODUCTS

To be filled in by the SOC.

VI. LIST OF RELEVANT FIRMS

To be filled in by the SOC.

VII. REQUIRED INDIVIDUAL DISCLOSURES

Required individual disclosures include significant interests, financial and non-financial, held currently and/or during the preceding 12-month period, that are related to the project-specific list of products and/or firms listed in the relevant Cover Memorandum. Significant individual interests are defined below.

A. Significant Financial Interests

The following specific rules concerning what constitute significant financial interests for an individual investigator in the context of the FDA’s Sentinel System activities are taken verbatim from the Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations (page 29)Particular applications of these rules to individual investigators who have responsibility for the design, conduct, or reporting of a Sentinel System project are noted in footnotes to this section.

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[1] and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:[2]

  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 spouse or dependent children) 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. The Institution’s FCOI policy will specify the details of this disclosure,[3] which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(3) The term significant financial interest does not include the following types of financial interests:

  • 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;
  • any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or 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 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; 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.

B. Significant Non-Financial Interests

1. Significant Leadership Interests

Significant leadership interests include any relationship or role in which the individual (and/or the individual’s spouse/domestic partner and/or dependent children) participates with decision-making authority on boards, committees, professional societies or associations, or processes that are related to the project-specific list of products and/or firms named in the relevant Cover Memorandum. This includes institutional responsibilities that relate to the subject matter of the Mini-Sentinel activity in which the participant proposes to become involved, such as participation with decision-making authority on committees that oversee purchases of medical products.

2. Significant Other Interests

Significant other interests include any relationship or role in which the individual (and/or the individual’s spouse/domestic partner and/or dependent children) is engaged that might pose a significant conflict of interest, or appearance of a conflict, such as a pending lawsuit that are related to the project-specific list of products and/or firms named in the relevant Cover Memorandum.  If an individual is aware that his or her institution has a significant conflict of interest with respect to the products and/or firms named in the Cover Memorandum, that conflict should be reported under this heading.

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[1] For the purposes of Sentinel, all references to spouses include domestic partners. Domestic partner is defined to include those individuals bound by domestic partnership agreements recognized as legally valid instruments in their state of primary residence.

[2] For the purposes of Sentinel, the “Investigator’s institutional responsibilities” are defined as those responsibilities that reasonably appear to be related to the products and/or firms named in the relevant Cover Memorandum for the specific Sentinel System project for which disclosures are being provided.

[3] Details of travel related disclosures required for the purposes of Sentinel are presented in the Sentinel Confidential Disclosure Report for Project Specific Individual Interests. The COI Committee “will determine whether further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a financial conflict of interest (FCOI).”

 

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[1] Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Washington (DC): National Academies Press (US); 2009. http://www.ncbi.nlm.nih.gov/books/NBK22934/.

[2] In this policy, “Sentinel Principal Investigator” refers to the Principal Investigator responsible for Sentinel as a whole rather than project-specific or site-based Principal Investigators.

[3] FDA retains ultimate decision-making authority for Sentinel-related activities.

[4] Per Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations p.53284: “Institutional responsibilities means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial COI, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.”

[5] Domestic partner is defined to include those individuals bound by domestic partnership agreements recognized as legally valid instruments in their state of primary residence.

[6] See Confidentiality for additional information.

[7] Text taken substantially from the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) website.