Lebrun Labs, LLC (the “Company”) was formed May 6, 2009. The Company recognized a unique opportunity to develop and commercialize products and services for defined areas of testing. The Company offers standard and customizable solutions within its areas of expertise.
Facilities & Other Resources
LEBRUN LABS, LLC
Lebrun Labs LLC is located at 3301 E. Miraloma Ave., Suites 194, 193 and 187, Anaheim, CA.
Facilities include approximately 2,000 sq. ft. of lab space and 1,800 sq. ft. of manufacturing space. The lab space includes two hazardous substance rooms, equipped with double doors and a ventilation-controlled staging area, HEPA-filtered air, and air scrubber exhaust. These rooms also contain biosafety cabinets, tissue culture incubators, assay chambers, plumbing for gasses, sink, water filtration, hazardous storage, and disposal, and various laboratory equipment. The cell/tissue/organ culture room has HEPA filtration, a cell culture incubator, a class 2 biohazard cabinet, and phase contrast and fluorescent microscopes. The engineering/molecular biology room has benches for molecular biology and for assembly and prototyping.
The non-GLP manufacturing facility includes laminar flow hoods, benches, storage areas for manufacturing operations, ovens and chambers for quality assurance testing, and dedicated documentation and storage areas.
The newly acquired manufacturing facility is dedicated to the manufacturing and assembly of OptiSafe kits. It has ample separate storage spaces for raw materials and supplies, shipping materials, and finished kit storage. It houses an area for assembly line-style kit production and two additional rooms for reagent formulation and bottling. The shipping department has receiving and shipping areas, kit construction and packing materials, packing scales, and product storage areas.
Lebrun Labs, LLC has defined and labeled areas for chemical storage, routine lab operations including reagent preparation, dishwashing, and sterilization, and general storage.
Company staff include one experienced Ph.D.-level scientist, one M.D.-level scientist, and four skilled laboratory technicians. Additional staff include quality assurance- and business-related personnel.
Lebrun Labs LLC
3301 E. Miraloma Ave., Suite 194
Anaheim, CA 92806
Phone (714) 345-4689
Fax (844) 272-9854
Financial Conflict of Interest (FCOI) Policy
Purpose and Applicability
The NIH requires recipient Institutions and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, Promoting Objectivity in Research (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements.
All Lebrun Labs LLC personnel will adapt and implement FCOI policy to comply with promoting objectivity in research and be free from bias resulting from the Investigator’s financial conflicts of interest.
Definitions
· Disclosure of significant financial interests: Investigator’s disclosure of significant information to Lebrun Labs LLC
· Financial conflict of interest (FCOI): Significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research
· FCOI report: Institution’s report of a financial conflict of interest to a PHS Awarding Component
· Financial interest: Anything of monetary value, whether or not the value is readily ascertainable
· HHS: United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated
· Institution: Any domestic or foreign, public or private, entity or organization (excluding Federal agent) that is applying for, or that receives, PHS research funding
· Institutional responsibilities: Investigator’s professional responsibilities on behalf of Lebrun Labs LLC, and as defined by Lebrun Labs LLC in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional service, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety monitoring Boards
· Investigator: 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 PHS, or proposed for such funding, which may include, for example, collaborators or consultants
· Manage: Taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias
· PD/PI: Project director or principal Investigator of a PHS-funded research project
· PHS: Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH)
· PHS Awarding Component: Organizational unit of the PHS that funds the research
· Public Health Service Act: PHS Act; 42 U.S.C 201
· Research: 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 based and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term 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
· Senior/key personnel: PD/PI and any other person identified as senior/key personnel by Lebrun Labs LLC in the grant application, progress report, or any other report submitted to the PHS by the institution
· Significant financial interest (SFI):
o 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 appears to be related to the Investigator’s institutional responsibilities:
§ With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any entity interest in the entity as of the date of disclosure, when aggregated, 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;
§ With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
§ Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests
o 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. Lebrun Labs LLC's FCOI policy will specify the details of this disclosure, 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 Lebrun Labs LLC'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.
o The term SFI 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.
· Small Business Innovation Research (SBIR) Program: Extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act
POLICY
Training Requirements
Lebrun Labs LLC will Inform each Investigator of Lebrun Labs LLC policy on FCOI, the Investigator’s responsibilities regarding disclosure of SFI, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every 4 years, and immediately when any of the following circumstances apply:
o Revision of FCOI policies or procedures in any manner that affects the requirements of Investigators
o New Investigator to Institution
o Institution finds Investigator is not in compliance with the Institution’s FCOI policy or management plan
Disclosure, Review and Monitoring Requirements
Lebrun Labs LLC will:
· Designate an institutional official(s) to review disclosures of SFIs from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.
· Require that each Investigator who is planning to participate in the PHS-funded research disclose to Lebrun Labs LLC's designated official(s) the Investigator's SFIs (and those of the Investigator's spouse and dependent children):
o No later than the time of application for PHS-funded research.
o At least annually, in accordance with the specific time period prescribed by Lebrun Labs LLC, during the period of the award.
o Within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
· Provide guidelines for the designated Lebrun Labs LLC official(s) to determine whether an Investigator's SFI is related to PHS-funded research and, if so related, whether the SFI is a FCOI. An Investigator's SFI is related to PHS-funded research when Lebrun Labs LLC, through its designated official(s), reasonably determines that the SFI: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research. Lebrun Labs LLC may involve the Investigator in the designated official(s)'s determination of whether a SFI is related to the PHS-funded research. A FCOI exists when the Institution, through its designated official(s), reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
Prior to Lebrun Labs LLC's expenditure of any funds under a PHS-funded research project, the designated official(s) of Lebrun Labs LLC shall:
o Review all Investigator disclosures of SFI
o Determine whether any SFI relate to PHS-funded research; determine whether a FCOI exists
o Develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI.
o Examples of conditions or restrictions that might be imposed to manage a FCOI include, but are not limited to:
§ Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research)
§ For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants
§ Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI
§ Modification of the research plan
§ Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
§ Reduction or elimination of the financial interest (e.g., sale of an equity interest)
§ Severance of relationships that create financial conflicts
Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses a SFI or an existing Investigator discloses a new SFI to Lebrun Labs LLC, the designated official(s) of the Lebrun Labs LLC shall, within 60 days:
o Review the disclosure of the SFI
o Determine whether it is related to PHS-funded research
o Determine whether a FCOI exists
o Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI
o Depending on the nature of the SFI, Lebrun Labs LLC may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date of disclosure and the completion of Lebrun Labs LLC's review
Whenever Lebrun Labs LLC identifies a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by Lebrun Labs LLC during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within 60 days:
o Review the SFI
o Determine whether it is related to PHS-funded research
o Determine whether a FCOI exists
o Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward.
o In addition, whenever a FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose a SFI that is determined by Lebrun Labs LLC to constitute a FCOI; failure by Lebrun Labs LLC to review or manage such a FCOI; or failure by the Investigator to comply with a FCOI management plan, Lebrun Labs LLC shall, within 120 days of Lebrun Labs LLC's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
§ Lebrun Labs LLC is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:
· Project Number
· Project Title
· PD/PI or contact PD/PI if a multiple PD/PI model is used
· Name of the Investigator with the FCOI
· Name of the entity with which the Investigator has a FCOI
· Reason(s) for the retrospective review
· Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
· Findings of the review
· Conclusions of the review
o Based on the results of the retrospective review, if appropriate, Lebrun Labs LLC shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
§ 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 the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).
o Thereafter, Lebrun Labs LLC will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the FCOI, Lebrun Labs LLC may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the FCOI or the Investigator's noncompliance is determined and the completion of Lebrun Labs LLC's retrospective review
Take such actions as necessary to manage FCOI, including any financial conflicts of a subrecipient Investigator. Management of an identified FCOI requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report.
Whenever Lebrun Labs LLC implements a management plan, Lebrun Labs LLC shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.
Reporting Requirements to NIH
Lebrun Labs LLC will:
· Report initial and ongoing FCOI reports to the PHS.
o Prior to Lebrun Labs LLC's expenditure of any funds under a PHS-funded research project, the Lebrun Labs LLC shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's SFI found by Lebrun Labs LLC to be conflicting and ensure that the Lebrun Labs LLC has implemented a management plan. In cases in which Lebrun Labs LLC identifies a FCOI and eliminates it prior to the expenditure of PHS-awarded funds, the Lebrun Labs LLC shall not submit an FCOI report to the PHS Awarding Component.
o For any SFI that Lebrun Labs LLC identifies as conflicting subsequent to Lebrun Labs LLC's initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), Lebrun Labs LLC shall provide to the PHS Awarding Component, within 60 days, an FCOI report regarding the FCOI and ensure that Lebrun Labs LLC has implemented a management plan in accordance with this subpart. If a FCOI report involves a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by Lebrun Labs LLC (e.g., was not timely reviewed or reported by a subrecipient), Lebrun Labs LLC also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. If bias is found, Lebrun Labs LLC is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
o Any FCOI report required shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of Lebrun Labs LLC's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:
§ Project number
§ PD/PI or Contact PD/PI if a multiple PD/PI model is used
§ Name of the Investigator with the FCOI
§ Name of the entity with which the Investigator has a FCOI
§ Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
§ Value of the financial interest (dollar ranges are permissible: $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
§ A description of how the financial interest relates to the PHS-funded research and the basis for the Institution's determination that the financial interest conflicts with such research
§ A description of the key elements of the Institution's management plan, including:
· Role and principal duties of the conflicted Investigator in the research project;
· Conditions of the management plan;
· How the management plan is designed to safeguard objectivity in the research project;
· Confirmation of the Investigator's agreement to the management plan;
· How the management plan will be monitored to ensure Investigator compliance; and
· Other information as needed.
§ For any FCOI previously reported by the Institution with regard to an ongoing PHS-funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the FCOI no longer exists. The Institution shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
§ In addition to the types of financial conflicts of interest as defined in this subpart that must be reported pursuant to this section, an Institution may require the reporting of other financial conflicts of interest in its policy on financial conflicts of interest, as the Institution deems appropriate.
· Based on the results of the retrospective review, if appropriate, Lebrun Labs LLC shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, Lebrun Labs LLC is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include:
o The key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project
o Extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).
· Thereafter, Lebrun Labs LLC will submit FCOI reports annually. Depending on the nature of the FCOI, Lebrun Labs LLC may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the FCOI or the Investigator's noncompliance is determined and the completion of Lebrun Labs LLC's retrospective review
· If the failure of an Investigator to comply with Lebrun Labs LLC's FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, Lebrun Labs LLC shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Lebrun Labs LLC on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Lebrun Labs LLC employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.
Maintenance of Records
Lebrun Labs LLC will establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.
Enforcement Mechanisms and Remedies and Noncompliance
Whenever Lebrun Labs LLC identifies a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by Lebrun Labs LLC during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within 60 days:
· Review the SFI
· Determine whether it is related to PHS-funded research
· Determine whether a FCOI exists
Lebrun Labs LLC is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:
o Project Number
o Project Title
o PD/PI or contact PD/PI if a multiple PD/PI model is used
o Name of the Investigator with the FCOI
o Name of the entity with which the Investigator has a FCOI
o Reason(s) for the retrospective review
o Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
o Findings of the review
o Conclusions of the review
In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported by Lebrun Labs LLC, Lebrun Labs LLC shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
Subrecipient Requirements
If Lebrun Labs LLC carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Lebrun Labs LLC (awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by:
· Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient's Investigators.
o If the subrecipient's Investigators must comply with the subrecipient's FCOI policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart.
o If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the FCOI of the awardee Institution for disclosing SFI that are directly related to the subrecipient's work for the awardee Institution.
o Additionally, if the subrecipient's Investigators must comply with the subrecipient's FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart.
o Alternatively, if the subrecipient's Investigators must comply with the awardee Institution's FCOI financial, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of SFIs to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this subpart
Public Accessibility Requirements
Maintain an up-to-date, written, enforced policy on FCOI and make such policy available via a publicly accessible website. If the Institution does not have any current presence on a publicly accessible Web site (and only in those cases), the Institution shall make its written policy available to any requestor within five business days of a request. If, however, the Institution acquires a presence on a publicly accessible website during the time of the PHS award, the requirement to post the information on that website will apply within 30 calendar days. If an Institution maintains a policy on financial conflicts of interest that includes standards that are more stringent than this subpart (e.g., that require a more extensive disclosure of financial interests), the Institution shall adhere to its policy and shall provide FCOI reports regarding identified financial conflicts of interest to the PHS Awarding Component in accordance with the Institution's own standards and within the timeframe prescribed by this subpart
Prior to Lebrun Labs LLC's expenditure of any funds under a PHS-funded research project, Lebrun Labs LLC shall ensure public accessibility, via a publicly accessible website or written response to any requestor within five business days of a request, of information concerning any SFI disclosed to the Institution that meets the following three criteria:
· The SFI was disclosed and is still held by the senior/key personnel
· The Institution determines that the SFI is related to the PHS-funded research
· The Institution determines that the SFI is a FCOI
The information that Lebrun Labs LLC makes available via a publicly accessible website or written response to any requestor within five business days of a request, shall include, at a minimum, the following:
· Investigator's name
· Investigator's title and role with respect to the research project
· Name of the entity in which the SFI is held
· Nature of the SFI
· The approximate dollar value of the SFI (dollar ranges are permissible):
o $0-$4,999
o $5,000-$9,999
o $10,000-$19,999
o Amounts between $20,000-$100,000 by increments of $20,000
o Amounts above $100,000 by increments of $50,000
o 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
If Lebrun Labs LLC uses a publicly accessible website for the purposes of this subsection, the information that Lebrun Labs LLC posts shall be updated at least annually. In addition, the Lebrun Labs LLC shall update the website within 60 days of Lebrun Labs LLC's receipt or identification of information concerning any additional SFI of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a SFI of senior/key personnel new to the PHS-funded research project, if Lebrun Labs LLC determines that the SFI is related to the PHS-funded research and is a FCOI. The website shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of Lebrun Labs LLC's identification of a new FCOI. If Lebrun Labs LLC responds to written requests for the purposes of this subsection, Lebrun Labs LLC will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the Lebrun Labs LLC's identification of a new FCOI, which should be requested subsequently by the requestor.
Information concerning the SFIs of an individual shall remain available, for responses to written requests or for posting via Lebrun Labs LLC's publicly accessible website for at least three years from the date that the information was most recently updated.
REFERENCES
· 42 CFR Part 50 Subpart F - Promoting Objectivity in Research Authority:42 U.S.C. 216, 289b-1, 299c-4; Sec. 219, Tit. II, Div. D, Pub. L. 111-117, 123 Stat. 3034. Source:76 FR 53283, August 25, 2011, unless otherwise noted. Available at: https://ecfr.io/Title-42/Part-50/Subpart-F
· 42 CFR Part 50 – Policies of General Applicability. Subpart F – Promoting Objectivity in Research. Available at: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#subpart-F
· NIH. Grants and Funding. Financial Conflict of Interest. Available at: https://grants.nih.gov/grants/policy/coi/index.htm
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