|FINANCIAL CONFLICT OF INTEREST POLICY FOR PFS FUNDED RESEARCH UNDER 42 CFR PART 50F||Policy 00-100|
This Policy is intended to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This Policy describes types of Financial Conflict of Interest (FCOI), identifies when disclosure should be provided, and explains Scarless Laboratories’ administration and enforcement procedures as required under 42 CFR Part 50 Subpart f.
Scarless Laboratories will adhere to this Policy when applying for, or receiving PHS research funding, by means of a grant or cooperative agreement. The policy is applicable to Senior/Key Personnel/ Investigators as defined below, who participate in Scarless Laboratories research. Participation includes having an active role in the development of protocols, the conduct of clinical trials, as well as the reporting of study results. This Policy it is not applicable to Phase 1 SBIR programs.
III. REFERENCES: 42 CFR 50f
- Designated Official(s): Person(s) responsible for the implementation of the FCOI Policy, designated by Scarless Laboratories.
- Equity Interest: Any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- Financial Interest: Anything of non-trivial monetary value, regardless of whether the value is readily ascertainable.
- Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
- Immediate Family: Investigator/senior/key personnel’s spouse or domestic partner and dependent children.
- Investigator: The project director or principal investigator (PD/PI) 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 subgrantees, contractors, consortium participants, collaborators, or consultants.
- Institution: Any domestic or foreign, public, or private, entity or organization (excluding a federal agency), including Biotechnology and Pharmaceutical companies, that submits a proposal, or that receives, PHS research funding. Scarless Laboratories is considered an “Institution” for the purposes of this policy.
- Institutional responsibilities: Any key/senior personnel/investigator’s professional responsibilities conducted on behalf of Scarless Laboratories and as defined by Scarless Laboratories, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards (IRB) or Data and Safety Monitoring Boards (DSMB).
- 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).
- Regulation or FCOI regulation: 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements.
- Remuneration: Salary and any payment for services, including consulting fees, honoraria, and paid authorship.
- Research: A systematic investigation, study, or examination designed to develop or contribute to generalizable knowledge relating broadly to public health including behavioral and social-sciences research. basic 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 PHS but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
- Senior/Key Personnel: The Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by Scarless Laboratories in the grant application, progress report, or any other report submitted to the PHS/NIH by Scarless Laboratories under the regulation who also receives total remuneration equal to or exceeding $5,000.00 for the 12-month reporting period from Scarless Laboratories that is not a part of an employee’s normal salary from Scarless Laboratories for work relating to a PHS funded grant.
- Significant Financial Interest (SFI): Financial interest consisting of one or more of the following interests of the investigator/senior/key personnel (and those of the investigator/senior/key personnel’s spouse and dependent children) that reasonably appears to be related to the Investigator/senior/key personnel’s Scarless Laboratories responsibilities:
- If a 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 equity interest in the entity as of the date of disclosure, when aggregated exceeds $5,000. For the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value. (Note: 14.a is not applicable to Scarless Laboratories.)
- If a 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 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.(Note: 14b. is applicable to Scarless Laboratories.)
- The term significant financial interest (SFI) does not include the following types of financial interests: salaries, royalties or other remuneration paid by Scarless Laboratories, Inc. to the investigator/senior/key personnel if the investigator/senior/key personnel is currently employed or otherwise appointed by Scarless Laboratories, including intellectual property rights assigned to Scarless Laboratories and agreements to share in royalties related to such rights; any ownership interest in Scarless Laboratories held by the investigator/senior/key personnel; income from investment vehicles, such as mutual funds and retirements accounts, as long as the investigator/senior/key personnel 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, 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.
- Investigator/senior/key personnel must also disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator/senior/key personnel and not reimbursed to the investigator/senior/key personnel so that the exact monetary value may not be readily available) related to their responsibilities to Scarless Laboratories; 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, medical center, or research institute that is affiliated with an Institution of higher education. Scarless Laboratories’ 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 Scarless Laboratories’ FCOI policy, Scarless Laboratories CEO or Designated Official will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.
- Small Business Innovation Research(SBIR) Program means the 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, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.
V. POLICY AND MANAGEMENT
Scarless Laboratories is a non-publicly traded company within the definition of 14b. above. A financial conflict of interest related to Scarless Laboratories’ activities may occur when an investigator/senior/key personnel employed or appointed by Scarless Laboratories has a significant financial interest that compromises, or appears to compromise, that individual’s independence and objectivity in the discharge of his/her Scarless Laboratories responsibilities in the design, conduct, or reporting of Scarless Laboratories’ research. Investigators/senior/key personnel should avoid potential for conflicts resulting from financial arrangements with third parties that could have a special interest in a Scarless Laboratories protocol.
Senior/key personnel/investigators are required to disclose SFIs (and those of the investigators, senior/key personnel’s immediate family) using Scarless Laboratories Form 001, Significant Financial Interest (SFI) Disclosure. This disclosure will be made at least annually during the award period [to include any information that was not disclosed initially to Scarless Laboratories or updated information regarding any previously disclosed SFI] and within 30 days of discovering or acquiring a new SFI (such as through purchase, marriage, or inheritance).
Scarless Laboratories will name its Chief Executive Officer (CFO) or “designee” to manage the FCOI policy. The CEO or designee will take 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. If a determination is made that a FCOI exists Scarless Laboratories’ CEO or designee will recommend a suitable action plan or management plan to eliminate or manage the FCOI consistent with the objectives of this policy.
The action plan or management plan shall provide for its periodic review and updating at least annually. Final review and determination must be completed prior to the expenditure of any PHS funds for the applicable Research. Scarless Laboratories shall review the action plan or management plan annually and can modify or approve additional work. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest 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 financial conflict of interest.
- 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); or
- Severance of relationships that create financial conflicts.
In the event that there is no reasonable way to manage a FCOI then the investigator/senior/key personnel may be prohibited from participating in the related Research until such a time as the FCOI is eliminated
A conflict should be managed, reduced, or eliminated within sixty (60) days of its identification. Scarless Laboratories’ CEO or other designated official will be responsible for monitoring and enforcing FCOI management plans. This policy also applies when, in the course of an ongoing PHS-funded research project, an investigator/senior/key personnel who is new to participating in the research project discloses a significant financial interest or an existing investigator/ senior/ key personnel disclose a new significant financial interest to Scarless Laboratories.
If an investigator/senior/key personnel fails to comply with Scarless Laboratories’ FCOI policy, within 120 days of discovery by Scarless Laboratories, Scarless Laboratories will complete a retrospective review of the senior/key personnel/investigator’s activities to determine potential bias.
If a bias is found, Scarless Laboratories will submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. Scarless Laboratories will work with the investigator/senior/key personnel to set up an FCOI management plan to mitigate the situation.
If PHS-funded research projects 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 an FCOI that was not managed or reported by Scarless Laboratories as required by the regulation, Scarless Laboratories in accordance with 42 CFR 50.606(c) will require the Investigator involved to:
- Disclose the FCOI in each public presentation of the results of the research
- Request an addendum to previously published presentations
VI. TRAINING, REPORTING, AND RECORD KEEPING
Training (42 CFR50.604(b))
All persons subject to the Scarless Laboratories Financial Conflict of Interest Policy will be required to train on Policy 00-001 by reading and affirming their understanding of, and intent to comply with, the FCOI policy and every four (4) years thereafter.
Immediate training will be required if Scarless Laboratories revises this policy in a manner that affects the investigator/senior/key personnel, when an investigator/senior/key personnel is new to Scarless Laboratories, or as a result of a finding of noncompliance with this policy or a management plan, or other related misconduct.
Scarless Laboratories’ senior/key personnel/ investigators shall also demonstrate understanding of FCOI by using the NIH web-based training which can be accessed online at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
Unless otherwise covered by a third-party FCOI Policy as agreed with Scarless Laboratories, each investigator/senior/key personnel is required to complete training on Scarless Laboratories’ FCOI Policy by reading and affirming the policy or demonstrate training on the NIH web based training on the following occasions:
- Prior to engaging in research related to any PHS-funded grant,
- At least every 4 years, and
- Immediately if 1) Scarless Laboratories revises the FCOI Policy in a manner that affects requirements of investigator/senior/key personnel, 2) Investigator/senior/key personnel is new to Scarless Laboratories, or 3) An investigator is not in compliance with the FCOI Policy or management plan
Reporting to NIH
As required by 42 CFR Part 50, Subpart F, Scarless Laboratories will file initial, annual (ongoing) and revised reports to the NIH providing information on every identified FCOI and the manner in which the FCOI is being or has been managed, reduced, or eliminated. Reports will include all the elements required by these regulations. Scarless Laboratories will notify NIH promptly and take corrective action for noncompliance with Scarless Laboratories Policy or management Plan and if bias is found with the design, conduct, or reporting of NIH-funded research, file a Mitigation Report in accordance with federal regulations. Reports will be submitted:
- Prior to expenditure of funds
- Within 60 days for new or newly identified FCOIs for existing investigators
- At least annually (at the time Scarless Laboratories submits its annual progress report, multi-year progress report, or extension) to provide the status of the FCOI and any changes to the management plan until the completion of the project
- Following a retrospective review to update a previously submitted report
The records of all financial disclosures and all actions taken by Scarless Laboratories will be maintained for at least three years from the date of submission of the final expenditures report or as required under 45 CFR 75.361.
VII. ADDITIONAL CONSIDERATIONS
When carrying out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Scarless Laboratories shall incorporate by written agreement (e.g., subaward contract) that the investigator/senior/key personnel of the subrecipient institution is required to either:
- Comply with the Scarless Laboratories’ FCOI Policy, or
- Comply with the FCOI Policy of the subrecipient institution and have said institution certify that its policy complies with 42 CFR 50 f. The written agreement,
under either policy, must specify the time period for the subrecipient to provide investigator/senior/key personnel disclosure and report of any FCOI to Scarless Laboratories.
At least 30 days from the reporting deadline for Scarless Laboratories’ annual disclosures, or in cases of discovery or acquiring new SFI, a maximum of 10 business days the subrecipient is to report to Scarless Laboratories, to enable Scarless Laboratories to comply timely with its review, management, and reporting obligations.
Scarless Laboratories will provide FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient investigator/senior/key personnel s prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
VIII. PUBLIC ACCESSIBILITY
Scarless Laboratories’ Financial Conflict of Interest Policy will be posted on the public portion of the Scarless Laboratories website. In addition, upon receipt of a written request for information concerning identified FCOI’s held by Senior/Key Personnel (as defined by this policy), Scarless Laboratories will make that information available within five (5) business days of the request. The information shall include all elements required by 42 CFR Part 50, updated through the date of the response.
- Be updated, at least annually (Web site only but any response to a written request should include the updated information)
- Be updated, within 60 days of a newly identified FCOI (Web site only but any response to a written request should include the updated information
- Remain available for three (3) years from the date the information was most recently updated.