Financial conflict of interest
Us Helping Us (“Us Helping Us” or “Organization”) is committed to ensuring that research is conducted in a manner that protects the rights of individuals involved and is free from financial conflicts of interest (FCOI) that may compromise the integrity of the research process. As such, Us Helping Us has developed the following policies to minimize the adverse effects of financial conflicts of interest.
The purpose of this policy is to; (a) implement the requirements of the federal regulations set forth in 42 CFR Part 50 (the “federal regulations”) governing the Organization’s and each Investigator’s responsibilities for promoting objectivity in Public Health Service (“PHS”) funded research, and (b) publish and disseminate standards that provide a reasonable expectation that the design, conduct, and reporting of research under PHS-funded grants, sub grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
Who is Governed by this Policy?
This policy shall apply to all persons at Us Helping Us who meet the definition of Investigator, as outlined below. Additionally, this policy applies to all Us Helping Us research activities which are funded by the PHS.
Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution.
Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report means an Institution's report of a financial conflict of interest to a PHS Awarding Component.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.
Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, 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.
Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Manage means 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 means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.
PHS means the 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 means the organizational unit of the PHS that funds the research that is subject to this subpart.
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Research means a 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 basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, 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 means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
Significant financial interest means:
(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:
(i) 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;
(ii) 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
(iii) 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, 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.
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.
All PHS-supported Investigators are required to complete mandatory FCOI training. These training must be completed prior to engaging in PHS-funded research and at least once every four years thereafter. Training will also be required when this policy is revised, an Investigator is new to the Organization, and when an Investigator is not in compliance with this policy or assigned management plan.
Training will be provided by….
Disclosure of Significant Financial Interest
Investigators must timely disclose all Financial Interests and Outside Activities in writing to the Designated Institutional Official (DIO), as outlined in the following section. All disclosures must be made:
Not later than the time of application or submission of a formal proposal for the PHS-funded research.
Annually during the period of the award. Such disclosure shall include any information that was not disclosed initially to the Organization, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).
Within thirty days of discovering or acquiring a new Significant Financial Interest; or after receiving reimbursement or sponsorship for travel related expenses.
Process for Reviewing Investigator Significant Financial Interests
Designated Institutional Official (DIO)
The Director of Research is the Organization’s Designated Institutional Official (DIO). The DIO shall solicit and review disclosures of significant financial interests from each Investigator (and those of the Investigator’s spouse and dependent children) who is planning to participate in, or is participating in, PHS-funded research at the Organization.
Initial Review and Action
Prior to the Investigator’s expenditure of and before the Organization disburses and funds for a PHS-funded research project, the DIO will do the following:
Solicit and review Investigator SFI disclosures and any other information determined to be relevant. The DIO may require the Investigator to provide additional information to aid in this review.
The DIO will determine whether an Investigator’s SFI is related to the PHS-funded research project. An Investigator’s SFI is related to PHS-funded research when the DIO 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. The DIO may involve the Investigator in the DIO’s determination of whether a SFI is related to the PHS-funded research. The DIO will be guided by the following practices and apply them as may be appropriate in determining whether the SFI is related to the PHS-funded research project.
Consider the nature and extent of the financial interest in the relationship of the investigator/family member and the external organization.
Give special consideration to the terms and conditions of sponsored project agreements that may mitigate or complicate the given situation.
Consult with and obtain additional information from the Investigator/family member as either the DIO or the Investigator/family member may feel to be helpful in resolving actual or potential conflicts.
Act in a timely manner so as to not delay unduly the conduct of the sponsored project.
Upon determination that the disclosed financial interest is a SFI, the DIO will review the SFI to determine whether a FCOI exists and thus whether further review and management is required. A FCOI exists when the Organization, through its DIO, reasonably determines that the significant financial interest: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research. The Organization may involve the Investigator in the designated official(s)'s determination of whether a significant financial interest is related to the PHS-funded research. A financial conflict of interest exists when the Organization, through its DIO, reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
Management of FCIO
When the DIO has determined that a FCOI exists, the DIO will develop and recommend for implementation a management plan that specifies the actions that have been and/or will be taken to manage the FCOI.
Conditions or Restrictions
If the Organization develops and implements a plan to manage the FCOI, examples of conditions or restrictions that might be imposed to manage the FCOI include, but are not limited to:
Public disclosure of financial conflicts of interest;
Disclosure of financial conflicts of interest directly to participants involved in human subjects research;
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; or
Severance of the relationships that create financial conflicts.
Monitoring Compliance with the Management Plan
The DIO shall conduct random monitoring on an ongoing basis of FCOI management plans until the PHS-funded research project concludes.
New SFIs During Ongoing PHS-Funded Research
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 the Organization, the DIO shall, within sixty (60) days of the disclosure:
Review the disclosure of the SFI;
Determine whether the SHI is related to PHS-funded research;
Determine whether a FCOI exists; and, if so,
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. Depending on the nature of the significant financial interest, the Organization 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 the Organization’s review.
Review of Existing SFI
Whenever the Organization identifies a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Organization during an ongoing PHS-funded research project, the DIO shall, within sixty (60) days o the identification:
Review the SFI;
Determine whether it is related to the PHS-funded research project;
Determine whether a FCOI exists; and, if so:
Implement, on at least an interim basis, a management plan that shall specify the actions that have been and will be taken to manage the FCOI going forward.
Whenever a FCOI is not identified or managed in a timely manner, including when an Investigator fails to disclose a SFI that is determined by the DIO to constitute a FCOI; failure by the Organization to review or manage such a FCOI; or failure by the Investigator to comply with a FCOI management plan, the Organization shall, within 120 days of the Organization’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 or such research.
In any case in which the Department of Health and Human Services determines that a PHS-funded research 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 an FCOI that was not managed or reported by the Organization as required by Federal regulation, the Organization shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research, and request an addendum to previously published presentations.
Under the federal regulation, the Organization is required to document the retrospective review. Such documentation shall include, but not necessarily be limited to, all of the following key elements:
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 financial conflict of interest;
Reason(s) for the retrospective review;
Detailed methodology used for the retrospective review;
Findings of the review; and,
Conclusion of the review.
Update FCOI Report
Based on the results of the retrospective review, if appropriate, the Organization shall update the previously submitted FCOI report, specifying the actions will be taken to manage the FCOI forward. If bias is found, the Organization is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include the key element documented in the retrospective review above and a description of the impact of the bias on the research project and the Organization’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Following submission of the Mitigation report, the Organization will submit FCOI reports annually. Depending on the nature of the FCOI, the Organization 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 the Organization’s retrospective review.
Reporting Requirements to NIH
The Organization shall provide a FCOI report regarding any Investigator's FCOI to the PHS Awarding Component before spending any funds received under a PHS-funded research project. However, if the Organization has identified and eliminated a FCOI prior to the expenditure of PHS-awarded funds, the Organization shall not submit an FCOI report to the PHS Awarding Component. The Organization shall provide the PHS Awarding Component with a FCOI Report regarding any FCOI identified after the Organization’s initial FCOI report during an ongoing PHS-funded research project within sixty (60) days of identification. The organization shall also provide the PHS Awarding Component with a FCOI Report for any Investigators newly involved in the project within sixty (60) days of identification. The Organization shall promptly notify and submit a mitigation report to the PHS Awarding Component if bias is found during a retrospective view. The organization shall provide annual reports to the PHS Awarding Component to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project. Annual reports will be made at the same time as when the Organization is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension.
All reports described above shall include, but is not limited to, the following components:
PD/PI or Contact PD/PI;
Name of the Investigator with FCOI;
Name of the entity with which the Investigator has a financial conflict of interest;
Nature and value of the financial interest
Description of how the financial interest relates to the PHS-funded research and the basis for the Organization’s determination that the financial interest conflicts with such research; and
Description of the key elements of the Organization’s management plan, which shall include:
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 Organization with regard to an ongoing PHS-funded research project, the Organization 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 FCOI is still being managed or explained with the FCOI no longer exists. The Organization shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period in the time and manner specified by the PHS Awarding Component.
Maintenance of Records
FCOI files shall be maintained for three (3) years from the date the final expenditures report is submitted to the PHS Awarding Component and from other dates specified in 45CFR 74.53(b) and 92.42(b) as relating to records retention. Records shall be maintained in such a way as to protect the confidentiality of all individuals involved. Records may only be accessed by the Investigator/family member and the DIO.
Enforcement Mechanisms and Remedies for Noncompliance
Failure to file a complete and truthful disclosure as required by this policy or to comply with the conditions or restrictions imposed in the resolution, management, or elimination of FCOI constitutes a violation of this policy and may violate state and/or federal law. The Organization may suspend an ongoing research project, halt the expenditure of funds, suspend technology transfer activities to prevent continued violation of this policy, or take other disciplinary actions deemed appropriate by the Organization.
The policies described in this document shall also apply to Investigators brought onto PHS-funded research projects as subrecipients. If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with the Organizations FCOI policy.. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the Organization for disclosing significant financial interests that are directly related to the subrecipient's work for the Organization.
Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the Organization. Such time period(s) shall be sufficient to enable the Organization to provide timely FCOI reports, as necessary, to the PHS as required by this policy.
Alternatively, if the subrecipient's Investigators must comply with the Organization’s FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the Organization. Such time period(s) shall be sufficient to enable the Organization to comply timely with its review, management, and reporting obligations under this policy.
Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
Public Accessibility Requirements
Prior to the Organization’s expenditure of any funds under a PHS-funded research project, the Organization shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the Organization that meets the following three criteria:
A. The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;
B. The Organization determines that the significant financial interest is related to the PHS-funded research; and
C. The Organization determines that the significant financial interest is a financial conflict of interest.
The information that the Organization makes available via a publicly accessible Web site or written response to any requestor within five business days of a request, shall include, at a minimum, the following: the Investigator's name; the Investigator's title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant 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.
If the Organization uses a publicly accessible Web site for the purposes of this subsection, the information that the Organization posts shall be updated at least annually. In addition, the Organization shall update the Web site within sixty days of the Organization's receipt or identification of information concerning any additional significant financial interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a significant financial interest of senior/key personnel new to the PHS-funded research project, if the Organization determines that the significant financial interest is related to the PHS-funded research and is a financial conflict of interest. The Web site 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 the Organization's identification of a new financial conflict of interest. If the Organization responds to written requests for the purposes of this subsection, the Organization 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 Organization's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.
Information concerning the significant financial interests of an individual shall remain available, for responses to written requests or for posting via the Organization's publicly accessible Web site for at least three years from the date that the information was most recently updated.