SHARP Research Policy
L&I Employee Policies and Procedures.
General Topic: Personnel.
Policy #: 3.44.
Issued: August 24, 2012 (no previous policy).
Subject: Promoting Objectivity in Research.
See also: Federal Regulation 42 CFR, Part 50, Subpart F; WAC 292-110-050; RCW 42.52, Ethics in Public Service.
Purpose and description
This policy applies only to Washington State Department of Labor and Industries' (L&I) research investigators who participate in the design, conduct, or dissemination of results of Public Health Service (PHS) funded research. The purpose of this policy is to meet Federal regulatory requirements regarding identifying and mitigating possible financial conflicts of interest in PHS funded research (42 CFR Part 50 Subpart F).
This policy does not change, in any way, an L&I employee's responsibilities for complying with the Washington State's Ethics in Public Service Act (RCW 42.52), or any other L&I policies. Under RCW 42.52.020 "No state officer or state employee may have an interest, financial or otherwise, direct or indirect, or engage in a business or transaction or professional activity, or incur an obligation of any nature, that is in conflict with the proper discharge of the state officer's or state employee's official duties."
Employees remain personally liable for violations of RCW 42.52 and the Department has no authority to lessen the prohibitions of the Ethics law. Research investigator financial conflicts of interest will be referred to the State Ethics Board.
This policy complies with federal regulations by adding institutional responsibilities for identifying and mitigating possible financial conflicts of interest. The federal regulation requires researchers involved in PHS research to report their significant financial interests to a designated institutional official to determine if those significant financial interests represent a financial conflict of interest pertaining to PHS funded research.
Definitions
Disclosure of significant financial interests
Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution.
Financial conflict of interest (FCOI)
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
FCOI report means an Institution's report of a financial conflict of interest to a PHS Awarding Component.
Financial interest
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS
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
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
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.
Research investigator
Research 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. For compliance with this policy, the definition of research investigator extends to the research investigator's spouse and dependent children.
Manage
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
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
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
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
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Research
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
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
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:
a. 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 $0. 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;
b. 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 $0, 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
c. 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; 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.
Policy
A. SHARP staff will provide training on this policy to all L&I research investigators working on PHS funded research.
1. Training will include:
a. Review of this policy, the investigators financial disclosure requirements, and the Federal Regulation (42 CFR, Part 50, Subpart F).
b. Review state ethics laws and L&I policies mandating the absence of financial conflicts of interests related to work responsibilities in state employment.
2. Training will occur immediately on implementation of this policy, when an investigator is new to L&I, when L&I updates this policy, and when an investigator is not in compliance with this policy.
3. Training will be refreshed every four years.
4. SHARP will maintain a training log documenting the dates when research investigators received training related to this policy.
B. All PHS funded research investigators (and those of the research investigator's spouse and dependent children) must disclose all significant financial interests (SFI) that meet or exceed the regulatory definition above. L&I's Assistant Director of Human Resources is the designated institutional official to review disclosures of SFI.
1. Researcher investigators must disclose all SFI prior to submission of a research proposal to a PHS entity.
2. During the period of the PHS award, all researcher investigators must submit annual disclosures of SFI.
3. Newly hired researcher investigators must disclose all significant financial interests or sponsored travel within 30 days.
4. Each research investigator is required to disclose any reimbursed or sponsored travel, not 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.
5. Disclosure of sponsored travel should include the following details:
a. the purpose, destination and duration of the trip, and
b. the identity of the sponsor/organizer.
6. Sponsored travel must be disclosed within 30 days of occurrence.
7. If a SFI is discovered, the research investigator has 30 days to disclose the SFI.
8. Research investigators will disclose significant financial interests in the following manner:
a. Investigator name,
b. PHS Project Name,
c. PHS Project Role (e.g. PI, PD, Investigator),
d. List of SFI(s).
9. The completed disclosure form must be submitted to L&I's Assistant Director of the Office of Human Resources with a copy of the research proposal.
10. Each Investigator shall complete an L&I Conflict of Interest Analysis Form for disclosed significant financial interests. The research investigator will provide a statement and rationale for why the disclosed significant financial interest is not a financial conflict of interest.
C. Any disclosed significant financial interest determined by the Assistant Director of Human Resources as a possible financial conflict of interest related to L&I research must be mitigated and eliminated prior to the use of state or federal funds for research.
1. For research proposals not yet submitted, the designated institutional office will review SFIs disclosed in accordance with the process in (A) to determine if a possible FCOI exists related PHS funded research. If a possible FCOI exists, the Assistant Director of Human Resources may solicit an advisory opinion from the State Ethics Board per WAC 292-110-050 to determine if there is financial conflict of interest. If a possible FCOI exists, the Assistant Director of Human Resources may require:
a. Institutional non-approval of the submission of the research proposal; or
b. Investigator divestiture of SFIs; or
c. Investigator severance of relationships that create actual or potential conflicts.
2. For research grants currently funded by a PHS entity at the time of implementation of this policy, or for new research investigators, or for occurrences of an acquired SFI by a research investigator (e.g. marriage, inheritance), the Assistant Director of Human Resources shall review all investigator disclosed SFI, determine if any financial interests relate to PHS funded research, and make a preliminary determination if a financial conflict of interest exists. If the Assistant Director of Human Resources determines that there is a possible financial conflict of interest, he may solicit an advisory opinion from the State Ethics Board per WAC 292-110-050 to determine if there is financial conflict of interest. If a FCOI is determined to exists, the Assistant Director of Human Resources may require investigator removal from research activities, investigator divestiture of SFIs; or investigator severance of relationships that create actual or potential conflicts, or any other action to eliminate the FCOI. Identified financial conflicts of interest may be referred to the State Ethics Board.
3. If made aware of a significant interest that was not disclosed within the required time frames, L&I's Assistant Director of Human Resources will review the disclosure and determine if there is a relationship to the project within sixty (60) days. If a financial conflict of interest is determined to exist the Assistant Director of Human Resources will implement a management plan to eliminate the financial conflict of interest. In addition, L&I's Assistant Director of Human Resources, will complete a retrospective review of the investigators activities within 120 days consistent with the requirements of 42 CFR Part 50 Subpart 4-F.
D. L&I will manage all identified FCOI according to state law (RCW 42.52.030). If a FCOI is identified, it will be reported in a timely manner to the PHS agency funding the research.
1. All FCOI reports will be submitted to the PHS sponsoring agency prior to expenditure of any funds under an award or within 60 days of identification of a FCOI for a new investigator or newly identified FCOI for existing investigators.
2. FCOI reporting will be updated annually to the PHS funding agency with notification in the grant continuation approval process.
3. If a FCOI existed, all products or information associated with the research (e.g. presentations of results, grant reports) will disclose the FCOI.
4. The PHS agency will be notified within 30 days if bias resulting from a FCOI is found in the design, conduct, or reporting of any PHS funded research.
5. The PHS agency will be notified within 30 days if bias resulting from a FCOI is found in the design, conduct, or reporting of any PHS funded research.
6. The PHS agency will be notified of retrospective reviews of previously undisclosed significant financial interests within 120 days.
E. Records pertaining to compliance with this policy will be retained for three years following the submission of the final expenditure report to the PHS funding agency.
F. Violation of this policy may be grounds for disciplinary action.
G. Collaborators, grant sub-recipients or subcontractors from other organizations on L&I PHS funded research grants must provide a certification that their organizations are in compliance with Federal policies regarding Investigator SFI disclosure and that their portion of the project is in compliance with their institutional policies regarding FCOI.
Exceptions to this policy may be made in order to comply with federal and state law requiring reasonable accommodation of individuals with disabilities.