Partnership to End Addiction Policy on Promoting Objectivity in Research/Investigators’ Conflicts of Interest (42 CFR Part 50, Subpart F)
Partnership to End Addiction (the Partnership) seeks to ensure the integrity of its research and to comply with the federal Public Health Service’s (PHS) requirements for institutions that seek research funding. The PHS has implemented regulations (Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought) (“FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest. The FCOI Regulations are applicable to institutions that apply for or receive PHS grants or cooperative agreements for research and to each investigator (as defined below) planning to participate in or participating in such research. This policy (the “FCOI Policy”) is implemented to fulfill the Partnership’s obligation under the FCOI Regulations to maintain an up-to-date, written, enforced policy and process on investigator conflicts of interest.
The Signing Official is the person responsible for the procedures under this FCOI Policy but may designate one or more individuals to assist in any or all of these responsibilities and/or may delegate any or all of these responsibilities to one or more individuals. References to the Signing Official shall include such individual(s), if any.
A. Researchers Covered and Financial Interests that Must be Disclosed
All “investigators” planning to or participating in PHS-funded “research” are required to disclose to the Partnership his/her known “significant financial interests” (and those of his/her spouse and dependent children) that reasonably appear to be related to the investigator’s “institutional responsibilities”.
- The term “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.
- The term “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). The term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement.
- The term “institutional responsibilities” means an investigator’s professional responsibilities on behalf of the Partnership, including research, research consultation, clinical or other professional practice, participation in scholarly events, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
- The term “significant financial interest” means a financial interest – defined as anything of monetary value, whether or not readily ascertainable – 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.
Publicly Traded Entities – 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.
Privately Held Entities – 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 and dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
Intellectual Property – Intellectual property rights and interests (e.g., patents, copyrights), must be disclosed upon receipt of income (e.g., royalties) related to such rights and interests. The filing of any patent application also should be disclosed.
Travel Expenses – 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 in the twelve months preceding the disclosure if the value of such travel, when aggregated from all sources, exceeds $5,000; 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. Disclosures relating to travel expenses must specify at a minimum the purpose and duration of the trip, the identity of the sponsor/organizer, and the destination.
Not included are the following types of financial interests: salary, royalties, or other remuneration paid by the Partnership to the investigator if the investigator is currently employed or otherwise appointed by the Partnership, including intellectual property rights assigned to the Partnership and agreements to share in royalties related to such rights; 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; and income from seminars, lectures, or teaching engagements sponsored by, and service on advisory committees or review panels for any of the following, if they are United States institutions, located within the United States: a Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
B. Mandatory Investigator Training Requirements
The Signing Official is responsible for ensuring that each investigator is informed about (i) this FCOI Policy, (ii) the investigator’s responsibilities regarding disclosure of significant financial interests relating to the investigator’s institutional responsibilities, and (iii) the FCOI Regulations.
The Signing Official shall ensure that each investigator completes training regarding items (i)–(iii) prior to engaging in research related to any PHS-funded grant or cooperative agreement, immediately upon being hired and at least every four (4) years.
The Signing Official also shall ensure that each investigator completes training immediately when any of the following applies, as advised by the General Counsel: (1) this FCOI Policy or procedures are revised in any manner that affects the requirements of the investigators or (2) the Partnership finds that an investigator is not in compliance with this FCOI Policy or a management plan.
“Immediately” shall mean the training is provided or made accessible and the investigators participate in the training expeditiously following the event that triggers the training requirement.
C. Disclosure Requirements
Prior to submission to PHS of an application for a research grant, the principal investigator shall identify to the Signing Official (1) all investigators (as defined above) anticipated to be participating in the research, (2) those who are senior/key personnel (as defined below), and (3) those who are subrecipients and the institution(s) employing them.
The term “senior/key personnel” means the project director or principal investigator and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to the PHS.
Also prior to submission of the application, the Signing Official shall ensure that each investigator submits a listing of his/her known significant financial interests (as described above) and those of his/her spouse and dependent children, that reasonably appear to be related to the investigator’s institutional responsibilities, if any. In accordance with Section H, the Signing Official shall ensure that subrecipient investigators either comply with this FCOI Policy or that their institution(s) provides assurances to enable the Partnership to fulfill the requirements of this FCOI Policy. In either case, the Signing Official shall ensure that the proper documentation as required under the FCOI Regulations is executed, also in accordance with Section H. Disclosure forms will be made available by the Partnership’s General Counsel.
All disclosures must be updated annually during the period of the award or within 30 days of discovering or acquiring (e.g., through purchase, marriage, inheritance or expansion of responsibilities) a new significant financial interest. The Signing Official shall ensure that annual update forms are sent to and promptly returned by each investigator. (One annual disclosure is sufficient to cover all on-going PHS awards.) Each investigator is responsible for submitting disclosure forms within 30 days of discovering or acquiring a new significant financial interest. Disclosures shall be provided by an investigator at any other time upon request.
The Signing Official shall ensure that each investigator new to the Partnership submits a listing of his/her known significant financial interests (as described above) and those of his/her spouse and dependent children that reasonably appear to be related to the investigator’s institutional responsibilities, if any, within 30 days of starting employment.
D. Review of Disclosures and Monitoring & Reporting FCOI
The Signing Official shall be responsible for reviewing all forms disclosing a significant financial interest, making the requisite determinations and taking any subsequent action.
Prior to the expenditure of funds or, with respect to an on-going PHS-funded project, within 60 days of the disclosure or discovery of a significant financial interest, the Signing Official shall:
- review all disclosure forms and determine whether (a) an investigator’s significant financial interest is related to PHS-funded research and (b) if so related, whether the significant financial interest is a financial conflict of interest (FCOI); and
- in the case of a FCOI, develop and implement a management plan specifying actions that have been and shall be taken to manage the FCOI; and
- submit initial and on-going FCOI reports to the PHS Awarding Component as required under the FCOI Regulations [§50.605(b)(3), (4)].
An investigator’s significant financial interest is related to PHS-funded research when the Signing Official 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. In determining whether an investigator’s significant financial interest is related to PHS-funded research, the Signing Official will consider all relevant factors and information, including but not limited to whether there is an on-going relationship between the investigator and the payer.
A financial conflict of interest (FCOI) exists when the Signing Official reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. In determining whether there is a FCOI, the Signing Official will consider all relevant factors and information, including but not limited to the nature of the research, the magnitude of the financial interest and degree to which it is related to the research, the extent to which the interest could be directly and substantially impacted by the research, and the degree of risk to the human subjects, if any, that is inherent in the research protocol.
Prior to making the decision whether a FCOI exists, the Signing Official may impose interim measures, may ask the investigator to submit additional information and may meet or communicate with the investigator. The investigator may be encouraged to suggest procedures, protocols, or other measures designed to manage the FCOI.
If the Signing Official, in the exercise of his or her sole discretion determines it to be helpful or useful to convene a Conflict of Interest Review Committee to consider whether a Significant Financial Interest (“SFI”) constitutes an FCOI, the Institutional Official shall appoint a Conflict of Interest Review Committee (CIRC). Membership in the CIRC shall be comprised of at least the Signing Official (or his/her designee) and the General Counsel. In addition, the Signing Official may designate such other Partnership to End Addiction staff as the Signing Official determines may be knowledgeable about the grants and SFIs at issue, but shall not include the investigator who identified the SFIs.
“Manage” means taking action to address a FCOI, 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.
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 involving human subjects, disclosure of financial conflicts to research participants;
- Monitoring of the research by independent reviewers;
- Modification of the research plan;
- Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research;
- Reduction or elimination of the financial interest; and/or
- Severance of relationships that create such conflicts.
For all management plans, the Signing Official shall (1) monitor on-going investigator compliance and (2) submit annual updates to the PHS Awarding Component at the time and in the manner specified by the PHS Awarding Component, both until the completion of the PHS-funded research project to which the FCOI relates.
With respect to FCOI related to research sponsored by NIH, annual FCOI reports will be submitted through the eRA Commons FCOI Module for the duration of the project period (including extensions with or without funds) at the same time annual progress reports are required to be submitted and at the time of extension (if any).
If the FCOI is identified and eliminated prior to the expenditure of any PHS-awarded funds, no FCOI report need be submitted.
E. Noncompliance & Remedies
If an investigator has failed to comply with a management plan or, for whatever reason, a FCOI is one that was not identified, reviewed or managed in a timely manner, the Signing Official shall (in addition to the steps required in Section D above), within 120 days of the determination of noncompliance, conduct a retrospective review of the investigator’s activities and the research project to determine whether any PHS-funded research or portion thereof conducted during the period of noncompliance was biased in design, conduct or reporting. The review shall be documented consistent with the FCOI Regulations [§60.605(a)(3)(ii)(B)]. If bias is found during the course of the review, the Signing Official will promptly notify the PHS Awarding Component (which may take its own action and/or require further action by the Partnership and/or the investigator, as it deems appropriate) and submit a mitigation report consistent with the FCOI Regulations [§60.605(a)(3)(iii)]. If appropriate, the Signing Official will update the previously submitted FCOI report. In any event, the Signing Official shall submit FCOI reports annually thereafter.
For clinical research projects supported by the PHS, if the Department of Health and Human Services 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 was designed, conducted, or reported by an investigator with a FCOI that was not properly disclosed or managed as required under the FCOI Regulations, the investigator shall disclose the FCOI in each public presentation of the results of the research (such as articles, manuscripts and oral presentations) and the Partnership shall request an addendum to previously published presentations.
F. Maintenance of Records
The Signing Official shall maintain all disclosure forms and related records of determinations made and actions taken for a period of three years from the date of submission of the final expenditures report to the PHS (or, where applicable, from other dates specified in 45 CFR 74.53(b)).
G. Enforcement Mechanism & Sanctions
All researchers to whom this FCOI Policy applies are expected to fully and promptly comply with it. The Signing Official may impose sanctions for noncompliance which may include, but is not limited to, the following:
- Failure to make timely, full or accurate disclosures;
- Failure to provide information requested;
- Failure to update a disclosure form as necessary; or
- Failure to comply with a management plan.
For Partnership employees sanctions may include suspension or dismissal, denial of eligibility to engage in the research at issue, or other appropriate penalties. Such sanctions may require giving notice of relevant information to funding agencies, professional bodies or journals, or the public. For subrecipient investigators, sanctions may include suspension or expulsion from participation in the research at issue and/or further Partnership research. The Signing Official will determine what sanctions, if any, are to be applied.
H. Subrecipient Requirements
A subrecipient relationship is established when the Partnership passes through federal funds to another individual or entity who will be conducting a substantive portion of the research project and is accountable to the Partnership for programmatic outcomes and compliance matters.
The Partnership is responsible for ensuring any subrecipient’s compliance with the FCOI Regulations, for reporting subrecipient investigator FCOI, and for monitoring subrecipient investigator management plans.
The Partnership’s FCOI Policy shall apply to subrecipient investigators for disclosing significant financial interests directly related to the subrecipient’s work for the Partnership unless the subrecipient institution certifies that its FCOI policy complies with the FCOI Regulations.
In either event, a written agreement will be entered into with the subrecipient institution and contain all items required by the FCOI Regulations [§50.604(c)] to ensure reporting by the Partnership to the PHS of any subrecipient investigator FCOIs in a timely manner, i.e., prior to the expenditure of funds or within sixty (60) days of any subsequently identified FCOI.
I. Public Accessibility Requirements
This FCOI Policy will be posted on the Partnership’s publicly accessible website, as required by the FCOI Regulations.
Prior to expending any funds under a PHS-funded grant or cooperative agreement, the Partnership shall ensure public accessibility to information concerning a FCOI held by a senior/key personnel by providing a written response to any written request, such response to be postmarked or dated (if replying by electronic means) within five (5) business days of the receipt of the written request. Such information shall consist of that required to be provided under the FCOI Regulations [§50.605(a)(5)(ii), (iii)], shall be updated at least annually and within 60 days of the receipt or identification of information concerning an additional significant financial interest, and shall remain available for three years from the date the information was most recently updated.
J. Additional Information
The Partnership may be asked to provide records related to this FCOI Policy, including disclosure forms, to the Department of Health and Human Services or other federal agencies or entities. The Partnership will provide the requested information and make any other disclosures necessary to comply with this FCOI Policy or as required by law. Such records may be requested and provided whether or not the disclosure resulted in a determination that a FCOI existed.
K. Effective Date
This FCOI Policy is effective August 15, 2012 and shall apply to all new grants for which an application is submitted subsequent to August 15, 2012 and to all outstanding grants with an issue date of a Notice of Award subsequent to August 15, 2012.