Partnership to End Addiction Policy on Promoting Objectivity in Research/Investigators’ Conflicts of Interest (42 CFR Part 50, Subpart F) (last revised 10/2014)
Partnership to End Addiction 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 PHS1 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 Partnership to End Addiction’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 Partnership to End Addiction 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”.
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) Partnership to End Addiction 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 Partnership to End Addiction 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 Partnership to End Addiction 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 ongoing 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 Partnership to End Addiction 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 and 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 ongoing PHS-funded project, within 60 days of the disclosure or discovery of a significant financial interest, the Signing Official shall:
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 ongoing 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 an 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 an 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.
“Manage” means taking action to address an 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 an FCOI include, but are not limited to:
For all management plans, the Signing Official shall (1) monitor ongoing 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 and Remedies
If an investigator has failed to comply with a management plan or, for whatever reason, an 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 Partnership to End Addiction 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 an 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 Partnership to End Addiction 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 and 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:
For Partnership to End Addiction 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 to End Addiction research. The Signing Official will determine what sanctions, if any, are to be applied.
H. Subrecipient Requirements
A subrecipient relationship is established when Partnership to End Addiction passes through federal funds to another individual or entity who will be conducting a substantive portion of the research project and is accountable to Partnership to End Addiction for programmatic outcomes and compliance matters.
Partnership to End Addiction is responsible for ensuring any subrecipient’s compliance with the FCOI Regulations, for reporting subrecipient investigator FCOI, and for monitoring subrecipient investigator management plans.
Partnership to End Addiction’s FCOI Policy shall apply to subrecipient investigators for disclosing significant financial interests directly related to the subrecipient’s work for Partnership to End Addiction 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 Partnership to End Addiction 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 Partnership to End Addiction’s publicly accessible website, as required by the FCOI Regulations.
Prior to expending any funds under a PHS-funded grant or cooperative agreement, Partnership to End Addiction shall ensure public accessibility to information concerning an FCOI held by a senior/key personnel member 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
Partnership to End Addiction 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. Partnership to End Addiction 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 an 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.
1PHS means Public Health Service, an operating division 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 NIH.
2A “PHS Awarding Component” means the organizational unit of the PHS that funds the research.