Financial Conflict of Interest Policy
AMYLOIDOSIS RESEARCH CONSORTIUM, INC.
Policy on Financial Conflicts of Interest in the Conduct of Research
Effective as of December 21, 2020
Amyloidosis Research Consortium, Inc. (“ARC”) is committed to the highest standards of objectivity in scientific research. The purpose of this Policy is to assure that the design, conduct, and reporting of research in which ARC is involved is free from bias resulting from financial conflicts of interest of investigators. This Policy applies to all persons who are responsible for the design, conduct or reporting of research at or under the auspices of ARC. “Research” as used in this Policy includes basic, sponsored, and clinical research. “Investigators” include all persons affiliated with ARC who are responsible for the design, conduct, and/or reporting of scientific research. This Policy is intended to comply with the requirements set forth in the U.S. Department of Health and Human Services regulations at 42 CFR 50.603 through 50.606 (the “PHS Regulations”).
In designing, conducting and reporting research, ARC investigators are subject, as well, to any requirements that may be imposed by a reviewing Institutional Review Board and other applicable ARC policies and procedures.
2.1 “Financial Conflict of Interest” (or “FCOI”) means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of research.
2.2 “Designated Official” means an ARC official designated to solicit and review disclosures of Significant Financial Interests from ARC investigators. The Designated Official is the Chair of the Board of Directors of ARC or such other individual as the Chair may designate in writing.
2.3 “Compliance Committee” means the disinterested members of the Board of Directors of ARC (the “Board”), acting as the body designated under this Policy to solicit and review investigator disclosures, determine whether Significant Financial Interests are FCOIs, specify any conditions that should be imposed to manage FCOIs, and generally enforce this Policy. In order to assure that the members of the Board serving as the Compliance Committee are disinterested, all Board members will be required to disclose any SFIs, as defined below, at the time an application for research is submitted or proposed to an Institutional Review Board, as well as annually during the period of the funding and updated within 30 calendar days of discovering or acquiring a new SFI. Any member of the Board found to have a SFI will not be considered disinterested and will, in such case, be ineligible to serve or continue to serve on ARC’s Compliance Committee.
2.4 “Institutional Responsibilities” means an investigator’s professional responsibilities on behalf of ARC.
2.5 “PHS-Funded Research” means any research for which funding is available from the Public Health Service of the U.S. Department of Health and Human Services (“PHS”) and any components of PHS to which the authority involved may be delegated, including the National Institutes of Health, 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, and any research for which funding is available from any organization, foundation or other sponsor who has adopted the PHS regulation.
2.6 “Significant Financial Interest” (or “SFI”) means a financial interest consisting of one or more of the following interests of an investigator or those of an investigator’s spouse or dependent children that appear to be related to the investigator’s Institutional Responsibilities:
(a) With regard to 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. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship fees). 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 a non-publicly traded entity, a SFI 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 options, or other ownership interests); and
(c) Intellectual property rights and interests, upon receipt of income related to such rights and interests.
(d) For investigators engaged in PHS-Funded Research, a SFI includes reimbursed or sponsored travel paid on behalf of the investigator and not reimbursed to the investigator, which is related to the investigator’s Institutional Responsibilities and which exceeds $5000 in value in the aggregate from a single entity.
2.7 The following financial interests are not considered to be SFIs:
(a) Salary, royalties, or other remuneration paid by ARC to an investigator if the investigator is currently employed or is otherwise appointed by ARC;
(b) Intellectual property rights assigned to ARC and agreements to share in royalties related to such rights.
(c) 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;
(d) 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; and
(e) 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.
3. Investigator Responsibilities
Investigators must (i) disclose all SFIs that reasonably appear to be related to the investigators’ Institutional Responsibilities; (ii) comply with the Review Process set forth in Section 3.2 below; and (iii) for PHS-Funded investigators, complete the training described in Section 3.3 below.
4. Investigators who are planning to participate in research must disclose their SFIs to ARC by no later than the time of application to the sponsor for funding or prior to the submission of a proposal for the research to an Institutional Review Board.
5. Investigators who are participating in research must submit an updated disclosure of SFIs at least annually during the period of the funding. The disclosure must include any information that was not disclosed initially pursuant to subsection 3.1(a) above, or in any subsequent disclosure of SFIs and must include updated information regarding any previously disclosed SFIs.
6. Investigators who are participating in research must submit an updated disclosure within 30 calendar days of discovering or acquiring a new SFI (e.g. as a result of a purchase or marriage).
7. For each research proposal, the principal investigator identified in the grant application or other report submitted to the PHS funder (the “Principal Investigator”) is responsible for identifying other investigators who are required to comply with the disclosure requirements of this Policy.
8. For PHS-funded investigators, the disclosure of travel will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration. The travel 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.
3.2 Review Process
Before ARC disburses any funds for a research project, ARC, acting through its Compliance Committee, will:
(a) Solicit and review investigator SFI disclosures and any other information deemed relevant and, if deemed necessary, require investigators to provide additional information;
(b) In consultation with ARC’s Designated Official, determine whether investigators’ SFIs are related to research and, if so, whether the SFIs are Financial Conflicts of Interest (“FCOIs”). A SFI is considered to be related to research when the SFI could be reasonably affected by the research or is in an entity whose financial interests could be reasonably affected by the research;
(c) Make final determinations in writing and, if a final determination is that a SFI is a FCOI, specify any conditions or restrictions that should be imposed to manage the FCOI, and take any actions necessary to manage the FCOI. Management of a FCOI may include actions such as reducing or eliminating the FCOI to assure, to the extent possible, that the design, conduct, and reporting of research is free from bias.
(d) Provide copies of final decisions to investigators and/or the Principal Investigator of and the responsible Institutional Review Board (if human subjects’ research is involved).
(e) With respect to existing management plans, provide in writing, as necessary, for any appropriate guidance and/or state that no additional safeguards or conditions are needed.
Upon receipt of a decision from the Compliance Committee, an investigator must either acknowledge the decision in writing or submit a written appeal. In instances when a management plan is required, funding will be held by ARC until the investigator agrees to comply with the plan. The investigator has 10 business days from receipt of the decision to submit an appeal in writing to the Designated Official. The appeal must include the specific provisions being challenged, the reason for the appeal, the justification for a different outcome, and/or an alternative management plan, as well as any additional information that the investigator believes would be helpful to the Compliance Committee in making its final decision. The decision of the Compliance Committee will be final.
3.3 Training for Investigators Engaged in PHS-Funded Research
Every investigator who will be engaged in PHS-Funded Research must complete a training on investigator responsibilities (i) prior to engaging in the PHS-Funded Research and at least once every 4 years thereafter; (ii) immediately after any revision of this Policy that affects the requirements of investigators engaged in PHS-Funded Research; (iii) if the investigator is new to ARC, even if the PHS-Funded Research has already begun; and (v) if the investigator has failed to comply with this Policy or with a management plan imposed by the Compliance Committee.
4. Enforcement by ARC
4.1 If an investigators fails to comply with a final decision of the Compliance Committee, the Compliance Committee will develop a corrective action plan, which may include actions such as suspension, denial of eligibility to engage in research, and/or notification of professional bodies or journals and the public.
4.2 If an investigator fails to comply with this Policy or a management plan in a way that could have biased the design, conduct, or reporting of research, ARC will promptly notify the PHS unit that funded the research or other funder/sponsor, as required, of the corrective action taken or to be taken and implement corrective action.
5. ARC Management of FCOIs
5.1 Any management plan imposed by ARC’s Compliance Committee will specify the actions that have been taken and will be taken by ARC to manage the FCOI. Conditions that may be imposed include, but are not limited to:
• Public disclosure of the FCOI (e.g., when publishing the research);
• Disclosure of the FCOI directly to human subjects, if approved by the Institutional Review Board;
• Appointment of an independent monitor to protect the research against bias;
• Modification of the research;
• Change of personnel or disqualification of personnel from participation in the research;
• Reduction or elimination of the FCOI; and
• Severance of relationships that create the FCOI.
5.2 There will be a rebuttable presumption that stringent management of a FCOI is appropriate for any FCOI that is related to clinical research. If the U.S. Department of Health and Human Services (“HHS”) determines that clinical PHS-Funded Research has been designed, conducted, or reported by an investigator with an FCOI and was not managed or reported by ARC as required, HHS may require the investigator to disclose the FCOI in each public presentation of the results of the research and in an addendum to any previously published presentation.
5.3. ARC’s Compliance Committee will monitor investigator compliance with management plans on an ongoing basis until the completion of the research.
5.4 If an investigator engaged in a research project discloses a new SFI, or if an investigator who is new to an ongoing research project discloses an SFI, the ARC Compliance Committee will, within 60 calendar days:
(a) Review the SFI;
(b) Determine whether the SFI is related to research;
(c) Determine whether a FCOI exists or could be perceived to exist; and, if so
(d) Implement a management plan that will specify the actions that have been, and will be, taken to manage such FCOI.
5.5 The ARC Compliance Committee will take the following actions with respect to a FCOI in ongoing PHS-Funded Research:
(a) For any SFI that was not disclosed timely by an investigator or was not previously reviewed during ongoing PHS-Funded Research, within 60 calendar days undertake the review, determinations and management plan implementation set forth in Section 5.3 above.
(b) For any FCOI connected to ongoing PHS-Funded Research that is not identified or managed in a timely manner or where the Investigator failed to comply with a management plan, within 120 calendar days complete a retrospective review of the investigator’s activities and the PHS-Funded Research to determine whether any research was biased in design, conduct, or reporting. The retrospective review will be documented in accordance with federal requirements set forth in 42 CFR §50.605(a)(3)(ii)(B)(1)-(9), for PHS-Funded research grants or cooperative agreements, or 45 CFR §94.5(a)(3)(ii)(B)(1)-(9), for PHS-Funded research contracts, and if appropriate, will update any previously submitted FCOI report, describing the new management plan.
(c) Where bias or actual harm, to the design, conduct, or reporting of PHS-Funded Research is found as a result of the newly discovered FCOI, the ARC Designated Official or his/her designee will promptly notify the PHS unit that funded the research and submit a mitigation report, as required by and including all key elements specified in 42 CFR, Part §50.605(a)(3)(iii) and 45 CFR §94.5a)(3)(iii), described further in Section 7, below.
5.6 At any time, the Compliance Committee may determine that interim measures are necessary with regard to an investigator’s participation in the research.
6.1 If ARC carries out any PHS-Funded Research through subcontractors or consortium members (individually or collectively, “Subrecipient”), ARC will take reasonable steps to ensure that Subrecipient investigators comply with the PHS Regulations by specifying in ARC’s written agreement with the Subrecipient whether this Policy or a FCOI policy of the Subrecipient will apply to the Subrecipient’s investigators. The written agreement will state either that:
(a) The Subrecipient’s policy applies and the Subrecipient will certify as part of the agreement that its policy complies with the PHS Regulation and that the Subrecipient’s investigators will comply with the Subrecipient’ s FCOI policy; or
(b) The subrecipient cannot provide certification that its policy complies with the PHS Regulation, and that Subrecipient investigators are subject to this Policy for disclosing SFIs that are directly related to the Subrecipient’s work for ARC, as the awardee institution.
6.2 If the Subrecipient’s policy applies in Section 6.1above, the agreement will specify the time period(s) for the Subrecipient to report all identified FCOIs to the ARC Compliance Committee, which time period(s) will be sufficient to enable ARC to meet its reporting obligations to the PHS funder. If this Policy applies in Section 6.1 above, the agreement will specify the time period(s) for the Subrecipient to submit all disclosures of SFIs to the ARC Compliance Committee to enable ARC, as the awardee institution, to comply with its review, management, and reporting obligations to the PHS funder.
7. ARC Reporting of FCOIs
7.1 Prior to ARC’s expenditure of any research funds, ARC’s Compliance Committee will provide to the PHS funder or other funding agency, as required, an FCOI report regarding any investigator’s FCOI that has not been eliminated and ensure that a management plan has been implemented. The report to PHS will contain all information required under federal regulations at 42 CFR§50.605(b)(3) and 45 CFR§94.5(b)(3), as applicable. For newly acquired FCOIs during ongoing PHS-Funded Research as described in Section 5.4 above, the Compliance Committee will provide within 60 calendar days a report ensuring that ARC has implemented a management plan.
7.2 For FCOIs not previously disclosed, reviewed or managed during ongoing PHS-Funded Research as described in Section 5.5 above, the Compliance Committee will, if the retrospective review results in a finding of bias in the design, conduct or reporting of the research, promptly submit its mitigation report to the PHS funder. In accordance with 42 CFR§50.605(a)(3)(iii) and 45 CFR§94.5a)(3)(iii), the mitigation report will include the key elements documented in the retrospective review, a description of the impact of the bias on the research and ARC’s plan of action taken to eliminate or mitigate the effects of the bias.
7.3 After the submission of any initial FCOI report relating to ongoing PHS-Funded Research, the Compliance Committee will provide the PHS funder with annual FCOI reports that address the status of the FCOI and any changes to the management plan for the duration of the research at the same time as ARC is required to submit the annual progress report or at the time of project extension.
7.4 If requested by the PHS funder, the Compliance Committee will make information available relating to any investigator disclosure of financial interests and ARC’s review of and response to the disclosure, whether or not the disclosure resulted in a determination of an FCOI.
8. Maintenance of Records and Public Accessibility
8.1 ARC’s Compliance Committee will maintain records relating to investigator SFI disclosures, ARC’s review of and response to such disclosures, and any other action under this Policy for at least 3 years from the date the final expenditures report is submitted to the funder.
8.2 ARC will make this Policy available via a publicly-accessible website. For PHS-Funded Research, ARC will ensure public accessibility of information concerning the FCOIs currently held by the Principal Investigator. The Compliance Committee will provide a written response within 10 business days of receipt of a written request for information regarding any SFI disclosed to ARC that meets the following three criteria:
• The SFI was disclosed and is still held by the project director/principal investigator as defined by the PHS Regulations;
• ARC determines through the procedure set forth in this Policy that the SFI is related to the PHS-Funded Research; and
• ARC determines through the procedure set forth in this Policy that the SFI is an FCOI.
Requests should be sent to the attention of _Grace Fan_, [Operations Manager], Amyloidosis Research Consortium
320 Nevada Street, Suite 210, Newton, MA 02460.
The information provided by ARC in its written response will be the minimum required by the PHS Regulations. In compliance with 42 CFR 50.605(a)(5)(iv), information concerning the SFIs of the ARC Principal Investigator will remain available for responses to written requests for at least 3 years from the date that the information was most recently updated.
Approved by the ARC Board of Directors as of December 21, 2020