Malecare Compliance with Federal Financial Conflicts of Interest Policy (January 12, 2022)
- FINANCIAL CONFLICT OF INTEREST STANDARDS
The federal Department of Health and Human Services (HHS) has determined that Investigators sponsored by Public Health Services (PHS) grants are subject to specific requirements regarding the disclosure and management of conflicts of interest about research in order to provide a reasonable expectation that PHS-sponsored research will be conducted free of bias resulting from Investigator financial conflicts of interest.
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.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
These Standards apply to all grants and cooperative agreements awarded to MALECARE with an issue date of the Notice of Award on or after August 24, 2012 (including noncompeting continuations), and to solicitations issued and contracts awarded after August 24, 2012, that are for research. These federal requirements are applicable to all MALECARE research grant proposals for extramural awards submitted to PHS.
Investigators receiving PHS research support from MALECARE are required to disclose Significant Financial Interests. These Investigators shall submit a disclosure of Significant Financial Interests in accordance with MALECARE implementation procedures.
The requirement that an Investigator disclose a Significant Financial Interest under the terms of these Standards does not in and of itself imply the existence of an actual or potential financial conflict of interest. Malecare grants director will determine the existence of an actual financial conflict of interest, based upon the relationship of the Investigators’ Significant Financial Interests to the Investigators’ responsibilities, with input from the Investigator. If a financial conflict of interest is identified, Malecare grants director shall recommend additional steps to manage or eliminate the conflict.
Malecare grants director will review the Investigators’ Significant Financial Interest disclosures, with each PHS proposal, progress report, incremental funding, or extension, to determine whether there are any Significant Financial Interests that reasonably appear to be related to the PHS-funded research activity in which the Investigator is engaged. Investigators shall have an opportunity to indicate whether they believe the Significant Financial Interest(s) they report are related to their PHS-funded research activities.
MALECARE will make any required reports to the appropriate PHS agency regarding identified financial interests and MALECARE’s steps for managing potential financial conflicts of interest in a way that preserves the integrity of the research project.
- DEFINITIONS
MALECARE Grants Director:
Malecare grants director is designated to solicit and review Investigators’ completed Disclosure of Financial Interest forms and may determine whether the Investigator has a Financial Conflict of Interest.
Financial Conflict of Interest:
A Significant Financial Interest that is related to the PHS-funded research activity in which the Investigator is engaged and that could directly and significantly affect the design, conduct and/or reporting of PHS-funded research activity.
Financial Conflict of Interest Review Team (FCOIRT):
The FCOIRT is made up of Malecare’s Project Manager, a representative from MALECARE’s Legal, Malecare’s Compliance Manager and Malecare’s Executive Director and is responsible for advising Malecare grants director on the development and implementation of a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.
Investigator:
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, Co-Investigators, Volunteers who are serving as Investigators or any other project-related capacity, or consultants.
Principal Investigator:
The person(s) identified in that role in the grant application, progress report or any other report submitted to the PHS.
Key Personnel:
Malecare Project Director, Investigator(s) and any other personnel considered essential to work performance and identified as Key Personnel in the contract proposal, grant, or contract.
Significant Financial Interest (SFI):
Consistent with federal regulations (42 CFR Part 50.603 and 45 CFR Part 94.3), Significant Financial Interest means a financial interest consisting of one or more of the following interests of the Investigator or the Investigator’s spouse or registered domestic partner and dependent children for the following categories, except in the case of travel:
- 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. Included are salary, consulting fees, honoraria, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measure of fair market value.
- 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, registered domestic partner, or dependent children) holds any equity interest.
- Intellectual property rights and interests, upon receipt of income, exceeding $5,000 during the twelve months preceding disclosure from such rights and interests.
- In the case of travel, sponsored travel or reimbursements made to or on behalf of, the Investigator, regardless of amount, by a for-profit or non-profit entity related to the Investigator’s Institutional Responsibilities. However, Significant Financial Interests do not include travel reimbursed or paid by a federal, state, or local government agency, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with an institution of higher education.
The term “Significant Financial Interest” does not include the following types of financial interests:
- Salary, royalties, or other payments made by Malecare to a MALECARE Investigator who is currently employed or otherwise appointed by the MALECARE.
- Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a federal, state, or local government, agency, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with an institution of higher education.
- Income from investment vehicles, such as mutual funds and retirement funds, in which the Investigator does not directly control investment decisions.
III. IMPLEMENTATION PROCEDURES
- DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS
Investigators receiving PHS research support from MALECARE are required to disclose Significant Financial Interests. These Investigators shall submit a disclosure of Significant Financial Interests in accordance with MALECARE implementation procedures.
Investigators as defined by the Standards shall disclose to Malecare all Significant Financial Interests within 15 days of committing to participate in a proposed project, but no later than 5 business days prior to application submission.
This initial disclosure responsibility is separate from and in addition to an Investigator’s ongoing duty throughout the period of a PHS research award to disclose to Malecare grants director his or her Significant Financial Interests, and those of his or her spouse or registered domestic partner, and dependent children related to the Investigator’s responsibilities to the MALECARE:
- Within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) any new Significant Financial Interest (with the exception of travel disclosures, noted below); and
- At least annually throughout the period of the award.
Under the terms of these implementation procedures, Principal Investigators must identify all Investigators on the award (that is, all individuals who will have responsibility for designing, conducting, or reporting the research to be funded by PHS) who are required to disclose Significant Financial Interests.
Sponsored or reimbursed travel may be disclosed:
- Prospectively listing all anticipated travel (including information about the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration of the trip, as well as any other information that may be required by the MALECARE) for the 12-month period following the filing of the Investigator’s annual disclosure form; or
- Within 30 days of the occurrence of travel that either was not listed on the prospective annual travel report pursuant to paragraph a) or that significantly varied in the threshold reporting details from what was listed in the prospective report.
Collaborators from other organizations who share responsibility for the design, conduct or reporting of research results, and who will conduct research under a sub-grant or subcontract from the MALECARE, are expected to comply with the policies and procedures for disclosure and review of Significant Financial Interests at the organization at which they are employed or, if their employer does not have a conflict of interest policy that complies with the DHHS regulations, with these policies and procedures. Subawards issued by Malecare will require the subrecipient organization to certify that its policy complies with DHHS conflict of interest regulations. If so, the recipient organization is responsible for reviewing the disclosures submitted by its Investigators and, if a Financial Conflict of Interest is identified, for sending Malecare notification of the conflict and of the subrecipient organization’s actions, including its plan to manage, reduce or eliminate the identified conflicts.
Collaborators who share responsibility for the design, conduct, and reporting of research results, who are not covered by a Financial Conflict of Interest policy that complies with DHHS conflict of interest regulations and who will participate in research should be identified as Investigators by the Principal Investigator and should complete Malecare disclosure forms. If, upon review, Malecare determines that these financial interests could directly and significantly affect the design, conduct, or reporting of the research to be performed under the agreement, Malecare will require the collaborator to adhere to the plans put in place to eliminate, reduce, or manage the identified conflicts of interest.
- REVIEW OF DISCLOSURES: MANAGEMENT PLAN
Malecare grants director will review the Investigators’ Significant Financial Interest disclosures, with each PHS proposal, progress report, incremental funding, or extension, to determine whether there are any Significant Financial Interests that reasonably appear to be related to the PHS-funded research activity in which the Investigator is engaged. Investigators shall have an opportunity to indicate whether they believe the Significant Financial Interest(s) they reported are related to their PHS-funded research activities. If Malecare grants director concludes that an Investigator’s Significant Financial Interest reasonably appears to affect the design directly and significantly, conduct or reporting of the PHS-funded research, or is in an entity whose financial interest could be affected by the research, Malecare grants director will send the Disclosure and appropriate documentation to the FCOIRT for consideration. The FCOIRT shall determine any conditions or restrictions should be placed on the project to eliminate or manage the Financial Conflict of Interest before the support can be accepted.
For Disclosures prior to project initiation, Malecare will implement all management plans prior to the MALECARE’s expenditure of PHS funds awarded for the research project, and shall specify the actions required to manage the Financial Conflict of Interest, including:
- The role and principal duties of the conflicted Investigator.
- Conditions of the management plan.
- How the plan will safeguard objectivity in the research activity.
- Confirmation of the investigator’s agreement to the plan; and
- How the plan will be monitored.
The same review process takes place when an Investigator reports a new Significant Financial Interest.
- REPORTING TO PHS
Prior to the MALECARE’s expenditure of any funds provided under a PHS award, Malecare must provide to the PHS funding agency an initial report regarding Investigator Financial Conflict of Interest. If Financial Conflicts of Interest are eliminated before research funds are expended, Malecare is not required to submit a report to the PHS funding agency.
During the period of the award, Malecare shall, within 60 days of receipt of disclosure of a new or newly discovered Significant Financial Interest, review the disclosure, determine whether it is related to PHS-funded research, determine whether it constitutes a Financial Conflict of Interest, and if so, implement a management plan and report the Financial Conflict of Interest to the PHS funding agency.
For any Financial Conflict of Interest that Malecare reports to a PHS awarding agency, Malecare shall provide to the PHS awarding agency an annual Financial Conflict of Interest report that addresses the status of the conflict and any changes to the management plan, for the duration of the project. The annual report shall specify whether the financial conflict is still being managed or explain why it no longer exists. Malecare must provide annual reports to the PHS awarding agency for the duration of the project period ((including extensions with or without funds). Within 60 days of determining that a Financial Conflict of Interest exists for a new Investigator who joins an ongoing PHS-funded research activity, Malecare must implement a management plan and submit a report to the PHS funding agency.
If the Department of Health and Human Services (DHHS) determines that a PHS-sponsored 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 a Financial Conflict of Interest that was not managed or reported by Malecare as required by these Standards and Federal regulation, Malecare shall require the Investigator to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
- MONITORING
Any management plan put in place by Malecare shall specify how Malecare will monitor the Investigator’s compliance with the plan until completion of the PHS-funded research project.
- RETROSPECTIVE REVIEWS AND MITIGATION REPORTS
When, during the course on ongoing PHS-funded research project, Malecare identifies a Significant Financial Interest that was not disclosed in a timely manner by an Investigator or which was not previously reviewed, Malecare grants director will, within 60 days, review the Significant Financial Interest to determine whether it is related to PHS funded research activity, determine whether a Financial Conflict of Interest exists, and if so, implement a management plan on at least an interim basis.
In addition, whenever (a) a Financial Conflict of Interest is not identified or managed in a timely manner, regardless of whether the Investigator did not disclose an SFI that was later determined to be a Financial Conflict of Interest, (b) Malecare did not review or manage the Financial Conflict of Interest, or (c) the Investigator failed to comply with a previously implemented management plan, Malecare must complete a retrospective review of the Investigator’s activities and the PHS-funded research within 120 days of the determination of non-compliance. The purpose of this retrospective review is to determine if the ongoing PHS[1]funded research was biased in its design, conduct or reporting. Malecare will document the retrospective review including the project number, project title, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has a Financial Conflict of Interest, the reasons for the retrospective review, detailed methodology used for the retrospective review, findings, and conclusions.
Based on the results of the retrospective review, if appropriate, the previously submitted Financial Conflict of Interest report should be updated to specify the actions that Malecare will take to manage the identified Financial Conflict of Interest going forward. If bias was found during the retrospective review, Malecare will promptly notify the PHS funding agency and will draft a mitigation report that at a minimum, documents the key elements of the retrospective review, describes the impact of the bias on the research, and outlines the MALECARE’s plans to eliminate or mitigate the effect of the bias.
- RECORD RETENTION
Malecare will maintain records of financial disclosures related to any grant and the MALECARE’s review of, or response to such disclosures, whether or not a disclosure resulted in the MALECARE’s determination of a Financial Conflict of Interest, and all actions under these Standards or retrospective review for at least 3 years from the date of submission of the final expenditure report or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report for the subject award or as otherwise required under 45 CFR Part 75.361 (pertaining to pending litigation and audits), or where real property and equipment purchased under the award are retained beyond 3 years, when records are transferred to or maintained by the HHS awarding agency, or indirect cost proposals and cost allocation plans. Records relating to unfunded awards need not be retained.
- TRAINING
Each Investigator, including collaborators, consultants, or subcontractors, must complete NIH[1]compliant training about the PHS financial conflicts of interest policy prior to engaging in research related to any PHS-funded project and at least every 4 years thereafter, while receiving PHS research funding, and at other times as may be required by Malecare in accordance with DHHS regulations. For PHS-funded Investigators who are new to Malecare or who are joining an ongoing PHS Research Activity, Malecare should establish a reasonable, expeditious timeframe when Investigators must complete training.
- PUBLIC ACCESS TO INFORMATION
Malecare grants director manage the receipt and response to public requests for information under the PHS regulations and these Standards and shall take action necessary to provide reasonable notice of those addresses to the public, including prominently posting this information on Malecare web site.
Malecare must respond within 5 business days to any request for information about Significant Financial Interests held by Key Personnel when Malecare has determined that the disclosed Significant Financial Interests are related to the PHS funded research and constitute Financial Conflicts of Interest. The 5- day response time shall be measured from the date that the request for information is received at the MALECARE-designated address until the date a response is sent to the requestor.
Disclosure forms, Disclosure Update forms, and Management Plans including determinations of Financial Conflicts of Interest under these Standards are public records open to public inspection, under federal and state law.
- SANCTIONS
Malecare may terminate Consultants for cause who either fail to file a complete disclosure or fail to comply with any conditions or restrictions imposed by MALECARE. Malecare may remove other Key Personnel from the project and prohibit them from use of or credit in the resulting reports, data or other deliverables. In addition, federal regulations may require Malecare to report any violations of federal regulations and MALECARE policy to the federal sponsor of the project. Where appropriate, Malecare may seek reimbursement of any improperly disbursed funding due to any Key Personnel’s intentional or grossly negligent failure to comply with the above policy and procedures.
- COMPLIANCE / RESPONSIBILITIES SUMMARY
| Function | Responsibilities |
| Investigators, as defined by these Standards |
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| Collaborators, consultants, volunteers, or subcontractors who share responsibility for the design, conduct or reporting of research results, and who will be conducting research under a subgrant or subcontract from the MALECARE |
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| Institutions that receive subawards issued by Malecare for PHS funded research |
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