1.0 Purpose:

1.1 The purpose of this policy is to promote objectivity in research by establishing standards that provide reasonable expectation that the design, conduct, or reporting of funded research, grants, or cooperative agreements will be free from bias resulting from Investigator’s financial conflicts of interest (and/or of the Investigator’s spouse and/or dependent children). This policy complies with the following 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

2.0 Scope:

2.1 This policy applies to Investigators who are participating in, or planning to participate in, the design, conduct, reporting, or proposing of research. Specific guidance and requirements regarding Public Health Service (PHS) or National Science Foundation (NSF) funded research at Workit Health are noted in this policy in Section 5.11.

This policy does not apply to applications and awards supported under the Small Business Innovation Research Phase I Program or the Small Business Technology Transfer Phase I Program.

If a research project involves subcontractors, subgrantees, or sub awardees (collectively subrecipients), the subrecipient institution must provide written assurance that a financial conflict of interest in research policy is in effect at that institution and compliant with all applicable federal regulations. Should Public Health Services (PHS) or National Science Foundation (NSF) funds be subcontracted by Workit Health to a subrecipient institution without a conflict of interest in research policy, a written agreement must state that this policy shall apply to the subrecipient.

3.0 Definitions: 

A conflict of interest occurs when a person’s personal interests conflict with their responsibility to act in the best interests of the Workit Health. Personal interests include direct interests as well as those of family, friends, or other organizations a person may be involved with or have an interest in. 

These situations present the risk that a person will make a decision based on, or affected by, these influences, rather than in the best interests of Workit Health.

4.0 Policy

Each Investigator who conducts research on behalf of Workit Health must disclose via the electronic system all significant financial interests (SFIs) that are relevant to the Investigator’s institutional research responsibilities no later than at the time of application for PHS-funded research. Each year during the period of the award, the Investigator must also disclose all relevant SFI’s, and they must disclose all new SFI’s within 30 days after they become aware of the new SFI., or.

Investigators are required to complete the annual disclosure form even if they have no financial interest to report. Transactional disclosure by the PI is also required at the time a research proposal is submitted to Sponsored Programs in order to ensure compliance with federal disclosure and management requirements.

5.0 Procedure:

5.1 Investigator Responsibilities

5.1.1 Investigators are responsible for:

• Disclosing all significant financial interests
• Providing updates to disclosed information as needed
• IF acting as the PI/PD, providing a list of individuals who meet the definition of “investigator” (see 3.9) within the required disclosure timeline
• Completing all required training and education
• Completing the annual disclosure form even if they have no financial interests to report.
• Ensuring that an updated FCOI in Research DIsclosure is on file at the time of Institutional Review Board (IRB) or the Institutional Animal Care and Use Committee (IACUC) approval for any new research proposals.

5.2 Financial Conflicts of Interest

A financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research. Examples include, but are not limited to, the following:

5.2.1 Investigator (and/or an Investigator’s spouse and/or dependent children) entering into a paid consultancy with an outside entity that has an interest in the investigator’s Workit Health-based research;

5.2.2 Investigator (and/or an Investigator’s spouse and/or dependent children) receiving royalties or non-royalty payments related to ongoing research;

5.2.3 Investigator (and/or an investigator’s spouse and/or dependent children) having an equity interest (e.g., stocks, stock options, warrants) related to ongoing research;

This policy addresses individual financial conflicts of interest; however, Workit Health may also have conflicts of interest in research whenever the financial interests of Workit Health, or of a Workit Health official acting within his or her authority on behalf of Workit Health, might affect – or reasonably appear to affect – Workit Health processes for the conduct, review, or oversight of research. IF institutional conflicts of interest are identified via the process described below, they will normally be addressed in a manner that is consistent with this policy.

5.3 Review of FCOIs

Prior to Workit Health’s expenditure of any funds under the NIH-funded research project, the designated Research Administration staff member/consultant (Designee) conducts an initial review of all disclosures. If necessary, the Designee obtains additional information from the Investigator and other individuals (including the Investigator’s spouse and dependent children) to help determine whether the SFI disclosed is related to NIH-funded research. The Designee then formally identifies cases that require further review and refers such cases to the Policy Review Committee (PCR).

The PCR will review the collected information in accordance with its Charter to determine whether a financial conflict of interest exists by considering the following:

5.3.1 Impact on integrity of research data;

5.3.2 Risks to rights and safety of animal and/or human research subjects;

5.3.3 Risks to the rights of students and trainees participating in research; and

5.3.4 Appearance of conflict of interest.

If a financial conflict of interest is identified, the PCR will determine whether the research can be undertaken with appropriate management.

5.4 Management of FCOIs

For cases that require management, a Management Plan will be developed by the Designee and PCR. The Management Plan will be developed collaboratively and examples of conditions or restrictions that may be employed to manage conflicts include:

5.4.1 Public disclosure of significant financial interests (e.g., when presenting or publishing the research), if appropriate;

5.4.2 Disclosure of significant financial interests directly to subjects involved in human research;

5.4.3 Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of research;

5.4.4 Modification of research plan;

5.4.5 Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research;

5.4.6 Reduction or elimination of the financial interest (e.g., sale of an equity interest);

5.4.7 Severance of relationships that create the actual or potential conflict of interest;

5.4.8 If it proves impossible to reach an acceptable Management Plan, funds will be returned to the sponsor.

A draft Management Plan will be provided to the Investigator for review and comment before it is finalized. The Investigator and their immediate supervisor must sign the final PRC-approved plan to acknowledge their agreement to comply.

Only after these steps are completed will Workit Health begin the expenditure of any funds under the NIH-funded research project.

If Workit Health Identifies a new SFI that was not disclosed or reviewed in a timely manner or if a new Investigator becomes engaged with the project,  it will initiate the review process and an interim management plan will be implemented when necessary.

5.5 Monitoring

Investigator compliance with Management Plans will be monitored by Workit Health officials until the completion of the project. The frequency of monitoring will be dictated by sponsor/agency requirements and Management Plan provisions.

5.6 Research Involving Vulnerable Populations

Special consideration and scrutiny must be given to protect human subjects in research. Investigators with an identified financial conflict of interest or a significant financial interest that could directly and significantly affect the design, conduct, or reporting of the research shall not ordinarily participate in any research involving human subjects. This presumption against the participation in human subjects’ research by financially interested individuals may be rebutted by compelling circumstances. Compelling justification may include factors such as unique investigator expertise, unique institutional resources, unique access to particular patient populations, nature of the science, level of risk to human subjects and the degree to which the financial conflict of interest and the research are related.

The compelling justification and the degree of risk to human subjects must be presented and reviewed by the Research Official, in collaboration with the Research Compliance Committee. If compelling circumstances justify a waiver of this policy, the research will be subject to the development and implementation of a management plan to ensure the safety of human subjects and the integrity of the research. The IRB must review the research with consideration given to the requirements of the management plan developed by the Research Compliance Committee. The IRB may require additional safeguards to be implemented but may not determine less stringent financial conflict of interest management requirements.

5.7 Appeals

Investigators may appeal Research Compliance Committee decisions in writing within 15 days of receipt of the finalized management plan or other decision of the committee. The written appeal should include details regarding circumstances which support the request for a proposed revision to a committee decision. An Appeals Committee will be formed for purposes of investigating the appeal and making a final decision. A meeting of the Appeals Committee will be convened to review the SFI information, the Management and Monitoring Plan, and previous meeting minutes to make a decision. The Investigator may be invited to describe reasons for the appeal and to address further questions. The appeals process will take no more than 60 days from the date requested by the Investigator. The decision of the Appeals Committee is final and binding.

5.8 Confidentiality

Financial and other information disclosed in compliance with this policy will be kept confidential and disclosed only on a need-to-know basis as required to perform appropriate review and evaluation required by the policy, except in the case of required public accessibility of identified financial conflicts of interest held by senior/key personnel (see Section 5.11.4).

5.9 Enforcement

Failure on the part of an Investigator to comply with this policy will result in disciplinary action and/or sanctions which may include formal reprimand, non-renewal/termination of appointment or affiliation, additional training requirements, additional supervision, closing existing research or denying future research by the Investigator, and/or any other enforcement action mandated by the applicable funding agency or Workit Health.

5.10 Policy Revision

Workit Health may modify this policy to conform to organizational changes and circumstances including revisions to federal or state law or regulations. The Research Compliance Committee will have five business days to review and comment on any proposed revisions. They will review all proposed revisions, in collaboration with the Workit Health team, and will consider company feedback during the review process. When necessary, procedures will be developed or modified to implement this policy.

5.11 Additional Requirements

The following additional requirements also apply to all research funded by the PHS of the U.S. Department of Health and Human Services and any PHS Awarding Component including the NIH.

5.11.1 Reporting

Workit Health will provide to the PHS Awarding Component a FCOI report as outlined in the regulations:

Initial Report: Prior to expenditure of any funds under the NIH-funded research project, the Institution will provide a FCOI report regarding any SFI found to be a FCOI. Workit Health will also provide a FCOI report within 60 calendar days from the date of a new SFI disclosure determined to be a FCOI, a new Investigator with an identified FCOI becomes engaged in the project or when the Institution identifies a FCOI not previously disclosed. This report will include the following information:

• Grant/Contract Number
• PD/PI
• Name of Investigator with FCOI
• Nature of the FCOI (e.g., equity, consulting fees, travel reimbursement or honoraria)
• Value of the financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value
• Description of how FCOI relates to PHS-funded research and the basis for the determination that the financial interest conflicts with such research
• Key elements of the Management Plan

Annual updates to this report will be submitted to the PHS Awarding Component for the duration of the research project. The annual report will include:

• Status of the FCOI
• Changes to the Management Plan
• Justification if FCOI no longer exists

5.11.2 Subrecipients

For PHS-funded research that involves subcontractors, subgrantees or sub awardees (collectively subrecipients) at other Institutions, Workit Health will require a written agreement that includes terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient Institution will apply to subrecipient Investigators. This agreement will specifically address time periods to meet disclosure and/or financial conflict of interest reporting requirements. If the FCOI policy of the subrecipient Institution will apply to subrecipient Investigators, the subrecipient will provide Workit Health with a certification that its FCOI policy complies with the applicable regulations. 

Subrecipient Institutions who rely on their Financial Conflict of Interest policy must report identified financial conflicts of interests to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the PHS Awarding component.

Subrecipients who do not have such a conflict of interest policy will be required to follow the Workit Health FCOI in Research policy. A subrecipient’s failure to promptly comply with the Workit Health policy will be considered grounds for immediate termination by Workit Health of any applicable subcontract or subaward. The written agreement terms required by Workit Health will contain a provision that subrecipients will report to Workit Health as the awardee Institution, any identified FCOI in sufficient time to allow Workit Health to report and manage the FCOI to meet the reporting obligations described above. If applicable, the written agreement will also include a requirement to solicit and review subrecipient Investigator disclosures that enable Workit Health to identify, manage, and report identified FCOIs to the NIH. 

5.11.3 Travel Disclosure

PHS-funded Investigators must disclose the occurrence of reimbursable or sponsored travel related to their institutional responsibilities, regardless of the value. At a minimum the travel disclosure must include:

• Purpose of the trip
• Identity of the sponsor/organizer
• Destination
• Length
• Monetary value, if known
• The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
• 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

Travel disclosures will be reviewed by the Research Official and be referred to the Research Compliance Committee as appropriate, to determine if the travel represents a FCOI with PHS-funded research. Additional information may be requested at the time of review. Disclosure of travel must occur no more than 30 days after the last day of the trip.

5.11.4 Public Accessibility

• This policy will be posted on the Workit Health public website. In addition, information concerning identified FCOIs held by senior/key personnel will be made available to requestors via an email response within five business days from when the Research Official receives the request. This information may be requested by emailing hello@workithealth.com
• The written response will include:
  • Senior/key personnel name
  • Senior/key personnel’s role in the research project
  • Name of the entity in which the FCOI is held
  • Nature of the FCOI
  • Approximate dollar value of the FCOI or a statement that the value cannot be readily determined

This information will be updated at least annually on the Workit Health public website. Within 60 days of a newly identified FCOI, this information will be updated on the Workit Health public website. All written responses will include the updated information. This information will remain available for three years from the date the information was most recently updated.

5.11.5 Training Requirements

Prior to the Investigator engaging in PHS-funded research and at any other appropriate time, Workit Health (Via computer based-training) will inform each Investigator of: 

• Workit Health’s policy
• The Investigator’s disclosure responsibilities
• Federal regulation

PHS-funded Investigators must complete FCOI training prior to engaging in research related to any PHS-funded grant or contract and at least every four years thereafter. Training must also be completed as soon as reasonably possible under the following circumstances:

• This policy changes in a manner that affects Investigator requirements
• An Investigator is new to Workit Health and will be working on PHS-funded research
• An Investigator is found to be noncompliant with this policy or their approved Management Plan

5.11.6 Investigator/Institutional Non-Compliance

If an SFI is not disclosed or reviewed in a timely manner, Workit Health will review the Investigator’s financial interest, and determine if it is related to PHS-funded research; determine whether a FCOI exists, and if so:

• Implement a Management Plan for ongoing research, at a minimum implement an interim Management Plan
• Complete a retrospective review of Investigator’s activities and the PHS-funded research project within 120 days of a non-compliance finding to determine if bias was present in the design, conduct, or reporting of such research; and
• If bias/non-compliance is found, the Institution will promptly inform the PHS Awarding Component by submitting a mitigation report that includes all reporting elements required by the regulation

If appropriate, Workit Health will send a revised FCOI report to the NIH to update a previously submitted report following a retrospective review.

If the retrospective review finds that the Investigator knew, or should have known about the FCOI related to his/her institutional responsibilities, but failed to disclose in compliance with this policy, the costs associated with the retrospective review and mitigation report may be pulled from the Investigator’s Indirect Cost Allocation portion, the Investigator’s Department, or directly billed to the Investigator. If the Department of Health and Human Services determines that a PHS-funded clinical research project 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 conflicting interest that was not managed or reported by Workit Health, the Investigator must disclose the FCOI in each public presentation of the results of the research and must request an addendum to previously published presentations.

5.11.7 NSF Reporting Requirements

If Workit Health is unable to satisfactorily manage a conflict of interest involving NSF funding, it will appropriately notify NSF’s Office of the General Counsel.

6.0 Responsibilities and Authorities:

Investigators participating in, or planning to participate in the design, conduct, or reporting of research including Public Health Service (PHS) or National Science Foundation (NSF) funded research at Workit Health have the authority and responsibility for the activities in this policy.

7.0 Records

Workit Health will maintain all records related to the implementation of this policy for at least three years after:

• the date of creation;
• the date of termination or completion of a research award or contract;
• the submission of the final expenditures report; or
• the date of final resolution of any investigation, audit, or similar action involving the records.