Conflicts of Interest and Research

• All outside financial interests and associational relationships that relate to research or other institutional responsibilities from previous 12 months and expected to receive over the next 12 months
• Consulting or other compensation for services
• Equity or other ownership interests
• Including startup companies, even if they exist only on paper
• Royalties, IP payments, and intellectual property rights
• Sponsored travel
• Disclosure includes self, spouse/domestic partner and other immediate family member
• $0 threshold for disclosure

Principal investigator, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or proposed research. Examples include:

• Designing or directing research
• Enrolling research subjects (including obtaining informed consent)
• Making decisions related to eligibility or risks of participating
• Collecting, analyzing or reporting data
• Contributing to manuscripts for publication
• This can include trainees, residents, technicians, volunteers, collaborators and/or consultants

The following roles are typically exempt from COI research disclosure:

• Individuals who performance is purely ancillary
• Hospital or staff who provide only ancillary or intermittent care as a service
• Hospital or staff who do not make direct and significant contribution to the research data

• Payments received as part of HMH salary
• Research funding (unless it does not flow through HMH)
• Other compensation (e.g. bonuses, travel reimbursement) received by HMH, excluding payments from Intellectual Property negotiations
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as there is no direct control of the investment decisions made in these vehicles
• Sponsored travel paid for by/through HMH, or funded by the U.S. government, U.S. university, U.S. academic medical center, or U.S. affiliated research institution

All disclosures are confidential. The COI Office will conduct an initial review of disclosed interests and make initial determinations if there is a significant financial interest (SFI). If an SFI is identified, the COI Office will compare to new and ongoing research projects to determine if there is relatedness between the SFI and the project. Any SFI that is potentially related gets reviewed by the COI Committee. The COI Committee makes the final decision if a disclosed SFI constitute a Financial Conflict of Interest (FCOI) and how best to mitigate the FCOI.

The Committee will determine which mitigation is appropriate to protect against actual or perceived introduction of bias and minimize risk to study subjects and institutional reputation. These may include:

• Reduce/eliminate the financial interest: a conflicted investigator is asked to divest interests or reduce payments in order to maintain on the study
• Removal from the study (keep the financial interest)
• Or, in the event compelling circumstances are identified, a management plan may be implemented. The conflicted investigator must agree to abide by the management plan and all management plans are subject to review for compliance.

Final COI approval is not provided until an identified FCOI has been mitigated.

The COI Committee meets monthly (2nd Tuesday). The Committee includes 9 voting members representing research across the HMH enterprise and non-voting members from compliance, research administration and legal. Ad-hoc members may attend as subject matter experts. The Committee must identify compelling circumstances in order to determine a conflict is manageable. Compelling circumstances include:

• Investigator is uniquely qualified (such that no other unconflicted HMH investigator can conduct study
• Status of the company and/or technology (new vs. established)
• The project/study addresses a critical need/illness
• The study design provides adequate safeguards to mitigate biases
• Effective oversight and management can be implemented and followed

A well-managed FCOI should not affect the integrity of the study. There are proven benefits interacting with industry however it is known that a COI can introduce actual or perceived bias, which is why HMH has established policies and procedures to review and mitigate potential FCOIs.

Transparency is key! If the interest or relationship is related to your institutional responsibilities – then yes!

If the interest is related to your institutional responsibilities (or has the possibility of appearing to be related), you must disclose. According to HMH policies and procedures, only the Committee can determine if there is a COI and the appropriate mitigation.

Immediate family members include: spouse/domestic partner, sibling, parent, grandparent, child, and grandchild IF they live in the same household or you manage their financial affairs OR if you have knowledge without special inquiry.

It is assumed you know the financial interest of your spouse/domestic partner and dependent children and reporting of relevant interests is required. It is not expected that you specifically inquire about the financial interests or relationships of other family members. However, if you know of a relevant interest or relationship, then it is expected you disclose as appropriate.

The COI Office provides any relevant COI information, including management plans to the IRB. The IRB may request additional management and disclosures, which does not override the Committee’s management plan however may add additional measures. Each study is reviewed for COI.

Anytime. COI review is a parallel process to other institutional procedures. The protocol, contract and/or grant can be in any stage of review/negotiation for a COI review to be conducted. The sooner a potential financial conflict of interest is identified, the sooner it can be mitigated.

No, you can updated your disclosure at any time. It is required that you update within 30 days of acquiring a new interest or relationship.

Yes - Per HMH policy, it is the expectation that researchers disclose financial interest that relate to their research as required by publishers, conference organizers and other professional “norms.”

FDA regulations require sponsors to collect financial disclosures for FDA regulated studies. In addition, external IRBs may require additional disclosures to be filed per their SOPs. If you have other research or faculty appointments outside HMH, you may need to file a disclosure with that institution. It is the responsibility of the research to file these disclosures and ensure their accuracy and consistency.