Conflicts of Interest and Conflicts of Commitment (COI-COC)
The Children’s Hospital of Chicago Medical Center (the “Medical Center”), doing business as Ann & Robert H. Lurie Children's Hospital of Chicago, is dedicated to identifying and managing conflicts of interest (COI) and conflicts of commitment (COC) that arise when an individual’s outside activities overlap with either their Medical Center responsibilities or their Medical Center research.
The Conflict of Interest and Conflict of Commitment (COI-COC) process is designed to ensure objectivity in the design, conduct, or reporting of research. As required by federal regulations, a designated official must review all financial disclosures, determine whether a financial conflict of interest exists, and, if so, determine what actions should be taken by the organization to manage, reduce, or eliminate such conflict of interest.
For questions about COI-COC process, contact us at ResearchCOI@luriechildrens.org.
Medical Center Policies and Procedures:
- Conflicts of Interest and Commitment in Research Policy
- Workforce Conflict of Interest Policy
- Vendor Relations Policy
Federal/Sponsor Requirements:
The sponsors listed below require financial conflict of interest disclosure as specified by the federal Public Health Service (PHS) conflict of interest disclosure rules. The list includes the PHS agencies and other organizations that have adopted the PHS financial conflict of interest rules. Updated September 2024.
- Administration for Community Living (ACL)
- Administration on Aging (AoA)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Alliance for Lupus Research (ALR)
- Alpha-1 Foundation
- American Asthma Foundation (AAF)
- American Cancer Society (ACS)
- American Foundation for Suicide Prevention
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- Biomedical Advanced Research and Development Authority (BARDA)'
- Centers for Disease Control and Prevention (CDC)
- CurePSP
- Food and Drug Administration (FDA)
- Harrington Discovery Institute
- Health Resources and Services Administration (HRSA)
- Indian Health Service (HIS)
- Juvenile Diabetes Research Foundation (JDRF)
- Lupus Foundation of America (LFA)
- National Institutes of Health (NIH)
- Office of Global Affairs (OGA)
- Office of Minority Health Resources Center (OMH)
- Office of Population Affairs (OPA)
- Office of Public Health and Science (OPHS)
- Office of Research Integrity (ORI)
- Office of Research on Women’s Health (OWH)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Planning and Evaluation (ASPE)
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Patient-Centered Outcomes Research Institute (PCORI)
- Sage Bionetworks
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Susan G. Komen for the Cure
Training
All investigators participating in sponsored research are required by regulations and policy to complete conflict of interest (COI) training PRIOR to engaging in such research, and no less than once every four years thereafter. Training is embedded in the disclosure form in eDisclosure, but it is possible to complete training independently from the disclosure.
To complete training:
- Log into the eDisclosure system using your NetID and password.
- Click the "Complete Training" button on the left side of the screen.
- Click the link for "Research Conflict of Interest Training Module" which will open a document in another window for you to review.
- Check the box attesting to having completed the training module and click "OK."
Please contact Research Compliance if you have any questions, or experience issues with obtaining or accessing your eDisclosure account.
Disclosure
Disclosure of outside professional activities and financial interests that relate to an investigator’s role(s) and responsibilities at the Medical Center is required by the Medical Center’s Conflicts of Interest and Commitment in Research Policy.
If you are involved in federally or industry sponsored research, or research submitted to the IRB, this also applies, and requires disclosure of Significant Financial Interests (SFIs).
When do investigators need to disclose?
- At least annually (usually the January-March disclosure period)
- Within 30 days of acquiring any new significant financial interest
- Whenever an investigator initiates a new outside activity that reasonably appears related to their Medical Center responsibilities
Note: If updates are submitted in eDisclosure outside of the annual process, that information will be saved and pre-populated for you during the annual process. It will not be necessary to enter the information twice.
A Conflict Management Plan (CMP) is implemented when there appears to be overlap between an individual’s outside relationships and/or interests and their Medical Center responsibilities. A CMP is a written document that is created to reduce or eliminate the risk of bias in a situation where an individual's personal interests may conflict with their professional responsibilities.
Management plans strategies may vary depending on the circumstances of each relationship and/or situation. Some general strategies for a CMP include:
- Recusal from decisions involving the outside company the investigator has a relationship with.
- Parameters around using Medical Center resources for activities with an outside entity.
- Restrictions on using direct reports or trainees in outside activities without proper agreements and/or reporting line changes in place.
For research projects, the most common management strategies are:
- Disclosure to collaborators and team members.
- Disclosure in publications, presentations, and press releases.
- Disclosure in informed consent documents (as applicable).
The Office of Research Integrity and Compliance’s (ORIC) Research Compliance team will coordinate with investigators as necessary with the development and execution of any needed CMP. This may include consultation with an investigator’s unconflicted leadership as applicable. For more information about CMPs, please reach out to the Research Compliance team.
Small Business Innovation Research and Small Business Technology Transfer Grants
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant programs are highly competitive and encourage domestic small businesses to engage in federal research and development with the potential for commercialization. These grants are designed to stimulate technological innovation and provide opportunities for small businesses to meet federal research and development needs.
Small Business Entities (or “SBEs”) are always the applicant and awardee of SBIR and STTR projects, while research institutes, such as the Medical Center, may be sub-awardees. SBEs may collaborate with a research institution in Phase I and Phase II through the issuance of a subcontract between the two parties.
These program grants are structured into three phases:
- Phase I: Proof of Concept (6-12 months)
- Partnership with non-profit research institution allowed
- Principal Investigator (PI) employed by small business
- Phase II: Technology Development (24 months)
- Fosters tech transfer from research institution to SBE and into market
- Partnership with research institution required
- PI may be employed by SBE or research institution
- Phase III: Commercialization
- Not federally funded
- SBE pursues commercialization based on success of Phase I/II
The Medical Center supports its investigators’ participation in SBIR and STTR programs through an SBE, given the possibility for researchers and their start-ups to make rapid progress towards commercialization of important inventions. However, situations may arise that create a conflict of interest (COI) for investigators or members of the Medical Center’s research team when they have a financial interest in the SBE that’s applying for the funding and will also conduct research funded by the SBE.
Guidelines for Small Business Innovation Research and Small Business Technology Transfer Preparation
In accordance with the Medical Center’s policies, as well as federal regulations, please consider the following guidelines when preparing for SBIR and STTR participation:
Note: Lurie Children’s employees/investigators may not serve as both the SBE principal investigator and Medical Center’s principal investigator on the sub-award from the employee-owned company.
When serving as Principal Investigator of a subaward to the Medical Center
An employee may serve as the principal investigator (PI) of a subaward to the Medical Center from the prime award to the small business, provided that the following conditions are met:
- The Medical Center’s investigator does not serve as the lead principal investigator, investigator, or consultant for the SBE on the award from the sponsor.
- The sponsoring agency does not explicitly preclude the Medical Center’s investigator from serving as an investigator under the Medical Center’s subaward.
- Medical Center personnel, including any students, postdocs, or research staff working under the Medical Center’s investigator on the subaward to the Medical Center are only to work on the Medical Center’s scope of work unless otherwise approved by Research Compliance, and must be fully informed of any conflicts of interest that may exist between the SBE and the Medical Center’s investigator.
- The Medical Center’s investigator does not utilize Medical Center resources or any federal funds to benefit the SBE in a manner inconsistent with the institution’s non-profit status and without institutional approval
- Research Compliance should be alerted if the subaward is modified and a protocol is submitted to the Institutional Review Board for approval.
- The Medical Center’s investigator should generally not be a subordinate to anyone conflicted with the SBE
- All intellectual property that is created must be presented to the Innovate2Impact program.
- Phase II awards may require a Conflict Management Plan (CMP), which must be prepared and approved in accordance with the Medical Center’s Conflicts of Interest and Commitment in Research Policy.
When serving as Principal Investigator of the Prime Award to the SBE
A Medical Center investigator may serve as the PI of a SBIR/STTR grant submitted by a SBE, should the following conditions be met:
- The relationship with the SBE must be disclosed within the investigator’s COI disclosure.
- In order to serve as the PI of an SBIR grant, where the individual is required to be employed 51% by the SBE, the investigator would need to adjust their Medical Center appointment accordingly, with the appropriate institutional approvals.
- In cases where a Medical Center investigator serves as the PI of the prime award to the SBE, another Medical Center employee must be identified to serve as the PI of any subaward to the Medical Center.
- The PI of any subaward to the Medical Center may not be a student or subordinate of the PI of the prime award.
- Conflicts of interest must be managed in accordance with Medical Center’s Conflicts of Interest and Commitment in Research Policy, and the interest of students and other employees must be protected.
More Information:
- About SBIR and STTR
- SBIR-STTR Funding Opportunity Announcements (FOA)
- Research previously funded by SBIR-STTR can viewed on NIH Reporter.
International collaborations are critical to creating breakthrough advances, and the Medical Center highly values our global partnerships. However, there are increasing concerns about improper foreign interference with regards to international research, and the federal government has established regulations and framework because of that.
As such, federal agencies have been actively updating their policies and procedures in alignment with recent regulations and legislations, including the National Security Presidential Memorandum-33 (NSPM-33) and the CHIPS and Science Act of 2022. Specifically, the federal government continues to regulate participation in Foreign Government Talent Recruitment Programs. Due to a new federal mandate, researchers applying for or working on a federal award cannot be a Malign Foreign Talent Recruitment Program participant consistent with the Medical Center’s Conflict of Interest and Conflict of Commitment in Research policy which addresses “Malign” Foreign Talent Recruitment Programs.
Medical Center investigators must disclose if they are a talent program member of any kind during the annual disclosure for review within eDisclosure. In addition, participation in a Foreign Talent Recruitment Program of any kind must be disclosed prior to submission of a federal proposal and within 30 days of becoming a member of a foreign talent recruitment program, malign or otherwise.
Federal requirements vary by agency, so reviewing award terms and guidance and asking questions is essential. It is important to work closely with your research administrators, OSP, and Research Compliance to understand any foreign-influence related conditions within proposal or award agreement requirements.
Please contact ORIC’s Research Compliance team for additional guidance.
Applicable Regulations
- For general training on COI: CITI COI-COC Training
- Guidance for Start-Ups: Innovate2Impact (I2I) Program