FAQs-Office of Research Integrity and Compliance - Carnegie Mellon University

Conflict of Interest FAQs

General

Conflict of Interest

Externally Funded Researchers

Public Health Service Funded Investigators

Management Plans

Sub-contractors and Collaborators

  • General

    Where can I find CMU's policy on conflict of interest?

    CMU has two policies related to conflict of interest which are available on CMU’s website.

    Details are discussed in COI Guidelines

    Who is required to complete a Conflict of Interest Certification and Disclosure?

    CMU faculty, staff and students working on sponsored research who meet the federal definition of Investigator need to complete a Certification.  Some Investigators will complete a Disclosure as part of the Certification process.

    How do I know if I'm an Investigator and required to complete a COI Certification?

    An Investigator is the Project Director, Principal Investigator, Co-Investigator or any other person, who is responsible for design, conduct or reporting of research funded or proposed for funding.   

    For research sponsored by a Public Health Service (PHS) agency the term Investigator also includes key personnel identified in the grant application, progress report or other report submitted to the funding agency by the Institution.  

    If you are a master’s degree or undergraduate student, you generally do not need to disclose unless you have been asked to do so by your PI or the Office of Research Integrity and Compliance (ORIC).

    How do I complete a COI Certification?

    PHS funded Investigators
    All Investigators seeking and/or receiving funds from a PHS agency must complete a COI certification via SPARCS.  Go to http://sparcs.cmu.edu.

    All other  Investigators
    From April 1, 2015 on, all Investigators must complete a COI Certification via SPARCS.  Prior to that date some colleges will be using SPARCS and others will continue to use paper forms.  If you are seeking or receiving non-PHS funds please complete the Conflict of Interest Disclosure and e-mail it to coi-compliance@andrew.cmu.edu.

    Where can I find the paper disclosure forms? (only until February 28, 2015)

    Forms and additional information are available on the Office of Research Integrity and Compliance (ORIC) website.   The forms are designed to be completed electronically and e-mailed to coi-compliance@andrew.cmu.edu.

    Who can help me if I have questions about completing a Certification?

    If you have questions you may contact the SPARCS help desk by e-mailing sparcs-help@andrew.cmu.edu, calling 412-268-3485, or looking for information on the ORIC website or SPARCS website.

    What is the difference between a Certification and a Disclosure?

    In SPARCS a Certification is a set of questions you will answer, relating to your responsibilities at CMU and possible conflicts of interest. This Certification will be submitted, reviewed, and approved all within SPARCS. There are multiple types of Certifications: Annual, Research, and Updates.

    A Disclosure is a set of questions you will answer within SPARCS, relating to your financial interests. Disclosures are embedded within Certifications. However, it may be useful to understand that the term "Disclosure" when used in SPARCS refers specifically to the financial information you have provided.

    When do I need to file a Certification?

    Annual Certifications must be completed by all Investigators with external funding.  You will receive an e-mail from SPARCS letting you know that it’s time to do your Annual Certification.  

    Research Certifications are made prior to submission of a proposal for funding.  When Office of Sponsored Programs (OSP), via Sponsored Programs EXchange (SPEX), is made aware that you are submitting a proposal, you will receive an e-mail from SPARCS prompting you to complete a Research Certification.   This is a very quick process.

    What if my information changes after I file my disclosure?

    Disclosures must be updated annually or when your significant financial interests change. This can be done easily via SPARCS.

    Who will see the information I disclose?

    Staff in the Office of Research Integrity and Compliance (ORIC) will review all certifications that are flagged by SPARCS as having a Significant Financial Interest.  Disclosures indicating there is a potential conflict of interest may be shared with the Vice President for Research, the Conflict of Interest Committee, legal counsel or the Investigator’s department head or Dean.

    PHS requires the university to disclose information to the funding agency and the public in limited situations.  If it is determined that a financial conflict of interest exists, CMU is required to provide certain information to the PHS funding agency. If it is determined that a financial conflict of interest exists, CMU is required to make certain information available to the public, upon request.

    NSF requires the university to notify the NSF Office of General Counsel in the event a financial conflict of interest is identified and CMU finds that is it unable to appropriately manage the conflict.

    Is there mandatory training?

    Yes.  Training is embedded into SPARCS.  The first time you use the system, you will go through the training.  Thereafter, you will be prompted to review the material every three years.

    Conflict of Interest

    What is a conflict of interest?

    Conflicts of interest in research occur when university members are in a position to influence research and their extramural activities are such that they or their family may receive a financial benefit or improper advantage from the research.

    For example, if you received funding for research and want to sub-contract a portion of the work to an entity where you, your spouse or dependent child have an ownership or other financial interest, a conflict of interest exists.

    What if I have a potential or actual conflict of interest?

    If it is determined that you have (or may have) a conflict of interest, you will be contacted by someone from the ORIC office.  Additional information will be gathered.    Depending on the circumstances the facts will be reviewed by ORIC, the Vice President for Research, the COI committee, legal counsel and your department head or Dean.   If appropriate, a management plan will be established.  You will be involved in this process.

    Externally Funded Researchers

    Do I have to file a Certification?

    If you meet the federal definition of Investigator and you seek or receive external funds for research, you need to complete an Annual Certification and a Research Certification prior to proposal submission. This is being phased in College by College between October 21, 2014 and March 31, 2015.

    Which types of financial interest need to be disclosed?

    For most externally funded researchers disclosure of Significant Financial Interests that create a potential conflict of interest is required.  For researchers seeking or receiving PHS funding, disclosure of Significant Financial Interests related to Institutional Responsibilities are required.

    What is a Significant Financial Interest for non-PHS funded Investigators?

    Significant Financial Interests (SFI) include certain payments, ownership interests and intellectual property rights and interests.  SFI includes:

    What are Significant Financial Interests for PHS disclosures?

    “Significant Financial Interests” (SFI) include certain payments, ownership interests and intellectual property rights and interests.  SFI includes:

    Are there any financial interests that do not have to be reported?

    Yes.

    What is not a Significant Financial of Interest for PHS disclosure?

    My financial interests change periodically.  When do I have to update my disclosure?

    You have an ongoing obligation to disclose your SFI throughout the course of an award.  The regulation states that Investigators must update financial disclosures within thirty (30) days of acquiring or discovering a new SFI.  Once disclosed, CMU has 60 days to review the disclosure and determine whether the SFI is related to your research, if a COI exists, and to manage the COI and report to the funding agency.

    You do not need to disclose ongoing fluctuations in the value of your previously disclosed SFIs.  Annual updates are sufficient.

    What is a Financial Conflict of Interest?

    Conflicts of interest in research occur when university members are in a position to influence research and their extramural activities are such that they or their family may receive a financial benefit or improper advantage from the research.

    Public Health Service Funded Investigators

    What agencies are part of the Public Health Service?

    Do other sponsors follow the PHS regulations?

    Yes.  A list of these sponsors is available at http://sites.nationalacademies.org/PGA/fdp/PGA_070596.

    What are Instituional Responsibilities?

    “Institutional Responsibilities” involve a variety of scholarly and professional obligations carried out on behalf of the university such as teaching, research, scholarship, professional practice and service (on university, association, advisory or technical committees, editorial boards).  Activities related to an individual’s field of professional expertise are usually either Institutional Responsibilities or related to their Institutional Responsibilities.

    My financial interests change periodically.  When do I have to update my disclosure?

    You have an ongoing obligation to disclose your SFI throughout the course of an award.  The regulation states that Investigators must update financial disclosures within thirty (30) days of acquiring or discovering a new SFI.  Once disclosed, CMU has 60 days to review the disclosure and determine whether the SFI is related to your research, if a COI exists, manage the COI and report to the funding agency.

    What travel related information must I disclose?

    PHS funded Investigators are required by the regulation to disclose the occurrence of certain types of reimbursed or sponsored travel  related to the Investigator’s Institutional Responsibilities.  You are not required to disclose travel unless the total value of travel sponsored by a single organization in a 12-month period exceeds $5,000.  For detailed guidance see CMU’s COI Guidance.

    Management Plans

    When is a management plan needed?

    If it is determined that a conflict exists or appears to exist, a management plan will be established.  The conflicted investigator is involved in the development of the plan.

    What does a management plan require?

    Examples of mechanisms that are used to manage conflicts include:
    Every situation is unique.  Every management plan is tailored to the specifics of the research activity and conflict.

    Who will know that there is management plan in place?

    In some instances the funding agency will be notified that a management plan is in place.  Conflicted Investigators are required to notify other members of the research team that they have a financial conflict of interest.   Department administrators will have access via SPARCS COI to the information that a management plan is in place, but will not have access to the details of the plan via SPARCS unless the individual plan calls for them to be given detailed information.

    Is the management plan monitored?

    Yes, ORIC monitors COI management plans.

    Sub-contractors and Collaborators

    If I am collaborating with someone from another university do they need to disclose to CMU?

    PHS Funded Research: Sub-contractors and consultants must comply with Public Health Services regulations regarding conflict of interest, but that does not necessarily mean disclosing to CMU.  If a sub-contractor has certified via the FDP Clearinghouse website that their institution complies with PHS regulations, then they are not required to disclose to CMU.  Consultants, or sub-contractors who have not made this public certification of compliance, must disclose to CMU using the External Collaborator form available for download from the ORIC website.   This disclosure must be made before the proposal is submitted. 

    All Other Research: Sub-contractors, consultants, and other collaborators do not routinely have to disclose to CMU.  If they are involved in a conflict of interest (for example, a subcontractor who is also a CMU faculty member, or a consultant who is the CMU PI’s family member) then they may be asked by ORIC to disclose.