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

Conflict of Interest FAQs

General

Federally Funded Researchers

Public Health Service Funded Researchers

Conflict of Interest

Management Plans

General

Why is the CMU Conflict of Interest policy changing?

Federal regulations for disclosure, management and reporting financial conflicts of interest have been in force for almost two decades. New regulations have been issued with a compliance deadline of August 24, 2012. Recipients of federal research funds (Institutions and Investigators) must comply with the regulations as a condition of funding.

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 the FCOI Guidelines [PDF].

Who is required to complete a Financial Conflict?

CMU faculty, staff and students working on federally funded research that meet the federal definition of Investigator need to complete either a Significant Financial Interest Disclosure or a Financial Conflict of Interest Disclosure.

How do I know if I’m an Investigator and required to disclose?

An Investigator is the Project Director, Principal Investigator or any other person, regardless of title or position, who is responsible for design, conduct or reporting of research funded or proposed for funding. This 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, do not disclose unless you have been asked to do so by your PI or the Office of Research Integrity and Compliance (ORIC).

Which disclosure forms should I complete?

If you are seeking or receiving Public Health Service (PHS) funds please complete the Significant Financial Interest Disclosure. If you are the recipient of PHS funds you may also need to complete a Sponsored and Reimbursed Travel Disclosure. If you are seeking or receiving any other federal funding please complete the Financial Conflict of Interest Disclosure.

Where can I find the disclosure forms?

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 the disclosure?

If you have questions you may contact someone in ORIC by e-mailing coi-compliance@andrew.cmu.edu, calling 412-268-4727, or looking for information on the ORIC website.

When do I need to file a disclosure?

Federal regulations require that disclosures are made prior to submission of a proposal for funding. If a proposal is funded, disclosures need to be updated when your interests change and annually. Investigators receiving a Notice of Award from a PHS agency on or after August 24, 2012 are required to file a disclosure prior to spending on the award.

What if my information changes after I file my disclosure?

Disclosures must be updated annually or when your significant financial interests change.

Who will see the information I disclose?

Staff in the Office of Research Integrity and Compliance (ORIC) will review all disclosures. 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.
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. Researchers with Public Health Service Funding are required to take training every four (4) years. CMU is using an on-line tutorial to satisfy the training requirement. Once you have completed the tutorial, enter your name into the certificate, save the certificate in PDF format and e-mail to coi-compliance@andrew.cmu.edu. Proof of training must be submitted to ORIC prior to spending on an award from a PHS agency.

Federally Funded Researchers

Do I have to file a disclosure?

It depends. If you meet the federal definition of Investigator and you seek or receive federal funds for research, you need to complete either a Significant Financial Interest Disclosure or a Financial Conflict of Interest Disclosure. Investigators funded by the Public Health Service must disclose Significant Financial Interests according to the PHS regulations. See the section below specific to PHS requirements. All other federally funded Investigators are required to disclose Financial Conflicts of Interests as described in this section of the FAQs

Which types of financial interests need to be disclosed?

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

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

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

  • An ownership interest that both exceeds $10,000 in fair market value and represents more than 5% ownership in a single entity.
  • Salaries, consulting fees, royalties, and other payments that when aggregated over the next twelve month period are expected to exceed $10,000.

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

Yes.

  • Income from investments such as mutual funds or retirement accounts where you do not directly control investment decisions;
  • Salary, compensation, royalties or other payments from CMU;
  • Income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities in the U.S.;
  • Income from service on advisory committees, or review panels for public or non-profit entities in the U.S.

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 Researchers

What agencies are part of the Public Health Service?

  • National Institutes of Health
  • Centers for Disease Control and Prevention
  • Food and Drug Administration
  • Agency for Healthcare Research and Quality
  • Agency for Toxic Substances and Disease Registry
  • Health Resources and Services Administration
  • Indian Health Services
  • Substance Abuse and Mental Health Services Administration.

What if I don’t have Public Health Service (PHS) funding, but have other sponsored research?

Investigators seeking or receiving federal research funding, not from a PHS agency, should complete the Financial Conflict of Interest disclosure. The disclosure requirements are significantly different.

When do I need to file a disclosure?

Federal regulations require that disclosures are made prior to submission of a proposal for funding. If a proposal is funded, disclosures need to be updated when your interests change and annually. Investigators receiving a Notice of Award from a PHS agency on or after August 24, 2012 are required to file a disclosure prior to spending on the award.

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:

  • A Significant Financial Interest exists, related to a publicly traded company, if the value of any compensation or payment in the preceding twelve (12) months and the value of any equity interest as of the date of this disclosure when aggregated, exceeds $5,000. This includes salary, payment for services, stock, stock options or other ownership interest.
  • A Significant Financial Interest exists, related to a privately held company, if the value of any compensation or payment in the preceding twelve (12) months and the value of any equity interest as of the date of this disclosure when aggregated, exceeds $5,000. This includes salary, payment for services, stock, stock options or other ownership interest.
  • A Significant Financial Interest exists when you have income from intellectual property rights and interests such as patents and copyright, upon receipt of income, where the payments are not from CMU.

What is not a Significant Financial Interest for PHS disclosure?

  • Salary, royalties, or other payments from CMU.
  • Income from investments such as mutual funds or retirement accounts where you do not directly control investment decisions.
  • Income from seminars, lectures, or teaching engagements sponsored by a U.S. government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, or a medical center or research institute affiliated with a U.S. institution of higher education
  • Income from service on an advisory committee or review panel for a U.S. government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, or a medical center or research institute affiliated with a U.S. institution of higher education

What are Institutional 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.

Is there mandatory training?

Yes. Researchers with Public Health Service Funding are required to take training every four (4) years. CMU is using an on-line tutorial to satisfy the training requirement. Once you have completed the tutorial, enter your name into the certificate, save the certificate in PDF format and e-mail to coi-compliance@andrew.cmu.edu. Proof of training must be submitted to ORIC prior to spending on an award from a PHS agency.

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. If appropriate, a management plan will be established. You will be involved in this process.

Management Plans

When is a management plan needed?

If it is determined that a financial 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:

  • Public disclosure of SFIs;
  • Monitoring of research by independent reviewers;
  • Modification of the research plan; or
  • Change of personnel.

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 many 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.

Is the management plan monitored?

Yes, ORIC monitors FCOI management plans.