Conflict of Interest Disclosure (COI)

Carnegie Mellon University

Conflict of Interest Disclosure (COI)

Researchers Supported byExternal Sponsors

(Excluding the Public Health Service)

If you are seeking or receiving funding from a PHS[i] agency, do not complete this form.

Complete a Certification via SPARCS; see the ORIC website for information.

This form can be completed electronically in Microsoft Word, saved and e-mailed to

. If you have questions please call 412-268-4727.

Instructions & Definitions

Federal regulations[ii]and CMU policy require that recipients of research funding disclose certain financial interests to the university.
A conflict of interest occurs when there is the possibility (or perception of a possibility) that an individual’s private, financial interests or his /her family’s interests may influence the individual’s professional actions, decisions or judgment. In research, a conflict may compromise the collection, analysis, and interpretation of data as well as the hiring of staff, procurement of materials, sharing of results, protocol design and use of human subjects.
Investigators are responsible for filing an accurate disclosure prior to submitting a proposal for funding. Disclosures must be updated annually and within thirty (30) days of discovering or acquiring (through marriage, purchase, gift, inheritance, etc.) a new Conflict of Interest
As defined by federal regulation, Investigator means 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. The questions below, in section C, will assist you in determining if you are an Investigator and if you need to fully complete this COI disclosure.
Your disclosure will be reviewed in CMU’s Office of Research Integrity and Compliance (ORIC). If it appears that you may have a Financial Conflict of Interest[iii], you will be contacted by someone from ORIC. At that point, you may be asked to provide additional details about your activity.
For additional information refer to the following:

CMU policies on Conflict of Interest and Commitment and Financial Conflicts of Interest in Research.
CMU Guidelines on Compliance with Financial Conflict of Interest Regulations
CMU COI webpage

Contact Information

Individual Making this Disclosure:
Department: / Title:
CMU E-mail: / Telephone:
Department Head or Supervisor:
Is this disclosure related to a specific proposal or award? Yes No
If Yes, please provide the following: Title:
CMU Proposal Number: / CMU Award Number: / Funding agency:
If this COI is related to a proposal with an upcoming deadline, what is the deadline for submission?

Role at CMU

Have you been asked by your PI, or a member of the Office of Research Integrity and Compliance (ORIC) or Office of Sponsored Programs (OSP) to complete this form?

Yes, skip to question 6 and proceed.
No, continue

Are you involved in research at CMU? Do any of your CMU responsibilities and/or activities include the design, conduct or reporting of research?

Yes, continue
No, go to section G to certify your response and exit

Do you receive or expect to apply for financial support at CMU from external funds (e.g., National Science Foundation, Department of Energy, DARPA, a foundation, etc.) for your research activities?

Yes, continue
No, go to section G to certify your response and exit
Unsure, continue

At CMU, are you responsible as a Principal Investigator, Co-Investigator, Project Manager or key personnel for the design, conduct, or reporting of funded research?

Yes, skip question 5 and proceed to question 6.
No, continue

At CMU are you responsible for the design, conduct or reporting of research in a role other than as a Principal Investigator, Co-Investigator, Project Manager or key personnel? Not all individuals working on sponsored research reach this level of responsibility. If you are unsure, please consult with the PI(s) on the award(s) in which you participate.

Yes, continue
No, go to section G to certify your response and exit

Are you (choose the most appropriate answer):

Faculty
Special Faculty
Post-Doc
Staff
PhD student
Master’s student enrolled in a thesis program
Undergraduate student – continue only if you have been specifically asked by a CMU person to complete a disclosure, otherwise skip to section G to certify your response
External Collaborator (e.g., subcontractor or consultant), continue only if you have been specifically asked by a CMU person to complete a disclosure. Contact if you are not sure how to proceed.

External Funding

Please indicate your sources of support by checking all that apply below
Public Health Service Agencies
National Institutes of Health (NIH) / Indian Health Services (IHS)
Agency for Healthcare Research and Quality (AHRQ) / Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC) / Health Resources and Services Administration (HRSA)
Substance Abuse and Mental Health Services Administration (SAMHSA) / Food and Drug Administration (FDA)
If any of the above PHS boxes are checked, please discontinue completing this form and instead complete or update your Certification in SPARCS(see the ORIC website)
Other Federal Agencies
Air Force / Department of Transportation
Army / Environmental Protection Agency
Central Intelligence Agency / IARPA
Department of Defense / National Academy of Sciences
DARPA / NASA
Department of Education / National Endowment for the Arts
Department of Energy / National Endowment for the Humanities
Department of Homeland Security / National Institute of Standards and Technology
Department of Housing and Urban Development / National Science Foundation
Department of the Interior / Navy
Department of Justice / Office of the Director of National Intelligence
Department of Labor / Other federal agency: please specify
Other
Industry: please specify / Foundation: please specify
State: please specify

Disclosure of Significant Financial Interests that may Create a Conflict of Interest

In this section you should disclose Significant Financial Interests that may be a Conflict of Interest or create the perception of a conflict of interest.
“Significant Financial Interests” (SFI) include anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees, or honoraria); equity interests (e.g., stocks, stock options or other ownership interest); and intellectual property rights (e.g., patent, copyrights and royalties from such rights). Mutual funds and retirement accounts over which you have no direct control are not SFIs.
SFI includes:

An ownership interest that exceeds $10,000 in fair market value and represents more than 5% ownership in a single entity; or
Salaries, consulting fees, royalties, and other payments that when aggregated over the next twelve (12) month periodare expected to exceed $10,000.

For example, if you own $10,000 of Acme Inc. stock and this represents 6% of Acme’s total fair market value, you have a Significant Financial Interest. If you expect to receive more than $10,000 in payment from Acme in the next twelve months, you have an SFI.
SFI does not include:

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,
Income from service on advisory committees, or review panels for public or non-profit entities.

A “Conflict of Interest” (COI) exists when it is determined that a significant financial interest could directly and significantly affect the design, conduct or reporting of the funded research or educational activities.
For example, if you own 10% of Acme Inc.’s stock and the stock is worth $15,000, you have a SFI. If Acme is involved in research at CMU, you should disclose this conflict of interest. However, if you own $15,000 in Microsoft stock, this constitutes less that 5% ownership in Microsoft. Even if you receive funding from Microsoft for research, you do not have a SFI and do not need to disclose a conflict of interest.
So that researchers do not have to disclose the value of privately held entities to CMU, we ask that researchers consider any ownership interest in a privately held entity to be a SFI. For example if you own stock in a start-up company and that company is somehow involved in research with CMU, you should disclose this as a conflict of interest.
For purposes of this disclosure “you” means you and your immediate family (spouse, domestic partner - as defined by CMU for the purpose of receiving insurance benefit coverage under the CMU employee benefit plans, or dependent child).
Exclude mutual funds and retirement accounts over which you have no direct control.
E.1. Relationships with Publicly Traded Entities
Yes No I (or my spouse or dependent children) have an ownership interest (greater than $10,000and greater than 5% ownership of the entity) in a publicly traded entity that may create aconflict of interest with my funded research.
Yes No I (or my spouse or dependent children) expect to receive payments or compensation exceeding $10,000 in the next twelve (12) months, from a publicly traded entity, that may create a conflict of interest with my funded research.
If you answered “yes” to either of the above questions, please continue below. Otherwise, proceed to section E.2.
I (or my spouse or dependent children) do have a relationship(s) with publicly traded entities, exceeding $10,000, that may create a conflict of interest with my funded research.
Indicate the type of relationship you have with each publicly traded entity for which you have an ownership interest that exceeds $10,000 and 5% of total ownership or remuneration you expect to receive in the next twelve (12) months that exceeds $10,000. Provide details below. Use the Comments field to provide any information you feel may be helpful. Attach additional pages if necessary.See Federal Agencies Supplemental Pages for Publicly Traded Entities

Name of publicly traded external entity:

Name of publicly traded external entity:

Name of publicly traded external entity:

Name of publicly traded external entity:

Does total ownership value in this entity exceed $10,000 and 5% ownership? Yes No
Do total payments from this entity exceed $10,000? Yes No
Type of Financial Interest (Check all that apply) / Comments
Stock / Yes
Stock options / Yes
Other form of ownership / Yes
Payment for consulting or advising / Yes
Payment for serving on the Board / Yes
Payment for speaking engagement(s) / Yes
Payment for editorial services / Yes
Payment for other roles/services / Yes
Royalties related to Intellectual Property / Yes
E.2. Relationships with Privately Held Entities
Yes No I (or my spouse or dependent children) have an ownership interest in a privately held entity that may create a conflict of interest with my funded research.
Yes No I (or my spouse or dependent children) expect to receive payments or compensation exceeding $10,000 in the next twelve (12) months, from a privately held entity, that may create a conflict of interest with my funded research.
If you answered “yes” to either of the above questions, please continue below. Otherwise, proceed to section F.
I (or my spouse or dependent children) do have a relationship (s) with privately held entities that may create a conflict of interest with my funded research.
Indicate the type of relationship you have with each privately held entity for which you have any ownership interest or remuneration you expect to receive in the next twelve (12) months that exceeds $10,000. Provide details below. Attach additional pages if necessary. See Federal Agencies Supplemental Pages for Privately Held Entities.

Name of privately held external entity:

Doyou have any form of ownership interest? Yes No
Do total payments from this entity exceed $10,000? Yes No
Type of Financial Interest (Check all that apply) / Comments
Stock / Yes
Stock options / Yes
Other form of ownership / Yes
Payment for consulting or advising / Yes
Payment for serving on the Board / Yes
Payment for speaking engagement(s) / Yes
Payment for editorial services / Yes
Payment for other roles/services / Yes
Royalties related to Intellectual Property / Yes

Name of privately held external entity:

Name of privately held external entity:

Name of privately held external entity:

Other

Do you have any financial interests that you believe create a conflict of interest or the perception of a conflict of interest with your work at CMU?

Yes No
If yes, please describe.

Are you a founder of or do you serve in an advisory capacity (Board of Directors, Scientific Advisor, etc.) for any company or organization that is currently in existence? Exclude professional associations and community service organizations.

Yes No
If yes, please identify the organization and the approximate date of its founding.
Organization Name / Date of Founding / Do you still have a relationship?
Yes No
Yes No
Yes No
Yes No
Yes No

Are you doing science/engineering/work that could directly benefit one of the organizations listed above?

Yes No
If yes, please describe.

Do you intend (in the next twelve month period) to hire (as employee, consultant, independent contractor, etc.) any CMU students, faculty or staff to work in any entity in which you have an ownership interest?

Yes No
If yes, please describe.

Are you currently on leave or do you plan to take a leave within the next 12 months?

Yes No
If yes, please describe.

Signature & Certification

Please acknowledge your understanding by checking both oftheboxes below. You may insert an electronic signature on the signature line. Please e-mail the completed form from your CMU e-mail account.
I understand that I am to comply with Carnegie Mellon University’s policies related to Conflict of Interest and research. As a researcher receiving federal funds, I understand that I have an obligation to adhere to applicable federal regulations regarding Conflict of Interest.
To the best of my knowledge, I have disclosed all of my financial relationships as required by CMU policy and federal regulations. I understand that I have a continuing responsibility to comply with these and update my disclosure as necessary.
Signature: ______
Date: ______

This form can be completed electronically in Microsoft Word, saved and e-mailed to

. Please e-mail the completed form from your CMU e-mail account.

If you have questions please call 412-268-4727.

v.10/12/2014

[i]Agency for Health Care Research & Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), Office of Global Affairs (OG), Office of the Assistant Secretary for Health (OASH), Office of the Assistant Secretary for Preparedness and Response (ASPR), Substance Abuse and Mental Health Services Administration (SAMHSA).

[ii]HHS COI regulation, NSF COI requirements

[iii]Financial Conflict of Interest means a significant financial interest that could directly and significantly affect the design, conduct or reporting of federally funded research.