CONFIDENTIAL

Non-IU Affiliate Financial Conflict of Interest Disclosure Form

Conflict of Interest Training Policies, Regulations and Investigator Responsibilities

IU Policy on Financial Conflicts of Interest in Research

Individual Responsibilities
  • University personnel and students who are covered by the Indiana University Policy on Financial Conflicts of Interest in Research (policy) share an obligation to conduct their professional affairs in a manner consistent with the University's mission and to conduct their relationships with each other and with the University with candor and integrity.
  • Persons covered by the policy share an obligation to identify and, when possible, avoid financial conflicts of interest. When conflicts cannot be avoided, covered persons must disclose outside financial relationships that create, or reasonably appear to create, conflicts of interest, and work with University officials to manage or resolve those conflicts. Please see more information.
Application:
  • The policy applies to all persons at IU who are "Investigators" which include anyone who is responsible for designing research, collecting research data or performing other substantive research activities, or reporting research.
  • Investigators may include academic appointees, staff, students, unpaid researchers, consultants and anyone who is responsible for the design, conduct or reporting of research.

PHS Regulation

Regulation
  • Promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements is free from bias resulting from Investigator financial conflicts of interest (FCOI).
Definitions:
  • Significant financial interest is an outside financial interest that reasonably appears related to an individual's university responsibilities including, but not limited to, activities such as research, research consulting, teaching, professional practice, institutional committee membership and service on panels such as Institutional Review Boards or Data Safety Monitoring Boards.
  • A financial conflict of interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
  • Family membersare defined as the individual’s spouse or domestic partner under Indiana University procedures and dependents.
Please see for the completed text of the PHS regulations.

Investigator's Responsibility

What must be disclosed?
  • Financial interests of an individual and his/her spouse or registered domestic partner and dependent children related to the individual's university responsibilities which exceeds $5,000 from one entity in the preceding twelve months. This includes equity ownership,remuneration,reimbursed or sponsored travel, and/or interests or rights from intellectual property when aggregated together.
  • All equity (e.g., stock, stock option, or other ownership interests) in nonpublic entities such as start-up companies or equity interest which totals 5% or more in public entities.
  • Do not report compensation or travel reimbursed or sponsored by a US federal, state, or local government agency, a US Institution of higher education, a US academic teaching hospital, a US medical center, or a research institute that is affiliated with a US Institution of higher education.
  • You do not need to include income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
Who must submit a disclosure?
  • Anyone responsible for the design, conduct or reporting of research.
When are disclosures made?
  • Annually.
  • Within 30 days of a change in an individuals' Significant Financial Interests or acquiring new interests.

Resources

IU Policy on Financial Conflict of Interest in Research
Department of Health and Human Services FCOI Information
IU Conflict of Interest Website
IU Conflict of Interest Offices:
  • Bloomington - / 812-856-1706
  • Indianapolis - / 317-278-4894

I have read the training material and understand the purpose of this disclosure:
Signature:______Date: ______

This disclosure is being completed due to participation in the following:

Name: / Affiliate IU Campus:
Email: / Preferred phone:
Current Employer: / Role on IU research:

Human Subjects Research

PHS funded project or other agency requiring disclosure

Please answer the questions below by clicking the checkboxes. If you answer “Yes” for anyquestion, please complete a Disclosure Attachmentfor each external interest. If you answer “No” to allquestions, please sign below and submit the formto the appropriate office.

1. / Yes
No / During the past twelve months, did you and/or your Family Membersreceive aggregated compensation – monetary or otherwise—exceeding $5,000 in value from an external (non-IU) entity operating in areas relating to your role in IU research?
Please include any Compensation paid to you and your family such as but is not limited to:
Consulting Fees / Honoraria
Speaking Fees / Sponsored or Reimburse Travel
Income Related to Any Interests / Rights in Intellectual Property
Stipends / Dividends
Stock Options / Gifts
You do not need to include income from seminars, lectures, teaching engagements, advisory committees, review panels or travel that is reimbursed or sponsored by a US federal, state, or local government agency, a US Institution of higher education, a US academic teaching hospital, a US medical center, or a research institute that is affiliated with a US Institution of higher education.
2. / Yes
No / Did you and/or your Family Members, hold at some point during the past twelve months , any ownership interest in a publicly traded external entity operating in areas relating to theIU research you are involved inand which, when aggregated together for all of you, represents an equity interest that exceeds $5,000 in value or 5% ownership of a public entity.
3. / Yes
No / Did you and/or your Family Members hold at some point during the past twelve months an ownership interest in a non-publicly tradedexternal entity operating in areas relating to the IU research you are involved in(i.e., a faculty start-up company or family business related to your research)?

I hereby affirm that the above information (and the information contained in the attached statements, if any) is true to the best of my knowledge and that I will update promptly if my circumstances change.

Signature: ______Date: ______

DISCLOSURE ATTACHMENT

Name of the entity from which you are receiving or will receive the disclosed compensation, in which you hold an ownership interest in, or who has or will sponsor your travel:*

Please list your current sponsored program and/or research including the name of the principal investigators and title of the study.*

My IU sponsored programs and research work are sponsored by DHHS/PHS agencies (including NIH among others).*

Yes

No

Type of remuneration:*

Compensation

Equity Ownership

Intellectual property rights or interests

Travel

Purpose of Travel:*

Destination:*

Duration of Travel:*

Type of entity:*

For profit (publicly traded)

For profit (not publicly traded)

Non profit

Governmental

  1. Describe the business of this entity: *

2. Please provide a brief narrative of how your disclosed external relationship with the above notedentity does or does notrelate to your IU responsibilities: *

  1. Please provide a brief description of your role and responsibilitiesor ownership interest in the entity, including any applicable titles for which you and/or your Family Members will receive compensation.*
  1. Please indicate the aggregate annual amount of compensation (including the total value of any compensation, sponsored or reimbursed travel, intellectual property rights or interest and any other remuneration received or expected to be received from the entity)by checking the appropriate box(please note that amounts of $5,000 or less need not be reported)

$5,000-$9,999

$10,000-$19,999

$20,000-$39,999

$40,000-$59,999

$60,000-$79,999

$80,000-$99,999

$100,000-$149,999

$150,000-$199,999

$200,000-$249,999

$250,000-$299,999

$300,000-$349,999

$350,000-$399,999

$400,000-$449,999

$450,000-$499,999

$500,000+

  1. Please indicate the aggregate fair market value of ownership interest by checking the appropriate box(es) (please note that amounts under $5,000 need not be reported unless you are reporting equity in a non-publicly traded, for profit entity):

For profit (publicly traded)

$5,000-$9,999

$10,000-$19,999

$20,000-$39,999

$40,000-$59,999

$60,000-$79,999

$80,000-$99,999

$100,000-$149,999

$150,000-$199,999

$200,000-$249,999

$250,000-$299,999

$300,000-$349,999

$350,000-$399,999

$400,000-$449,999

$450,000-$499,999

$500,000+

For profit (not publicly traded)

under 5%

over 5% to 10%

over 10% to 25%

over 25% to 50%

over 50% to 75%

over 75% to 100%

  1. When did/will the compensation and or travel occur?
  1. Is the disclosed interest royalties or licensing fees? If so, please describe the intellectual property to which the payments are relatedand how it is or is not related to your IU responsibilities.
  1. Is this entity or any of its employees using space, equipment, or facilities at IU? Do NOT include IU work done pursuant to sponsored research agreements.*

Yes

No

If “Yes” selected please identify where and describe the work:

  1. Products and/or services made by the above noted entity in which I have a financial relationship are being used during performance of my IU responsibilities.*

Yes

No

Signature: Date: ______
Printed name:______

IUPUI Conflicts of Interest Office  980 Indiana Ave., Indianapolis, IN 46202 

317.278.4894  FAX: 317.274.1470 

IU Bloomington and Regional Conflicts of Interest Office  517 E. Kirkwood Ave., Ste. 4, Bloomington, IN 47408 

812.856.1706  FAX: 812.855.5511 

Last Revision: 08-11-2017