Office of Research Administration

Frequently Asked Questions

Annual Disclosure

Who do I contact for help?

If you have technical problems, or questions regarding navigating through the Disclosure form, please contact the COI Call Center at (203) 737-5954.  The Call Center is open from 7 a.m. to 5 p.m. Monday through Friday.

 

If you have questions about the form, how to use it, or anything else related to conflicts of interest, contact the Conflict of Interest Office at:

 

Conflict of Interest Office
37 College Street
Suite 146
New Haven, CT

Phone 1: (203) 785-4780
Phone 2: (203) 785-4456
Phone 3: (203) 785-4774
Phone 4: (203) 785-4773

Fax: (203) 785-4255
Email: conflicts@yale.edu

Who do I contact if I have questions about disclosure requirements or the Disclosure Form?

Please call the Conflict of Interest Office at 203–785–4780 or 203–785–4456. You can also email your questions to conflicts@yale.edu.

Why am I receiving email notifications?

A variety of events will trigger email notifications:

  1. Your disclosure was received: this notification will be sent immediately after you have submitted your disclosure.
  2. Your annual disclosure is up for renewal: you will receive these notifications when your annual disclosure is close to expiring and your disclosure should be recertified. The first notification will be sent 60 days before your disclosure expires and a second notification will be sent 30 days later if you don’t submit your disclosure.
  3. Your disclosure has expired: if your disclosure expires, you will receive a notification the day it expires. Additional notifications will be sent 15 days and then monthly until an annual disclosure has been submitted.
  4. Your annual disclosure is required: you will receive this notification if you are required to submit an annual disclosure and do not have a disclosure on file.
When is my annual disclosure due?

The disclosure due date is one year following the submission date of your last disclosure and will be listed on your Profile Homepage (External Interest Disclosure Form Login). You will also receive email notifications reminding you to submit your disclosure that will also list the date of your last submission. For a list of the notifications you may receive, please see the FAQ above "Why am I receiving email notifications?"

Where can I review my disclosure status?

After your disclosure has been reviewed, it will be assigned a status. If you would like to see the status of your disclosure, please login to TMS. Please see below for a description of each status:

How often should I disclose?

Yale and Federal regulation require the ongoing disclosure of all significant interests in order to maintain compliance with disclosure requirements. You must disclose at least annually (i.e., your disclosure anniversary date is one year from the signature date of your last disclosure) and within 30 days of acquiring a new significant financial interest (SFI).  For PHS investigators this includes any new travel.

How can I prepare for the annual disclosure process?

For Yale (Non-PHS, Non-NSF):

Prior to completing the annual disclosure, compile a list of your activities, financial interests and income received over the previous 12 months that exceeds $10,000. You may consider keeping a list throughout the year to assist you in completing the annual disclosure.  Be sure to include the approximate number of days devoted to each activity so that your department chair or supervisor may review the overall commitment for potential Conflict of Commitment. You will also be asked to include any related interests of your spouse, or dependent children, as these may also present the appearance of a conflict or pose an actual conflict.

For PHS & PHS-like Sponsors:

Prior to completing the annual disclosure, compile a list of your activities, financial interests and income received over the previous 12 months that exceeds $5,000. You may consider keeping a list throughout the year to assist you in completing the annual disclosure.  Be sure to include the approximate number of days devoted to each activity so that your department chair or supervisor may review the overall commitment for potential Conflict of Commitment. You will also be asked to include any related interests of your spouse, or dependent children, as these may also present the appearance of a conflict or pose an actual conflict.  Remember any new SFIs, including travel, must be disclosed within 30 days of acquisition.

For NSF:

Prior to completing the annual disclosure, compile a list of your activities and income received over the previous 12 months and income or financial interests that you expect to receive or hold in the upcoming 12 months that exceeds $10,000. Be sure to include the approximate number of days devoted to each activity so that your department chair or supervisor may review the overall commitment for potential Conflict of Commitment. You will also be asked to include any related interests of your spouse, or dependent children, as these may also present the appearance of a conflict or pose an actual conflict.

For PHS & NSF:

Prior to completing the annual disclosure, compile a list of your activities and income received over the previous 12 months and income or financial interests that you expect to receive or hold in the upcoming 12 months that exceeds $5,000. Be sure to include the approximate number of days devoted to each activity so that your department chair or supervisor may review the overall commitment for potential Conflict of Commitment. You will also be asked to include any related interests of your spouse, or dependent children, as these may also present the appearance of a conflict or pose an actual conflict.

How do I recertify my annual disclosure in InfoEd?

For your annual disclosure, you will receive email notifications reminding you that your annual disclosure will need to be submitted along with a link to access your disclosure. The email notification will also contain the date your disclosure will expire. Rather than creating a new disclosure each year for your entity detail, University activities and Intellectual property, the information you previously entered in your previous disclosure is saved and those responses will be automatically populated. To recertify your disclosure, follow the steps below to recertify your disclosure:

  • Log in to COI portal using your Yale NetID and password: External Interest Disclosure Form Login
  • Your InfoEd Profile home page will display
  • Click ‘Recertify or update disclosure’
  • Answers from your previous disclosure are automatically populated
  • Review your answers to the screening questions first
  • If you have additional pages, please review each page to verify if your responses need to be updated
  • Mark each page as complete
  • Certify and submit your disclosure
What information will I be asked to disclose if I have intellectual property (IP)?

You will be asked to provide a description of the intellectual property, describe the nature of your intellectual property, and indicate whether your intellectual property is related to your research, used in clinical practice, or directly involved in purchasing decision and provide a description of the relationship.

What information from the annual disclosure will be used for conflict of commitment purposes?

The conflict of commitment review process is separate from the conflict of interests review process. The annual disclosure captures the type of external activity and the number of days committed to each activity; this information is used for conflict of commitment purposes. The value of the external activities will not be reviewed for conflict of commitment purposes. Your Dean, Department Chair, or supervisor will review the overall commitment to these external activities with your University responsibilities. Since conflicts of commitment are handled within your department, they are not addressed by the Conflict of Interest Committee. Individuals who did not disclose any external activities or interests in his or her annual disclosure will not be reviewed for conflict of commitment.

How do I navigate between pages?

You can navigate between pages anytime by clicking the page names in the navigation bar. You can use the navigation bar to move forward or backwards and return to pages you have already completed. Please note: if you check the “complete” box, you will be automatically directed to the next page in the disclosure form.

How do I preview my disclosure before I submit it?

If you have completed your disclosure and want to preview it before it is submitted, preview your disclosure by clicking on each page in the navigation bar. When you have finished reviewing, click on the back to the certification page.

How do I know if my disclosure has been submitted?

After you click the “submit” button on the certification page, the page will refresh and the date it was submitted and a PDF print icon will replace the “submit” button. You will also be sent an email notification confirming your disclosure has been successfully submitted.

Why can’t I “complete” my disclosure and submit it?

If you click the “complete” button and get an error message, most likely the form has not been filled out completely and unanswered questions remain. Please review the page and answer all the questions.

If you try to submit your disclosure and get an error message, review the navigation bar at the top and ensure each page of the disclosure form has a green check mark next to it. If a page does not have a green check mark, please click on that page and complete all unanswered questions and check “complete”. If you still receive an error message, please contact the COI office.

How do I print my disclosure?

Once a disclosure has been submitted, there are two options to print your disclosure. Please note: if your disclosure is still in progress and has not been completed and submitted, you will not be able to print the disclosure.

  1. Immediately after you have submitted your disclosure, you can print your disclosure from the certification page. Click the PDF icon at the bottom of the page and your completed disclosure will open in another window as a PDF.
  2. You can also print your disclosure from your profile homepage.
What if I made an error on my disclosure but already submitted it?

If you made a mistake and need to change a response, please use the same process to change an error as recertifying your annual disclosure.

  • Log in to COI portal using your Yale NetID and password: External Interest Disclosure Form Login
  • To re–open your disclosure, click “recertify or update disclosure”
  • Answers from your previous disclosure are automatically populated
  • Review each page and make any necessary changes
  • After you review and/or update each page, check the “completed” button
  • Once all pages have been marked complete, please certify and submit your disclosure
  • Please note: you cannot revise a disclosure once it has been submitted without certifying and resubmitting
How do I log out of InfoEd?

To log out of InfoEd when you are filling out your disclosure
Click on the ‘Save’ button located on the top left portion of the form and then close your browser window.

To log out of InfoEd when you are on the discloser profile page
Click on the ‘Exit’ button located on the top left portion of the form.

General FAQs

What is a conflict of commitment?

A conflict of commitment occurs when the commitment to external activities of a faculty or staff member adversely affects his or her capacity to meet University responsibilities.

Yale’s Faculty Handbook provides guidance about the amount of time that may be given by faculty members to outside activities; it stipulates, for example, that a faculty member may not accept salaried employment at another institution while a full-time employee of Yale, that faculty may not spend more than one day in a seven–day work week on consulting activities, and that faculty ownership or management of private enterprises is subject to review and to limitations. It is important to recognize, however, that the obligations of Yale faculty move beyond the letter of these obligations to their spirit. The University requires that its faculty will meet their classes, but it also expects that they will be available to students outside of the classroom, will carry their share of committee responsibilities, will remain productively involved in their research and other scholarly pursuits, and, where applicable, will meet their clinical obligations. External activities that compromise or diminish a faculty member’s capacity to meet these obligations represent a conflict of commitment.

Full–time non–faculty employees are expected to satisfy all of the requirements of their jobs, and should not permit outside activities to interfere with the performance of their Yale obligations. Some departments prohibit staff employees from consulting or engaging in other outside employment because of the likelihood of such interference. Other departments may permit certain outside activities, with appropriate notice to and written approval by the employee’s supervisor, so long as they do not interfere with employees’ Yale obligations.

Your dean, department chair, or direct supervisor is in the best position to determine whether your outside activities pose a conflict of commitment and is your initial contact for discussing potential options for eliminating conflicts of commitment. In order to assure the elimination of the conflict of commitment, your dean, department chair, or direct supervisor may seek further consultation with the Provost.

What is disclosable travel?

 

If you are NOT responsible for the design, conduct or reporting of research funded by the Public Health Service (PHS) or other agencies/sponsors that have adopted the PHS regulations): You are not required to disclose travel expenses.

 
If you ARE responsible for the design, conduct or reporting of research funded by the Public Health Service (or other agencies/sponsors that have adopted the PHS regulations):  You must disclose t
hird party paid travel related to your institutional responsibilities that exceeds $5,000 per year from a single entity.

 

Third party paid travel means:

  • Third party directly pays in whole or in part for travel on your behalf
  • You pay for travel and third party reimburses you in whole or in part
  • Yale pays in whole or in part for travel and the third party reimburses Yale

PHS regulations require you to disclose travel paid by:

  • External professional organizations and societies;
  • Academic journals and publishing companies; and
  • ANY travel reimbursed or sponsored by a foreign Institution of higher education or the government of another country.

PHS regulations exclude travel paid by:

  • Yale or funded by a sponsored award to Yale;
  • U.S. Federal, state or local government agencies;
  • U.S. Institutions of higher education or U.S. research institutes; and
  • U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education.

 

 

What are the PHS agencies and other sponsors that have adopted the PHS regulations?

The following is a list of PHS agencies and other sponsors that have adopted the PHS regulations:

  • Administration on Aging (AoA)
  • Administration for Children and Families (ACF)
  • Agency for Healthcare Research & Quality (AHRQ)
  • Agency for Toxic Substances & Disease Registry (ATSDR)
  • Alliance for Lupus Research (ALR)
  • American Cancer Society (ACS)
  • American Heart Association (AHA)
  • American Lung Association (ALA)
  • Arthritis Foundation (AF)
  • California Breast Cancer Research Program (CBCRP)
  • California HIV/AIDS Research Program (CHRP)
  • Centers for Disease Control & Prevention (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources & Services Administration (HRSA)
  • Indian Health Service (IHS)
  • Juvenile Diabetes Research Foundation (JDRF)
  • Lupus Foundation of America (LFA)
  • National Institutes of Health (NIH)
  • Patient-Centered Outcomes Research Institute (PCORI)
  • Substance Abuse & Mental Health Services Administration (SAMHSA)
  • Susan G. Komen for the Cure
What if I am uncertain as to whether or not I should disclose a particular outside activity or financial relationship?

If, after reading the questions on the Disclosure Form, you are unsure as to whether or not you should report an outside activity/financial interest then you should err on the side of caution and disclose the information. If an issue should arise in the future, having reported the activity/relationship offers some protection to you and the University in terms of how the matter is perceived by others. Failure to report an activity/relationship may be misinterpreted as a desire to hide the activity. No one is criticized for “over–reporting.”

I have no outside activities or external financial interests; do I still have to submit a Disclosure Form?

Yes. If you do not have any outside activities or external financial interests, you can simply answer “no” to the Screening Questions in Part One of the Disclosure Form.

I am certain I have no conflicts. Do I still have to submit a Disclosure Form?

Yes. University Policy requires disclosure of outside activities and financial interests. While many of these activities do not constitute a conflict of interest or conflict of commitment, they must be reported on the forms approved by the Provost.

When will my disclosure be reviewed?

Certain disclosures of a routine and “de minimis” nature may qualify for expedited review by either the COI Office or the COIC Committee Chairs. Other, more complex disclosures are presented to the Provost’s Committee on Conflict of Interest and Conflict of Commitment (COIC Committee). The COIC Committee will determine whether an apparent or actual conflict of interest exists, and, if so, by what means the conflict should be managed or avoided. The COIC Committee convenes once each month. Disclosures received after the agenda for a monthly meeting has been established are reviewed at the following meeting.

Why won’t the Office of Grant and Contract Administration set up my award while my disclosure status is pending?

Federal policy requires that prior to the expenditure of any funds under an award, any conflicts of interest be satisfactorily managed, reduced or eliminated in accordance with the Institution’s COI policy.

What can I do to facilitate my award set–up?

Federal regulation requires that prior to the expenditure of any funds under an award, any conflicts of interest be satisfactorily managed, reduced or eliminated in accordance with the Institution’s COI policy.  Therefore, in order to facilitate your award set-up you should ensure that disclosures for all investigators and individuals who are designated by the PI to be responsible for the design, conduct or reporting of the research project have been submitted and updated in a timely fashion.  Disclosure forms should be submitted with enough time to allow for the COIC to manage, reduce or eliminate any financial conflicts of interest prior to the date you expect the award to be set-up.

If your annual COI anniversary date coincides with your annual grant renewal date you should consider submitting your disclosure earlier than required. Note that the Training Management System (TMS) will send you an email notice 30 days prior to an approaching disclosure anniversary date. In addition, your prompt response to requests from the COI Office for clarifications/additional information will help to facilitate a more timely review of your disclosure. Since the COI Office cannot process incomplete forms, disclosers should make every effort to provide all of the information required by the Disclosure Form.    

What is a transactional review?

If any significant financial interests are identified in your disclosure, these interests will be compared to each new research award on which you are identified as responsible for the design, conduct, or reporting of the research to determine if a COI exists related to that research award. This is called a “transactional review”. Certain sponsors require that they be notified of the existence of a conflict of interest and require details about the nature of the FCOI and the management plan.

What is a management plan?

A management plan is developed to manage, reduce, or eliminate any conflicts of interest identified during the review process. Considerations in the development of a management plan may include:

  • The number of days spent interacting with the external entity;
  • Complexity and extent of the relationship between the external entity and your University activities;
  • Degree to which the involved parties stand to benefit (or may be negatively impacted);
  • Level of the external interest associated with an activity;
  • Value of the external interest;
  • Degree of risk to human research participants.
Will the content of my disclosure form be kept confidential?

Your disclosure will be maintained in confidence as far as possible. The information you submit will not be shared except with those who have a need to know. In addition to Yale employees with a need to know, disclosure may be made to the government, to the extent required by law, and, for faculty who serve as members of a health care institution’s medical staff or affiliated medical staff, disclosure may be made to that institution for purposes of its COI process.

 

PHS regulations require that prior to  the expenditure of any funds under a PHS-funded research project, Yale must make publicly available information about any significant financial interest (SFI) that has been determined to be a financial conflict of interest (fCOI) and is held by senior/key personnel.

 

Yale has created a web form for the public to submit written requests directly to Yale’s COI Office.  The information that Yale is required to provide includes:

  • the Investigator’s name;
  • the Investigator’s title and role with respect to the research project;
  • the name of the entity in which the significant financial interest is held;
  • the nature of the significant financial interest; and
  • the approximate dollar value of the significant financial interest (in dollar ranges, e.g., $5,000-$9,999; $10,000-$19,999)

 

What if I am not satisfied with the decision of the Provost’s Committee on Conflict of Interest and Conflict of Commitment?

If you are not satisfied with the decision of the Provost’s COIC Committee, you may contact the COIC Committee Chair to discuss your concerns and alternative solutions. You may also request that the matter be referred to the Provost for a decision. Any matter referred to the Provost in this way shall be accompanied by a written statement of the findings and recommendations of the Provost’s Committee, with copies to the individual, and the appropriate dean or department chair. The Provost will notify the individual, the Provost’s Committee, and the dean or department chair of his or her decision.

The Provost’s decision will be final, and any failure by the individual to adhere to the decision will be cause for disciplinary action, including, in severe cases, termination.

External Interest Disclosure Form Instructions

How do I submit a disclosure?

The revised Web–based Disclosure Form, which was developed with significant input from our faculty, is designed to offer a more efficient means for faculty and other research personnel to meet their obligations to disclose outside activities and financial interests. The disclosure form also incorporates the mandatory training on PHS COI regulations and Yale COI policy. You will need your Yale NetID and password to login to the Web–based Disclosure Form.

Where do I report royalty payments?

For Yale (Non-PHS, Non-NSF):

If you have royalties resulting from intellectual property, you will be asked to report them on the intellectual property page. If you receive royalties related to intellectual property, please answer in the affirmative that you do have a license agreement and you will be asked to provide further details in the intellectual property page.

For PHS & PHS-like Sponsors:

Under the PHS regulations certain royalties are subject to disclosure, as are other interests related to intellectual property.  Royalties from and agreements to share in royalties related to intellectual property rights paid to you (or to your spouse or dependent children) are covered by the regulation and are subject to the $5,000 threshold for a significant financial interest. 

Royalties you receive directly from Yale are excluded from the PHS definition of a Significant Financial Interest if you are currently employed or otherwise appointed by Yale. Unlicensed intellectual property that does not generate income is also excluded from the PHS definition of Significant Financial Interest.  Accordingly, Yale does not treat these particular interests in and of themselves as “significant.” However, depending upon certain circumstances, Yale may take intellectual property rights into consideration as a factor in determining whether or not a financial conflict of interest exists.  Also, because Yale’s Institutional Review Board (IRB) may consider intellectual property rights in its review of human research protocols and for purposes related to the protection of research participants, you should include these intellectual property interests on the Disclosure form when prompted by the appropriate question.

For NSF:

If you have royalties resulting from intellectual property, you will be asked to report them on the intellectual property page. If you receive royalties related to intellectual property, please answer in the affirmative that you do have a license agreement and you will be asked to provide further details in the intellectual property page.

For PHS & NSF:

Under the PHS regulations certain royalties are subject to disclosure, as are other interests related to intellectual property.  Royalties from and agreements to share in royalties related to intellectual property rights paid to you (or to your spouse or dependent children) are covered by the regulation and are subject to the $5,000 threshold for a significant financial interest. 

Royalties you receive directly from Yale are excluded from the PHS definition of a Significant Financial Interest if you are currently employed or otherwise appointed by Yale. Unlicensed intellectual property that does not generate income is also excluded from the PHS definition of Significant Financial Interest.  Accordingly, Yale does not treat these particular interests in and of themselves as “significant.” However, depending upon certain circumstances, Yale may take intellectual property rights into consideration as a factor in determining whether or not a financial conflict of interest exists.  Also, because Yale’s Institutional Review Board (IRB) may consider intellectual property rights in its review of human research protocols and for purposes related to the protection of research participants, you should include these intellectual property interests on the Disclosure form when prompted by the appropriate question.

What additional information should I provide if I have an interest that is valued over $100,000?

Please provide additional details about the relationship with the entity. Specific details might include the length of the relationship, contractual obligations, the level of involvement, and the compensation structure.

What is the Conflict of Interest Disclosure Form for Senior Administrators?

Certain senior, non–faculty administrators designated by the President are also required to submit annual disclosures of outside activities and financial interests. These disclosures must be prepared on the Conflict of Interest Disclosure Form for Senior Administrators and submitted to the Office of the Vice President and General Counsel. The form will be provided to those administrators who are designated to submit them.