Frequently Asked Questions
- What is the definition of Investigator?
- Who must disclose their financial interests?
- What is meant by "Significant Financial Interest"?
- Am I required to report Significant Financial Interests that are in no way related to my research under the new regulations? research under the new regulations?
- What are "institutional responsibilities"?
- When do I have to complete my Annual Certification?
- When must a disclosure be made?
- Please explain the requirements for disclosing sponsored travel.
- How do I know when I have gone over the $5000 de minimus and must report a Significant Financial Interest?
- Am I required to disclose interests in mutual funds or retirement accounts? And how do I report the daily fluctuation in value of financial holdings such as publicly traded stock?
- How much time does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest?
- What happens if I don't provide required disclosures or reports within 30 days?
- Is any education or training for Investigators required?
- I am involved in research that receives pass-through funding (for example, funding from the National Institutes of Health to another university, then to Emory). Am I considered a Public Health Service Investigator?
- We have subcontracted a portion of our PHS-funded research to another institution. Does this policy apply to subinvestigators?
- We have received a subcontract from another institution to participate on PHS-funded research. Do we have to follow that institution's Conflict of Interest Policy instead of Emory's?
- I am a student/trainee (graduate student or post-doctoral fellow). How does this policy affect me?
- What are the consequences if I decide NOT to disclose as required by this policy?
- Are the disclosures I make available to the public?
- Is the information I enter into the eCOI system secure?
- Other Significant Contributors
The term “Investigator” always includes:
- Principal Investigator
- Project Director
- Senior or key personnel listed on a grant/contact application, award, or progress report
In addition, anyone identified by the PI or PD who is responsible for and has the authority to make independent decisions regarding the design, conduct or reporting of research meets the definition of “Investigator.”
Public Health Service regulations require that Emory provide to the public information about Senior or Key Personnel’s Financial Conflicts of the Interest related to PHS funded research; therefore, individuals listed in these roles should complete disclosures unless a waiver is approved by the Assistant Vice President for Research Administration.
Principal Investigators should be judicious in identifying senior/key personnel. Misidentifying personnel as senior/key unnecessarily increases burden for the preparation of the application, submission of Just-in-Time information and annual reporting requirements, in addition to required financial interest disclosures.
All Emory Investigators involved with research must disclose their Significant Financial Interests using the Investigator Financial Interest in Research Report component of the eCOI system.
Please note: Investigators must report Significant Financial Interests of their spouses, same-sex domestic partners, and dependent children as well as their own.
Investigators named on a proposal or subcontract who are not employed by Emory do not have access to the eCOI system. For federally funded studies they must complete the Statement of Intent to Establish a Consortium Agreement and submit it to OSP with the grant proposal. That form can be found under the Policies and Forms page of this website.
A Significant Financial Interest is a financial or fiduciary relationship with an entity related to an Investigator’s institutional responsibilities that meets the following thresholds:
- Consulting fees or honoraria from for-profit or non-profit entities that exceed $5000 during a 12 month period
- Equity interests that are valued at greater than $5000 if the equity interest is in a publicly traded entity
- Any ownership or equity interest in a privately traded entity
- A fiduciary role in a for-profit entity
- Receipt of licensing fees or royalties that exceed $5000 annually
Significant Financial Interests do not include salary support on a research grant or contract.
Income from the following is also exempt from disclosure requirements:
- federal, state or local government agencies
- US institutions of higher education
- US academic teaching hospitals
- US medical centers
- research institutes that are affiliated with a US institution of higher education
Am I required to report Significant Financial Interests that are in no way related to my research under the new regulations? research under the new regulations?
All faculty members must report their outside consulting activities as required by the Faculty Handbook.
If you are an Investigator (PI/PD, Senior or Key Personnel) on a project sponsored by the Public Health Service, you must report all Significant Financial Interests that are, in general, related to your institutional responsibilities (i.e. teaching, research, administration, and clinical duties). You should think about companies that are in the general fields of research, teaching, or scholarship and report interests that meet the threshold.
Institutional Responsibilities are defined by Emory Policy 7.7 (Policy for Investigators Holding a Financial Interest in Research) as activities related to an Investigator's Research, Teaching, Clinical, Administrative, or Professional Duties at Emory.
The Annual Certifications for all faculty members must be submitted prior to the earliest of the of the following dates:
- submission of a new research proposal
- notice of award for a new PHS-funded award or a continuing award (including subcontracts)
- submission of an annual progress report for a PHS-funded project
An Investigator has an ongoing obligation to disclose a new Significant Financial Interest within 30 days of acquisition or receipt. Previously disclosed Significant Financial Interests, such as royalty payments, may be updated at any time through the individual’s eCOI Homepage. A a new Significant Financial Interest may be added by selecting “Add New” under the appropriate category for the interest. For example, payments received for a newly licensed Intellectual Property would be added below “My Licensing fees/royalties.” When additional payments result from the license the amount previously reported can be updated by selecting “Edit” in the action column and then updating the amount received.
The value of investments, such as stock holdings, only must be updated annually with the Annual Certification, or when asked to complete the Investigator Financial Interest Related to Research Form.A new Investigator Financial Interest Related to Research Form must be completed for each year of an award. The Research Administrator or PI will edit the previously submitted Proposal Financial Interest Related Research Form, updating the Investigators for the next year at time the annual progress report is due and the eCOI system will send out notices to those investigators requesting that they complete a new form.
This requirement applies only to Investigators on projects or subcontracts funded by the Public Health Service. PHS Investigators must disclose travel reimbursed or sponsored by commercial entities as well as by non-profit entities, such as professional associations, that is more than $5000 from any single entity. PHS Investigators must report the following travel information for trips related to their Institutional Responsibilities:
- purpose of travel
Travel that is paid through a research grant or contract through Emory does not have to be disclosed, nor does travel paid for by:
- federal, state or local government agencies
- US institutions of higher education
- US medical centers
- Research institutes that are affiliated with a US institution of higher education
Sponsored travel must be reported within 30 calendar days of completion. The eCOI system allows you to enter a sponsored travel report in advance of travel. A new report can be added under “My Sponsored Travel’” found at the bottom of the Investigator’s eCOI home page
How do I know when I have gone over the $5000 de minimus and must report a Significant Financial Interest?
Earnings received from a single entity that exceed $5000 during the preceding 12 months constitute a Significant Financial Interest that must be disclosed. You are not required to report a Significant Financial Interest in advance. However, because all financial interests must be reported within 30 days of acquiring them you might want to report earnings you anticipate will exceed the threshold. Should you cross the threshold level, you won't be out of compliance if you forget to disclose them within 30 days.
Am I required to disclose interests in mutual funds or retirement accounts? And how do I report the daily fluctuation in value of financial holdings such as publicly traded stock?
As in the past, holdings in investment vehicles such as mutual funds do not need to be reported unless you directly control the investment decisions, e.g. you choose which stocks to buy or sell in the fund. Stocks held in a retirement account are reportable if you have the authority to tell your broker which stocks should be purchased or sold. Income received from dividends must be reported.
Reporting the current values of stock on your Annual Certification Form is sufficient. New purchases and other acquisitions must be reported within 30 days.
How much time does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest?
An Investigator has an ongoing obligation to disclose financial interests throughout the year. Disclosure must be made within thirty (30) days of a change in previously-disclosed financial interests or the occurrence/discovery of a new financial interest.
If you do not report a new Significant Financial Interest within 30 days, Emory must review all PHS research on which you are an investigator to determine whether an FCOI exists. If an FCOI is found the PHS research must be reviewed for potential bias. The review must be documented in accordance with PHS regulations and Emory’s policies.
Yes. Investigators must receive training about Conflict of Interest policy when they begin research at Emory and again at least every 4 years thereafter. This training is currently part of the eCOI system and must be completed before you will be allowed to submit your next Investigator Financial Interest in Research Report or Annual Certification. You will receive notice whenever your training must be renewed.
I am involved in research that receives pass-through funding (for example, funding from the National Institutes of Health to another university, then to Emory). Am I considered a Public Health Service Investigator?
Yes, in this scenario you are considered to be involved in PHS-funded research. You would be required to complete a PHS Investigator Financial Interest Related to Research Form and a PHS Annual Certification.
We have subcontracted a portion of our PHS-funded research to another institution. Does this policy apply to subinvestigators?
Possibly. For Research sponsored by the US Public Health Service that involves subcontractors, subgrantees or subawardees (collectively "Subrecipients") at other Institutions, Emory requires a written agreement from Subrecipients that establishes whether Emory's policy or the Subrecipient policy shall apply to the Subrecipient's Investigators.
- If the Subrecipient's policy is used, the Subrecipient must certify that its policy is compliant with the federal regulations and will be responsible for ensuring compliance with those regulations. Subrecipients must report any identified Financial Conflicts of Interest to Emory no later than 45 days after the conflict is identified.
- If Emory's policy is used, the Subrecipient must ensure that its Investigators submit the External Investigator Report of Financial Interests in Research to Emory at the time of application by Emory or at the time the Subrecipient signs an institutional letter of support if during an on-going award grant or contract.
In all cases, Emory must report to the PHS funding agency any Subrecipient Financial Conflicts of Interest prior to the execution of the subcontract or within 60 days of identification of a new Financial Conflict of Interest by the Subrecipient or Emory that arises during the term of the subcontract.
We have received a subcontract from another institution to participate on PHS-funded research. Do we have to follow that institution's Conflict of Interest Policy instead of Emory's?
If you are an Investigator on a research project (see FAQ #1, above), you need to submit an Investigator Financial Interest Report each year the funding is renewed.
Generally, no. If you are the PD/PI or Senior or Key Personnel on a project sponsored by the Public Health Service and Emory’s Conflict of Interest Review Committee finds that you have a Financial Conflict of Interest, federal regulations require that certain information be made available if requested. The information that Emory will provide is: the PHS Project Number, the name of the Investigator with a conflicted interest, the Investigator’s title and role with respect to that project, the nature of the financial interest (e.g. equity, consulting fee, travel reimbursement, honorarium), the value of the financial interest (in ranges) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value. The information will be sent to the requestor in a letter and you will be copied.
Please note that if you are a subcontractor on a PHS-funded activity, the Primary awarded institution could provide the above Financial Conflict of Interest information through its publically available website.
As with all information systems connected to the Internet there is no guarantee that the system can't be compromised, but there are a large number of controls in place to protect the data:
- The database resides in the HIPAA-compliant network zone so all of the network controls, including firewall and intrusion detection, are in place. As such, there is very limited access to the database server.
- All of our servers are managed by the UTS system administrator team who are professional system administrators (that's the only job) and have at least five years of experience managing systems. All individuals who manage the systems must pass a background check before employment.
- All uploaded documents are encrypted as they are stored onto the file server.
- Access to root, which is the administrator level, requires two factor authentication so individuals must know the password and have a token in their possession.
- The system is kept patched and updated. As new security patches are released, we implement them in the system.
- The application is scanned for vulnerabilities on a regular basis.
- The servers are stored in the UTS-managed facility which has 24x7 video monitoring.