Frequently Asked Questions

All Covered Individuals, any person, regardless of title or position, who is responsible for the design, conduct or reporting of research. should disclose financial interests. It is important that anyone who is involved with the design, conduct, or reporting of any research in particular disclose their financial interests.

Principal Investigators and/or Project Directors are always subject to this requirement. In addition, this includes, but is not limited to “Covered Individuals” which  includes, but is not limited to:

1. Principal Investigators, Project Directors, Senior/Key Personnel, consultants, postdoctoral fellows, trainees, visiting scientists, and Research personnel (e.g., Research coordinators, Research nurses, etc.);
2. External Collaborating Entities/Investigators, consultants, and Subrecipients who do not have a policy compliant with 42 CFR Part 50 Subpart F or 45 CFR Part 94, as applicable;
3. Students enrolled at Emory who are responsible for the design, conduct, or reporting of Research managed by Emory under a grant or contract. A student's supervising faculty member who is in doubt about whether the student is a Covered Individual must request a determination by the COI Official

• During the 60-day annual certification period
• Within 30 days of discovering or acquiring a new Financial Interest​ (e.g., through purchase, marriage, or inheritance) 
• Within 30 days of hire

All research applications need to have an up-to-date disclosure on file. Grant proposals will not submitted if the disclosure profile is not completed and/or updated.

One or more foreign or domestic Financial Interests held by a Covered Individual or Covered Family Member that meet the following thresholds:

1. From any single, publicly traded entity: Any Remuneration (e.g., salary consulting fees, honoraria, paid authorship) or gift for services received in the preceding 12 months, and any investment interests (e.g., equity interest, stock, stock option or other ownership interest) as valued on the date of disclosure by reference to public prices or other reasonable measures of fair market value, all of which, when aggregated for the Covered Individual and Covered Family Members, exceeds $5,000;
2. From any single, non-publicly traded entity: Any Remuneration or gift for services received in the preceding 12 months, all of which, when aggregated, exceeds $5,000, or any investment interest in the entity;
3. Any intellectual property ownership, licensing fees, and/or royalties
4. Any ownership interest (e.g., stock, stock options, dividends, equity) in a privately held entity (i.e., start-up companies, LLCs) by the Covered Individual or their spouse/dependent children.
5. Holding any management or fiduciary position (e.g., director, officer, trustee, management employee, etc.) in a non-Emory entity
6. Travel valued at $5,000 or more paid directly to or on behalf of the Covered Individual.

Note: The following items are not Significant Financial Interests:

1. Salary or other payments for services from Emory University
2. Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, and a medical center, or a research institute that is affiliated with a United States institution of higher education.
3. Income from service on advisory committees or review panels for a United States federal, state, or local government agency, a United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.
4. Income from investments where the Covered Individual does not control the investment vehicle (e.g., mutual funds, retirement accounts)
5. Gifts to Emory University where the Covered Individual has no signing authority for the Emory account.
6. Travel paid by Emory or travel reimbursed or sponsored by U.S. federal, state, or local government, U.S. institution of higher education, U.S. academic teaching hospital, U.S.

Yes. Covered Individuals must disclose travel reimbursed or sponsored by an entity that is related to a Covered Individual’s institutional responsibilities and is more than $5,000 from any single entity within a 12-month period. The following information must be provided:

• Purpose of the trip
• Duration
• Identity of the sponsor/organizer
• Destination

Exceptions:
Travel that is paid through a research grant or contract through Emory does not have to be disclosed, nor does reimbursed or sponsored travel paid for by:

• A U.S. federal, state, or local government agency
• A U.S. institution of higher education
• an academic teaching hospital
•  a medical center
• A Research institute that is affiliated with a U.S. institution of higher education

Sponsored travel must be reported within 30 calendar days of completion.

Covered Individuals must receive FCOI training upon hire, prior to engaging in research, and every four years. This training must be completed prior to submitting your first disclosure profile in eDisclose. Training is currently embedded in eDisclose as part of disclosure profile update and completion.

Additional training may be required for non-compliance with with Emory’s FCOI policy or expectations.

Yes, if they meet the definition of a Covered Individual and/or are responsible for the design, conduct, or reporting of research. Trainees and postdocs are also required to obtain approval before engaging in certain external professional activities.

Stock, stock options and other ownership interests, whether currently vested or not that have an overall value of $5,000 or more need to be disclosed. However, income from investment vehicles in which the owner does not directly control the investment decisions, such as mutual funds or retirement accounts, should not be reported.

You do not need to account for daily fluctuations. Disclosing the value of stock once per year during the annual certification period is sufficient. New purchases and other acquisitions must be reported within 30 days of discovering or acquiring a new financial interest.

For Research sponsored by the U.S. 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 prior to the expenditure of funds under a new subcontract or no later than 45 days after the conflict is identified during the period of an NIH-funded award. For additional subrecipient requirements for NIH funded research, refer to NIH FAQ K.1 here - Frequently Asked Questions (FAQs) | grants.nih.gov 
• If Emory's policy is used, Emory will solicit the finaical disclosure for the PD/PI of the Subrecipient institution and any other  person who meets the regulatory definition of “Investigator” for Emory’s determination of an FCOI. The subrecipient Investigator (Covered Individual) will submit the External Investigator Report of Financial Interests in Research (PDF) 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 Public Health Service funding agency any Subrecipient Financial Conflicts of Interest prior to the expenditure of funds under 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.

Contact us at edisclose@emory.edu and we can address any questions you may have.

Emory has enacted a policy that is compliant with the federal regulations governing Investigator's Financial Conflicts of Interest and will be responsible for ensuring that our Key Personnel comply with the federal regulations. You would complete your disclosure in eDisclose as you would for all other studies on which you are involved. Emory will be responsible for reporting any identified Financial Conflict of Interest to the awardee institution. Please note that if an outside institution has a policy that requires posting of that Financial Conflict of Interest related to research at their institution be made publicly available, that would include your Financial Conflict of Interest information.

The solution is SaaS (Software as a Service). The vendor’s Data Center is located in a secured access facility and is accessible only by authorized personnel and/or contracted, authorized third party personnel. It is monitored 24 x 7 x 365 with on-site personnel and closed-circuit video surveillance.

Services provided: 

• Monitoring and management of appropriate settings, caching, diagnostic tools, and other parameters to ensure highest performance and availability.
• Professionals apply rigorous discipline and industry best practices to manage changes, updates, and patches to the production software and server.
• Monitoring and management of the database for continual best performance including allocation and management of physical space, index management, log monitoring, etc.
• Management and monitoring of storage utilization and trends as well as routine maintenance of the database.
• Redundant web application firewall and routing to prevent malicious behavior and ensure all traffic continues to occur if any point along the connection fails.
• Historic availability is 99.999% with a guarantee of 99.9%.

A broad set of physical and software security measures that ensure the protection of the solution and data from intrusion. These include the following:

• Physical & Network Security
• HIPAA/FERPA Compliance Training
• SSAE 16 (SAS 70) Compliance
• ISO27001 Certification
• Geographically Diverse Data Centers

The Covered Individual is ultimately responsible for ensuring that they make necessary disclosures to Emory required by this Policy and follow any management plan. Failure to do so shall be deemed a violation of Emory University Policy 7.7. The Investigator's department, Dean, and/or Research Compliance and Regulatory Affairs may inspect any necessary records to ensure compliance with the plan. Sanctions for non-compliance may include reprimands or other appropriate measures, up to and including termination.

Generally, disclosure of financial interests are not available to the public. However, for PHS-funded awards (e.g., NIH), the federal regulations require Emory to provide certain information, if requested, when an FCOI is identified for “Senior/Key Personnel.”  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 value of the interest 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 within five business days of the request, and you will be copied.

In all cases it is the prime Institution’s responsibility to make FCOI information publicly accessible.  However, when the subrecipient Investigator is required to comply with the subrecipient’s FCOI policy, the subrecipient Institution will also make such information publicly accessible.  Therefore, in these situations, the prime Institution may consider including the requirement for the subrecipient Institution to make FCOI information publicly available as part of the written subaward agreement.

We may be obligated to share disclosures with funding agencies, collaborators, and/or regulatory agencies (i.e.; FDA, USDA, NIH etc.) 

Earnings received from a single entity that exceed $5,000 during the preceding 12 months constitute a Significant Financial Interest. You are not required to report a Significant Financial Interest in advance of its receipt. However, because all financial interests received must be reported within 30 days of acquiring or discovering them, you might want to report earnings you anticipate will exceed the threshold to allow for an appropriate review to take place.

*Please note:

1. From any single, publicly traded business entity: A Significant Financial Interest exists if the value of any remuneration (salary, consulting fees, honoraria, paid authorship, or other payments) or gift for services received from the entity in the 12 months preceding the disclosure, and the value of any equity interest in the entity as of the date of disclosure when aggregated for the covered individual and covered family members, exceeds $5,000;
2. From any single, non-publicly traded business entity: A Significant Financial Interest is any remuneration (salary, consulting fees, honoraria, paid authorship, or other payments) or gift for services received from the entity in the 12 months prior to the disclosure, all of which, when aggregated, exceeds $5,000, and/or when the Investigator (including spouse or dependent children) holds any equity interest in the business entity (e.g., stock, stock option, or other ownership interest);

Financial Conflict of Interest refers to situations in which Emory determines that a Covered Individual or Covered Family Member’s Significant Financial Interest (SFI) is related to the Research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and the SFI could directly and significantly affect the design, conduct, or reporting of the Research.

Federal regulations require that institutions make information related to identified financial conflicts of interest of Senior/Key Personnel publicly accessible. Information will be available for up to seven years from the date the Financial Conflict of Interest (FCOI) information was last updated. Upon written request, Emory will provide written information regarding determinations of financial conflicts of interest. Please be aware that under no circumstances will Emory respond to inquiries sent via email or telephone.

Written requests must contain the following:

• The name of a specific PHS Investigator about whom information is requested;
• The project number of the study about which information is requested;
• A named recipient to receive Emory's written response;
• A return address, including a physical street address (P.O. Boxes not acceptable);
• And should be mailed to:
  
   Conflict of Interest/Conflict of Commitment (COI/COC)
   Research Compliance and Regulatory Affairs Department
   EMORY UNIVERSITY
   1599 Clifton Rd. NE, 5th Fl.
   Atlanta, GA 30322
   Mailstop: 1599-001-1BU
   Phone: 404-712-0046

If you need help finding the information necessary to complete your written request, please check the NIH e-Reporter.

Emory will send its response within five business days of its receipt of the written request. The written response will be sent of a return receipt request. Please be aware that the information provided will be current as of the date of Emory's written response. It is subject to updates at least annually and within 60 days of Emory's identification of a new financial conflict of interest. Please note that this updated information must be requested under separate cover by the requestor.

Emory will provide the following information to the requestor:

• Project Number;
• Name of the Investigator with a financial conflict of interest;
• Investigator's title and role with respect to the research project;
• Name of the entity in which the Investigator has financial interest;
• Nature of the financial interest (e.g. equity, consulting fees, travel reimbursement, honorarium); and
• 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 measures of fair market value.

Yes, you may apply for an SBIR/STTR grant if you have an SFI with the Small Business

The Conflict of Interest Office will work with the other offices on campus and will provide guidance on navigating these grants. 

Contact us at edisclose@emory.edu and we can address any questions you may have.

PIs, PDs, Sub-Investigators, Co-Investigators, Key Personnel, clinical research coordinators (CRC), clinical research nurses (CRNs), and statisticians.

Data coordinators and regulatory specialists do not need to disclose because they are not responsible for the design, conduct, or reporting of research.

Regular faculty, postdoctoral fellows or trainees, and full-time and part-time employees including staff scientists who:

• Contribute intellectually to research; or
• Design studies, collect data, conduct experiments, conduct analyses, complete reporting or dissemination activities; or
• Will receive authorship or formal attribution on resulting publication(s) or scholarly products; or
• Otherwise support the research infrastructure in a way that could influence the outcome of the research.

The following roles are NOT required to obtain prior approval:

• Staff who solely perform writing functions for which the writer does not receive authorship or formal attribution and is under the close supervision of a researcher; and
• Staff who solely perform administration functions, such as budget management or performing research administration activities
• Other staff who have no role in the research ecosystem.

Professional Activities that are based on expertise and knowledge conducted on behalf of another institution regardless of whether compensation is received.

Activities exempt from the disclosure and approval process:

• Seminars, one-off or invited lectures, service on an advisory committee, or review panel when these activities are undertaken on behalf of a U.S. federal, state, or local government, domestic institution of higher education, or a U.S. academic teaching hospital, medical center or research institute affiliated with a domestic institution of higher education. 
• Fellowships or awards managed through Emory’s Office of Sponsored Projects.
• Service to the academic or professional discipline (e.g., serving on a committee for a national scientific organization).
• Activities that are not related to specific expertise as long as commitments to Emory are not impacted.

A Conflict of Commitment is the institutional determination that an individual’s intellectual energy, time, or effort to external activities interferes with Emory responsibilities.

Conflict of Interest refers to situations in which financial or other personal considerations may compromise — or have the appearance of compromising — an investigator’s professional judgment in conducting or reporting research. A COI depends on the situation and not on the actions or character of an individual investigator.

Conflict of Commitment refers to situations where an individual's intellectual energy, time, or effort to external activities outside interferes with their responsibilities to Emory University.

Only Professional Activities that are based on expertise and knowledge conducted on behalf of another institution regardless of whether compensation is received.

Activities exempt from the disclosure and approval process:

• Seminars, one-off or invited lectures, service on an advisory committee, or review panel when these activities are undertaken on behalf of a U.S. federal, state, or local government, domestic institution of higher education, or a U.S. academic teaching hospital, medical center or research institute affiliated with a domestic institution of higher education. 
• Fellowships or awards managed through Emory’s Office of Sponsored Projects.
• Service to the academic or professional discipline (e.g., serving on a committee for a national scientific organization).
• Activities that are not related to specific expertise as long as commitments to Emory are not impacted

You must disclose compensation earned or honoraria received over $5,000 for any services (e.g., editorial) except:

• Salary, other compensation for services, or sponsored travel paid by Emory
• Income from non-promotional educational seminars, lectures, or teaching engagements sponsored and paid for by governmental entities; or
• Income from service on advisory committees or review panels established by and paid for by governmental entities.