Frequently Asked Questions

All Investigators must disclose. This includes all Principal Investigators, Project Directors, Senior/Key Personnel, anyone listed on a grant/contact application, award, or progress report, or anyone responsible for the design, conduct, or reporting of research. 

• During the 60-day annual certification period (November 17, 2022 - January 18, 2023)
• Within 30 days of discovering or acquiring a new Signficant Financial Interest​ (e.g., through purchase, marriage, or inheritance) 
• Within 30 days of hire

All Significant Financial Interests (SFIs). SFIs include one or more of the following financial interests held by Investigators/Key Personnel, their spouse, or dependent children:​

1. Remuneration or honoraria over $5,000 from an entity within a 12-month period​ (e.g., consulting fees)
2. Ownership interests valued over $5,000 in a publicly traded entity​ (e.g., stocks)
3. Any ownership interests in a privately held entity (e.g., start-up companies, LLCs)​
4. Any intellectual property ownership, fees, or royalties​
5. Holding any management positions in a non-Emory entity within a 12-month period (e.g., director, officer, trustee, management employee)​
6. Sponsored travel over $5,000 within a 12-month period (except from Emory, U.S. government, U.S. higher ed, U.S. academic medical centers) 

The following are NOT Significant Financial Interests and do not need to be disclosed:

1. Salary or other payments for services from Emory​
2. Income from U.S. government, U.S. institutes of higher education, U.S. academic teaching hospitals and U.S. medical centers, etc. ​
3. Income from investments where individual does not control the investment vehicle (mutual funds, retirement accounts)​
4. Travel paid by Emory​
5. Gifts to Emory where Investigator/Key Person has no signing authority for the Emory account

Yes. 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 within a 12-month period.

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

• U.S. 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.

Investigators must receive COI training upon hire and every four years. This training is currently part of the eCOI system and must be completed before can submit your first disclosure. 

You will be notified when your training must be renewed.

Yes, if they are an Investigator 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.

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.

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.

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 (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 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.

Emory's. Emory has enacted a policy that is compliant with the federal regulations governing Investigator's Conflicts of Interest and will be responsible for ensuring that our Investigator's comply with the federal regulations. You would complete your disclosure in eCOI as you would for all other studies on which you are involved. Emory will be responsible for reporting any identified Financial Conflicts 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 posted on their website, your Financial Conflict of Interest information will be posted.

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.

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 Investigator is ultimately responsible for ensuring that they makes 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, no. However, when a PHS investigator has a Financial Conflict of Interest, federal regulations require Emory to provide certain information 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 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, 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 publicly available website.

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. 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. 

Federal regulations require that institutions make information related to identified financial conflicts of interest publicly accessible. Information will be available for up to three 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 made after August 24, 2012. 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 and Conflict of Commitment Office
  Emory Mailstop: 1599 -001-1BU
  1599 Clifton Road
  Atlanta, GA 30322

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. SBIR and STTR Phase I grants are exempt from 

This subpart is applicable to each Institution that is applying for, or that receives, PHS research funding by means of a grant or cooperative agreement and, through the implementation of this subpart by the Institution, to each Investigator who is planning to participate in, or is participating in, such research; provided, however, that this subpart does not apply to SBIR Program Phase I applications. In those few cases where an individual, rather than an Institution, is applying for, or receives, PHS research funding, PHS Awarding Components will make case-by-case determinations on the steps to be taken, consistent with this subpart, to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a financial conflict of interest of the individual.

PIs, 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

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.

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

No. However, you must disclose compensation earned or honoraria received over $5k 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.