COI News

NEW SYSTEM ENHANCEMENT:
 
Emory has long required significant financial interest disclosures to be completed at the time of project submission and each year that a research project is active.  Research administrators responsible for creating Proposal Financial Interest in Research Reports (PFIRR) in the eCOI system have long requested that the system would prompt them each year as a reminder to initiate the yearly disclosure requirement. 

In order to meet this need, a new notification was set up in eCOI last year to send automated reminders every 12 months for the research proposal's Research Administrator/Coordinator or Business Administrator, and Lead Principal Investigator to renew the Proposal Financial Interest in Research Report (PFIRR) if the award is still ongoing, or to remove it if the award is not active. This is to ensure that the PFIRR is reviewed and renewed every 12 months for ongoing awards. It will no longer be needed to create a new PFIRR form each year for the award, but to just renew the existing PFIRR that was previously submitted.  

If the award is continuing, you or the appropriate RAS staff member will need to access that PFIRR and renew or remove the appropriate report.   If the award was not funded, the form should be removed.  If the award has ended, just disregard the email and take no further action.

Please contact our office for any questions, concerns or clarifications.  Thank you!


 

Requirements for Disclosure of Other Support, Foreign Relationships and Activities, as well as Conflicts of Interest

In recent weeks, numerous reports and presentations have been published by NIH and the Director of the Office of Science and Technology Policy on principled international collaborations, protecting research against foreign influence, and ensuring the security and objectivity of research.  NIH has a website specifically addressing these issues entitled Protecting U.S. Biomedical Intellectual Innovation.  NSF has also updated the Proposal & Award Policies & Procedures Guide (PAPPG) and clarified which relationships, affiliations, and resources must be disclosed under biographical sketch and the current and pending support through a Frequently Asked Questions guide.  These reports and resources may be found at the Emory Research webpage on International Collaborations.

Emory continues to be unwavering is in its support of international collaboration with our research partners around the world.  Researchers must be fully transparent about their financial support and resources from and affiliations with international institutions and ensure that this information is updated throughout the life of a federal award.

For NIH, the disclosure of all sources of research support, prior approval of all foreign components, and appropriate reporting and management of financial conflicts of interest is required.  The attached chart is helpful in identifying the different types of disclosures and under which form disclosure is required.

Under the Emory policy, the threshold levels for FCOI reporting are:

  • $5,000 received annually, in aggregate, from for profit or non-profit (US or foreign) entities for services fees, consulting, honoraria, travel and accommodation
    • Exclusion from this requirement are:
      • Payments from the US federal, state, or local government agencies
      • Payments from US Institutions of higher education
      • Payments from US teaching hospitals
      • Payments from research institutes affiliated with US Institutions of higher education
    • Holding equity interests in a publicly traded company that exceeds $5,000 in value
    • Holding any ownership/equity interest in a privately held company
    • Holding a fiduciary role in a for profit entity
    • Licensing fees or royalties that exceed $5,000 annually

Under the Emory Faculty Handbook, all faculty are required to disclose all external activities such as consulting and advisory roles prior to engagement and obtain prior approval from your Department Chair and Dean’s Offices.    Additionally, teaching, research, or service at other institutions must also be disclosed, reviewed and approved by the Department Chair and Dean. These disclosures may be made through eCOI system, which automatically forwards the information to the Department Chair and Dean for approval.

2019 Annual Certification Forms

The Emory eCOI system is available for Emory faculty and physicians to complete their 2019 Annual Certification forms.  All regular full-time and part-time faculty members who are involved in research are required to complete and submit an Annual Certification form through the eCOI system.  In addition, all physicians who are members of Emory Healthcare must complete the Annual Certification Form, which also fulfills the requirements of the Emory Healthcare Conflict of Interest Policy.  The completion of the form is a requirement of federal regulations and Emory policies.  Faculty members and Emory Healthcare physicians at Emory must complete their forms by August 31, 2020.  Faculty members and physicians hired after August 31, 2020 must complete the Annual Certification by December 31, 2020. 

Please use Firefox or Google Chrome as the web browser for accessing the eCOI System.  Functionality and data may be lost when Internet Explorer is used.

EPA Forms

Investigators submitting grants to the US Environmental Protection Agency must submit additional forms required by the funding agency.  The forms can be found here.


Revised External Investigator Report of Financial Interests in Research Form

Please be aware there is a now a revised External Investigator Report of Financial Interests in Research form.  This form is expanded to all awards and contracts that follow the US Public Health Services (PHS) Regulations.  You can obtain this form on our website, under “Forms.”

eCOI Disclosure and Reports Processes

Please take a look at the new process flow charts for External Activites Reports (EARs) and Financial Interest in Disclosure Reports (PFIRRs). These flow charts serve as a guide to help Faculty and Staff members understand the approval process of EARs and PFIRRs after submission.

For External Activity Reports click here.

For Financial Interest in Research Disclosure click here.

Office of Compliance FDA Financial disclosure form

ORC has replaced the financial disclosure forms on the FDA regulated studies FAQ pages. For more information continue reading here for a drug study and here for a device. NOTE: The FDA financial disclosure form is different from and is in addition to any financial disclosure forms that are required by NIH.

Spotlight

NEW THIS YEAR FOR ANNUAL CERTIFICATIONS:  Due to increased scrutiny regarding international affiliations and collaborations, we are asking all federally funded investigators to report as an External Activity, any appointments at non-US academic or research institutions, as required by Faculty Handbook, Section 13.3.A., Policy Regarding Teaching, Research, and Other Service Outside the Faculty Member’s School at Emory or Other Institutions.  Faculty must report whether they are receiving research or other funding through external organizations in addition to any stipends, salary, living expenses, travel or honoraria.

Reminders:

Activities of Investigators that require disclosure include: 

  • remuneration greater than $5,000 from any US and foreign consulting relationships;
  • any ownership interest in any privately held company (e.g., in a US or foreign start-up company);
  • equity (i.e., stock holdings) greater than $5000 in any publicly traded company;
  • management/fiduciary roles in any non-Emory entities;
  • any IP Licensing fees and/or royalties greater than $5000; and
  • any sponsored travel paid by a foreign institution or government, company, or foundation that is greater than $5000.

Disclosure should be made annually, as well as within 30 days of acquiring a new financial interest. 

Investigators who are faculty with nine-month contracts or are part-time faculty must report remuneration if it meets the above criteria thresholds and is received during the previous year regardless of whether or not they are not on campus.

 

Timing:

  • For all research performed at Emory, investigators must complete Financial Interest in Research Reports for the below listed situations:
    • at time of initiation for the project
    • on an annual basis for the life of the award
    • at time of annual progress report
    • twelve months after the Notice of Award, and/or
    • twelve months after initiation of the project
  • All research projects, including clinical trials and internally funded research, require annual Investigator Financial Interest Related to Research forms. This includes No-Cost Extensions. Research Administrators and/or PIs must initiate a new Proposal Financial Interest in Research Report each year of the project in the eCOI system.
  • Only select "amend" to make changes to Proposal Financial Interest in Research Report during the last 12 months (e.g., adding new team members, change of PI).
  • Public Health Service Studies: Once TBD investigators have been identified, they must complete an Investigator Financial Interest in Research Report within 30 days.
  • COI disclosures are not needed for individuals listed as "Other Significant Contributors" unless the PI has indicated that the individuals are responsible for and has the authority to make independent decisions regarding the design, conduct or reporting of the research.
  • If you have added a project to the eCOI system that either was not funded or no longer active, please remove the Proposal Financial Interest in Research Report form from your dashboard:
    • Go to your eCOI Home page
    • Click "manage my proposals"
    • Find the report and click "remove" under proposal actions¿