Financial Conflict of Interest Information
In response to a bill passed by Congress in 2011, the Public Health Service (PHS) has revised the regulations for Financial Conflict of Interest (FCOI) which went into effect on August 24, 2012. These revisions, which all institutions receiving PHS funding must adhere to, are more stringent than in past years.
The guiding principle behind this revision is intended to promote objectivity in research by defining a set of standards that provide a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from investigator (any individual responsible for the design, conduct, or reporting of research) financial conflicts of interest.
While there are a number of revisions contained in the updated federal regulations, some key changes you need to be aware of are:
- Threshold: Previously, we asked for disclosure of significant financial interests over $10,000, under the new guidelines this has been dropped to $5,000.
- Full Disclosure: Under the old system, investigators were asked to judge whether their interests were significant enough to disclose, now they are being directed to disclose all significant interests and to allow the University's representative to determine whether they are potential conflicts.
- Travel: The new system requires that sponsored travel be included in the disclosure, regardless of value. This does not, however, include travel that is included the budget for a grant, nor for travel funded by the University.
- Training: We have developed a mandatory conflict of interest training module which must be reviewed every 4 years. See the Training section below on this page to view the mandatory training video.
- Exempted Sources: Previously, all payments from non-profit organizations were exempted from disclosure. Now, only those payments from accredited institutions of higher education, government bodies and research institutions will be exempted.
- Public Accessibility: Previously, there was no requirement for making information accessible to the public. Now certain information is required to be made available to the public concerning identified FCOIs held by senior/key personnel via a written response to any requestor within five business days of a request, and update such information as specified in the rule.
As a result of these changes in the regulations, Syracuse University’s revised Policy on Financial Conflict of Interest, has been updated, and requires all investigators to file an Annual Disclosure of FCOI and to update their disclosure within 30 days of the occurrence of a new reportable financial interest(s). In order to maintain a single system of disclosure for all grant applications, Syracuse University has adopted these new standards for all researchers involved in externally funded research. More information regarding the applicability of the requirement is at the bottom of the page in addition to other useful resources.
Syracuse University's Training Plan for FCOI
The PHS Conflict of Interest regulation, as implemented by Syracuse University, requires mandatory Training for all "Investigators" meaning "the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of externally funded projects, or proposed for such funding.” Training is required prior to engaging in research related to any externally funded project and at least every four years, and immediately when any of following conditions apply: 1) The institution revises its financial conflicts of interest policies or procedures in any manner that affects the requirements of the investigators; 2) a researcher is new to the institution; or 3) when a researcher is found to be out of compliance with the regulations or with the institution's financial conflicts of interest policy or management plan.
The goal of SU’s training modules is to introduce investigators not only to the technical requirements of the policy, but to inform them about the underlying ethical questions and to show how SU’s policies and procedures address those concerns within our own context, while remaining sensitive to the privacy of investigators.Our training system is simple: investigators need to watch two training modules—which are embedded in the MySlice Significant Conflict Interests portal and can also be found directly below this text—and then certify on their disclosure that they have done so. In total, the training should take roughly 20 minutes and only needs to be repeated once every four years.
"What is the process?"
SU is pleased to announce the development of a new Financial Conflict of Interest (FCOI) portal. Our goal is to make the FCOI process as seamless and efficient as possible, while assuring compliance and achieving regulatory intent.
This collaborative effort between the Office of Research, Office of Audit and Management Advisory Services, and Information Technology & Services has resulted in the merging of the two previously disparate conflict of interest submission requirements into one single process. Both the COI questionnaire (required by SU Policy for all SU full time faculty and staff, and most part time staff) and the FCOI questionnaire (required by federal regulation and enacted in SU Policy for all *Investigators on sponsored projects) will now be accessible through the Myslice portal using the same login credentials. The submission calendars have also been aligned and will begin with the April 2013 timeframe and annually thereafter.
* Investigators include "the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of externally funded projects, or proposed for such funding.”
Where can I find more information?
If you have any questions, please call the Office of Research at x2492 or the Office of Sponsored Programs at x2807. For copies of official documents please follow these links:
- Syracuse University Policy and Procedures for Financial Conflicts of Interest (updated 8/24/2012)
- Disclosure of Significant Financial Interests (SFI) form for Investigators
- The form can be accessed via Myslice by clicking the Significant Financial Interests link under the Employee Services section.
- Public Disclosure Request Forms. This form is for outside individuals seeking information on relevant conflicts of interest involving public funds. The Office of the Vice President will reply to these requests within five working days of submission.
- Other Forms: Management Plans, Public Disclosures, PHS Report, Retrospective Review Reports, Mitigation Reports
- Outside Sources: Federal Guidelines, NIH Frequently Asked Questions (last revised May 18, 2012), Publication of Revised Regulations in the Federal Register, 8/25/2011, NIH Overview of FCOI Regulation and Changes, NIH FCOI tutorial (Note: THIS TUTORIAL IS SUPPLEMENTARY DOCUMENTATION AND DOES NOT TAKE THE PLACE OF REQUIRED TRAINING MODULES), Summary of Major Changes (.doc)