News Items

New Financial Conflict of Interest (FCOI) policy

By the end of the summer, JMU is required to develop and implement a new Financial Conflict of Interest (FCOI) policy to support a directive from the National Institutes of Health (NIH). The requirements of this NIH regulation will cause many changes in this area. On August 25, 2011, the federal Department of Health and Human Services (HHS) enacted new, more stringent rules regarding financial conflicts of interest (FCOI) in research. As implemented, the regulations will substantially impact principal investigators (PIs) on research involving the use of human subjects and sponsored research activities, who have personal financial interests in the sponsor of their research, or in companies, providing other financial support to sponsored projects.

The most significant change for PIs in the new regulation is a reduction in the monetary interest considered to be a "significant" financial interest-- from the current $10,000 threshold to $5,000 received within the past twelve (12) months. Under the new regulations, receipt of $5,000 or more from a research sponsor in consulting income, honoraria, stock or equity ownership, or personal payment of travel expenses by a sponsor will now be considered significant and require formal disclosure of the PI's interest to HHS and a FCOI management plan. Additionally, the new regulations now cover financial interests received from any source (with the exception of federal and state agencies, U.S. colleges and universities, and academic medical centers), which may relate to all professional activities of an investigator--not just his/her research-related activities. Changes include: a requirement for FCOI training prior to working on NIH funded research.

What is the most significant difference between the 1995 regulation and the 2011 revised regulation? (Institution and Investigator)
The 2011 revised regulation includes comprehensive changes, focusing on these areas in particular:

1. Definition of Significant Financial Interest
2. Extent of Investigators' disclosure of information to Institutions regarding their Significant Financial Interests;
3. Institutions' management of identified Financial Conflicts of Interest
4. Information reported to the PHS funding component (e.g., NIH);
5. Information made accessible to the public (i.e., Institutional FCOI policy and FCOIs of senior/key personnel); and
6. Investigator training.

What is a "Financial Conflict of Interest?" (Institution and Investigator)
A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator's Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.

What information must the Institution obtain from Investigators and when should it be collected? (Institution and Investigator)
Under the 2011 revised regulation, Investigators are required to disclose their Significant Financial Interests (and those of the Investigator's spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities:

1. No later than at the time of application for NIH-funded research;
2. Within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
3. At least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.

Do I need to disclose the occurrence of any reimbursed or sponsored travel related to my institutional responsibilities? (Investigator)
Yes. The regulation requires Investigators to disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator's institutional responsibilities.  However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

1. A federal, state, or local government agency,
2. an Institution of higher education as defined at 20 U.S.C. 1001(a),
3. an academic teaching hospital,
4. a medical center, or
5. a research institute that is affiliated with an Institution of higher education.

Check with your Institution's FCOI policy since it will specify the details of this disclosure, which will include, at a minimum, the following:

1. Purpose of the trip,
2. the identity of the sponsor/organizer
3. the destination, and
4. the duration.

In addition, the Institution's FCOI policy may also determine if additional information is needed, such as a determination or disclosure of monetary value, in order to determine whether the travel constitutes a Financial Conflict of Interest with the NIH-funded research.

Does an Investigator need to disclose all reimbursed or sponsored travel, no matter the dollar level, if it is reimbursed or sponsored by sources other than those excluded from disclosure (i.e., Federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education)? (Institution and Investigator)
Yes. The 2011 revised regulation does not provide a de minims threshold for the disclosure of reimbursed or sponsored travel. The 2011 revised regulation requires disclosure of basic information about such travel including at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration but not including the dollar amount. As provided in the regulation, the Institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. The regulation does not specify the process to be used by Institutions for review of Investigator travel disclosures; however, the Institution is responsible for determining whether such travel constitutes a Financial Conflict of Interest with PHS-funded research. Travel to scientific meetings and to present Investigator's research to colleagues and other interested parties is an integral part of the scientific research enterprise and affords many important opportunities for forging relationships and collaborations among researchers. The provisions in the revised regulations are not intended to discourage this type of travel but require the disclosure of the occurrence of any reimbursed or sponsored travel related to the Investigator's institutional responsibilities provided the travel is not sponsored or reimbursed by those identified sources excluded in the final rule.

Is an Investigator required to disclose remuneration received in excess of $5,000 from an outside entity for services performed (e.g., data analysis) when the payment is made directly to the Investigator’s Institution. (Institution and Investigator)
No. Since the payment for services is paid to the Institution, Investigator disclosure is not required. However, if payment for services is paid directly to the Investigator, the remuneration must be disclosed by the Investigator, no matter if the Investigator turns the money over to the Institution or if the money will be used to support the Investigator's future research activities.

Does the regulation require Investigator training? (Institution and Investigator)
Yes. Each Investigator (as defined by the regulation), including sub-recipient Investigator(s), must complete training prior to engaging in NIH-funded research and at least every four years, and immediately under the designated circumstances:

1. Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
2. An Investigator is new to an Institution
3. An Institution finds that an Investigator is not in compliance with the Institution's Financial Conflict of Interest policy or management plan.

While JMU is still developing our internal policy, the NIH policy can be accessed at: http://grants.nih.gov/grants/policy/coi/index.htm.

NIH has also posted useful Frequently Asked Questions at: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm.

We will keep you apprised of our progress in meeting this regulation and we appreciate your cooperation with a successful implementation of this Federal mandate.

COS Pivot is replacing COS funding Opps

COS Funding Opportunities on the COS.com platform will be retiring within the next few weeks. The Office of Sponsored Programs encourages users to become familiar with COS Pivot, prior to the cos.com shut-down to allow ample time to become accustomed to the new features and functionality of Pivot, while being able to continue to use the current Funding Opps product during this transition.

Everyone should start going to the new URL: http://pivot.cos.com. If you do not have an account, you can create one at the Pivot url below, but you must use your JMU email address to be verified.

Users' log ins will not be affected by the change. If you currently have an account, that username/password will work in Pivot. You can link to this page: http://pivot.cos.com/support which has a plethora of materials for users.

In the next few days, you'll notice several NEW enhancements to Pivot including:

Tracked Opp Updates

Pivot users will receive an "opp updated email" if the opp they are tracking (on their Tracked or Active list) was updated by a Pivot Admin--in addition to updates provided by the Pivot funding editors. Updates by the admin that would trigger the update email include adding a note or message to a funding opportunity, updating or creating an internal deadline info for an opp, or indicating if your university has been invited to submit a proposal for a particular funding opportunity.

New Funding Opps Export Option

You will be able to export funding opportunities as an Excel csv (comma separated value) in addition to the other formats already available (HTML, ASCII, and tagged text).

April Pivot Webinars Added

As always, don't forget to take advantage of the end-user training available to you. The end-user training can be found here: https://refworks.webex.com/refworks/onstage/g.php?p=4&t=m

Pivot User Tip

Did you know that when you search for a term in the Profiles area, you're not only searching the content of all profiles, but any web content within those profiles? Any URL listed in the Web section of the profile is indexed and searched when you run a Pivot profile search. Web page information is also used by the Pivot Advisor when recommending funding.

 

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