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... continued from Updates from the Director

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.

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... continued from the Compliance Corner

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.

 

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