(Please carefully review memo for details.)
As you know, the Public Health Service of the US Department of Health and Human Services (PHS) recently issued new regulations regarding financial conflicts of interest in research. These regulations have resulted in changes to the significant financial interest disclosure requirements for all investigators funded by PHS agencies (the largest of which is the NIH) and certain other independent sponsors of research.
Among these changes is the requirement that PHS-funded investigators disclose travel related to their institutional responsibilities when it is sponsored or reimbursed by an outside entity. The regulations did not explicitly include a disclosure threshold for sponsored/reimbursed travel. Reflecting this, the Dartmouth policy to date has been to require disclosure of all such travel. However, the NIH recently issued FAQs on this topic, indicating that a $5,000 de minimis threshold may be applied to sponsored or reimbursed travel.
Therefore, investigators will no longer be required to disclose sponsored/reimbursed travel of less than $5,000 in the aggregate from the same entity over the last 12 months, and which is not expected to exceed $5,000 in the aggregate from the same entity over the next 12 months.
The NIH has also clarified two other items regarding the disclosure of sponsored/reimbursed travel, namely that disclosures of sponsored or reimbursed travel events will now:
(1) Extend to the investigator's spouse, domestic partner, and dependent children where travel taken by these individuals is related to the investigator's institutional responsibilities, and;
(2) Include travel events meeting the above requirements that occurred over the previous 12 months (including events that occurred before the regulations went into effect on August 24, 2012).
In sum, if you are a PHS-funded investigator (or receive funding from an independent sponsor which requires adherence to the PHS conflict of interest regulations), travel which is related to your Dartmouth/D-H institutional responsibilities and which has been sponsored or reimbursed by an outside entity -- whether that travel is taken by you, your spouse/domestic partner, or your dependent child -- should be disclosed through the online COI disclosure system if the following conditions are met:
Sponsored/reimbursed travel need not be disclosed if:
a. An institution of higher education in the U.S. or a related medical center or research institute OR
b. A federal, state or local government agency.
**As a reminder, sponsored/reimbursed travel should be disclosed either before or within 30 days after a trip.**
(A) A pharmaceutical company that sponsors my research reimburses me for a trip to Scotland valued at $4,000. My spouse accompanies me on this trip, and the sponsor also reimburses me $2,000 for my spouse's airfare and meals, making the total amount of reimbursed travel $6,000. This trip needs to be disclosed.
(B) My spouse consults for a pharmaceutical company and they reimburse travel for my spouse to attend a seminar valued at more than $5,000. The seminar has nothing to do with my institutional responsibilities. I do not have any interactions with this company. This trip does not need to be disclosed.
(C) I am taking a trip to California in March 2013 to give an invited talk at a conference. My travel expenses, which will be around $3,000, will be reimbursed to me by a professional society. The same society also reimbursed me for a trip to a conference in Seattle in July 2012, for about $2500. Since the California trip will put me over the $5000 threshold for travel reimbursed by a single entity in a given 12-month period, both trips need to be disclosed.
Questions about this Notice or about the Dartmouth College Conflict of Interest Policy or procedures?
Please contact Tammy Hickox, COI Officer, at Tammy.M.Hickox@dartmouth.edu or 646-9523.
Last Updated: 4/29/13