Timelines for reporting under the new regulations
When do investigators need to submit? At the time a proposal for PHS funding is submitted for routing through the Office of Sponsored Programs, on or before the due date of a Progress Report/Non-Competing Continuation Proposal is due, and at the time a no-cost extension is requested or whenever a supplement is requested, which would also extend the period of performance of the project. See UMBC's procedures. Training and disclosures verifcation is required prior to award set-up.
How long does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest? Under the regulations, each Investigator must submit an updated disclosure of Significant Financial Interests within 30 days of acquiring or discovering a new Significant Financial Interest.
When do I need to start reporting sponsored travel? Investigators must disclose ALL third party sponsored reimbursed or paid travel that appears related to university responsibilities (see travel FAQ section below)
Do I still need report a conflict of interest disclosure if my proposal is not funded by PHS? Absoutely! The UMBC Policy on Individual Conflicts of Interest in Research & Product Development covers situtations such as these. The policy and forms are found here.
Am I required to take FCOI education? Yes. Investigators must receive training about the UMBC policy and procedures prior to UMBC accepting an award and intitiating the research This training has to be repeated at least every four years. Training must also be completed when UMBC revises this policy, when an individual is new to UMBC, or if UMBC finds an individual is not in compliance with the policy or an approved Conflict of Interest COI Management Plan.
Would we be able to have an educational session on the regulations at a department faculty meeting? Yes, absolutely! Let us know if you would like this, by contacting us at firstname.lastname@example.org. We also offer a series of education sessions in the ORPC conference room. Go to http://my.umbc.edu/groups/compliance/events for a schedule of presentations.
Changes in reporting thresholds
In the past, we've always had to report the significant financial interest earnings if they were above $10,000. The revised regulations now say we have to reports such earnings in the prior 12 consecutive months and/or if we anticipated such earnings in the coming 12 months. Will I need to worry about this for the $5,000 threshold? The new policies will no longer include the requirement to report earnings that are anticipated to reach the de minimus level. However, because all financial interests must be reported within 30 days of acquiring them, you may want to report anticipated earnings above the threshold, just as you have in the past. That way, you won't be out of compliance if you forget to do so within 30 days of reaching that $5,000 level.
Does the regulation require the Investigator to keep up with day-to-day changes in value of publicly traded stock or other similar interests that have fluctuating value? No. It is okay to provide current stock values on the annual disclosure submission.
Am I required to disclose interests in mutual funds or retirement accounts? Usually not. The revised regulation does not require the disclosure of income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
In the past, there were exemptions for income from most non-profit agencies. Is this still the case? The new regulations will require that you report earnings from non-profit entities and foreign entities other than federal, state, or local government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes that are affiliated with an institution of higher education if above the $5,000 limit for a 12-month period. An institute of higher education is in turn defined in the regulations 20 U.S.C. 1001(a)
In the past, UMBC asked about licensed intellectual property and about royalty income if they were above $10,000 . Has that changed? Yes, licensed intellectual property and royalty income must now be disclosed if income is above $5000 12-months from the last disclosure.
What if I have some financial interests but they are in no way related to my research. Right now, I'm not reporting those. Will I have to with the new regulations? Yes, you will need to report all significant financial interests that are in any way related to your institutional responsibilities (e.g., as a faculty member). This might include consulting, travel, earnings through stocks or royalties and speaking engagements, if they are related to your institutional responsibilities.
Retrospective Reviews of Research
The regulations state that if I don't report in a timely manner, my research may be audited? Why? The new regulations require that when there is noncompliance with reporting requirements of significant financial conflicts of interest, Public Health Service (PHS) funded research must be reviewed for potential bias in the design, conduct or reporting. So, for example, if a significant financial interest is reported outside the 30-day guideline and is found to meet the criteria of describing a financial conflict of interest, then a retrospective review of the related PHS funded research must be conducted. Retrospective reviews are also triggered if an investigator does not comply with a Conflict of Interest Management Plan.
We have to report any sponsored travel we do as related to our research or other institutional responsibilities. Really? Yes, really. Investigators must disclose ALL external entity sponsored reimbursed or paid travel that appears related to university responsibilities using the PHS Conflict of Interest Assessment Form. Travel by spouses, domestic partners, and dependent children must also be disclosed if it appears related to the investigator’s university responsibilities and reimbursement reaches this threshold .Travel information includes the purpose of the trip, the identity of the sponsor/organizer, the destination, and duration.
Travel does not have to be disclosed if reimbursed by:
- UMBC department funds;
- a grant or contract to UMBC;
- a U.S. federal, state or government agency;
- other U.S. institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with a U.S. institution of higher education.
Travel paid for by foreign institutions, such as universities and governments, must be disclosed.
What counts as travel? What if I am not staying overnight or am combining a conference with vacation? Any time you have an activity (related to your institutional responsibilities) that requires a reimbursement for your travel to get there (like a train trip or reimbursed mileage), that is reportable. If vacation is tacked on to a sponsored or reimbursed trip, only the portion of the trip paid by the external entity needs to be reported (e.g., the flights and the hotel nights they are covering).
What if I take a trip to another university to give a seminar, that university reimburses me, but the university got funding for the seminar from industry? If the reimbursement came to you from the university (not from industry) then you do not need to report it.
What if I do a talk or consulting for a non-profit? Does that travel need to be disclosed? Yes, that does need to be disclosed (unless it is a government entity or directly affiliated with an institution of higher education-see above FAQ). Note that if you receive greater than $5,000 earnings over a 12-month period, from this non-profit, then that also needs to be reported on the CoI disclosure.
last updated: 11/05/2012
Adopted from Oregon Health & Science University - Upcoming changes to the Conflict of Interest in Research Regulations : http://www.ohsu.edu/xd/research/about/integrity/coi/coir-regulation-changes.cfm