Upcoming Changes to the Conflict of Interest in Research Regulations

The NIH has announced final revisions to the Conflict of Interest in Research regulations. The compliance date for the revised regulations is August 24, 2012. Over the next year, we will be working to revise our policies and procedures to reflect these new requirements.

How will this affect you?

What must be disclosed has changed significantly, and will include:

• all significant financial interests related to institutional responsibilities
• compensation or stock amounts greater than $ 5000
• any reimbursed or sponsored travel (excluding that sponsored by a government agency or another university)

New financial interests must be disclosed within 30 days of obtaining the financial interest.

In the event of non-compliance, a retrospective review must be completed in order to determine whether any PHS funded research conducted during the period of noncompliance was biased in the design, conduct, or reporting of such research.

Investigators must be trained on requirements every 4 years (at minimum).

No changes to disclosures need to be made at this time. Stay tuned for more information and opportunities to provide input during this process.
Read more about the updated NIH regulations taking effect August 24, 2012 and check the NIH FAQ's

Timelines for reporting under the new regulations

When do new regulations take effect at OHSU? New regulations will take effect at OHSU sometime in August 2012, coinciding with the release of the revised policies, revised electronic disclosure system (eCoI), and the Integrity Booster updates.Stay tuned for announcements in the summer.Importantly, all investigators will need to have an updated CoIR form on file by the time of their next grant award after the 8/24/12 compliance deadline.

Do I still do my conflict of interest disclosure when I get reminder notices, or should I wait until we get new instructions? Yes, file these just as you would have previously. Continue to follow the directions as they appear in the CoIR disclosures system. Also, continue to update disclosures mid-year if you develop a new financial interest that would previously have met disclosure guidelines.

We haven't been asked to update our Conflict of Interest module in Big Brain for some time. Why not?Notifications in the current CoI module in Big Brain have been turned off while the planned all-in-one CoI disclosure system (eCoI)--that will accommodate the revised CoIR regulations—is in development.If you have NEW or REVISED outside activities  to report, the existing Big Brain module is still active and should be completed as needed. (By the way, if you would like to help us test the new reporting system for conflicts of interest and outside activities, contact us at coir@ohsu.edu.)

How long does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest? Under the revised regulation, each Investigator must submit to his/her Institution an updated disclosure of Significant Financial Interests within 30 days of acquiring or discovering a new Significant Financial Interest.

When does the clock start on the 30 days? When I enter into an agreement or when I receive the payment?

Technically, the disclosure does not need to be made until the payment (if over $5000) has been received.However, you may report in advance if you choose.Note that certain outside activities (OAs) are required to be disclosed and approved in advance (such as consulting)—see guidance for Outside Activities.With the new disclosure system that will combine CoIR with the current Big Brain CoI module, receiving approval for such OAs in advance will usually satisfy the CoIR disclosure requirement as well.

When do I need to start reporting sponsored travel? Because the implementation of the revised policy at OHSU will be based upon the next grant award date after the compliance date of 8/24/12, and because travel does not need to be disclosed retrospectively, sponsored travel (see travel FAQ section below) does not need to be disclosed until the compliance date effective for you (based on either your next grant award date after 8/24/12, or your next CoIR annual due date, which ever comes soonest).

Changes in reporting thresholds

I heard that we have to start reporting earnings as soon as they hit $5,000/year now, instead of above $10,000 in the past. Is that right? Yes, this is correct, but not until the new policies take effect in August. Some important notes: The $5,000 de minimis means a monetary threshold of $5,000 and applies to the aggregated amount of any compensation received from any one entity in the twelve months preceding disclosure, including the value of any equity interest in that entity, as of the date of disclosure. Only financial interests related to institutional responsibilities (see below FAQ) need to be reported.

So far, we've always had to report the significant financial interest earnings if they were above $10,000 in the prior 12 consecutive months and/or if we anticipated such earnings in the coming 12 months. Is this still the same with 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 (See also above FAQ "when does the clock start").

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 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, OHSU asked about licensed intellectual property on the disclosure form but not specifically about royalty income.Has that changed? Yes, royalty income must now be disclosed if income is above $5000 over a 12-month period.

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.

I keep hearing the word, "institutional responsibilities." What are "institutional responsibilities?" "Institutional responsibilities" are defined by the revised regulation as an Investigator's professional responsibilities on behalf of the Institution, which may include, for example, activities such as research, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Retrospective Reviews of Research

I heard that if I don't report in a timely manner, my research may be audited? For what purpose?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 CoIR management plan.

Travel Disclosures

I am hearing that we are going to have to report any sponsored travel we do, as related to our research or other institutional responsibilities. Really? Yes, really. You will need to report all sponsored or reimbursed travel, unless it is paid by a governmental agency, another university (see above FAQ on non-profit entities qualified for exemption), or through OHSU; so, that means traveling for CME events and professional societies' meetings must be reported unless you pay for it yourself or it's paid through OHSU.Information you'll log includes purpose of travel, duration, location and sponsor. To make this as simple as possible, we anticipate that our new electronic system will allow you to enter travel occurrences as they happen (or even in advance!), without having to file a whole new CoIR disclosure. You will NOT be able to wait until the time of annual CoIR disclosure to report all the travel from the prior year because, as for other financial interests, a 30-day reporting limit is imposed.

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 pharma? If the reimbursement came to you from the university (not from pharma) 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.

Do the NIH regulations mandate any new education or training for investigators? Yes. Investigators must receive training about the CoIR policy when they begin research at OHSU and again at least every 4 years. This training will be made available through the Integrity Education Booster in the Big Brain system, and we will send you reminders when this training becomes available and when you are due for renewal.Investigators will need to complete the updated Integrity Booster training before their next grant award (after the compliance date of August 24).Additional training will also be required if noncompliance with the OHSU policies or with issued CoIR management plans are identified.

Would we be able to have an educational session on the new regulations at a department faculty meeting? Yes, absolutely! Let us know if you would like this, by contacting us at coir@ohsu.edu.