OHSU

Changes to the Conflict of Interest in Research Regulations

NIH revisions to the Conflict of Interest in Research (CoIR) regulations went into effect August 24, 2012. The related OHSU policies have revised may be reviewed on the CoI policies page.  

How will this affect you?

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

  • all significant financial interests related to institutional responsibilities
  • compensation and stock amounts greater than $ 5000
  • royalty income (including source and monetary value) must now be reported
  •  Public Health Service (PHS) funded investigators must report sponsored/reimbursed travel in some circumstances.

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

In the event of non-compliance with the new policies, 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 receive training on requirements. This is part of the updated Integrity Booster  module in Big Brain and is now live.

The new CoI reporting system, eCoI, is now live. Read the FAQs below to determine when you need to submit a new form in eCoI.

Contact us with any additional questions: coir@ohsu.edu or 503 494 7887 option #1

Timelines for reporting under the new 2012 regulations

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

How do I know when to start filing in the new system? If you have a new significant financial interest, then you need to submit a disclosure in the eCoI system. Otherwise, you will be notified to submit in one of the following ways:

  • By the eCoI disclosure system if your annual update is due; or
  • By the RGC office if you have a new grant award after the 8/24/12 compliance date but you have not yet updated your disclosure in eCoI.
  • If you are in doubt about what to do in your specific case, feel free to contact us.

As a department administrator, how can I tell if our investigators' CoIRs are up to date? There are a few ways you will be able to do this in the new system (applicable to current systems as well):

  • Have your investigators add you as their contact in the eCoI system, and then check status by searching for their names (e.g., via the Contacts Report feature).
  • Coming Soon: Request access to Big Brain as a manager for tracking compliance for your department (this requires manager approval).  If you are granted this access in Big Brain, you will be able to run a report for your ORG(s) that will give you a snapshot view of the compliance status for all (except students, which are excluded for FERPA reasons).
  • Use the ORIO compliance records tool (available on OHSU's O2to look people up individually. Note that student records are excluded.)

I'm still confused about how my funding determines when I need to file the next CoI disclosure. Let's talk about the implementation period. The NIH is allowing us to implement the regulations on a grant-by-grant basis. This is good because it means fewer investigators having to do new disclosures right away. Here's how it works: If you have a new grant award—this could be a brand new grant or a non-competing renewal or even a no-cost extension—then you do need to have a disclosure filed in the new eCoI system before that funding can be released. If this happens before your next annual CoI disclosure is due, then indeed you'd need to do a disclosure earlier than usual. After that, your next disclosure would be due in another year (unless you have a new significant financial interest or a new Outside Activity to report). So, for example if a notice of grant award (NOGA) comes in on 11/1/12, then everyone at OHSU listed on that grant would need to file a new disclosure in eCoI, even if they filed one as recently as 8/5/2012 in the previous CoIR disclosure system. But, once they've gone through this original implementation phase, then they just update as before, typically annually.

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 a financial 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, which combines CoIR with the current Big Brain CoI module, receiving approval for such OAs in advance will usually satisfy the CoIR disclosure requirement as well.

Updated 3/21/2013  When do I need to start reporting sponsored travel? First of all, you only need to disclose travel if you receive any type of PHS funding and if the amount of reimbursement from any one entity cumulatively exceeds $5,000 in a 12-month period. See further details below in the travel section of these FAQs. If you do need to report, then: 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, sponsored travel 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). At that time, you begin entering in eCoI all sponsored/reimbursed travel that occurred in the prior 12 months and that meets the criteria for required reporting.

 PHS funded researchers may use the travel reporting tool in eCoI at any time as a way to keep track of their sponsored travel as it occurs. 

When do I need to report a new project (e.g., grant or IRB study) that is related to my conflict? You can do this as soon as you know about it (even if still pending) by going into eCoI, going to the Projects Tab, and clicking on "add a project." Doing this not only alerts the CoIR Committee in a timely manner, but it also saves you time later because that information will already be recorded for you when you do your annual disclosure.Changes in OHSU's Reporting of Financial Interests in PHS-funded Research. (Note that if you do not have financial interests to report, then you also do not need to report your research projects.)

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 minimis 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 term, "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.

Changes in OHSU's Reporting of Finanacial Interests

in PHS-Funded Research

Does NIH find out what I report as financial interests? Yes, if you have are involved in a project at OHSU that has PHS funding and if the CoIR Committee has found your financial interest to constitute a Financial Conflict of Interest (FCOI). The NIH and OHSU policy defines FCOI as "a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research." In the past, for grants with an FCOI, NIH has required that OHSU report the name of the investigator with a conflict and that the conflict is being managed. With the new regulations taking effect 8/24/12, required reporting is more detailed, including the name of the entity of financial interest, the approximate monetary value and nature of the conflict (e.g., speaking, consulting, stock holdings, company founder, inventor of licensed technology), a description of how the financial interest is related to the research (e.g., consulting is on the same drug that is used in an NIH-sponsored clinical trial, a licensed technology is used in the research) and why it is believed to constitute an FCOI, and the key elements of the plan to manage the conflict (e.g., disclosure in publications, restrictions on consenting subjects or data analysis).

I heard there is a public accessibility requirement in the revised regulations. How does that work? The regulation requires that either the institution post on a website or respond to public inquiries about senior key personnel on a grant, providing in writing (within 5 business days) the investigator's title and role in research, the name of the entity of financial interest and the approximate monetary value of the interest. Note that not everyone listed on a grant is considered "senior key" personnel (e.g., graduate students).Also, this report is only required for conflicts determined to be FCoIs (See above FAQ about reporting FCOIs to NIH).

 

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. Because of the additional amount of work required to conduct such reviews, a charge to the department may result. 

Travel Disclosures

Updated 03/21/2013 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, but only if you receive any Public Health Services (PHS) grants, including NIH, CDC, HRSA, etc. and the amount of sponsored travel exceeds $5000. 

Here's how it works: PHS funded researchers are required to disclose their (and their space, registered domestic partner or dependent children) sponsored travel related to their work at OHSU that exceeds $5000 when aggregated per entity over the last 12 months. Once the $5000 threshold in value of travel from a single non-exempt entity has been reached, disclosures descriping all travel sponsored by that entity must be entered in the travel section of eCoI within 30 days of reaching that threshold.

Updated 3/21/2013 As an administrator for an investigator who does lots of traveling, can I submit his travel disclosures in eCoI, or does he have to do that himself? If you are designated as a "contact" in eCoI, then yes, you may enter the travel on his/her behalf.

Updated 03/21/2013 Do I need to report travel for university lectures or CME activities? You will need to report all sponsored or reimbursed travel that meets the $5000 threshold, 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, eCoI will allow you to enter travel occurrences as they happen (or even in advance!), without having to file a whole new CoI disclosure. You will NOT be able to wait until the time of annual CoI disclosure to report all the travel from the prior year because, as for other financial interests, a 30-day reporting limit is imposed.

Updated 03/21/2013 What counts as travel? What if I am not staying overnight or am combining a conference with vacation?Any time you I(or a spouse, registered partner or dependent child)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 it meets the $5000 threshold. 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 if it meets the $5000 threshold (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 eCoI as a significant financial interest.  

Education/Training

Do the regulations and policies change CoIR education or training for investigators? Yes. Investigators must receive training about the CoIR policy when they begin research at OHSU and again annually via the Big Brain Integrity Booster. 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.