FAQs

  1. When did the new PHS FCOI regulation go into effect?
  2. What are the major changes to the FCOI policy?
  3. What PHS-funded agencies and offices are covered under the new FCOI policy?
  4. Can I submit a proposal prior to completing the Financial Disclosure Form (FDF)?
  5. Where and when do I submit my Financial Disclosure Form?
  6. What if I don’t have any new SFIs since I last completed a disclosure form?
  7. Do I have to complete my FCOI CITI training prior to submitting a proposal?
  8. I already completed my CITI training, why am I being asked to take it again?
  9. Where are the Financial Disclosure Forms stored and who has access to view the information?
  10. What happens if a disclosure is not made in a timely fashion?
  11. What is excluded from the reporting requirements?
  12. How long do I have to disclose a newly acquired SFI?
  13. If I have submitted my FDF within the past 365 days, I’m current, correct?
  14. Who is considered an Investigator under this new policy?
  15. I’m a PI on an NIH award, and we are anticipating a new Investigator participating in the project in Year 2.  What do I need to do?
  16. I will be collaborating with sub recipients/consultants that may not have a PHS FCOI compliant policy.  What should I do?
  17. Are post docs and grad students covered by the new regulation?
  18. I have a PHS funded contract, not a grant. Do I still need to follow these rules?
  19. Where can I get additional information?

 

1. When did the new PHS FCOI regulation go into effect?

The new regulation went into effect on August 24, 2012 and applies to all Investigators on new awards, new proposals, non-competing renewals, and no costs extensions received or submitted after the due date.

2. What are the major changes to the FCOI policy?

  • Lower financial disclosure thresholds – PHS-funded faculty are required to disclose any SFIs that, when aggregated, exceed $5,000.
  • New conflict of interest training - PHS-funded faculty are required to undergo training before spending funds from a PHS agency, every four years and upon changes to GW’s policy.
  • New public accessibility requirements – GW is required to respond to requests regarding faculty with FCOIs on PHs-funded awards within 5 business days.
  • Increased transparency for travel reimbursement – Sponsored travel means travel that is paid on behalf of the Investigator and not reimbursed to the Investigator (so that the exact monetary amount may not be readily determined).  The disclosure of reimbursed or sponsored travel must include, at a minimum, the purpose of the trip, the identity of the sponsor/organization, the destination, and the duration.  

3. What PHS-funded agencies and offices are covered under the new FCOI policy?

All PHS funded agencies and offices are covered under the new FCOI policy. Below is a list of the 8 agencies and 3 offices that are PHS-funded. Each link will take you to the agency or office’s website, where you can find a list of all centers, institutes and sub-offices that are also covered.

Agencies

Offices

In addition to the above, several non-federal entities have also elected to routinely include PHS FCOI terms and conditions in their awards.  Please review all award terms and conditions carefully to ensure you are following the sponsor’s expectations.  For a complete and current list of federal agencies and non-federal entities that follow PHS FCOI regulations, please refer to the Federal Demonstration Partnership Website located here.

4. Can I submit a proposal prior to completing the Financial Disclosure Form (FDF)?

No. The federal regulation and GW policy requires that you submit a Financial Disclosure Form prior to the submission of any award. There must be updated disclosures on file for all persons responsible for the design, conduct or reporting of research on the proposal.

5. Where and when do I submit my Financial Disclosure Form?

Financial Disclosure Forms should be submitted to [email protected] prior to the submission of a proposal. An OVPR research compliance administrator will check to ensure that the necessary disclosure forms are on file. Investigators are encouraged to complete and submit the forms as early in the proposal stage as possible in order to expedite the routing process.

In the event that the proposal is funded, disclosures for all Investigators on the project will be reviewed by Investigator’s Dean (or designee) and completion of the CITI FCOI training module for each Investigator will be verified prior to permitting any spending on the award.

6. What if I don’t have any new SFIs since I last completed a disclosure form?

If you do not have any SFIs since your last disclosure and your last disclosure has been within 365 days, you do not need to submit a new disclosure at this time. However, if your last disclosure has been over 365 days, you will need to submit a new disclosure to [email protected], even if you do not have any new SFIs to report.

7. Do I have to complete my FCOI CITI training prior to submitting a proposal?

No.  However, it is in your best interest to complete the FCOI CITI training as soon as possible as to not delay processing once the proposal is awarded.

8. I already completed my CITI training, why am I being asked to take it again?

Often Investigators take IRB or other modules of training within CITI and mistakenly believe they have completed the FCOI CITI training module.  The FCOI training is a separate module within CITI, is four questions long, and is good for four (4) years.  Please ensure you are taking the FCOI module to fulfill this requirement.

9. Where are the Financial Disclosure Forms stored and who has access to view the information?

In order to protect the privacy of Investigators, there is a controlled and limited number of people who have access to the Financial Disclosure Forms. Financial Disclosure Forms are stored in a database that can only be accessed by the OVPR’s research compliance administrators, finance director of the investigator’s school, and dean/dean’s designee.  If you are an Investigator and would like access to your disclosure forms, please contact [email protected].

10. What happens if a disclosure is not made in a timely fashion?

In cases of non-compliance related to PHS-funded awards, GW is required to conduct a retrospective review of the Investigator’s activities and determine whether the research or scholarly activity, or any portion thereof, conducted during the time period of noncompliance, was biased in design, conduct, or reporting.

11. What is excluded from the reporting requirements?

Compensation from the following entities does not need to be disclosed: Federal, state, or local government agencies, institutions of higher education as defined at 20 U.S.C. 1001(a), academic teaching hospitals, medical centers, or research institutes that are affiliated with an institution of higher education.

12. How long do I have to disclose a newly acquired SFI?

You must disclose a new SFI within 30 days of performing the new activity, acquiring the new interest, or discovering one that was not disclosed in a timely fashion. If any of your prior disclosures change you must update the change within 30 days. For example, if you acquire stock that, when aggregate, now puts you over the $5,000 reporting threshold, you must update your disclosure form within 30 days.

13. If I have submitted my FDF within the past 365 days, I’m current, correct?

Maybe.  As an Investigator participating in PHS funded research, you are required to update your Financial Disclosure Form every 365 days, or within 30 days of acquiring a new Significant Financial Interest (see Question #9).  Please refer to the GW’s Policy on Conflicts of Interest and Commitment for Faculty and Investigators for more information.

14. Who is considered an Investigator under this new policy?

Under 42 CFR Part 50, an Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research on the PHS funded award, or proposed for such funding, which may include, for example, collaborators or consultants.

15. I’m a PI on an NIH award, and we are anticipating a new Investigator participating in the project in Year 2.  What do I need to do?

All new Investigators to the University are required to complete the FCOI CITI training and submit a Financial Disclosure Form to [email protected] prior to engaging in PHS funded research.  Please notify [email protected] immediately if there will be a new Investigator working on your project, and ensure that forms and training are completed in a timely manner as to not delay the start of any Investigator participating on the PHS funded project.

16. I will be collaborating with sub recipients/consultants that may not have a PHS FCOI compliant policy.  What should I do?

If a sub recipient or consultant does not have a PHS FCOI compliant policy, they must comply with GW’s policy.  They will go through the same process that GW Investigator’s must follow (i.e. submitting Financial Disclosure Forms to [email protected], providing proof of CITI FCOI training completion, review by the Dean or Dean’s designee, etc.).  Collaborators that have a PHS FCOI compliant policy (for full list, click here) they will follow For more information on this process, please contact [email protected].

17. Are post docs and grad students covered by the new regulation?

Yes, if the postdoc or grad student meets the definition of “Investigator” (see Question #13). 

18. I have a PHS funded contract, not a grant.  Do I still need to follow these rules?

Yes! PHS funded contracts are subject to the same FCOI requirements as financial assistance awards per 45 CFR part 94

19. Where can I get additional information?

For additional Frequently Asked Questions maintained by the National Institutes of Health, see this page.