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2-4 Investigator Financial Disclosure

December 2013

It is UCAR's policy to ensure that the integrity of the research process is not biased or compromised by conflicting financial interests of its Investigators.  UCAR requires Investigators to disclose significant financial interests that would reasonably appear to affect research or educational activities funded or proposed for funding.

To comply with these requirements, Investigators must complete and submit a Significant Financial Interests (SFI) Disclosure Form, per the Investigator Financial Disclosure Procedures.  

Submitted disclosures will be forwarded to the appropriate Reviewer (as defined in the Investigator Financial Disclosure Procedures), who may seek input from the Vice President for Finance and Administration, the Office of General Counsel and/or the Investigator, to determine whether any disclosed SFI amounts to a Financial Conflict of Interest (FCOI) under applicable regulations. 

If  an FCOI is identified, UCAR: (a) will develop and implement a plan to manage, reduce, or eliminate the conflict prior to the expenditure of any funds on the grant, cooperative agreement, or contract, and (b) will disclose the FCOI and any related management plan provisions to the extent required by applicable law.

Failure to Comply: Failure to comply with this policy shall be grounds for disciplinary action, up to and including termination of employment.

See related investigator procedures and reviewer guidelines.

Contact the Vice President for Finance and Administration for interpretation of this policy.

Affiliated Policies

2-2 Congressional and Agency Interactions and Lobbying
2-3 Conflict of Interest
2-8 Anti-Fraud
6-9 Outside Employment

 

Affiliated Procedure(s) or Guideline(s):

December 2013

Definitions

Equity: Equity includes any stock, stock option, or other ownership interest. Value of equity interests is determined through reference to public prices or other reasonable measures of fair market value.

Financial Conflict of Interest (FCOI): means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of funded research or educational activities.

Investigator: means a project director or principal investigator and any other person, regardless of title or position, responsible for the design, conduct, or reporting of funded research or educational activities (and may include collaborators or consultants).    

Institutional Responsibilities: means an Investigator’s professional responsibilities on behalf of his/her institution, including activities such as research (sponsored or unsponsored) projects, academic activities, administrative duties, scholarly events, participation on institutional committees, and service on panels, regardless of when and where the activities occur.

Significant Financial Interest (SFI): A Significant Financial Interest consists of one or more of the following interests of the Investigator (and/or the Investigator's spouse or domestic partner and dependent children) that might reasonably appear to be related to the Investigator’s Institutional Responsibilities:

1.     With regard to any publicly traded entity, a Significant Financial Interest is an aggregated value of $5,000 or more composed of any remuneration received from the entity in the 12 months preceding the disclosure plus the value of any equity interest in the entity as of the date of disclosure plus the value of any loans between the Investigator (and/or Investigator's spouse or domestic partner and dependent children) and the publicly traded entity.

2.     With regard to any non-publicly traded entity, a Significant Financial Interest exists if the Investigator (and/or Investigator's spouse or domestic partner and dependent children): (a) has received any remuneration from the entity in the 12 months preceding the disclosure, which when aggregated, exceeds $5,000; or (b) holds any Equity interest, regardless of value (e.g., any stock, stock option, or other ownership interest) in the entity; or (c) has received or provided any loan of any amount to or from the non-publicly traded entity.

3.     Any intellectual property right or interest (e.g., patent, copyright, license) from which any income has been received by the Investigator (and/or Investigator's spouse or domestic partner and dependent children).

4.     A title/position held by the Investigator (and/or Investigator's spouse or domestic partner and dependent children) as an officer or board member (governing or advisory board) in a for-profit entity, whether or not compensated.

The term “Significant Financial Interest” does not include the following, even if related to the Investigator’s Institutional Responsibilities:

  1. salary, royalties, or other remuneration paid to the Investigator by UCAR or the Subrecipient; provided that the Investigator is currently employed or otherwise appointed by the paying institution (UCAR or the Subrecipient);
  2. income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education (as defined at 20 U.S.C. 1001(a)),  an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
  3. income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education (as defined at 20 U.S.C. 1001(a)),  an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
  4. travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
  5. 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;

Reviewer: means the UCAR employee with authority to review disclosed SFI and determine whether such disclosures amount to FCOI under applicable regulations.  Depending upon the program in which the Investigator is employed (and except in those instances when the disclosing Investigator is a Lab or Program Director), the Reviewer shall be either the NCAR Lab Director or the UCAR/UCP Program Director.  In those instances in which the disclosing Investigator is the NCAR Lab Director or the UCAR/UCP Program Director, the Reviewer shall be the next higher level of authority.

In the case of proposals and/or awards involving Investigators from two or more labs or programs, the Vice President for Finance and Administration (VP F&A) along with the relevant NCAR Lab Director or UCAR/UCP Program Director will jointly determine whether or not an FCOI exists and how it will be managed, reduced, or eliminated.

 

Procedures

Investigator’s Disclosure Requirements: Investigators must complete an SFI Disclosure Form and submit the form in accordance with the following table.

 

Submission Requirements for Completed SFI Disclosure Forms

 

First form submission

 

For NSF or PHS requests for funding  (both direct and pass-through)

Prior to proposal submission, submit form to NCAR or UCP Budget Office

For other federally-funded awards (both direct and pass-through)

Prior to award acceptance, submit form to Contracts

For non-federal awards

Submit form as instructed by Contracts, at the stage required by sponsor

 

Subsequent form submissions

 

For all federally-funded awards

After award acceptance, submit form to Contracts annually

For all federally-funded awards

After award acceptance, submit form to Contracts within 30 days after a new SFI is acquired

For non-federal awards

Submit form as instructed by Contracts, at the stage required by sponsor

 

The Investigator shall use the form to disclose all SFIs (including qualifying interests of the Investigator's spouse and dependent children): (i) that would reasonably appear to be affected by the funded research or educational activities; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.

Unless disclosure is required by law or regulation, the Investigator’s SFI information will be treated as confidential and will be used by UCAR only to conduct its conflict of interest review and reporting.  

Disclosure Review and Management:

If the Investigator has no SFI, as indicated on the SFI Disclosure Form, then Contracts can proceed to finalize the award. 

If the Investigator has a SFI (as indicated on the SFI Disclosure Form), then a copy of the SFI Disclosure Form will be forwarded by Contracts to the appropriate Reviewer, who will determine whether any disclosed SFI amounts to an FCOI under applicable regulations.  In order to make the determination, the Reviewer will use the Reviewer Guidelines set forth at the end of these Procedures and/or may seek input from the VP F&A, the Office of General Counsel (OGC), and/or the Investigator to make his/her determination.

If the Reviewer determines that no FCOI exists, then the SFI Disclosure Form will be signed by the Reviewer and returned to Contracts.  Once the signed form is received by Contracts, then Contracts can proceed to finalize the award.

If the Reviewer determines that an FCOI exists, then the Reviewer is responsible for developing a plan, acceptable to both the Investigator and UCAR, to manage, reduce, or eliminate the FCOI.  The Reviewer will provide the management plan to the appropriate member of the President’s Council for review and approval.  Once the approved form and related plan are received, Contracts can proceed to finalize the award per the sponsor’s requirements. With respect to FCOI that arise during an active grant, cooperative agreement, or contract, the related management plan must be developed and implemented within sixty (60) days following the disclosure.   

Examples of conditions or restrictions that the Reviewer may choose to include in the plan to manage, reduce, or eliminate conflicts of interest include, but are not limited to:

1.     providing the public access, upon request, to information regarding SFI;

2.     for research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

3.     monitoring of research by independent reviewers;

4.     modification of the research plan;

5.     change of personnel or personnel responsibilities, or disqualification from participation in the portion of the funded research that would be affected by SFI;

6.     reduction or elimination of the Financial Interests (so that it is no longer Significant); or

7.     severance of relationships that create conflicts.

Compliance Monitoring: The Reviewer shall monitor Investigator compliance with any related management plan on an ongoing basis.

Enforcement: False reporting will be handled in accordance with the UCAR policies on Research Misconduct Ethical Conduct and Anti-Fraud.  If UCAR identifies a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by UCAR, then, the relevant Investigator may be subject to disciplinary action, up to and including termination.   Further action may also be taken on the federal level.

Investigator Appeals: The Investigator may appeal a Reviewer’s decision to the appropriate member of the President's Council.  Within fourteen (14) days of receipt of a written appeal, the President's Council member will endorse, reverse, or modify the decision and communicate that action to the Investigator and Reviewer.

Record Retention: Contracts and applicable UCAR Reviewers will maintain records of all financial disclosures and of their actions taken to review, respond to, resolve, and report conflicts of interest for three (3) years from the date that the final expenditure report has been submitted to the sponsor, or until the resolution of any sponsor action involving those records, whichever is longer.

Sponsor Reporting: In accordance with applicable sponsor requirements and federal regulations, Contracts will report FCOI and any other required information, prior to the expenditure of funds on grants, cooperative agreements, or contracts  and within sixty (60) days following the subsequent identification of any SFI that amounts to an FCOI. Additionally, Contracts will disclose the FCOI and any related management plan provisions to the extent required by applicable law.

For More Information: For more information regarding disclosure and reporting, see the following websites:  

Additional Requirements Applicable to PHS-Funded Awards: All institutions funded by an agency of the U.S. Public Health Service (PHS), including UCAR, are subject to the PHS financial conflict of interest (FCOI) regulations that took effect August 24, 2012.  See the end of these procedures for a list of PHS agencies.

Training:  The PHS regulations require PHS-funded institutions to not only create and maintain a written and enforced policy regarding the disclosure, monitoring, reporting and recording of significant financial interests, but also require FCOI training:

·      Prior to engaging in any grant, cooperative agreement, or contract funded by PHS agencies (including NIH);

·      At least every four years after initial training; and

·      When warranted by other circumstances, such as noncompliance.

UCAR’s Investigator Financial Disclosure training fulfills the requirement for FCOI training and is available via UCAR’s Skillsoft Online Training Portal at https://ucar.skillport.com/skillportfe/login.action.  Investigators are required to complete this course and repeat it every four years in order to access and maintain PHS-related award funding.

 

Subrecipients are subject to the same requirements, including training, as UCAR Investigators receiving PHS funding. The training requirement for subrecipients can be waived by UCAR Contracts, if the subrecipient can demonstrate that the training requirement has been fulfilled by other means.

 

Travel-related Significant Financial Interest (SFI): For Investigators in projects receiving funding from the U.S. PHS, any reimbursed or sponsored travel is an SFI if it is related to the Investigator’s Institutional Responsibilities and has been paid for by an entity that is not a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 2 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education (note that this exclusion does not encompass all nonprofit entities).

 

Public Access:  The new regulations require greater public accessibility to individual significant financial interest information. Institutions receiving funding from PHS agencies may decide if they will post SFI information on a publicly accessible website or make the information available upon request.


At UCAR, your SFI records will be treated in a confidential manner to the extent possible. However, SFI information that amounts to an FCOI may be disclosed to the government sponsor and will be disclosed to any requester within 5 business days of a properly written request, as required by federal and state law.

Retrospective Review Following Discovery of Noncompliance with PHS Disclosure Regulations

Public Health Service (PHS) regulations require UCAR to mitigate impact and conduct a retrospective review when it discovers that SFI has not been timely and accurately reported.  Within thirty (30) days of discovering an inaccurate disclosure, the Disclosure Review and Management process outlined above must be followed.  If any FCOI is identified, a management plan must be implemented within sixty (60) days of discovery.  In addition, whenever UCAR discovers that a FCOI related to a PHS-funded project was not identified or managed in a timely manner for any reason, including: (i) failure by the Investigator to disclose a SFI  that is determined to constitute a FCOI; (ii) failure by UCAR to review or manage such a FCOI; or (iii) failure by the Investigator to comply with a FCOI management plan, the Reviewer (who may seek input from the VP F&A, the OGC and/or the Investigator) shall, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any portion of the PHS-funded research, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.  

 

The Reviewer will document the retrospective review.  Such documentation shall include, but not necessarily be limited to, all of the following key elements:

(1) Project number;

(2) Project title;

(3) Principal Investigator;

(4) Name of the Investigator with the FCOI;

(5) Name of the entity with which the Investigator has a FCOI;

(6) Reason(s) for the retrospective review;

(7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

(8) Findings of the review; and

(9) Conclusions of the review.

 

If bias is found, the Reviewer will complete a mitigation report.   The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and UCAR's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). 

 

In creating the mitigation report, Reviewer may follow the same procedures as outlined herein for FCOI management plans.

 

Based on the results of the retrospective review, if appropriate, Contracts will update any FCOI report previously submitted to the sponsor.  If bias is found, Contracts must promptly notify the PHS awarding agency and submit the mitigation report. 


 List of PHS Agencies and Offices

 

  • National Institutes of Health (NIH)
  • Food and Drug Administration (FDA)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Agency for Healthcare Research & Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)
  • Agency for Health Care Research & Quality (AHRQ)
  • Office of Global Affairs (OGA)
  • Office of the Assistant Secretary for Preparedness and Response (OASPR)
  • Office of the Assistance Secretary for Health (OASH)


Latest Revision Log: Due to changes in Public Health Service (PHS) regulations as they pertain to Financial Interest Disclosures, UCAR has revised the Financial Disclosure Policy 2-4, Procedures, and Guidelines. The Significant Financial Interests (SFI) Disclosure Form has also been updated to meet these new requirements.

December 2013

Each financial disclosure must be evaluated by the Reviewer in order to: (1) determine if it amounts to a Significant Financial Interest (SFI); (2) determine whether the SFI is related to proposed research; and, (3) if so related, whether the SFI amounts to a Financial Conflict of Interest (FCOI). 

1.     Is the interest a SFI?
In order to evaluate whether the financial disclosure contains a SFI, compare it to the definition of a SFI in the Financial Disclosure Procedures associated with these Guidelines.

2.     Is the interest related to the proposed research? 
An Investigator’s SFI is related to the agency-funded research when the Investigator’s financial interest: (i) could be affected by the funded research; or (ii) is in an entity that could be affected by the research.  Reviewers may involve the Investigator in their determination of whether an SFI is related to the agency-sponsored research.

3.     Does the interest amount to a FCOI? 
A FCOI exists when the Reviewer reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the proposed research. 

Considering answers to the following questions can help the Reviewer determine whether the SFI could directly and significantly affect the design, conduct, or reporting of the proposed research and is, therefore, an FCOI:

Do the disclosed financial interests exceed predetermined thresholds of acceptability, where specified?

Do the Investigator's reported external commitments exceed permissible levels?

Is there any indication that research results have not been faithfully and accurately reported?

Is there any indication that the Investigator in his or her professional role has improperly favored any outside entity or appears to have incentive to do so?

Has the Investigator inappropriately represented the institution to outside entities?

Does the Investigator appear to be subject to incentives that might lead to inappropriate bias?

Is there any indication that obligations to UCAR or the sponsor are not being met?

Could the Investigator's circumstances represent any possible violation of federal, state, or local laws and requirements?

Do the current engagements of the Investigator present any conflicts between outside interests (e.g., working on projects simultaneously for competing business entities)?

Will the negotiation of relevant research affiliations or other contracts be handled by truly disinterested representatives of the institution?

Will the research work plan receive independent peer review prior to its initiation?

Are there mechanisms in place to prevent the introduction of bias into research projects?

Will the project be supervised by someone with authority and no conflicting interests?

Are there means to verify research results (e.g., independent corroboration in another lab)?

Will data and materials be shared openly with independent researchers? If not, who determines accessibility to such resources?

Will the product of the collaborative effort with an outside party be published in the peer-reviewed scientific literature?

Will the sponsorship and relevant interests receive acknowledgment in public presentations of the research results?

Affiliated Policies

2-1 Ethical Conduct
2-2 Congressional and Agency Interactions and Lobbying
2-3 Conflict of Interest
2-8 Anti-Fraud
6-9 Outside Employment

 

Latest Revision Log: Due to changes in Public Health Service (PHS) regulations as they pertain to Financial Interest Disclosures, UCAR has revised the Financial Disclosure Policy 2-4, Procedures, and Guidelines. The Significant Financial Interests (SFI) Disclosure Form has also been updated to meet these new requirements.

Last updated on December 18, 2013 - 12:43pm.
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