Financial Conflicts of Interest in Research Procedure

This Procedure Applies To:

Texas Children's Health Plan, Texas Children's Hospital, Texas Children's Hospital Foundation, Texas Children's Insurance Company, Texas Children's Pediatrics, Texas Children's Physician Services Organization, Texas Children's Urgent Care, Texas Children's Women's Specialists, The Center for Children and Women

DEFINITIONS:

Disclosure: an Investigator’s provision of information about his/her Significant Financial Interest(s) to Texas Children’s.

Financial Conflict of Interest (FCOI): a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of the Research.

Financial Interest: anything of economic or monetary value, whether or not the value is readily ascertainable, possessed by an Investigator and/or his/her spouse or dependent child.

Institutional Official: one or more persons designated by Texas Children’s as having responsibilities and authority under this policy. For the purposes of this policy, this is the Texas Children’s Compliance Officer.

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Texas Children’s, including Research, Research consultation, professional practice and/or management duties.

Intellectual Property: know-how, designs, inventions, discoveries, concepts, developments, original compilations of information and other intellectual work product that is or may be the subject of patent, copyright, trademark protection or that may constitute a trade secret or other proprietary right or any derivative works thereof.

Investigator: any person, regardless of title or position, who shares responsibility for the design, conduct or reporting of the Research, including Principal Investigators, collaborators, study coordinators, statisticians or laboratory personnel, contractors, subcontractors, and the spouses and dependent children of such persons.

Management Plan: a written plan to address a Financial Conflict of Interest to ensure, to the extent possible, that the design, conduct and reporting of Research will be free from bias.

Principal Investigator (PI): any person with the title of “Principal Investigator” of a Research or other sponsored project or otherwise having primary responsibility for the scientific and technical conduct, reporting, fiscal and programmatic administration of a Research project.

Recipient: the entity or individual receiving a grant or cooperative agreement.

Research: a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences Research. The term encompasses basic and applied Research (e.g. a published article, book or book chapter) and product development (e.g. a diagnostic test or drug) and also includes any activity for which Public Health Service (PHS) Research funding is available.

Senior/Key Personnel: any person identified as such, including the PI, in the grant application, award, or contract or in any progress report or any other report pertaining to the Research project submitted to the PHS.

Significant Financial Interest (SFI):

(1) a Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

(i) With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the Disclosure and the value of any equity interest in the entity as of the date of Disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

(ii) With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the Disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);

(iii) Intellectual Property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or

(iv) Any donations or payments designated specifically for an Investigator, Research project or lab, without any defined project proposal.

(2) A Financial Interest created by the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities; provided, however, that this Disclosure requirement does not apply to travel that is reimbursed or 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. The Disclosure must include, at a minimum, the purpose of the trip and the identity of the sponsor/organizer. The Institutional Official will determine if further information is needed, including a determination or Disclosure of monetary value, in order to determine whether the travel constitutes an FCOI.

(3) The term Significant Financial Interest does not include the following types of Financial Interests:

  • Salary, royalties, or other remuneration paid by Texas Children’s or the Recipient to the Investigator if the Investigator is currently employed or otherwise appointed by Texas Children’s or the Recipient, including Intellectual Property rights assigned to Texas Children’s or the Recipient and agreements to share in royalties related to such rights;
  • 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;
  • 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;
  • 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.

Sponsored Research: any Research project for which an application/proposal is submitted for funding, on behalf of Texas Children’s or any of its affiliates.

Subrecipient: an entity or individual that receives funds or property in lieu of funds from a Recipient or Subrecipient pursuant to a legal instrument in exchange for performing a substantive portion of the grant-supported program or project and is accountable to the Recipient or Subrecipient for the use of the Federal funds provided under the legal instrument.

PROCEDURE


1. INVESTIGATOR RESPONSIBILITIES

Investigators are required to report to the Texas Children’s Compliance and Privacy Office, any Significant Financial Interests (SFIs) that might reasonably appear to be related to the Investigator’s Institutional Responsibilities for every Research project. Individuals should err on the side of reporting any SFI that may be related to their Institutional Responsibilities. The Texas Children’s Compliance and Privacy Office will confirm whether the interest constitutes a FCOI that must be managed, reduced, or eliminated.

1.1 All Investigators employed by a Texas Children’s entity are required to disclose SFI as
follows:

1.1.1. To the Texas Children’s Compliance and Privacy Office prior to the submission of a
proposal/application for Research funding;

1.1.2. Annually, to the Texas Children’s Compliance and Privacy Office;

1.1.3. Within 30 days of discovering or acquiring a new SFI;

1.1.4. At the time of employment by Texas Children’s or one of its affiliates; and

1.1.5. Upon direction from the Texas Children’s Compliance and Privacy Office.

1.2 All Investigators employed by Baylor College of Medicine, but who perform research at Texas Children’s, are required to disclose SFI as follows:

1.2.1. To Baylor College of Medicine Office of Research prior to the submission of a proposal/application for Research funding;

1.2.2. Annually, to the Texas Children’s Compliance and Privacy Office;

1.2.3. Within 30 days of discovering or acquiring a new SFI, to the Texas Children’s Compliance and Privacy Office; and

1.2.4. Upon direction from Baylor College of Medicine Office of Research to the Texas Children’s Compliance and Privacy Office.

1.3 Types of Financial Interests/Significant Financial Interest Thresholds

Types of Financial
Interests
Significant Financial
Interest (SFI)
Threshold
Exclusions
Any payments for services not identified
as salary, such as fees or honoraria from consulting, advisory boards, review panels, seminars, lectures or teaching
$5,000 aggregate (including all categories) from any single entity in a 12 month period Income from seminars, lectures or teaching engagement paid by a Federal, State or local government agency, institution of higher education, teaching hospital,
medical center, or a research institute affiliated with an institution of higher education
All equity interests in publicly traded entities including stock, stock options, and other ownership interests; value based on most recent public price or FMV
$5,000 aggregate (including all payments categorized elsewhere) from any single entity in a 12 month period
Mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles
All equity interests in non-publicly traded entities including stock, stock options, and other ownership interests
Any equity interest
Mutual funds and retirement accounts as long as the Investigator does not directly control the investment decisions made in these vehicles
All Intellectual Property rights including patents, copyrights, royalties, agreements to share in royalties, and milestone payments
Any royalties or milestone payments in a 12 month period
Royalties, Intellectual Property rights assigned to Texas Children’s or the Recipient, and agreements to share in royalties related to such rights, if paid by Texas Children’s or the Recipient, if the Investigator is currently employed or otherwise appointed by Texas Children’s or the Recipient
All reimbursed or sponsored Travel shall be disclosed and shall
include, at a minimum, the purpose of the trip and the identity of the sponsor/organizer.
At the discretion of the Texas Children’s Compliance Officer
None
Any donations/payments designated specifically for an Investigator
and/or Research project/lab without any defined project proposal.
$5,000 aggregate (including all categories) from any single entity within a 12 month period
Donations/payments without restriction to Texas Children’s and/or a Texas Children’s entity; excludes grant funding

1.4 Investigators must comply with any Management Plan established by the Texas Children’s Compliance and Privacy Office.

1.5 Investigators must complete FCOI training through Baylor College of Medicine Office of Research and provide Texas Children’s with evidence of completion:

1.5.1. At least every 4 years;

1.5.2. Upon hire at Texas Children’s;

1.5.3. As mandated by the Texas Children’s Compliance and Privacy Office;

1.5.4. Upon determination of non-compliance with this policy; or

1.5.5. As required by a Management Plan.

2. PRINCIPAL INVESTIGATOR/SUPERVISOR OF RESEARCH RESPONSIBILITIES
 
2.1 In addition to the responsibilities outlined for all Investigators above, Principal Investigators are required to:
 
2.1.1. Ensure the Principal Investigator and all Investigators involved in a Research project have submitted all required SFI Disclosures, including those of newly hired Investigators, prior to their participation on the Research project;
 
2.1.2. Ensure the Principal Investigator and all Investigators involved in a Research project promptly disclose any new or updated SFIs;
 
2.1.3. Ensure the Principal Investigator and all Investigators involved in a Research project have completed the FCOI training required under this policy; and
 
2.1.4. Identify the Key Personnel on a Research project upon request.
 
3. REVIEW OF DISCLOSURES
 
3.1. The Texas Children’s Compliance and Privacy Office shall review all Investigator SFI Disclosures and determine whether SFI Disclosures are related to a specific Research project. If the SFI is Research-related, the Financial Conflict of Interest (FCOI) shall be managed, reduced, or eliminated.
 
3.2. Depending on the nature of the disclosed SFI, the Texas Children’s Compliance and Privacy Office may implement additional interim measures regarding the Investigator’s participation in the Research project between the date of Disclosure and the completion of the SFI review.
 
4. MANAGEMENT OF FCOI
 
4.1. If the Texas Children’s Compliance and Privacy Office determines that a SFI Disclosure constitutes a FCOI relating to a Research project, it shall develop and implement a Management Plan specifying actions that have been or will be taken that, in the reasonable judgment of the Texas Children’s Compliance and Privacy Office, will manage, reduce or eliminate such FCOI. The Management Plan will be approved by the Texas Children’s Compliance Officer.
 
4.2. No Investigator having a FCOI may participate in the related Research project without prior written approval from the Texas Children’s Compliance and Privacy Office. A completed or updated Management Plan will generally serve as such written approval.

4.3. In developing a Management Plan, the Texas Children’s Compliance and Privacy Office may conduct factual inquiries and consult with and receive recommendations from such persons or committees as the Texas Children’s Compliance and Privacy Office deems necessary and appropriate.

4.4. The actions detailed above (Disclosure, Review of Disclosure and Management of FCOI) will be completed prior to the expenditure of any Research project funds, or within 60 days of a Disclosure of a SFI during the course of a Research project by an existing Investigator or an Investigator new to the project.

4.5. Whenever a Management Plan is implemented, Texas Children’s Compliance and Privacy Office shall take such actions as it deems reasonable to audit and/or monitor compliance with the Management Plan until the completion of the Research project or until the Management Plan is no longer required.

5. FCOI REPORTING FOR PHS-FUNDED RESEARCH

5.1. The Texas Children’s Compliance and Privacy Office will submit FCOI reports to a PHS Awarding Component:

5.1.1. Prior to expenditure of any funds under a PHS-Funded Research project, if an FCOI has not been eliminated;

5.1.2. Within 60 days of identifying an FCOI during an ongoing Research project; and

5.1.3. Annually for any FCOI previously reported in regard to an ongoing PHS-Funded Research project. The report shall specify the status of the FCOI (if the FCOI is still being managed or explain why it no longer exists) and if appropriate, any changes to the Management Plan. The report shall be submitted annually for the duration of the Research project.

5.2. Any FCOI report submitted to a PHS Awarding Component shall include the minimum elements as required by 42 CFR Part 50 Subpart F and contain sufficient information to understand the nature and extent of the financial conflict and assess the appropriateness of the Management Plan.

6. PHS-FUNDED RESEARCH THROUGH SUBRECIPIENTS

6.1. If Texas Children’s engages a Subrecipient for PHS-Funded Research, Texas Children’s will take reasonable steps to ensure that any Subrecipient Investigator complies with 42 CFR Part 50 Subpart F by incorporating the following as part of the written agreement with the Subrecipient:

6.1.1. Terms that establish whether this policy or the Subrecipient’s FCOI policy will apply to the Subrecipient Investigators;

6.1.2. If the Subrecipient Investigators will comply with the Subrecipient’s FCOI policy, the Subrecipient shall certify in the agreement that its policy complies with 42 CFR Part 50 Subpart F; and

6.1.3. Time period(s) for the Subrecipient to report all identified FCOI (if the Subrecipient’s FCOI policy applies) or for submission of all Subrecipient Investigator SFI Disclosures to the Texas Children’s Compliance and Privacy Office (if this policy applies).

7. PUBLICLY ACCESSIBLE INFORMATION

7.1. This policy shall be available on the Texas Children’s Hospital website.

7.2. For PHS-Funded Research, the Texas Children’s Compliance and Privacy Office shall make information concerning Significant Financial Interests that meet the criteria below available to the public, upon written request for such information:

7.2.1. SFI was disclosed and is still held by Senior/Key Personnel (as defined in this policy);

7.2.2. Texas Children’s Compliance and Privacy Office determined the SFI is related to a PHS-Funded Research project; and

7.2.3. Texas Children’s Compliance and Privacy Office determined the SFI constitutes a FCOI

7.3. The above information made available shall consist of the minimum elements as required by 42 CFR Part 50 Subpart F, and shall be provided by written response to the requestor within the time frame required by 42 CFR Part 50 Subpart F.

7.4. The above information shall remain available for public request for at least three years from the date that the information was most recently updated.

8. RETROSPECTIVE REVIEW OF FCOI FOR PHS-FUNDED RESEARCH

8.1. Whenever the Texas Children’s Compliance and Privacy Office identifies a SFI that was not disclosed in a timely manner or was not previously reviewed during an ongoing PHS-Funded Research project, the Texas Children’s Compliance and Privacy Office shall within 60 days:

8.1.1. Review the SFI;

8.1.2. Determine whether it is related to a PHS-Funded Research project; and

8.1.3. Determine whether a FCOI exists.

8.2. If the Texas Children’s Compliance and Privacy Office determines a FCOI exists, the Texas Children’s Compliance and Privacy Office shall implement (at least on an interim basis) a Management Plan that specifies the actions that have been taken and will be taken to manage such FCOI.

8.3. Whenever a FCOI related to a PHS-Funded Research project is not identified or managed in a timely manner due to noncompliance by the Texas Children’s Compliance and Privacy Office or an Investigator, including if an Investigator fails to comply with a Management Plan, the Texas Children’s Compliance and Privacy Office shall:

8.3.1. Notify the Compliance Officer and Vice President over Research Administration;
 
8.3.2. Within 120 days of non-compliance identification, complete and document a retrospective review of the Investigator’s activities and the Research project. Documentation of the review will include all elements as specified by 42 CFR Part 50 Subpart F;
 
8.3.3. Based on the results of the retrospective review, if appropriate, update the previously submitted FCOI report and specify the actions that will be taken to manage the FCOI moving forward;
 
8.3.4. If bias is found, notify the PHS Awarding Component promptly and develop and submit a mitigation report. The mitigation report shall consist of the minimum elements as required by 42 CFR Part 50 Subpart F; and
 
8.3.5. Submit FCOI reports to the PHS Awarding Component annually thereafter for the duration of the Research project.
 
9. VIOLATION OF POLICY SANCTIONS AND REMEDIES
 
9.1. If the Texas Children’s Compliance and Privacy Office determines an Investigator has violated this policy, including failure to submit required Disclosures or failure to comply with the requirements of a Management Plan, it shall report the violation to the Texas Children’s Compliance Officer and Vice President over Research Administration. The Compliance Officer and Vice President over Research Administration shall take reasonable steps to respond appropriately to violations, including, but not limited to:
 
9.1.1. Suspending Research activity expenditures;
 
9.1.2. Administratively suspending any Research study related to the FCOI;
 
9.1.3. Instituting disciplinary measures up to and including suspension or termination.
 
9.2. If required to do so, Texas Children’s will submit to HHS, or permit on site review of, all records pertinent to compliance with this policy and federal regulations.
 
9.3. In the case in which it is determined that a PHS-Funded Research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported, Texas Children’s shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the Research and shall request an addendum to previously published presentations.

10. RECORD RETENTION

10.1. The Texas Children’s Compliance and Privacy Office shall maintain records relating to:

10.1.1. All Investigator Disclosures of Financial Interests;

10.1.2. Its review and response to such Disclosures;

10.1.3. Actions taken under this policy or retrospective reviews.

10.2. For PHS-Funded Research, these records shall be maintained for at least three years from the date the final expenditures report is submitted to the PHS Awarding Component or as required by 45 CFR 74.53(b) and 92.42(b). For all other Research, these records shall be maintained for at least three years from the date of the final expenditures report.

REFERENCES:
Creation Date: 05/05/2016 Last Review Date: 06/29/2016 Effective Date: 06/29/2016