Financial Conflicts of Interest in Research Policy

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

POLICY STATEMENT:

Texas Children’s seeks to maintain the highest standards of business conduct and ethics, and is dedicated to maintaining the integrity and credibility of Research-related activities. It is the policy of Texas Children’s that its Investigators strive to avoid Financial Conflicts of Interest or the appearance of such conflicts, and must immediately disclose any Financial Interest that is, or could be perceived to be, a Financial Conflict of Interest.

This policy addresses the responsibilities of Texas Children’s, its affiliates, and its Investigators in both safeguarding Research objectivity and complying with the requirements of all applicable state and federal regulations, including the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

No Research or technology transfer activities occurring at or on behalf of Texas Children’s shall be unduly influenced by the Financial Interests of persons involved in those activities. The Texas Children’s Compliance and Privacy Office will administer a process under which Investigators are required to disclose Financial Interests that are, or could be perceived to be, Financial Conflicts of Interest. Any Investigator having a Significant Financial Interest must disclose such interest to the Texas Children’s Compliance and Privacy Office at least annually and/or prior to participating in a Research or technology transfer activity. The Compliance and Privacy Office is responsible for reviewing Disclosures and, when required, instituting an adequate plan for the elimination, reduction or management of any identified Financial Conflicts of Interest.

This policy applies to all Investigators who:

  • Participate in Research in which Texas Children’s is the entity directly receiving the Research funding;
  • Participate in Research on Texas Children’s premises; or
  • Are employed by Texas Children’s and participate in Research anywhere.

In addition to complying with this policy, all Investigators employed by Baylor College of Medicine, and all Investigators employed by Texas Children’s with faculty appointments at Baylor College of Medicine, must also follow Baylor College of Medicine policies regarding Financial Conflicts of Interest in Research.

Public requests for information concerning PHS funded investigators who have financial conflicts of interest must be made in writing to:

Michael Gorfinkle
Assistant Director
Compliance and Privacy Office
Texas Children’s Hospital
2450 Holcombe
Suite 31G
Houston, TX 77021

The request must include the name of the investigator, the nature of the request and a return address. A written response to the person making the request will be provided within five business days from the receipt of the request in the Compliance and Privacy Office.

REFERENCES:

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