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Handbook of Operating Procedures

Conduct of Research

Policy Number: 168

Subject:

Research and research training

Scope:

Employees and students

Date Reviewed:
September 2016
Responsible Office:
Office of the Executive Vice President & Chief Academic Officer
Responsible Executive:
Executive Vice President & Chief Academic Officer

I. POLICY AND GENERAL STATEMENT

The University of Texas Health Science Center at Houston ("university") requires all research and research training conducted by its employees and students to be carried out with the highest ethical standards in accordance with the principles in the Responsible Conduct of Research developed by the National Institutes of Health ("NIH") and the Office of Research Integrity. Employees and students who engage in research must adhere to all federal, state and local statutes and regulations; to The University of Texas System Board of Regents' Rules and Regulations; and to the university's policies, regardless of whether the research is conducted on the university's campuses or at an external facility.

All proposals for sponsored research by employees or students shall be made by and through the agencies of the university and must meet all policy and procedural standards. All awards for sponsored research are made to the university.  The principal investigator(s) named in the award is authorized to administer the research funding on behalf of the university in accordance with university business procedures.

The Executive Vice President & Chief Academic Officer has been delegated authority by the President to oversee the university's research enterprise and to monitor the conduct of research for compliance with all applicable university policies, state and federal statutes and regulations, and restrictions by funding agencies.

Many of the policies in the Handbook of Operating Procedures ("HOOP") relate to the research effort. The researcher and particularly the principal investigator are required to be familiar with all of these relevant HOOP policies:

Principal investigators who publish results of NIH-funded research or who are involved with clinical trials have the following additional statutory reporting requirements:

  • Any paper describing research supported all or in part by an NIH grant must be submitted by the principal investigator to PubMed Central ("PMC") within 12 months of its publication date. Anyone submitting an application, proposal, or progress report to the NIH must include the PMC or NIH Manuscript Submission reference number when citing applicable papers that arise from his/her NIH-funded research.
  • All applicable clinical trials must be registered by the responsible party (as defined in NIH’s Elaboration of Definitions of Responsible Party and Applicable Clinical Trial) at www.ClinicalTrials.gov. When the principal investigator is the responsible party, the principal investigator must register the applicable trial at www.ClinicalTrials.gov no later than 21 days after enrollment of the first patient in the trial and must also report adverse events and study results on the timelines as described by U.S. Public Law 110-85

Faculty members and other employees who conduct or participate in sponsored research must conspicuously disclose the identity of each sponsor in any public communication that is based on the results of the sponsored research.

Failure or refusal to provide the required reporting and to abide by the principles herein places the university at considerable risk. Such failure or refusal by an employee may be cause for administrative and/or disciplinary action including, but not limited to, the suspension of all IRB approvals and research privileges and/or termination of employment.

II. CONTACTS

    • Office of the Executive Vice President & Chief Academic Officer
    • 713-500-3082
    • http://www.uth.edu/index/research.htm