23.01

Conduct of Research

POLICY OVERVIEW

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 for the Responsible Conduct of Research developed by the National Institutes of Health 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 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 for Research 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 the policies within Chapter 23 of the HOOP as well as the following policies, which are relevant to research activities:

• 1.04 Authority to Execute Contracts and Make Purchases
• 2.19 Conflicts of Interest and Outside Activities
• 2.48 Publication of Professional Literature and Newsletters
• 10.08 Applications or Proposals for Sponsored Project Funds.
• 10.09 Gift Funds
• 13.26 Purchase of Animals
• 13.28 Purchase of Drugs, Pharmaceuticals, and Controlled Substances
• 16.01 Accountability and Responsibility for State Property

Principal investigators who publish results of National Institutes of Health (“NIH”)-funded research or who are involved with clinical trials have additional statutory reporting requirements as noted below:

• Any article 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 articles that arise from his/her NIH-funded research.

All Phase II-IV drug and device trials must be registered by the principal investigator at ClinicalTrials.gov within 21 days of enrollment of the first participant. The principal investigator(s) must report or ensure that trial sponsors report to ClinicalTrials.gov the results of such trials for FDA-approved drugs and devices in the format and specificity required by ClinicalTrials.gov, as mandated by federal law and regulation. The principal investigator(s) must report, or ensure that the trial sponsors report to ClinicalTrials.gov, within 12 months of trial completion, or within 30 days of FDA approval, all serious or frequent adverse events as defined by federal law.

POLICY CONTACT

For questions concerning this policy, contact the Office of Research.

Created 02/1992; Updated 07/08, 05/09

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