Policy Number: 168
Conduct of Research
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 for Academic and Research Affairs 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 relevant policies listed below:
- 91 International Affiliations
- 92 Research Data Retention and Access
- 93 Certifying Effort Certification Reports
- 94 Research Conflicts of Interest
- 95 Research Training
- 96 Cost Transfers
- 97 Deceased Human Bodies and Anatomical Specimens
- 140 Stipends
- 168 Conduct of Research
- 200 Review of Research
- 201 Intellectual Property
- 202 Honesty in Research
- 195 Multi-Media Creations
- 124 Authority to Execute Contracts and Make Purchases
- 20 Conflicts of Interest and Outside Activities
- 35 Publication of Professional Literature and Newsletters
- 64 Applications or Proposals for Sponsored Project Funds
- 203 Gifts: Solicitation, Acceptance, Processing, Acknowledgement and Stewardship
- 78 Purchase of Animals
- 79 Purchase of Drugs, Pharmaceuticals, and Controlled Substances
- 84 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 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.
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 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.
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