Handbook of Operating Procedures

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.

Employees may not independently conduct research for or on behalf of another entity, receive research funding or support from an outside source, or operate a lab or research facility outside of the University. 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, and all research funds must be deposited in University-approved accounts.  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:

• 20 Conflict of Interest, Conflict of Commitment and Outside Activities
• 35 Publication of Professional Literature and Newsletters
• 64 Applications or Proposals for Sponsored Project Funds
• 69 Indirect Costs
• 79 Purchase of Drugs, Pharmaceuticals, and Controlled Substances
• 84 Accountability and Responsibility for State Property
• 91 International Affiliations
• 92 Research Data Ownership, Retention and Access
• 93 Effort Certification
• 94 Research Conflicts of Interest
• 95 Research Training
• 96 Cost Transfers
• 97 Deceased Human Bodies and Anatomical Specimens
• 124 Authority to Execute Contracts and Make Purchases
• 140 Trainee Stipends
• 168 Conduct of Research
• 200 Review of Research
• 201 Intellectual Property
• 202 Research Misconduct
• 203 Gifts: Solicitation, Acceptance, Processing, Acknowledgement and Stewardship

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.
• Per section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR 11), all Applicable Clinical Trials (as defined in the Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial) must be registered by the Responsible Party (as defined in 42 CFR 11.10(a)) at ClinicalTrials.gov no later than 21 days after enrollment of the first study participant. Per FDAAA 801 and 42 CFR 11, the Responsible Party must also report study results for all Applicable Clinical Trials at ClinicalTrials.gov no later than one year after the trial's Primary Completion Date (defined in 42 CFR 11.10(a) as the date of final data collection for the primary outcome measure). If a principal investigator has initiated an Applicable Clinical Trial or is the IND/IDE holder for an Applicable Clinical Trial, then the principal investigator is the Responsible Party and will thus be responsible for registration and results reporting ((42 CFR 11.4(c)). Further, a principal investigator who conducts an NIH-funded study that meets NIH’s definition of clinical trial must register and report results of the study at ClinicalTrials.gov per NIH’s Policy on Dissemination of NIH-Funded Clinical Trial Information, regardless of whether the study meets the definition of Applicable Clinical Trial.

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

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