Handbook of Operating Procedures

I. POLICY AND GENERAL STATEMENT

To ensure adherence to regulatory, ethical and safety standards, The University of Texas Health Science Center at Houston (“University”) has procedures for reviewing planned research, demonstration and development projects and training grants.  Proper reviews of research allow the University to maintain a safe environment, to maintain the confidence of the public, and to preserve federal and other sources of research funding.

Department chairs, deans, and other individuals in the hierarchy of each operating unit have an administrative responsibility and ethical obligation to ensure individual investigator compliance with this and related policies and procedures. Researchers who fail to comply with the review requirement or who fail to conduct research in accordance with the requirements of the applicable review committee are subject to disciplinary action up to and including termination of employment.

II. PROCEDURE

Research is subject to committee review as described below. Intellectual property matters are defined and addressed in HOOP 201, Intellectual Property.

A.      Committee for the Protection of Human Subjects

All research involving human participants must be reviewed and approved by the Committee for Protection of Human Subjects (“CPHS”) when:

• the research is conducted by any University employee, student, or resident in any facility/location (including, but not limited to, Memorial Hermann Healthcare System, Harris County Psychiatric Hospital and Harris Health System); or
• the research involves subjects/patients from any University facility (including Harris County Psychiatric Hospital).

If an activity meets the definition of research involving human subjects (see https://www.uth.edu/cphs/policies/requires-review.htm), the researcher must submit an application for CPHS review and receive approval prior to initiation of the project. Changes in approved research, during the period for which CPHS approval has already been given, may not be initiated without CPHS review and approval, except when necessary to eliminate apparent immediate hazards to the subject. The researcher must submit and receive approval from the CPHS before initiating any changes to a research study. Continuing review is required as long as the research remains active, including recruitment, enrollment, participant follow-up, and analysis of identifiable data. The researcher is responsible for the accurate documentation, investigation, follow-up and timely reporting of any problems encountered during the course of the research as outlined in CPHS policy. Researchers must submit proposals to CPHS via the iRIS system. To access CPHS policies and procedures see https://www.uth.edu/cphs/policies/. For additional information contact CPHS office at https://www.uth.edu/cphs/contact-cphs.htm

B.      Animal Welfare Committee

A research project using vertebrate animals must be reviewed and approved by the Animal Welfare Committee (“AWC”) before the project is initiated. The researcher must submit an Animal Protocol form that provides a complete description of the animal manipulations and a justification for the use of animals. Researchers who use animals must be familiar with the National Research Council’s Guide for the Care and Use of Lab Animals (current edition), the University’s Public Health Service Animal Welfare Assurance, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Federal Animal Welfare Act.  Animal Protocols can be submitted online through iRIS.

All personnel working with research animals must attend the required training courses, enroll or decline the occupational health program, and complete the Research Conflict of Interest (RCOI) certification form with financial disclosure.  No animal research protocol will be approved until the personnel requirements are completed and any applicable safety protocols (biological, chemical, radiation) are approved.

If portions of the funded research involving animals will be performed at another institution, the AWC must review and approve the Institutional Animal Care and Use protocol from the collaborating institution.  This process requires the submission of an Umbrella protocol to the AWC.  This form may also be required for the production of certain custom antibodies.  The submission form is available in iRIS.

Any changes or modifications to an approved protocol or personnel must be reviewed and approved by the AWC before they are implemented.  Proposed amendments are reviewed weekly and can be initiated by submitting a Change Request Form.

Deviations from the approved protocol, adverse events and unexpected problems must be reported to the AWC and may require reporting to the Office of Laboratory Animal Welfare.  Federal funds associated with protocol deviations must be returned to the NIH.  Significant deviations may result in the suspension of previously approved animal welfare protocols or activities.

Additional information is available on the AWC website, by email (awc@uth.tmc.edu) or by telephone (713-500-3625).

C.      Radiation Safety Committee

Before an investigator may acquire any quantity of radioactive material or any radiation-producing device for use in a research project, he or she must obtain approval from the Radiation Safety Committee. Application forms for the use of radioactive materials (benchtop, within animals, and/or human use) may be accessed via Environmental Health & Safety’s (“EHS”) website.

The forms must be submitted to EHS for initial review. EHS staff will then forward the application to the Radiation Safety Committee for consideration and approval. Refer to the Radiation Safety Manual or the Laser Safety Manual as applicable.

For additional information and assistance, contact EHS at OCB 1.330 or by telephone at 713-500-8100.

D.      Institutional Biosafety Committee

Work with infectious agents designated as requiring biosafety level 2 (BSL-2) or biosafety level 3 (BSL-3) facilities and practices, as described by the Centers for Disease Control and Prevention/National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories publication, must be registered or reviewed and approved by the Institutional Biosafety Committee ("IBC"), depending on the classification of the work according to NIH guidelines, before any procedure is initiated. The same requirements apply to work with recombinant or synthetic nucleic acid molecules, as described by the National Institutes of Health NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.  The researcher must submit forms for research procedures; information on the agent(s) to be used; and a protocol with references for the laboratory procedures to be followed when using the agent(s), including details of the containment, safe work practices, decontamination procedures, and methods for handling wastes.

Additionally, work with select agents or toxins requires additional controls and registration with either the Centers for Disease Control and Prevention or the United States Department of Agriculture prior to initiation of work.  EHS can assist with the proper designation of agent categories and appropriate application forms, including select agent registration.

EHS assists researchers with determining which agents and recombinant or synthetic nucleic acid molecules are considered to be non-exempt.

For assistance, contact EHS at OCB 1.330 or by telephone at 713-500-8100. Necessary forms can be accessed via Environmental Health & Safety’s website.

E.      Chemical Safety Committee

Any use of chemicals classified as highly toxic, carcinogenic, pyrophoric, select toxin, poison gas, antineoplastic, pesticide, explosive, or nanoparticles must be reviewed and approved by the Chemical Safety Committee before any procedure is initiated. The researcher must submit forms for research procedure; information on the chemical to be used; and a protocol with references for the laboratory procedures to be followed when using the chemical, including details of the safety practices to be followed for addressing losses of containment and methods for handling wastes.

EHS assists researchers with determining which chemicals are classified as acutely toxic and warrant committee review. For assistance, contact EHS at OCB 1.330 or by telephone at 713-500-8100. Necessary forms can be accessed via Environmental Health & Safety’s website.

F.      Research Conflicts of Interest Committee

All proposed research must include a completed Research Conflicts of Interest (“RCOI”) Certification Form for all individuals responsible for the design, conduct, or reporting of the proposed research (“covered individuals”). The Principal Investigator is responsible for ensuring that all covered individuals submit the form. The RCOI Certification Form indicates whether covered individuals have significant financial interests (defined in HOOP Policy 94 Research Conflicts of Interest) related to the proposed research. The RCOI Certification Form must be submitted with all applications to the Office of Sponsored Projects (“OSP”), the CPHS or the AWC.  In addition, all proposed research to be funded by internal funds (e.g., gifts designated for a covered individual’s research, department startup funds) must include RCOI Certification Forms for all covered individuals and must be submitted to the department, school, or other responsible area performing the funding review.

If a covered individual has a significant financial interest related to the proposed research, he/she must submit an RCOI Disclosure Form.  RCOI Disclosure Forms are submitted directly to the EVP/CAO/Conflict of Interest Program Office, which will initiate the required review.

Disclosures of significant financial interests related to proposed research will be reviewed by the RCOI Committee. The RCOI Committee advises the EVP/CAO if the significant financial interest represents a financial conflict of interest in the research and, if so, whether the conflict can be managed. The EVP/CAO makes the final decision about whether any conditions or restrictions are required to resolve or manage conflicts. The review must be completed and any required management plan implemented before any research funds may be expended.

Updated disclosures must also be submitted during an award/contract period if new reportable interests are obtained during the award period or at any time if there is a change in the financial interest or in the research. Updated disclosures must be submitted to the EVP/CAO/Conflict of Interest Program Office within 30 days of the change.

G.      Human Stem Cell Research Oversight (SCRO) Committee

All research involving human embryonic stem cells (hESCs) or human induced pluripotent stem cells (hIPSCs) conducted at the University by its employees and/or involving use of its facilities or resources must be reviewed and approved by the Human Stem Cell Research Oversight (SCRO) Committee before it is initiated. Some research involving hESCs or hIPSCs may require additional approval by the AWC, IBC and/or CPHS. For more information on the application process, please contact the SCRO office at scro@uth.tmc.edu.

H.       Institutional Anatomical Oversight Review Committee

All deceased human bodies and anatomical specimens entering, in possession of, utilized, or leaving the University must do so as part of an activity, program or protocol that is registered with the Institutional Anatomical Oversight Review Committee (“IAORC”). 

The IAORC has delegated to the Director of the Human Structure Facility (“HSF”) responsibility for reviewing and approving requests for use of anatomical specimens.  Requests must be reviewed and approved by the IAORC before specimens may be used.  The Review and Approval form used by the Office of Sponsored Projects must include the IAORC approval number.

Necessary forms and additional information are available on the IAORC website.  HSF staff members are available to assist with questions about use of anatomical material and the process of obtaining IAORC review and approval (713-500-6154).  See also HOOP 97 Deceased Human Bodies and Anatomical Specimens.

III. CONTACTS

• • Office of the Executive Vice President & Chief Academic Officer
  • 713-500-3082
  • https://www.uth.edu/index/research.htm
• • Committee for Protection of Human Subjects
  • 713-500-7943
  • cphs@uth.tmc.edu
  • https://www.uth.edu/cphs/
• • Office of Technology Management
  • 713-500-3369
  • uthsch-otm@uth.tmc.edu
  • https://www.uth.edu/otm/
• • Environmental Health & Safety
  • 713-500-8100
  • https://www.uth.edu/safety/
• • Research Conflict of Interest
  • 713-500-3082
  • https://www.uth.edu/evpara/rcoi/
• • Animal Welfare Committee
  • 713-500-3625
  • awc@uth.tmc.edu
  • https://www.uth.edu/animal-research/awc.htm
• • Human Structure Facility
  • 713-500-6154
  • https://med.uth.edu/nba/administrative/human-structure-facility/

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